12/21/2020

• • Congressional leaders on Sunday reached a hard-fought agreement on a $900 billion stimulus package that would fund the distribution of vaccines and send immediate aid to Americans and businesses to help them cope with the economic devastation of the pandemic.
  • NIH Director Dr. Anthony Fauci and HHS Sec. Alex Azar will be vaccinated on Tuesday morning during an event at NIH in Bethesda, Maryland.
  • The Advisory Committee on Immunization Practices, an expert panel which advises the CDC, said in a meeting today that adults over 75 and frontline essential workers should be in second Covid-19 vaccine priority group.
    • The committee also voted to recommend that the third stage of the national vaccination program focus on adults 65 to 74, people 16 to 64 years old with high-risk medical conditions, and essential workers not included in the second phase.
    • Find slides from the meeting here.
  • Rep.-elect Luke Letlow (R-LA) has been hospitalized after testing positive for COVID-19 on Friday.
  • Virginia and Maryland are each sending 8,000 extra COVID-19 vaccine doses from their own supply to D.C. as the city scrambles to inoculate health care workers amid the worsening pandemic. Under the current distribution formula, which is based on residency, D.C. received 6,825 doses of the Pfizer-BioNTech vaccine — a figure Mayor Muriel Bowser said would cover less than a tenth of the city's health care workers who are first in line to receive the vaccine.
  • The NIH announced last Thursday that it has begun two Phase 3 clinical trials evaluating investigational monoclonal antibody therapeutics for people hospitalized with COVID-19.
  • • The trials are part of the ACTIV-3 master protocol, which is sponsored by the National Institute of Allergy and Infection Diseases (NIAID)
  • On Friday, the FDA approved Moderna’s COVID-19 vaccine for EUA. The vaccine requires two doses like the Pfizer-BioNTech vaccine, but it does not require ultracold storage.
  • • Roughly 6 million doses of the vaccine will be shipped to more than 3,700 locations around the country this week, adding to the nearly 3 million doses of the Pfizer-BioNTech vaccine that were dispatched mostly to health care workers starting last week.
    • Health care workers at the East Boston Neighborhood Health Center were among the first people to receive Moderna's vaccine on Monday.
  • OWS estimates there will be enough vaccine doses available to vaccinate 20 million people in December, 30 million in January, and 50 million by the end of February.
  • President-elect Joe Biden received the coronavirus vaccine on live television on Monday at the Christiana Hospital in Newark, Del., sending a message to Americans across the country that the vaccine is safe to take. Vice President Mike Pence, House Speaker Nancy Pelosi and Senate Majority Leader Mitch McConnell all received the first dose of the vaccine on Friday.
  • The CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on its dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
    • • Holiday Celebrations and Small Gatherings
      • Operational Considerations for Schools
      • Guidance for K-12 School Administrators on the Use of Masks in Schools
      • Understanding mRNA COVID-19 Vaccines

12/18/2020

• • The FDA has authorized the first at-home COVID-19 test that doesn't require a prescription and provides results within 20 minutes. The Ellume COVID-19 Home Test is an NIH-funded antigen test that detects fragments of proteins from the SARS-CoV-2 virus on a nasal swab and then reports results to your phone. The company says it will deliver 20 million at-home tests, which are manufactured in Australia, to the U.S. in the first half of 2021.
  • The FDA has also granted EUA to Abbott for at-home use of its BinaxNOW rapid test, which it says can deliver “results in minutes.” The test will cost about $25 – the lowest available price for at-home testing – and will become more widely available in 2021, Abbott said. Thirty million tests should be available in the first quarter of 2021 and another 90 million in the second quarter.
  • Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an EUA. The agency has also notified the CDC and OWS, so they can execute their plans for timely vaccine distribution.
  • HHS and CDC said they will award $140 million for COVID-19 vaccine preparedness and almost $87 million for tracking and testing to 64 jurisdictions, including all 50 states and U.S. territories.
  • HRSA announced it has completed review of Phase 3 applications from the Provider Relief Fund (PRF) program and will distribute $24.5 billion to over 70,000 providers. Up from the $20 billion originally planned, the addition of another $4.5 billion in funding is being used to help with each applicant’s reported lost revenues and net change in expenses caused by the coronavirus pandemic in the first half of 2020.
  • The latest NIH Director's Blog talks about the new HHS/NIH/OWS website called Combat COVID.
  • The most recent COVID-19 Science Update from the CDC is here.
  • The CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on their dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
  • • Holiday Celebrations and Small Gatherings
    • Operational Considerations for Schools
    • Guidance for K-12 School Administrators on the Use of Masks in Schools
    • Understanding mRNA COVID-19 Vaccines
  • As of today, 304 tests and sample collection devices are authorized by FDA under EUAs; these include 232 molecular tests and sample collection devices, 62 antibody tests, and 10 antigen tests.
  • Vice President Pence led a discussion with the chief executives and senior leaders of approximately 50 states, territories, and the White House Coronavirus Task Force to discuss local, state, and federal COVID-19 response and recovery efforts including the continued collaboration on vaccine distribution and administration planning and execution. View a readout here.
  • The ACL and CMS host a monthly webinar series that invites subject matter experts and practitioners from across the home-and-community-based services (HCBS) spectrum to share insights and best practices to develop high quality HCBS services and programs. Next month's webinar will be, "Reducing Food Insecurity and Nutrition-Related Chronic Diseases During COVID Among Medicaid HCBS Beneficiaries."
  • Reps. Barry Loudermilk (R-GA), Mike Rogers (R-AK), Cedric Richmond (D-LA), and Joe Wilson (R-SC), and Interior Sec. David Bernhardt have all tested positive for COVID-19.
  • Vice President Pence and Second Lady Karen Pence will publicly receive the COVID-19 vaccine on Friday.
  • The question of supplemental COVID-19 funding has shifted from an "if" to a "when". The few remaining sticking points are expected to be ironed out in the next few days. While a bipartisan coalition of lawmakers released text of two proposals on Monday, leadership has continued to negotiate adjust the package. Attached here is the text for the $748 billion proposal that includes another round of Paycheck Protection Program assistance for small businesses, an unemployment benefit, and more money for schools, vaccine distribution and other widely agreed-upon items. Attached here is a section-by-section summary of the $748 billion proposal. Attached here is the text for the $160 billion proposal that ties together funding for state and local governments and protections for businesses from coronavirus-related lawsuits. For more detail on the legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update.

Previous Updates

• On Dec. 11, the FDA issued the first EUA for a COVID-19 vaccine. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. The Agency has said the totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.
  • If you have questions about the Pfizer vaccine or about getting vaccinated, try What to Expect after Getting a COVID-19 Vaccine, What to Expect at Your Appointment to Get Vaccinated for COVID-19, When Vaccine is Limited, Who Gets Vaccinated First?, or general COVID-19 vaccine information from the CDC.
  • Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the vaccine.
• The FDA held a virtual press conference to announce the COVID-19 vaccine EUA on Dec. 12. You can view it here.
• CDC's MMWR published ACIP's interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine.
• The CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on their dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
  • Holiday Celebrations and Small Gatherings
  • Support for Teens and Young Adults
  • General Business Frequently Asked Questions
  • Considerations for Communities of Faith
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• HHS and DoD said they will purchase an additional 100 million doses of a COVID-19 vaccine from Moderna if their vaccine candidate receives EUA from the FDA.
• The NIH announced that an NIAID-funded study found the combination of baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, reduced time to recovery for people hospitalized with COVID-19. The clinical trial results were published in the New England Journal of Medicine.
  • The COVID-19 Treatment Guidelines Panel’s Statement on the EUA of Baricitinib for the treatment of COVID-19 is here.
• NIH's Office of Behavioral and Social Sciences Research has shared A Communicator’s Tip Sheet for COVID-19 Vaccination.
• The ACL and CMS host a monthly webinar series that invites subject matter experts and practitioners from across the home-and-community-based services (HCBS) spectrum to share insights and best practices to develop high quality HCBS services and programs. Next month's webinar will be, "Reducing Food Insecurity and Nutrition-Related Chronic Diseases During COVID Among Medicaid HCBS Beneficiaries."
• Today, the FDA posted a video on safely using hand sanitizerExternal Link Disclaimer, with tips for consumers and their families on how to use and store hand sanitizer, as an alternative when handwashing with soap and water isn’t possible.
• As of Dec. 14, 299 tests and sample collection devices are authorized by FDA under EUAs; these include 230 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests.
• The last FDA virtual Town Hall for SARS-CoV-2 test developers will be Dec. 16 at 12:15 PM. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
• Veterans Health Administration executive Richard Stone said that about 73,000 doses of a COVID-19 vaccine would be available in the first wave of vaccinations, which is about enough to cover  36,500 individuals.
• The DoD held an OWS briefing on Dec.12 which you can view here.
• Rep. Devin Nunes (R-CA) said he tested positive for coronavirus antibodies, indicating he was previously infected with the virus.
• Hope is alive for an additional COVID-19 supplemental funding package in Congress, however there has still been no agreement on liability protections or funding for state and local aid. Attached here is the text for the $748 billion portion of the proposed bill that includes another round of Paycheck Protection Program assistance for small businesses, an unemployment benefit, and more money for schools, vaccine distribution and other widely agreed-upon items. Attached here is the text for the $160 billion portion that ties together funding for state and local governments and protections for businesses from coronavirus-related lawsuits. Attached here is a section-by-section summary of the two bills. For more detail on the legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update.
• The FDA’s VRBPAC, made up of independent scientific and public health experts from around the country, met to discuss the first request for EUA for Pfizer's COVID-19 vaccine. The panel ultimately voted 17 to 4 in favor of the vaccine, with one member abstaining. The FDA’s top vaccine official, Peter Marks, has said that the agency could greenlight the vaccine within days, after the internal review concluded that the shot showed “a favorable safety profile, with no specific safety concerns.”
• As a reminder, the Advisory Committee on Immunization Practices (ACIP) at CDC met last week to vote on the phased allocation of COVID-19 vaccines and who will be the first to receive vaccines. The group voted in favor of vaccination in Phase 1a being be offered to both health care personnel and residents of long-term care facilities. Slides are available here. MMWR's summary of the interim allocation recommendations is here. CDC Director Robert Redfield has accepted these recommendations.
  • • Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.
    • Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.
• The FDA issued an EUA to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test. The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer (non-prescription) test system, allowing a person to self-collect a nasal sample in their home and then send the sample to LabCorp for testing. It can be used by anyone aged 18 or over, and purchased online or in a store without a prescription.
• The Congressional Research Service released a report on COVID-19 and domestic PPE production and distribution. The report specifically examines the domestic supply, federal actions to increase PPE availability, and policy options concerning PPE production and distribution.
• The most recent NIH Director's Blog highlights a study from England of thousands of health care workers. Those who got COVID-19 and produced antibodies against the virus were very unlikely to become infected again, at least over the several months that the study was conducted.
• HHS released new hospital COVID-19 capacity data at the facility level. Previously released data about hospital capacity that had been released was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a "week at a time" picture to protect patient privacy, while providing a view of how COVID-19 is impacting hospitals and local communities across the country.
  • The CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on their dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
• The most recent COVID-19 Science Update from the CDC is here.
• The ACL and CMS host a monthly webinar series that invites subject matter experts and practitioners from across the home-and-community-based services (HCBS) spectrum to share insights and best practices to develop high quality HCBS services and programs. Next month's webinar will be, "Reducing Food Insecurity and Nutrition-Related Chronic Diseases During COVID Among Medicaid HCBS Beneficiaries."
• DoD officials provided a briefing on the Department's COVID-19 vaccine distribution plan. The transcript is available here.
• The last FDA virtual Town Hall for SARS-CoV-2 test developers will be Dec. 16 at 12:15 PM. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
• As of Dec. 9, 298 tests and sample collection devices are authorized by FDA under EUAs; these include 229 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests.
• On Tuesday, Dec. 8, President Trump signed an EO to focus vaccination efforts on the U.S. before facilitating international access. The Order does not create any new rules or prevent pharmaceutical companies from entering into bilateral agreements with foreign nations.
• Negotiations about a COVID-19 supplemental funding package in Congress remain stuck as there has been no agreement on liability protections. For more detail on the legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update.
• An NIH-funded tool can now help organizations choose a COVID-19 testing strategy that will work best for their specific needs. The COVID-19 Testing Impact Calculator is a free resource that shows how different approaches to testing and other mitigation measures, such as mask use, can curb the spread of the virus in any organization. It is the first online tool in the nation to provide schools and businesses with clear guidance on risk-reducing behaviors and testing to help them stay open safely.
• The NIH recently updated their COVID-19 treatment guidance. The guidelines narrowed the scope of recommended use for remdesivir (Veklury) in hospitalized COVID-19 patients.
• The White House is set to host a “COVID-19 Vaccine Summit” tomorrow for vaccine manufacturers, drug distributors, and government officials. Pfizer and Moderna have reportedly declined the invitation to attend.
• VRBPAC will meet in open session on Dec. 10 to discuss EUA of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. You can tune in here starting at 9 AM. The group will meet again on Dec. 17 to discuss the Moderna vaccine.
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on their dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
  • • Testing Overview
    • Daily Activities and Going Out
    • Workplaces and Businesses
    • Ventilation
• The ACL and CMS host a monthly webinar series that invites subject matter experts and practitioners from across the home-and-community-based services (HCBS) spectrum to share insights and best practices to develop high quality HCBS services and programs. Next month's webinar will be, "Reducing Food Insecurity and Nutrition-Related Chronic Diseases During COVID Among Medicaid HCBS Beneficiaries."
• FDA Commissioner Stephen Hahn delivered remarks to the FDA-CMS summit which you can see here.
• Late last week, the FDA authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.
• The FDA has added content to the question-and-answer appendix in its guidance titled, “Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency.” The updated guidance includes a new question and answer regarding considerations for disposing unused investigational drug product when a study participant cannot return it to the study site. The guidance addresses considerations for using alternative procedures for the disposition of the investigational product provided that such procedures do not expose humans to risks from the drug.
• The FDA issued a guidance, “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency.” This guidance provides the FDA’s enforcement policy regarding certain requirements for mammography facilities and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency.
• PrecisionFDA has launched the COVID-19 Precision Immunology App-a-thon. The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors. The challenge is open now through January 29, 2021.
• The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The remaining Town Halls will take place:
  • • Dec. 9, 12:15 PM
    • Dec. 16, 12:15 PM
• HHS announced it will distribute $523 million in second round performance payments to over 9,000 nursing homes. These nursing homes are being rewarded for successfully reducing COVID-19 related infections and deaths between September and October. The announcement is the second of five evaluation cycles rewarding nursing homes for their performance reducing nursing home infection and mortality rates. Nursing homes will begin receiving payments December 9.
• The Senate Commerce Committee will hold a hearing on Thursday morning at 9:30 AM titled, "The Logistics of Transporting a COVID-19 Vaccine."
• Education Sec. Betsy DeVos announced Friday that pandemic relief for about 41 million federal student loan borrowers will continue until Jan. 31.
• President Trump is expected to sign an EO tomorrow to state that U.S. efforts to assist other countries in vaccinating their populations against COVID-19 will be a lower priority than domestic inoculations.
• The Office of Refugee Resettlement within HHS said there have been 1,061 lab-confirmed COVID-19 cases among unaccompanied migrant children in their care.
• Rep. Robert Aderholt (R-AL) is the most recent Member of Congress to test positive for COVID-19.
• Liability protection seems to be the last piece holding up an additional COVID-19 supplemental funding package in Congress. For more detail on the legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update.
• The CDC on Wednesday urged Americans to postpone holiday travel after a busy Thanksgiving weekend that likely led to a further surge in coronavirus cases.
• The White House is set to host a “COVID-19 Vaccine Summit” on Dec. 8 for vaccine manufacturers, drug distributors, and government officials.
• VRBPAC will meet in open session on Dec. 10 to discuss EUA of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. You can tune in here starting at 9 AM. The group will meet again on Dec. 17 to discuss the Moderna vaccine.
• The Advisory Committee on Immunization Practices (ACIP) at CDC met on Monday to vote on the phased allocation of COVID-19 vaccines and who will be the first to receive vaccines. The group voted in favor of vaccination in Phase 1a being be offered to both health care personnel and residents of long-term care facilities. Slides are available here. MMWR's summary of the interim allocation recommendations is here.
  • • Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.
    • Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.
• President Trump issued a memorandum on Thursday that extends governors’ use of the National Guard in responding to COVID-19.
• The CDC has published and updated a significant number of COVID-19 and vaccine materials and resources on their dashboard. Please continue to check these for information on things like recommended quarantine periods and return-to-work guidance. To highlight a few of the recent updates:
  • • Health equity
    • Know your travel risk
    • How CDC is making vaccine recommendations
    • When to stop isolating
• The transcript from yesterday's CDC telebriefing is available here.
• The most recent COVID-19 Science Update from the CDC is here.
• The FDA updated the SARS CoV-2 reference panel comparative data on their website to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2.The FDA provided the panel, comprised of standardized samples, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their EUA.
• The FDA has reissued the Aug. 23 EUA for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.
• As of Dec. 1, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 antigen tests.
• HHS announced  that all tribal health programs and UIOs have chosen their preferred method for receiving the vaccine. Tribal health programs and UIOs had the option of receiving the vaccine either through the Indian Health Service or their respective state. Once available, COVID-19 vaccines will be allocated to jurisdictions, including the IHS, who will then distribute to tribal health programs and UIOs.
• The DoD released the first images of a COVID-19 vaccination record card and vaccine kits on Wednesday, which will be one method to keep track of doses.
• The DoD is readying to receive both the Pfizer and Moderna COVID-19 vaccines within the next three weeks while the services work to prioritize their distribution.
• The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The remaining Town Halls will take place:
  • • Dec. 9, 12:15 PM
    • Dec. 16, 12:15 PM
• The most recent NIH Director's blog talks about a study that suggests the vast majority of pregnant women with COVID-19 will not have complications. 
• NIAID is hosting a virtual workshop on Post-Acute Sequelae of COVID-19 on Dec. 3 and 4 to summarize existing knowledge on post-acute manifestations of COVID-19 and to identify key knowledge gaps. The first day will include an overview of the current challenges, talks on clinical observations (both US and international), and some insights from the patient's perspective. Day one will then switch to pathogenic features of coronaviruses as well as host immunological responses, and will end with a series of talks on post-acute sequelae of COVID-19 as reported to date in various focus areas. The second day will start with a talk on the intersection of social determinants of health and race/ethnicity on post-acute COVID-19 sequelae and the charge to the breakout groups, who will dive deeper to identify key knowledge gaps regarding the sequelae in various focus areas.
• Rep. Ted Budd (R-NC) is the most recent Member of Congress to test positive for COVID-19.
• Earlier this week, a bipartisan group of Senators introduced a $908 billion framework for a new COVID-19 supplemental. Both Senate Minority Leader Chuck Schumer (D-NY) and House Speaker Nancy Pelosi (D-CA) have endorsed the framework and are hopeful for a deal.
• HHS has started a new website combatcovid.hhs.gov.

• The GAO published a Report to Congressional Committees,"COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response." The report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic, and makes 12 new recommendations to federal agencies and congressional consideration on topics including medical supply shortages, COVID-19 testing, COVID-19 vaccines and therapeutics, nursing home care, assistance to individuals and businesses, and program integrity.
• VRBPAC will meet in open session on Dec. 10 to discuss EUA of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. You can tune in here starting at 9 AM. The group will meet again on Dec. 17 to discuss the Moderna vaccine.
• The Advisory Committee on Immunization Practices (ACIP) at CDC held a meeting on Nov. 23 during which they discussed the phased allocation of COVID-19 vaccines. You can view meeting materials here.
• Tomorrow, Dec. 1, ACIP is holding an emergency virtual meeting at 2 PM to vote on the COVID-19 vaccine allocations. The webcast is available here.
• Dr. Scott Atlas, a member of the White House's coronavirus task force, has resigned from his post in the Trump Administration.
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The FDA issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency.
• NIAID is hosting a virtual workshop on Post-Acute Sequelae of COVID-19 on Dec. 3 and 4 to summarize existing knowledge on post-acute manifestations of COVID-19 and to identify key knowledge gaps. The first day will include an overview of the current challenges, talks on clinical observations (both US and international), and some insights from the patient's perspective. Day one will then switch to pathogenic features of coronaviruses as well as host immunological responses, and will end with a series of talks on post-acute sequelae of COVID-19 as reported to date in various focus areas. The second day will start with a talk on the intersection of social determinants of health and race/ethnicity on post-acute COVID-19 sequelae and the charge to the breakout groups, who will dive deeper to identify key knowledge gaps regarding the sequelae in various focus areas.
• No new Members of Congress have tested positive for COVID-19 since last week
• Rep. Rick Allen (R-GA) is the most recent Member of Congress to test positive for COVID-19. There are currently 13 Members in quarantine who have tested positive.
• Acting USAID Deputy Administrator John Barsa has also tested positive for COVID-19.
• The FDA recently posted a new infographic, The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization, to explain a potential pathway for vaccines.
• The FDA yesterday published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators.
• Also yesterday, the FDA posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen collection devices using dried blood spot. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
• As of Nov. 24, 291 tests are authorized by FDA under EUAs; these include 225 molecular tests, 59 antibody tests, and 7 antigen tests.
• The Advisory Committee on Immunization Practices (ACIP) at CDC held a meeting on Nov. 23 during which they discussed the phased allocation of COVID-19 vaccines. You can view meeting materials here.
• With the likelihood that mRNA COVID-19 vaccines will be be approved within the next month, the CDC has published a resource to explain how mRNA vaccines work.
• The most recent COVID-19 Science Update from the CDC is here.
• NIAID announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with COVID-19 who require supplemental oxygen. The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the U.S. and other countries.
• NIAID is hosting a virtual workshop on Post-Acute Sequelae of COVID-19 on Dec. 3 and 4 to summarize existing knowledge on post-acute manifestations of COVID-19 and to identify key knowledge gaps. The first day will include an overview of the current challenges, talks on clinical observations (both US and international), and some insights from the patient's perspective. Day one will then switch to pathogenic features of coronaviruses as well as host immunological responses, and will end with a series of talks on post-acute sequelae of COVID-19 as reported to date in various focus areas. The second day will start with a talk on the intersection of social determinants of health and race/ethnicity on post-acute COVID-19 sequelae and the charge to the breakout groups, who will dive deeper to identify key knowledge gaps regarding the sequelae in various focus areas.
• Sen. Kelly Loeffler (R-GA) and Reps. Joe Courtney (D-CT) and Bryan Steil (R-WI) are the most recent Members of Congress to test positive for COVID-19. There are currently 12 Members in quarantine who have tested positive.
• The FDA published new information about the vaccine development and review process:
  • • Vaccine Development 101
    • Emergency Use Authorization for Vaccines Explained
    • The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization
• FDA announced it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request forEUA of a COVID-19 vaccine from Pfizer-BioNTech.
• The FDA issued an EUA for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.
• CDC uses Travel Health Notices (THNs) to alert travelers and other audiences to health threats around the world and how to protect themselves. On November 21, 2020, CDC adapted its 3-level notice system to a new 4-level system for COVID-19 and updated criteria used to determine THN levels.
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The Indian Health Service announced the IHS COVID-19 Pandemic Vaccine Plan November 2020. The plan details how the IHS health care system will prepare for and operationalize a vaccine when it becomes available. It also provides important guidance for all IHS federal, tribal health programs, and urban Indian organizations that choose to receive COVID-19 vaccine coordinated through IHS.
• HHS and DoD awarded Siemens Healthineers a $12 million contract to support domestic production of two diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. The funding is in addition to a $13 million HHS contract awarded Nov. 2 to enable the company to develop the tests.
• HHS announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab. In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug.
• NIH has awarded nearly $45 million to expand the research network of the Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) program, adding 20 institutions and seven states and territories. RADx-UP aims to enable and enhance COVID-19 testing of populations disproportionately affected by the disease, including African Americans, American Indians/Alaskan Natives, Latinos/Latinas, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated. This second round of awards brings the total investment in the RADx-UP program to more than $283 million at 55 institutions across 33 states and territories and the Cherokee Nation.
• NIAID is hosting a virtual workshop on Post-Acute Sequelae of COVID-19 on Dec. 3 and 4 to summarize existing knowledge on post-acute manifestations of COVID-19 and to identify key knowledge gaps. The first day will include an overview of the current challenges, talks on clinical observations (both US and international), and some insights from the patient's perspective. Day one will then switch to pathogenic features of coronaviruses as well as host immunological responses, and will end with a series of talks on post-acute sequelae of COVID-19 as reported to date in various focus areas. The second day will start with a talk on the intersection of social determinants of health and race/ethnicity on post-acute COVID-19 sequelae and the charge to the breakout groups, who will dive deeper to identify key knowledge gaps regarding the sequelae in various focus areas.
• The CDC is strongly urging Americans to stay home and avoid traveling for the Thanksgiving holiday. They've offered some tips for mitigating risks at Thanksgiving here.
• Reps. Doug Lamborn (R-CO), Ed Perlmutter (D-CO), and Dan Newhouse (R-WA), and Sen. Chuck Grassley (R-IA) have all tested positive for COVID-19 since Tuesday.
• The FDA issued an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular, single use test that is intended to detect SARS-CoV-2 (the virus that causes COVID-19).
• The FDA also issued an EUA for a combination coronavirus treatment consisting of Gilead's remdesivir and Eli Lilly's previously approved rheumatoid arthritis drug baricitinib, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older with severe cases. The decision to provide emergency use was based on a trial sponsored by the NIH's National Institute of Allergy and Infectious Diseases that enrolled more than 1,000 patients and showed the two drugs decreased the odds of death when compared only taking remdesivir.
• The FDA published a new “FDA Insight” podcast titled “Personal Protective Equipment and COVID-19External Link Disclaimer.” On this week’s episode, Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, welcomes Dr. Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health, for a discussion on PPE and its critical role in helping to reduce the spread of COVID-19.
• The most recent COVID-19 Science Update from the CDC is here.
• CMS is airing the first episode in a series of short podcasts for frontline nursing home staff. The series, “CMS Beyond the Policy: Nursing Home Series for Frontline Clinicians and Staff," is designed to reinforce training and infection control practices in nursing homes to help combat the spread of COVID-19.
• Ahead of the holidays, CMS is urging nursing home staff, residents, and visitors to follow established guidelines for visitation and adherence to the core principles of infection prevention. These guidelines include remaining six feet apart from individuals, wearing a face covering, and limiting the number of visitors in the nursing home at any one time.
• On Tuesday, CMS publicly recognized the 1,092 nursing homes at which 50 percent or more of their staff have completed CMS training designed to help staff combat the spread of COVID-19 in nursing homes. CMS applauds these facilities for taking this critical step to equip their staff with the latest information regarding infection control, vaccine distribution, and other topics. The Agency urges remaining home to take advantage of these resources.
• HHS launched a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes. Florida, Louisiana, Texas, New Jersey, and Alaska are the five states involved in the trial.
• NIAID is hosting a virtual workshop on Post-Acute Sequelae of COVID-19 on Dec. 3 and 4 to summarize existing knowledge on post-acute manifestations of COVID-19 and to identify key knowledge gaps. The first day will include an overview of the current challenges, talks on clinical observations (both US and international), and some insights from the patient's perspective. Day one will then switch to pathogenic features of coronaviruses as well as host immunological responses, and will end with a series of talks on post-acute sequelae of COVID-19 as reported to date in various focus areas. The second day will start with a talk on the intersection of social determinants of health and race/ethnicity on post-acute COVID-19 sequelae and the charge to the breakout groups, who will dive deeper to identify key knowledge gaps regarding the sequelae in various focus areas.
• NIH Director Dr. Francis Collins has posted a new NIH Director's Blog titled, "Mini-Lungs in a Lab Dish Mimic Early COVID-19 Infection." You can read it here.
• Reps. Tim Walberg (R-MI) and Cheri Bustos (D-IL) have both tested positive for COVID-19.
• The Administration for Community Living is hosting a webinar titled, "How Wyoming’s Tech2Connect Addresses Social Isolation Among Older Adults" on Nov. 19 at 3 PM. The webinar will highlight Wyoming’s “Tech2Connect” project, which seeks to decrease social isolation through the use of technology and increase access to virtual services and resources during the COVID-19 pandemic.
• HHS announced the FDA would resume reviewing and issuing EUAs for COVID-19 tests developed in labs, in a reversal aimed at extending liability protections to universities.
• The FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA. The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.
• The FDA also published a new webpage, A Closer Look at COVID-19 Diagnostic Testing, to provide health care providers and other public health professionals, including those who might purchase COVID-19 tests, more technical information and resources.
• As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.
• NIOSH has approved its first elastomeric half mask respirators (EHMR) without exhalation valves. When workers wear respirators to protect themselves against workplace hazards, they also need to maintain source control to protect others in case they are themselves sick with COVID-19. Concerns were raised that respirators with exhalation valves may allow unfiltered exhaled air to escape into the environment, therefore not offering source control.
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• And here is the most recent COVID-19 Science Update from the CDC.
• • NIAID is hosting a virtual workshop on Post-Acute Sequelae of COVID-19 on Dec. 3 and 4 to summarize existing knowledge on post-acute manifestations of COVID-19 and to identify key knowledge gaps. The first day will include an overview of the current challenges, talks on clinical observations (both US and international), and some insights from the patient's perspective. Day one will then switch to pathogenic features of coronaviruses as well as host immunological responses, and will end with a series of talks on post-acute sequelae of COVID-19 as reported to date in various focus areas. The second day will start with a talk on the intersection of social determinants of health and race/ethnicity on post-acute COVID-19 sequelae and the charge to the breakout groups, who will dive deeper to identify key knowledge gaps regarding the sequelae in various focus areas.
• On Tuesday, the Centers for Disease Control and Prevention updated its guidance on mask use, saying that masks benefit the wearer, as well as helping to protect those around them. The previous guidance focused on the ability of masks to curtail the spread of COVID-19. The CDC also stated that increasing the proportion of people who wear masks by 15 percent could prevent the need for lockdowns and cut associated economic losses of up to $1 trillion.
• The Department of Health and Human Services announced plans to allocate initial doses of Eli Lilly and Company’s investigational monoclonal antibody therapeutic, bamlanivimab, which received emergency use authorization from the U.S. Food and Drug Administration November 9 for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19. The federal government announced a purchase of 300,000 doses of bamlanivimab on October 28; a data-driven system will ensure fair and equitable distribution of these new products to state and territorial health departments.
• President-elect Biden formed a special COVID-19 transition team, which is expected to lay the groundwork for a White House coronavirus team after the inauguration. The group, whose members have not been publicly announced yet, consists of 52 transition officials that cover a wide swath of federal agencies, and is largely separate from the coronavirus task force the President-elect announced on Monday. The team covers three specialties – domestic, national security/foreign policy, and tech strategy delivery – and first met virtually on Tuesday. The domestic group includes Sarah Bianchi, a top economic and domestic policy aide to Biden when he was vice president; the national security/foreign policy group is headed by Rebecca Katz, director of Georgetown’s Center for Global Health Science and Security, and Dylan George; the tech strategy delivery is led by Mina Hsiang of the health care firm Devoted Health and Amy Pitelka, a tech legal and policy specialist.
• Bloomberg reported on Thursday that the Trump Administration will take a step back from negotiations over the next round of federal coronavirus relief legislation, and that Senate Majority leader Mitch McConnell (R-KY) will become the de facto lead Republican negotiator and replace Treasury Secretary Steve Mnuchin. House Speaker Nancy Pelosi (D-CA) and Sec. Mnuchin have been engaged in negotiations for months in an effort to reach an agreement, but Democrats and Republicans remain far apart on a path forward. President-elect Biden spoke with Speaker Pelosi and Senate Minority Leader Chuck Schumer (D-NY) about the “urgent need” for Congress to pass a lame duck stimulus bill.
• On Thursday, the Food and Drug Administration hosted a virtual Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they Flatten the Curve? The presentation provided an overview of the FDA’s research to evaluate the ability of facial coverings to reduce the spread of infection and how the FDA is developing a comprehensive risk-assessment tool to predict the probability of infection with individuals wearing a non-surgical face mask or cloth face covering; given the characteristics of non-surgical face masks, the population, and the pathogen.
• As of today, 288 tests are authorized by the FDA under EUAs: these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.
• The CDC has published and updated a significant number of COVID-19 materials and resources on their dashboard. To point to just a few:
  • • Celebrating Thanksgiving
    • The Impact of COVID-19 During Pregnancy
    • Risk Assessment and Management of COVID-19 Among Travelers at U.S. Airports
    • Frequently Asked Questions
• Several members and associates of the Trump Administration have recently tested positive for COVID-19. These include White House Director of Political Affairs Brian Jack, former White House aide Healy Baumgardner, Trump campaign advisers David Bossie and Corey Lewandowski, and three other unnamed White House officials. These are in addition to the earlier week’s announcement that White House Chief of Staff Mark Meadows and HUD Secretary Ben Carson have tested positive. Additionally, Rep. Don Young (R-AK), the oldest member of the House of Representatives at 87, announced on Thursday that he tested positive for COVID-19.
• The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The Town Halls will take place:
  • • Nov. 18, 12:15 PM
    • Dec. 2, 12:15 PM
    • Dec. 9, 12:15 PM
    • Dec. 16, 12:15 PM
• White House Chief of Staff Mark Meadows and HUD Sec. Ben Carson have both tested positive for COVID-19.
• The NIH has updated the COVID-19 treatment guidelines.
• OSHA has issued respiratory protection guidance focused on protecting workers in nursing homes, assisted living, and other long-term care facilities (LTCFs) from occupational exposure to coronavirus. Source control measures are recommended for everyone in healthcare facilities, including LTCFs, even if the wearer does not have symptoms of the coronavirus. The guidance describes various source control measures, including cloth face coverings, facemasks, and FDA-cleared or authorized surgical masks. Healthcare providers should wear source control products/devices at all times while inside a LTCF, including in breakrooms or other spaces where they might encounter other people.
• The CDC has published and updated a significant number of COVID-19 materials and resources on their dashboard. To point to just a few:
  • Benefits of Getting a COVID-19 Vaccine
  • Daily Activities and Going Out
  • Screening K-12 Students for Symptoms of COVID-19: Limitations and Considerations
  • Maternal, Neonatal, and Child Health Services during COVID-19
• The CDC provided additional information on the Text Illness Monitoring (TIM) system. TIM is a text messaging platform that helps monitor symptoms during an infectious disease outbreak. Public health officials have traditionally done symptom monitoring via telephone calls, which can be a time-consuming process requiring intensive resources. TIM allows for two-way short message service (SMS) text messaging to help public health organizations quickly identify enrolled participants reporting symptoms. TIM can be used to monitor an organization’s workforce or another specified population, such as contacts of an identified case.
• On Nov. 12, the FDA will host a Grand Rounds session providing an overview of the FDA’s research to evaluate the ability of facial coverings to reduce the spread of infection and how the FDA is developing a comprehensive risk-assessment tool to predict the probability of infection with individuals wearing a non-surgical face mask or cloth face covering; given the characteristics of non-surgical face masks, the population, and the pathogen. This presentation discusses how the filtration and leakage performance of cloth face coverings, using both experimental and computational methods, input into a risk assessment model that the FDA recently developed and is currently calibrating for COVID-19.
• A recent EO directed the FDA, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
• The FDA issued a Consumer Update, “Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy.” COVID-19 is one of many health issues that may cause oxygen levels to drop. When the levels are too low, consumers may need to take extra oxygen, known as oxygen therapy. One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.
• FDA Commissioner Stephen Hahn was a speaker for the Global Pharmaceutical Manufacturing Leadership Forum on Nov. 1. You can view his speech and read his remarks here.
• The FDA alerted clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the rapid detection of COVID-19. The FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings, and continues to monitor and evaluate these reports and other available information about device safety and performance. The FDA emphasized to clinical laboratory staff and health care providers the risk of false positive results with all laboratory tests.
• The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The Town Halls will take place:
  • Nov. 18, 12:15 PM
  • Dec. 2, 12:15 PM
  • Dec. 9, 12:15 PM
  • Dec. 16, 12:15 PM
• CMS launched a new toolkit designed for state Medicaid agencies to strengthen their infrastructure and develop robust home and community-based services (HCBS) for eligible beneficiaries because of how hard COVID-19 has hit care facilities. This toolkit is the latest in a series of CMS efforts to promote high quality, person-centered HCBS to safely transition older adults and individuals with disabilities back to their homes and communities, and decrease reliance on nursing home care.
• Last week, House Republicans unveiled the “Commitment to Defeat the Virus and Keep America Healthy Act” (H.R. 14), an effort to continue addressing the healthcare needs of those impacted by the coronavirus pandemic, but also use the lessons learned from this pandemic to ensure we are better prepared for future outbreaks. The bill, which is authored by Rep. Richard Hudson (R-NC), includes provisions from the Appropriations Committee as well as the House Energy and Commerce and Ways and Means Committees.
• Yesterday, Senate Majority Leader Mitch McConnell (R-KY) said that reaching a deal on a stimulus bill would be a top priority when Congress returns for lame duck after the election. House Speaker Nancy Pelosi (D-CA) has also been talking with the White House about a potential package.
• The U.S. Department of Justice has opened a civil-rights investigation into New Jersey veterans homes’ handling of deadly coronavirus outbreaks earlier this year, according to a letter from the department to the state’s governor, Phil Murphy (D)

• HRSA announced it will distribute approximately $333 million in first round performance payments to over 10,000 nursing homes. These nursing homes are being recognized for demonstrating significant reductions in COVID-19 related infections and deaths between August and September.
• NIH Researchers have discovered a biological pathway that the coronavirus appears to use to hijack and exit cells as it spreads through the body. The scientists say a better understanding of this pathway may provide important insight in stopping the transmission of the virus.
• Yesterday, the FDA updated an immediately in effect guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which includes capnographs and devices with a capnography feature.
• The FDA issued three warning letters jointly with the Federal Trade Commission to Peterson Research Laboratories dba Covercology, Predator Nutrition, and Beepothecary for selling unapproved and misbranded products with fraudulent COVID-19 claims.
• 285 tests are authorized by FDA under EUAs; these include 222 molecular tests, 56 antibody tests, and 7 antigen tests.
• The FDA's Dr. Peter Marks published an opinion piece pledging to make sure a COVID-19 is safe and efficacious.
• The CDC has published and updated a significant number of COVID-19 materials and resources on their dashboard. To point to just a few:
  • General FAQ
  • COVID-19 Questions and Answers: For People Who Use Drugs or Have Substance Use Disorder
  • Wear Face Masks on Public Transportation Conveyances and at Transportation Hubs
  • Considerations for Casinos and Gaming Operations
• The CDC is asking states to be prepared for vaccine distribution at key locations throughout the country. Officials want to move quickly once the FDA authorizes a vaccine and a CDC advisory panel issues recommendations on which populations should be vaccinated, according to a letter the CDC sent earlier this week to state preparedness and immunization officials. As part of that effort, the CDC wants states to provide important information, such as a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine that must be stored at ultracold temperatures of minus-70 Celsius, by next Tuesday.
• CMS released a comprehensive plan with proactive measures to remove regulatory barriers and ensure consistent coverage and payment for the administration of an eventual COVID-19 vaccine. CMS released a set of toolkits for providers, states, and insurers to help the health care system prepare to swiftly administer the vaccine once it is available. These resources are designed to increase the number of providers that can administer the vaccine and ensure adequate reimbursement for administering the vaccine in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover the vaccine at no charge to beneficiaries. In addition, CMS is taking action to increase reimbursement for any new COVID-19 treatments that are approved or authorized by the FDA.
• OSHA is facing a law suit by unions representing hundreds of thousands of nurses and health care workers who are alleging that the agency is violating its duties to keep workers safe by failing to issue an infectious disease standard to protect health care workers during the pandemic.
• Following an early morning letter to Treasury Sec. Steven Mnuchin about a response to remaining negotiation items, House Speaker Nancy Pelosi (D-CA) said today that she wants to reach a deal on an economic relief bill during Congress’s lame-duck session after the election. Full text of the letter can be viewed here.
• The FDA consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing, including for products to diagnose, cure, mitigate, treat or prevent COVID-19 and for other critically needed products to treat symptoms of COVID-19 or to provide supportive care to those with COVID-19. Manufacturers, applicants and sponsors, including those working under U.S. government contracts, can use these resources to find information on the applicable laws and regulations that govern drug development and manufacturing to protect the public health, including during the COVID-19 outbreak.
• The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary which provides a quick look at facts, figures and highlights of the agency's response efforts.
• The FDA updated the Antigen Template for Test Developers. This template provides the FDA’s current recommendations concerning data and information that should be submitted to the FDA in support of an EUA request for a SARS-CoV-2 antigen test. Today’s update adds recommendations regarding studies to support claims for screening asymptomatic individuals and multiplexed antigen tests.
• As of today, 284 tests are authorized by FDA under EUAs; these include 221 molecular tests, 56 antibody tests, and 7 antigen tests.
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• And here is the most recent COVID-19 Science Update from the CDC.
• The CDC has published and updated a significant number of COVID-19 materials and resources on their dashboard. To point to just a few:
  • Pregnancy, Breastfeeding, and Caring for Newborns
  • Flowchart for management of HCWs with exposure to a person with COVID-19
  • Toolkit for People 15 to 21
• On Saturday, Senate HELP Chairman Lamar Alexander (R-TN) made a statement urging New York Gov. Andrew Cuomo (D) and California Gov. Gavin Newsom (D) to “stop second guessing” analysis by scientists on the effectiveness of COVID-19 vaccines after the governors announced the creation of their own independent review boards. The statement comes after Newsom announced last week that California is planning to review federally approved coronavirus vaccines independently before distributing them to residents.
• Two of Vice President Pence's senior aides, Marc Short and Marty Obst, have tested positive for COVID-19. VP Pence said he does not plan to suspend campaign engagements.
• The NIH launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. The clinical trial aims to determine if modulating the excessive protein immune response, which leads to acute respiratory distress syndrome, can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system.
• In a new NIH Director's Blog, Dr. Francis Collins explores data showing that COVID-19 survivors continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms.
• The FDA issued a Consumer Update entitled, Advisory Committees Give FDA Critical Advice and the Public a Voice. It describes how the FDA relies on its many advisory committees to help it make sound decisions based on the best science available.
• In a new “FDA Voices”, entitled the FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines, Peter Marks, M.D., Ph.D., highlights the value of transparency. Dr. Marks states that facilitating the development of safe and effective COVID-19 vaccines is a high priority for the FDA, and that the FDA recognizes that being transparent about the data the agency will evaluate in support of the safety and effectiveness of these vaccines, and discussing this data with the members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), in a public forum is critical to building trust and confidence in their use by the public.
• The Center for Biologics Evaluation and Research’s (CBER) and VRBPAC met today in open session to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. You can view the meeting video here. Vaccine experts from academia, industry, nonprofits and government agencies peppered agency officials with a range of questions about its guidelines for approving a coronavirus vaccine.
• The FDA posted a new “FDA Insight” podcast featuring Deputy Commissioner Dr. Anand Shah, and Dr. Peter Marks, the Director of FDA's Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on Oct. 22.
• The White House coronavirus task force sent a report to state health officials which classified 31 states in the “red zone,” as the states’ number of new cases eclipsed 100 reported infections per 100,000 people the previous week. The top states, including the Dakotas, Montana and Wisconsin, were mostly in the Midwest, while other flagged states were in the South, such as Mississippi, Tennessee and Alabama.
• The CDC has published and updated a significant number of COVID-19 materials and resources on their dashboard. To point to just a few:
  • Screening K-12 Students for Symptoms of COVID-19: Limitations and Considerations
  • Wear Face Masks on Public Transportation Conveyances and at Transportation Hubs
  • Personal and Social Activities
• OWS chief Moncef Slaoui said in interview that he expects the U.S. trials of vaccines made by AstraZeneca and Johnson & Johnson to resume as soon as this week, but added that the FDA will make an official announcement.
• The HHS Office of the ASPR Technical Resources, Assistance Center, and Information Exchange (TRACIE), in collaboration with ASPR’s Pediatric Centers of Excellence are collaborating on a webinar series focused on how the COVID-19 pandemic may affect children. Topics will include impacts on child health and wellness, child emotional and social effects, the impact of COVID-19 on children with special healthcare needs, and how secondary/other disasters may affect children during the pandemic.
• OSHA has published a set of FAQ on how N95 respirators effectively protect wearers from coronavirus exposure.
• HHS and DoD announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs. The Pharmacy Partnership for Long-Term Care Program provides complete management of the COVID-19 vaccination process. This means LTCF residents and staff across the country will be able to safely and efficiently get vaccinated once vaccines are available and recommended for them, if they have not been previously vaccinated. It will also minimize the burden on LTCF sites and jurisdictional health departments of vaccine handling, administration, and fulfilling reporting requirements.
• CMS released data showing that 21 percent of Medicare beneficiaries report forgoing non-coronavirus care due to the pandemic, and nearly all - 98 percent - of beneficiaries have taken preventative measures to keep themselves safe from the virus. According to the survey, the most common type of forgone care because of the pandemic was dental care (43 percent), followed by regular check-up (36 percent), treatment for ongoing condition (36 percent), and diagnostic or medical screening test (32 percent). The most common reason cited for forgoing care was not wanting to risk being at a medical facility (45 percent).
• Here is the most recent COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• And here is the most recent COVID-19 Science Update from the CDC.
• The CDC has continued to publish and update COVID-19 materials and resources on their dashboard. Recently the CDC posted the following helpful pages:
  • Updates about how you can assess travel risks
    • Notably, the CDC is now strongly recommending that all passengers and workers on planes, trains, buses, and other public transportation wear masks to control the spread of COVID-19.
  • Testing Guidelines for Nursing Homes
  • Resources for colleges and universities to plan and prepare
• On Oct. 22, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. Read more here.
• 282 tests are authorized by FDA under EUAs; these include 220 molecular tests, 56 antibody tests, and 6 antigen tests.
• Since the start of the coronavirus pandemic through Oct. 8, OSHA has cited 85 establishments for violations relating to coronavirus, resulting in proposed penalties totaling $1,222,156. OSHA inspections have resulted in the agency citing employers for violations, including failures to: Implement a written respiratory protection program; Provide a medical evaluation, respirator fit test, training on the proper use of a respirator and personal protective equipment; Report an injury, illness or fatality; Record an injury or illness on OSHA recordkeeping forms; and Comply with the General Duty Clause of the Occupational Safety and Health Act of 1970.
• More than 1,000 current and former Centers for Disease Control and Prevention epidemic intelligence officers signed an open letter, decrying "the ominous politicization" of the agency throughout the coronavirus pandemic. Following the release of the letter, Sens. Elizabeth Warren (D-MA) and Gary Peters (D-MI) called on the GAO to investigate the Trump Administration’s political influence over the CDC and the FDA, and to determine whether this interference has violated the agencies' scientific integrity and communication policies.
• Talks between House Speaker Nancy Pelosi (D-CA) and Treasury Sec. Steven Mnuchin have continued, with major sticking points still remaining about additional COVID relief. Yesterday, Speaker Pelosi set a 48-hour deadline to strike a deal before the Election, but said any point after that window (end of the day Tuesday) will be too late for Congress to approve before Nov. 3. Meanwhile, Senate Majority Leader Mitch McConnell (R-KY) is bringing a $500 billion skinny bill to the floor this week.
• CMS announced new actions to pay for expedited coronavirus disease 2019 (COVID-19) test results. Starting Jan. 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected.  Also effective Jan. 1, 2021, for laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75. CMS wants to ensure that patients who test positive for the virus are alerted quickly so they can self-isolate and receive medical treatment.
• The FDA will host a virtual Town Hall for SARS-CoV-2 test developers on Oct. 21 at 12:15 PM. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. A second Town Hall will be on Oct. 28 at 12:15 PM.
• The FDA reissued the EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by NIOSH. Under the June 6, 2020 version of this EUA, a respirator was authorized if it met any of three predetermined eligibility criteria. Effective immediately, the reissued EUA no longer includes the three eligibility criteria, meaning the FDA will no longer review requests nor add to the list of authorized respirators–known as Appendix A—of this EUA based on those criteria.
• As of today, 281 tests are authorized by FDA under EUAs; these include 219 molecular tests, 56 antibody tests, and 6 antigen tests.
• The CDC has continued to publish and update COVID-19 materials and resources on their dashboard. Recently the CDC posted the following helpful pages:
  • 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans
  • 8 Things to Know About Vaccine Planning
  • Updated guidance and warnings about holidays
• Top U.S. health officials, including NIH's Tony Fauci and CDC's Robert Redfield have both noted this week that small household gatherings are driving the increase in COVID-19 cases in the U.S., and cautioned against large holiday gatherings in the coming months.
• OSHA has posted guidance for restaurants resuming in-person dining.
• Actions and comments by Senate Majority Leader Mitch McConnell (R-KY), House Speaker Nancy Pelosi (D-CA), and Treasury Sec. Steven Mnuchin all indicate there will be no supplemental COVID-19 package before Election Day.
• Vice Presidential candidate Sen. Kamala Harris (D-CA) announced she would be suspending campaign travel after two of her close campaign staff tested positive for COVID-19.
• President Trump has tested negative for COVID-19 on consecutive days according to White House Physician Sean Conley.
• The NIH's National Cancer Institute (NCI) has launched the Serological Sciences Network for COVID-19 (SeroNet), an initiative aimed at quickly increasing the nation’s antibody testing capacity and engaging the U.S. research community to understand the immune response to COVID-19. SeroNet will engage more than 25 of the nation’s top academic, government and private sector biomedical research institutions to study the immune response to COVID-19 to speed delivery of testing, treatments and vaccine development for combat the pandemic.
• NIH's NIAID today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials. The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized with COVID-19 at as many as 40 U.S sites, is being conducted in collaboration with the NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program.
• NIH Director Dr. Francis Collins penned a new blog in which he highlights some recent vaccine trial success, including one that indicates the Moderna vaccine candidate is both well tolerated and effective in generating a strong immune response when given to adults of any age.
• Today, the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular influenza (flu) viruses and respiratory syncytial viruses (RSV) tests require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify RSV.
• The FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of September 30, 2020, 550+ drug development programs were in planning stages, 350+ trials were reviewed by FDA and 5 COVID-19 treatments were currently authorized for emergency use.
• The FDA released a statement reaffirming its commitment to the safety and security of its public health laboratories.
• As of today, 279 tests are authorized by FDA under EUAs; these include 217 molecular tests, 56 antibody tests, and 6 antigen tests.
• CDC has a new webpage that features new ways of trick or treating and other Halloween activities. When trick or treating or participating in other Halloween activities with people outside your household, wear a mask. The agency encourages people to make it fun by making your mask part of your costume, but when it comes to slowing the spread of COVID-19, a costume mask is not a substitute for a cloth mask. They also say not to wear a costume mask over a cloth mask as it can make breathing more difficult.
• HHS and DoD announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company's COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent COVID-19.
• HHS and DoD also announced an agreement with Cytiva, headquartered in Massachusetts, to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines. BARDA collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide approximately $31 million to Cytiva for vaccine-related consumable products, such as liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors.
• In their final act of the day, HHS and DoD awarded a $481 million Other Transaction Agreement to Cue Health, Inc. to expand U.S. production capacity for a cartridge-based point-of-care COVID-19 molecular test that produces results in about 20 minutes. This partnership with HHS and DOD will allow Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021, and demonstrate this capacity through the delivery of six million COVID-19 tests and 30,000 instruments to the U.S. Government to support the domestic COVID-19 pandemic response.
• CMS released a statement about the integrity of COVID-19 testing.
• Though numbers have been tossed around, letters have been sent, and negotiations have continued, there is still no pandemic relief bill on the table. Senate Majority Leader Mitch McConnell (R-KY) said today that the Senate will take up another skinny bill when it comes back in session next week. It almost certainly won't be in line with what House Speaker Nancy Pelosi (D-CA) has expressed Democrats need to see.
• The FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support issuance of an EUA for investigational vaccines intended to prevent COVID-19.
• The FDA launched a new webpage at www.fda.gov/covid19vaccines to highlight new information as it becomes available.
• The FDA issued a letter to health care providers recommending that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nasal samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.
• 273 tests are authorized by FDA under EUAs; these include 215 molecular tests, 53 antibody tests, and 5 antigen tests.
• NIH, working in collaboration with BARDA, announced a third round of contract awards for scale-up and manufacturing of new COVID-19 testing technologies. The six new Rapid Acceleration of Diagnostics (RADx) initiative contracts total $98.35 million for point-of-care and other novel test approaches that provide new modes of sample collection, processing and return of results. Innovations in these new technologies include integration with smart devices, mobile-lab processing that can be deployed to COVID-19 hot spots, and test results available within minutes.
• CMS announced amended terms for payments issued under the Accelerated and Advance Payment (AAP) Program. This Medicare loan program allows CMS to make advance payments to providers and are typically used in emergency situations. Under the Continuing Appropriations Act, 2021 and Other Extensions Act repayment will now begin one year from the issuance date of each provider or supplier’s accelerated or advance payment. CMS issued $106 billion in payments to providers and suppliers in order to alleviate the financial burden healthcare providers faced while experiencing cash flow issues in the early stages of combating COVID-19.
• Tuesday, the CDC revised its page on people with certain medical conditions to reflect recent data supporting increased risk of severe illness from the virus that causes COVID-19 among adults with COVID-19 who have obesity, who have overweight, or who smoke or have a history of smoking. These revisions also make the document more explicit about data and implications for adults and for children. The listed underlying medical conditions in children were also revised to indicate that these conditions might increase risk to better reflect the quality of available data currently. This reflects the fact that there are less data available for children and does not imply that children are not at risk.
• The most recent CDC forecast, which combines the data from dozens of independent models, predicts U.S. deaths from COVID-19 could reach 233,000 by the end of the month.
• The CDC recently updated their page on Alcohol and Substance Abuse during the COVID-19 pandemic.
• There are multiple new releases in CDC's MMWR:
  • Characteristics Associated with Adults Remembering to Wash Hands in Multiple Situations Before and During the COVID-19 Pandemic — United States, October 2019 and June 2020
  • Trends in COVID-19 Incidence After Implementation of Mitigation Measures — Arizona, January 22–August 7, 2020
  • Adolescent with COVID-19 as the Source of an Outbreak at a 3-Week Family Gathering — Four States, June–July 2020
  • Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection — United Kingdom and United States, March–August 2020
• Energy and Commerce Committee Chairman Frank Pallone (D-NJ) wrote to White House Chief of Staff Mark Meadows urging him to allow contact tracers to investigate the large outbreak of coronavirus cases surrounding President Trump and White House staff.
• House Speaker Nancy Pelosi (D-CA) and Treasury Sec. Steven Mnuchin spoke again this afternoon to determine if there is really any hope of passing a comprehensive bill, but the call did not yield any positive results.
• President Trump is back in the White House to recover after leaving the Walter Reed medical center this evening. Last Friday, President Trump announced that he and the First Lady tested positive for COVID-19. Over the weekend, the President was checked into Walter Reed to receive treatment, including remdesivir and a dose of an experimental antibody cocktail being developed by the drug maker Regeneron.
• Today, CDC issued updated guidance to its How COVID-19 Spreads website, which includes information about the potential for airborne spread of the virus that causes COVID-19. The new language cites recent evidence that the virus can spread further than six feet indoors.
• The White House has reportedly blocked the FDA's new proposal of stricter guidelines for a COVID-19 vaccine. Key staff involved in the decision are objecting to provisions that would push approval of a vaccine past Election Day. The FDA is still looking to ensure that vaccines meet the guidelines stricter set of guidelines and is sharing the updated standards with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use.
• NIH's National Institute of Allergy and Infectious Diseases (NIAID) has partnered with Matrix Medical Network to help more than 20 academic medical centers involved in NIAID’s COVID-19 Prevention Network establish mobile health clinics at universities, hospitals and other locations across the U.S. Mobile clinics will serve communities in Arkansas, Colorado, Florida, Illinois, Kansas, Maryland, Missouri, New Jersey, New York, North Carolina, Texas, and Washington.
• The FDA posted a transcript of FDA Commissioner Stephen Hahn's remarks to the National Consumers League last week about the vaccine review process.
• FDA awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19.
• As of today, 270 tests are authorized by FDA under EUAs; these include 213 molecular tests, 52 antibody tests, and 5 antigen tests.
• OSHA published additional frequently asked questions and answers regarding the need to report employees’ in-patient hospitalizations and fatalities resulting from work-related cases of COVID-19. OSHA’s new FAQs provide information to help employers apply the agency’s existing injury and illness recording and reporting requirements to the coronavirus. In particular, the FAQs provide guidance on how to calculate reporting deadlines for in-patient hospitalizations and fatalities, and clarify the meaning of the term “incident” as it relates to work-related coronavirus in-patient hospitalizations and fatalities.
• OSHA issued Temporary Enforcement Guidance for tight-fitting powered air purifying respirators (PAPRs) used during the COVID-19 pandemic.
• President Trump signed an EO to address the negative impact of prolonged shutdowns on mental and behavioral health and increase suicide prevention efforts. The President is establishing a cabinet-level working group to assess the mental health needs of the most vulnerable, including the elderly, minorities, children, veterans, and people with disabilities. The order also focuses on providing grant funding to support mental health treatment services including telehealth, peer-to-peer, and safe in-person therapeutic services.
• Sen. Ron Johnson (R-WI) and White House Press Sec. Kayleigh McEnany have tested positive for COVID-19. Others within the Administration who have tested positive are listed here.
• After ongoing negotiations between House Speaker Nancy Pelosi (D-CA) and Treasury Sec. Steven Mnuchin, sharp disagreements remain about the main issues in an additional stimulus package. Earlier this week, House Democrats had released an updated version of the Heroes Act, their $2.2 trillion COVID-19 relief bill. The text of revised version of The Heroes Act is here. A one-pager on the legislation is here. A section-by-section summary is here. Additional information on the state and local relief provisions is here.
• President Trump and the First Lady have both tested positive for COVID-19. The President is being treated at Walter Reed hospital and has received a dose of an experimental antibody cocktail being developed by the drug maker Regeneron.
• HHS, through HRSA, announced $20 billion in new funding for providers on the frontlines of the coronavirus pandemic. Under this Phase 3 General Distribution allocation, providers that have already received Provider Relief Fund payments will be invited to apply for additional funding that considers financial losses and changes in operating expenses caused by the coronavirus. Previously ineligible providers, such as those who began practicing in 2020 will also be invited to apply, and an expanded group of behavioral health providers confronting the emergence of increased mental health and substance use issues exacerbated by the pandemic will also be eligible for relief payments. Providers can begin applying for funds on Oct. 5.
• HHS and The Rockefeller Foundation have signed an agreement to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools. The partnership establishes a pilot program with select cities and states in The Rockefeller Foundation's Testing Solutions Group (TSG), a network of public officials devoted to rapidly scaling COVID-19 testing, tracing, and tracking in their communities. HHS will provide at least 120,000 Abbott BinaxNOW COVID-19 Ag Card POC SARS-CoV-2 diagnostic tests to pilot sites. The initial pilot cities, selected collaboratively with The Rockefeller Foundation, are Louisville, Los Angeles, New Orleans, and Tulsa. In addition, Rhode Island has been selected as a pilot state.
• The FDA revised its EUA to reflect changes in the distribution and allocation of the antiviral drug Veklury (remdesivir). More information about the revised EUA can be found here.
• The Select Subcommittee on the Coronavirus Crisis held a hybrid hearing with HHS Sec. Alex Azar on the Department’s response to the coronavirus pandemic. The contentious meeting served mostly as a messaging board, during which Democrats stuck to questioning the Administration's lack of a national testing strategy and Republicans were a united front rejecting accusations of politics impacting scientific decisions within government agencies. A memo is available upon request for this hearing.
• Senator Patty Murray (D-WA), ranking member of the Senate Committee on Health, Education, Labor and Pensions, released a 44-page report, “COVID-19 & Achieving Health Equity: Congressional Action is Necessary to Address Racism and Inequality in the U.S. Health Care System,” outlining how the American health care system has failed communities of color due to entrenched bias, discrimination, and racism—and demonstrating how those failures have contributed to disproportionate and tragically high COVID-19 death and infection rates among the Black, Latinx, and Tribal communities. In the report, Senator Murray also lays out a series of recommendations on Congressional action to address inequality and racism within the U.S. health care system.
• HHS Sec. Alex Azar said during today's hearing that he is ordering a review of the $300 million-plus ad campaign aimed at boosting confidence in the Trump Administration's coronavirus response, one day after House Oversight select subcommittee on the coronavirus crisis Chair Jim Clyburn (D-SC), wrote that the Administration, "appears to be misusing taxpayer dollars to fund a political propaganda campaign — disguised as a public health effort—just weeks before a presidential election."
• Here is this week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• Sens. Mike Lee (R-UT) and Thom Tillis (R-NC) have tested positive for COVID-19.
• After ongoing negotiations between House Speaker Nancy Pelosi (D-CA) and Treasury Sec. Steven Mnuchin, sharp disagreements remain about the main issues in an additional stimulus package. Earlier this week, House Democrats had released an updated version of the Heroes Act, their $2.2 trillion COVID-19 relief bill. The text of revised version of The Heroes Act is here. A one-pager on the legislation is here. A section-by-section summary is here. Additional information on the state and local relief provisions is here

• House Democrats released an updated version of the Heroes Act, their $2.2 trillion COVID-19 relief bill. The text of revised version of The Heroes Act is here. A one-pager on the legislation is here. A section-by-section summary is here. Additional information on the state and local relief provisions is here.
• President Trump announced today that the federal government will ship 100 million rapid coronavirus tests to states by the end of the year. The first shipment of around 6.5 million tests will be divided and sent this week. The amount each state receives will be based on population data. President Trump and HHS testing czar Brett Giroir are encouraging state leaders to use the tests to help schools reopen, but governors will ultimately be in charge of deciding how to use the rapid tests they receive.
• Tomorrow at 12:00 PM, the FDA, NIOSH, and OSHA will host a webinar on Respirators and Other PPE for Health Care Personnel Use during the COVID-19 Pandemic.
• The FDA has announced a clinical hold on INOVIO's COVID-19 vaccine trials as the Agency has additional questions about the CELLECTRA® 2000 delivery device used in the trial. The hold is not the result of any adverse outcomes during the ongoing Phase 1 portion of INOVIO's study, and INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800.
• The FDA will host the last in their series of virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 30, 12:15 PM
• The CDC updated their guidance today on how to select, wear, and clean your mask.
• CDC's MMWR published an early release new article COVID-19 Trends Among School-Aged Children — United States, March 1–September 19, 2020. The findings indicate that children with underlying conditions are more likely to experience severe effects of COVID-19, but also that teens are more likely to contract COVID-19 than younger children.
• The House Committee on Energy and Commerce will hold a hearing on Wednesday titled, "Pathway to a Vaccine: Ensuring a Safe and Effective Vaccine People Will Trust.” You can view the witness panel here. A memo will be available upon request.
• Friday, the Select Subcommittee on the Coronavirus Crisis will hold a hybrid hearing with HHS Sec. Alex Azar on the Department’s response to the coronavirus pandemic. A memo will also be available upon request for this hearing.
• In President Trump's Friday briefing today he said, “...we expect to have enough vaccines for every American by April.”
• The CDC reversed a recommendation that people who have had close contact with someone infected with the coronavirus did not need to get tested unless they had symptoms after the recommendation sparked an outcry among public health officials. The agency now says anyone exposed to an infected person for more than 15 minutes should be tested.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.
• The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:
  • Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.”
  • Clarify that testing is authorized for laboratories certified under CLIA and meet the requirements to perform high, moderate, or waived complexity tests.
  • Clarify that testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.
• New data from the CDC show that adult obesity prevalence is increasing and racial and ethnic disparities persist. Notably, adults with obesity are at heightened risk for severe outcomes from COVID-19. The 2019 Adult Obesity Prevalence Maps show that twelve states now have an adult obesity prevalence at or above 35%: Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia. In addition to the maps, CDC has released a summary statement on obesity and race and ethnicity as related to COVID-19 risk.
• The Congressional Budget Office published a document titled, "The Effects of Pandemic-Related Legislation on Output."
• Here is last week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• After a day of rumblings about a potential deal, we still have nothing on the table heading into the weekend. For a more detailed description of what this means for the future COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• The NIH has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals. The list of awardees can be found here.
• The NIH also announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center.
• HHS and DoD released documents outlining the Administrations plan for distributing and administering millions of doses of a future COVID-19 vaccine to Americans for free. The plan involves an information campaign led by the HHS public affairs department; ramping up infrastructure so a vaccine can be delivered quickly once authorized; and sending 6.6 million kits of supplies needed to administer the vaccine, like syringes and alcohol pads. The strategy is outlined in a report to Congress and a 57-page playbook to states.
• The FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA).
• The FDA awarded a new research contract to the University of Liverpool and global partners to sequence and analyze samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19. The study will also examine in vitro coronavirus models, such as organs-on-chips. This regulatory science project, awarded in collaboration with the NIH/NIAID, will hopefully help inform development and evaluation of medical countermeasures for COVID-19.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• As of today, 249 tests are authorized by FDA under EUAs; these include 198 molecular tests, 47 antibody tests, and 4 antigen tests.
• Yesterday, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9 percent sodium chloride injection, indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth. This drug is included in the FDA’s Drug Shortage Database.
• Today, the CDC released indicators to help schools make dynamic decisions about in-person learning as local conditions evolve throughout the pandemic. When coupled with local data about community spread, these indicators are an important tool to help local health officials, school administrators, and communities prepare, plan, and respond to COVID-19. These indicators are the latest resources CDC has provided for schools during the COVID-19 pandemic, and they supplement previously released CDC guidance.
• CMS received the final report from the independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission), which was facilitated by MITRE.  CMS also released an overview of the actions the agency has taken to date to combat the spread of COVID-19 in nursing homes. The Commission’s findings align with the actions CMS has taken to contain the spread of the virus and to safeguard nursing home residents from the ongoing threat of COVID-19.
• Sens. Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) wrote a letter to HHS Sec. Alex Azar and Education Sec. Betsy DeVos encouraging the Education Department to issue new guidance for how schools and colleges should address the unique and increased mental health challenges students are facing due to COVID-19. In the letter, the Senators requested information about how schools and colleges should use federal funds to support students’ mental health needs, with a particular focus on minorities or those from tribal nations, students with disabilities, and students experiencing homelessness.
• Rep. Jim Clyburn (D-SC), Chairman of the Select Subcommittee on the Coronavirus Crisis, sent a letter to Vice President Pence and Coronavirus Response Coordinator Dr. Deborah Birx raising concerns that the Task Force has weakened or retracted previous science-based recommendations in numerous states still in the “red zone,” including states that failed to comply with previous Task Force recommendations. The letter also demands the release of all White House Coronavirus Task Force reports tracking the spread of the virus and making recommendations to contain the outbreak.
• The Senate Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies met today for a hearing at 10 AM titled, "Department of Health and Human Services’ Coronavirus Response: A Review of Efforts To Date and Next Steps." During the hearing, CDC Director Robert Redfield said he thought a vaccine would not be publicly available until the middle or end of 2021. President Trump later contradicted that, saying he thought perhaps Dr. Redfield had made a mistake. A memo on this hearing is available upon request.
• Assistant sec. of public affairs for HHS, Michael Caputo, announced he will be taking a two month leave of absence after he said he and his team had tried to water down MMWR reports out of the CDC. Caputo's science advisor, Dr. Paul Alexander, is leaving HHS entirely.
• An unidentified White House staff member has tested positive for COVID-19.
• Speaker of the House Nancy Pelosi (D-CA) has said members of her caucus will need to stay in Washington until a deal is reached on additional COVID-19 supplemental funding. Today, President Trump encouraged Republicans to "go for the much higher numbers." For a more detailed description of what this means for the future COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• Tomorrow, September 15, at 12:00 PM the FDA will host a webinar to review enforcement policy for gowns, other apparel, and gloves during the COVID-19 pandemic and umbrella EUA for gowns and other apparel. During this webinar, the FDA will present information on both the enforcement policy and the EUA for gowns and other apparel, and representatives from the FDA, CDC, and OSHA will be available to answer questions.
• The NIH announced results from an agency-funded study which indicate that people with substance use disorders (SUDs) are more susceptible to COVID-19 and its complications. The research was co-authored by Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA). According to the authors, the study findings underscore the need to screen for, and treat, SUDs as part of the strategy for controlling the pandemic. Additional research needs to be done to better understand how best to treat those with SUDs who are at risk for COVID-19 and counsel on how to avoid the risk of infection.
• The FDA awarded a new research contract to the University of Liverpool and global partners to sequence and analyze samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19. The study will also examine in vitro coronavirus models, such as organs-on-chips. This regulatory science project, awarded in collaboration with the NIH/NIAID, will hopefully help inform development and evaluation of medical countermeasures for COVID-19.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 16, 12:15 PM
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• FDA test figures remain the same with 247 tests authorized by FDA under EUAs, including 197 molecular tests, 46 antibody tests, and 4 antigen tests.
• OSHA has published guidance on the use of cloth face coverings while working in both indoor and outdoor hot and humid conditions.
• The Senate Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will meet this Wednesday, September 16, for a hearing at 10 AM titled, "Department of Health and Human Services’ Coronavirus Response: A Review of Efforts To Date and Next Steps."
• Even though the Senate voted on the Republican-led skinny bill last week, negotiations between chambers have not progressed. The odds of a separate COVID package and CR are slimming daily. For a more detailed description of what this means for the future COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• NIAID's Dr. Tony Fauci said today that, even with a vaccine at the end of this year or early 2021, "If you're talking about getting back to a degree of normality which resembles where we were prior to Covid, it's going to be well into 2021, maybe even towards the end of 2021."
• In a new FDA Voices entitled, The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, agency leaders explain that they are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines.
• FDA issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations. This guidance provides recommendations to help manufacturers prioritize products and activities as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply. The guidance for industry “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products” describes high-level considerations for resuming normal operations. This temporary guidance, however, provides more detailed considerations and is specific to the COVID-19 public health emergency.
• Several Senior FDA career employees defended the independence and professionalism of their agency in an op-ed seeking to allay concerns over the intermingling of politics and science.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 16, 12:15 PM
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• Here is this week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The NIH has launched two of three adaptive Phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, these trials will be conducted at more than 100 sites around the world and will involve patients in various clinical settings — those who have not been hospitalized, those currently hospitalized and those discharged after hospitalization for moderate to severe disease.
• Resources for Integrated Care (RIC) launched the Integrated Care Community of Practice (ICCoP), a learning community of health plans seeking to incorporate meaningful member feedback into their governance structures. Health plans face additional challenges to effective member engagement due to  COVID-19, but the pandemic also presents opportunities to re-examine meeting structures, strategies, and recruitment. Over the past five months, ICCoP participants shared challenges and promising practices. This panel discussion will offer promising practices, including those from ICCoP, for staying connected to member advisors and supporting their continued involvement during COVID-19. The panel is on Thursday, September 17 at 12:30 PM, and you can register here.
• Social isolation during the COVID-19 pandemic is a public health concern. Read what U.S. Surgeon General VADM Jerome Adams writes about how resources are available to help people stay connected even while physically distanced.
• Energy and Commerce Committee Chairman Frank Pallone (D-NJ) raised a series of questions in a letter to HHS Sec. Alex Azar today following press reports that the agency put out a bid for a more than $250 million communications contract for a COVID-19 public relations campaign in the months leading up to the presidential election. HHS reportedly sent multiple communications firms a performance work statement (PWS), in which the agency identified a series of goals for a new communications contract, including “defeat despair and inspire hope” about the COVID-19 pandemic, “instill confidence to return to work and restart the economy,” build a “coalition of spokespeople,” and provide public health, therapeutic and vaccine information as the country reopens.
• House Committee on Oversight and Reform Chairwoman Carolyn Maloney (D-NY), Chairman of the Select Subcommittee on the Coronavirus Crisis Rep. Jim Clyburn (D-SC), and Chairman of the Subcommittee on Economic and Consumer Policy Rep. Raja Krishnamoorthi (D-IL), also sent a letter calling on HHS Sec. Alex Azar to suspend a $250 million communications contract awarded to Fors Marsh Group to create public service announcements (PSAs) relating to the coronavirus crisis.
• The House Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will meet next Wednesday, September 16, for a hearing at 10 AM titled, "Department of Health and Human Services’ Coronavirus Response: A Review of Efforts To Date and Next Steps."
• Odds of a fourth COVID stimulus package passing before the November 3 election are reportedly low. The Senate did meet yesterday to vote on the Republican-led skinny bill, but Sen. Rand Paul (R-KY) was the only member to break party lines and vote against the measure. Bill text is here. Bill summary is here. For a more detailed description of what this means for the future COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• Today, HHS and the Assistant Secretary for Health issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they are made available. This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.
• The Indian Health Service (IHS) announced the formation of a COVID-19 Critical Care Response Team to provide deployable resources to augment urgent lifesaving medical care to COVID-19 patients admitted to IHS or tribal hospital emergency department or inpatient settings. The addition of expert critical care support assists IHS hospitals in managing the surge in critically ill patients resulting from the pandemic and provides what IHS has deemed the most vulnerable patients the greatest chance of survival. In the event of an urgent need, the CCRT can rapidly mobilize, usually as soon as within 24-48 hours of the decision to deploy the team.
• The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts.
• The FDA has deactivated the FDA registration for 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations.  Of these, 131 establishments list devices that are essential to the COVID-19 pandemic response.
• As of today, 244 tests are authorized by FDA under EUAs; these include 196 molecular tests, 44 antibody tests, and 4 antigen tests.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 16, 12:15 PM
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• The CDC announced today that, starting September 14, the U.S. government will remove requirements for directing all flights carrying airline passengers arriving from, or recently had a presence in, certain countries to land at one of 15 designated airports and halt enhanced entry health screening for these passengers. Currently, enhanced entry health screening is conducted for those arriving from, or with recent presence in, China (excluding the Special Administrative Regions of Hong Kong and Macau), Iran, the Schengen region of Europe, the U.K. (excluding overseas territories outside of Europe), Ireland, and Brazil.
• A recent CDC email outlined what the agency has done to monitor cases of multisystem inflammatory syndrome in children (MIS-C). CDC has a dedicated team investigating MIS-C to learn more about this syndrome and communicate information quickly to healthcare providers, parents and caregivers, as well as state, local and territorial health departments. The team is working with U.S. and international scientists, healthcare providers, and other partners to learn more about this new syndrome. They are learning about how often it happens and who is likely to get it, creating a system to track cases, and providing guidance to parents and healthcare providers.Since mid-May, the CDC has been tracking reports of MIS-C. Many questions remain about why some children develop it after a COVID-19 illness or contact with someone with COVID-19, while others do not. As of September 3, CDC has received reports of 792 confirmed cases of MIS-C and 16 deaths in 42 states, New York City, and Washington, D.C. Additional cases are under investigation.
• The CDC continues to update online resources and guidance documents. Check the list of most recent updates here.
• The HHS Assistant Secretary for Preparedness and Response recently published Discharge Planning and Care Coordination during the COVID-19 Pandemic, a resource developed in partnership with ACL and the Centers for Medicare & Medicaid Services. The tool is designed to support nurses, social workers, case managers, and others conducting discharge planning for adults with disabilities after COVID-19 treatment.
• The Senate HELP Committee met today for a hearing titled, "Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health."  NIH Director Francis Collins and U.S. Surgeon General Jerome Adams testified. A memo from this hearing is available upon request.
• Oversight and Reform Committee Chairwoman Carolyn Maloney (D-NY), Select Subcommittee on the Coronavirus Crisis Chairman Jim Clyburn (D-SC), and Subcommittee on Economic and Consumer Policy Chairman Raja Krishnamoorthi (D-IL) sent a letter to HHS requesting written responses and a staff briefing on the federal government’s plans to deploy a coronavirus vaccine after licensure or authorization. The Chairs asked about preparations for distribution, plans to prioritize the vaccine for at-risk populations, efforts to ensure public transparency and increase vaccine confidence, and safeguards to ensure decisions are made free from political considerations.
• The Senate will vote on a "skinny" stimulus package tomorrow. Majority Leader Mitch McConnell is hoping for 51 votes in favor of the bill, not the 60 that would be required for cloture. Bill text is here. Bill summary is here. For a more detailed description of what's on (or off) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• HHS, through HRSA, announced the details of a $2 billion Provider Relief Fund performance-based incentive payment distribution to nursing homes. This distribution is the latest update in the previously announced $5 billion in planned support to nursing homes grappling with the impact of COVID-19. Last week, HHS announced it had delivered an additional $2.5 billion in payments to nursing homes to help with upfront COVID-19-related expenses for testing, staffing, and PPE needs. Other resources are also being dedicated to support training, mentorship, and safety improvements in nursing homes.
• The FCC, HHS, and USDA announced that they have signed a Memorandum of Understanding to work together on the Rural Telehealth Initiative, a joint effort to collaborate and share information to address health disparities, resolve service provider challenges, and promote broadband services and technology to rural areas in America. This action comes as the coronavirus pandemic has highlighted the critical importance of telehealth in delivering quality healthcare to rural Americans. According to FCC Chairman Ajit Pai, recent telehealth efforts have, "allowed for more patients to be treated at home, freeing up valuable hospital beds for those who most need them, and reducing the risk of exposure to the virus."
• Earlier this week, the FDA updated its guidance, “Investigational COVID-19 Convalescent Plasma,” to provide additional information related to the recently issued EUA for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. This update includes a discussion regarding FDA’s intent to exercise temporary enforcement discretion regarding the IND requirements for the use of this product when blood establishments, hospitals, and health care providers collect plasma that does not meet the Conditions of Authorization of the EUA. The revised guidance continues to provide recommendations for health care providers who wish to administer and study convalescent plasma under an Investigational New Drug Application. In addition, the agency updated the web page, “Recommendations for Investigational COVID-19 Convalescent Plasma,” which also provides this information.
• The FDA’s COVID-19-related consumer updates are now available in at least five languages.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 9, 12:15 PM
  • September 16, 12:15 PM
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• The CDC has asked states to prepare to distribute a potential COVID-19 vaccine as soon as late October, according to a series of planning documents sent to public health officials last week. CDC Director Robert Redfield also sent a letter to governors asking them to fast-track permits and licenses so that vaccine distribution sites can be up and running by November 1 in their states.
• CDC Director Robert Redfield signed a declaration issuing a temporary halt in residential evictions and stated that the evictions of tenants could be detrimental to public health control measures to slow the spread of COVID-19.
• The CDC continues to update online resources and guidance documents. Here are a few of the most recent updates:
  • Children and Teens
  • A series of changes have been made to Operating schools during COVID-19: CDC's Considerations
  • Limiting Workplace Violence Associated with COVID-19 Prevention Policies in Retail and Services Businesses
  • How to Make 0.1% Chlorine Solution to Disinfect Surfaces in Healthcare Settings
  • Contact Tracing Resources for Health Departments
• The NIH has launched a study to track the prevalence and impact of SARS-CoV-2 infection among approximately 16,000 pregnant women in seven low- and middle-income countries. The study will follow women through pregnancy and 12 months after childbirth to compare maternal, fetal and newborn outcomes of participants who have been infected with the virus to those of pregnant women who have not been infected.
• NIH announced $129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. These tests add to initial awards made to seven companies on July 31.
• The Office of the Inspector General (OIG) recently posted FAQs pertaining to the application of the OIG's administrative enforcement authorities connected to the COVID-19 public health emergency.
• HHS said in a statement that they are canceling some remaining orders for ventilators as the SNS is full with nearly 120,000 ventilators available.
• HHS/HRSA announced assisted living facilities (ALFs) may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation, funding that was made possible through the bipartisan CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. Like other providers applying for Phase 2 funding, eligible ALFs will receive 2 percent of their annual revenue from patient care.
• Negotiations for an additional pandemic relief bill remain stalled. For a more detailed description of what's on (or off) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).

• Tomorrow, September 1, at 12 PM, the FDA and the CDC will host a webinar to review CDC/NIOSH’s Surgical N95 respirator guidance. During this webinar, CDC/NIOSH will present information on the guidance, and representatives from the CDC/NIOSH, FDA, and OSHA will be available to answer your questions.
• The FDA announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on October 22 to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19. The FDA intends to make background material available to the public, including the meeting agenda and Committee roster, no later than two business days before the meeting.
• The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
  • September 9, 12:15 PM
  • September 16, 12:15 PM
  • September 23, 12:15 PM
  • September 30, 12:15 PM
• The FDA alerted health care facility risk managers, procurement staff, and health care providers that medical gowns sold by Laws of Motion PPE, including surgical gowns, have potential quality issues that affect the level of fluid barrier protection and should not be used as personal protective equipment at this time. The Letter to Health Care Providers includes information for reporting problems with the Laws of Motion PPE gowns, including surgical gowns.
• The FDA broadened the scope of the existing EUA for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, regardless of disease severity.
• The CDC continues to update online resources and guidance documents. Here are a few of the most recent updates:
  • Guidance for dental settings
  • Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
  • A new video on how to stay safe at the pool and the beach
  • Updates to COVID-NET data
• Here is last week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The NIH announced that AstraZeneca's COVID-19 vaccine candidate has entered Phase 3 trials. The trial will enroll approximately 30,000 adult volunteers at 80 sites in the U.S. to evaluate if the candidate vaccine can prevent symptomatic COVID-19. The Phase 3 trial is being implemented as part of Operation Warp Speed. Read more here.
• Agriculture Sec. Sonny Perdue announced that the USDA Farmers to Families Food Box Program has distributed more than 75 million food boxes in support of American farmers and families affected by the COVID-19 pandemic. Earlier last week, President Trump announced an additional up to $1 billion will be added to the Farmers to Families Food Box Program.
• Sec. Perdue also announced the USDA will extend several flexibilities through as late as December 31 to allow summer meal program operators to continue serving free meals to all children into the fall months. This will help ensure that children continue to have breakfast and lunch during the COVID-19 pandemic.
• The GAO published a "Brief Update on Initial Federal Response to the Pandemic."
• Negotiations for an additional pandemic relief bill are still stalled. For a more detailed description of what's on (or off) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• HHS announced it has now distributed almost $2.5 billion of the planned $5 billion distribution to nursing homes to support increased testing, staffing, and PPE needs. This funding allocation was made through HRSA as a targeted distribution from the $175 billion Provider Relief program funded through the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. This distribution of almost $2.5 billion in additional funding to over 15,000 nursing homes nationwide supplements the $4.9 billion that was previously distributed to skilled nursing facilities. HHS plans on distributing another $2 billion to nursing homes later this fall based on certain performance indicators that will be shared in the future.
• The FDA posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Valerie Jensen, the associate director of the drug shortages staff in the FDA's Center for Drug Evaluation and Research, discussing drug shortages and how the COVID-19 pandemic can impact the drug supply chain.
• The FDA issued an EUA for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer. You can read more about how the test works here.
• The FDA is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested. The agency has discovered that some hand sanitizers are being packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles. Additionally, the FDA has found hand sanitizers that contain food flavors, such as chocolate or raspberry.
• Related, before you buy hand sanitizer or use hand sanitizer you have at home, the FDA recommends checking their do-not-use list here. They update the list regularly as new test results are released. The agency also recommends bookmarking the list in your web browser so that you can check each hand sanitizer before using it.
• CMS released guidance for nursing homes and clinical laboratories to assist in enhancing their abilities to prevent the spread of COVID-19 to nursing home residents and their frontline staff. The guidance requires all nursing homes to test all residents and staff for COVID-19.
• CMS released an additional list of FAQs to Medicare providers regarding the HHS Provider Relief Fund and the SBA’s Paycheck Protection Program payments. The FAQs provide guidance to providers on how to report provider relief fund payments, uninsured charges reimbursed through the Uninsured Program administered by HRSA, and SBA Loan Forgiveness amounts. The FAQs also address that provider relief fund payments should not offset expenses on the Medicare Cost Report.
• CMS is implementing a national nursing home training program for frontline nursing home staff and nursing home management. The training is designed to educate both frontline caregivers and their management about how to mitigate the spread of COVID-19 in their nursing homes. The training will be available on the CMS Quality, Safety & Education Portal.
• HHS announced the release of 1.5 million N95 respirators from the SNS for distribution to approximately 3,336 nursing home facilities across the U.S.
• The CDC recently revised testing guidelines, which no longer state asymptomatic individuals or individuals who have been exposed to an infected individual for less than 15 minutes should get tested for COVID-19. The change has been met with serious backlash from the public health community, who say the new guidelines diminish the importance and necessity of testing, particularly since asymptomatic people can transmit the virus. Today, CDC Director Robert Redfield said, "Everyone who needs a COVID-19 test can get a test. Everyone who wants a test does not necessarily need a test." Govs. Gavin Newsom (D) of California and Andrew Cuomo (D) of New York said their states will not be adopting the new guidelines.
• The CDC has updated their international travel guidelines and dropped the 14-day quarantine recommendation. The updated travel guidance does state that all returning travelers should social distance, wear a cloth face covering, wash their hands often, and watch for symptoms, but all of those have been recommended actions since the page was created back in March.
• The CDC announced the creation of MMWR Weekly COVID-19 Briefing, a weekly podcast to update readers on the latest scientific information from CDC’s COVID-19 response. In each episode, MMWR Editor-in-Chief Dr. Charlotte Kent provides an overview of the latest scientific information published in MMWR. New episodes are posted every Monday. You can subscribe here.
• The Administration of Community Living (ACL) is reminding everyone that this year's flu season may be complicated by the ongoing COVID-19 pandemic. Because some of the symptoms of flu and COVID-19 are similar, it may be hard to tell the difference between them based on symptoms alone, and testing may be needed to help confirm a diagnosis. The ACL says that, while there is currently no vaccine for COVID-19, you can safely get a flu vaccine at multiple locations including your doctor’s office, health departments, and pharmacies. Use VaccineFinder.org to find flu vaccines available near you.
• Rep. Jenniffer González-Colón, Puerto Rico’s nonvoting delegate to Congress, and Rep. Dan Meuser (R-PA) have tested positive for COVID-19.
• Though Speaker of the House Nancy Pelosi (D-CA) spoke with White House Chief of Staff Mark Meadows today about rekindling negotiations, there is still nothing new to report by way of an additional COVID relief package. For a more detailed description of what's on (or off) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• The FDA has issued an EUA for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on available scientific evidence, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product. The agency also published this decision memorandum.
  • The agency's decision has raised doubts among some experts who believe the therapy has not been adequately tested.
• The FDA issued a letter to health care providers (HCP) and health care facilities alerting them of the potential that passive protective barriers (those without negative pressure) pose an increased health risk to patients and HCPs when treating patients who are known or suspected to have Coronavirus Disease 2019 (COVID-19).
• The FDA issued an EUA to NovaSterilis, Inc. for its Nova2200, which can be used to decontaminate compatible N95 respirators for single-user reuse by HCP to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) during the COVID-19 pandemic.
• The FDA posted a new webpage that provides an overview of available resources related to SARS-CoV-2 screening testing and testing using pooled samples.
• The Department of Labor's Occupational Safety and Health Administration (OSHA) and the FDA have developed a checklist for human and animal food manufacturers to consider when continuing, resuming, or reevaluating operations due to the coronavirus pandemic. The checklist is useful for persons growing, harvesting, packing, manufacturing, processing or holding human and animal food regulated by FDA.
• The Administration for Community Living updated their COVID-19 resources page, which you can view here.
• Here is last week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The CDC continues to update its dashboard with new guidance documents and details, and I highly encourage exploring the newest toolkits. A few of the most recent additions include:
  • Updated considerations for schools
  • Overview of diagnostic testing
  • Guidance for shared or congregate housing
  • Food and coronavirus
• You can listen to the most recent CDC COVID-19 media telebriefing here.
• The CDC published their COVID-19 Response Health Equity Strategy: Accelerating Progress Towards Reducing COVID-19 Disparities and Achieving Health Equity. The guiding principles are: Reduce health disparities. Use data-driven approaches. Foster meaningful engagement with community institutions and diverse leaders. Lead culturally responsive outreach. Reduce stigma, including stigma associated with race and ethnicity.
• The CDC announced the creation of MMWR Weekly COVID-19 Briefing, a weekly podcast to update readers on the latest scientific information from CDC’s COVID-19 response. In each episode, MMWR Editor-in-Chief Dr. Charlotte Kent provides an overview of the latest scientific information published in MMWR. New episodes are posted every Monday. You can subscribe here.
• Rep. Jenniffer González-Colón, Puerto Rico’s nonvoting delegate to Congress, and Rep. Dan Meuser (R-PA) have tested positive for COVID-19.
• Last week, Republicans released their "skinny bill," another COVID-19 relief proposal. Bipartisan negotiations likely will not resume until after the nominating conventions have ended. For a more detailed description of what's on (or off) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).
• On Friday, HHS/HRSA announced an additional $1.4 billion in targeted distribution funding to almost 80 free-standing children’s hospitals nationwide. The announcement noted that children’s hospitals have seen decreasing patient visits and increased costs during the COVID-19 pandemic. This distribution will help to ensure children’s hospitals receive relief proportional to other hospitals across the nation and providers caring for children are able to continue operating safely in some of our most vulnerable communities. A preliminary state-by-state breakdown on validated distributions for next week can be found here. HHS will update this file once validation review of an additional 24 children’s hospitals are complete.
• HHS and the DoD, in support of Operation Warp Speed, announced that McKesson Corporation will be a central distributor of future COVID-19 vaccines and related supplies needed to administer the vaccinations. The CDC is executing an existing contract option with McKesson to support vaccine distribution. The company also distributed the H1N1 vaccine during the H1N1 pandemic in 2009-2010. The current contract with McKesson, awarded as part of a competitive bidding process in 2016, includes an option for the distribution of vaccines in the event of a pandemic.
• CMS announced on Friday that the agency has imposed more than $15 million in civil money penalties (CMPs) to more than 3,400 nursing homes during the public health emergency for noncompliance with infection control requirements and the failure to report COVID-19 data.
• The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts.
• The FDA issued an EUA for the emergency use of Baxter Healthcare Corporation’s REGIOCIT for adult patients being treated with continuous renal replacement therapy (CRRT) and for whom regional citrate anticoagulation is appropriate. The use of this product under the EUA is limited to critical care settings. CRRT is a “dialysis” treatment that provides renal support for critically ill patients with acute kidney injury. Baxter Healthcare Corporation’s REGIOCIT is available for use only in healthcare facilities that the company has qualified for receiving this product.
• The FDA is providing a device shortage list as part of the implementation of section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The device shortage list reflects the categories of devices that the FDA has determined to be in shortage at this time, and will be updated as the COVID-19 pandemic evolves. In addition, the FDA is providing a list of medical devices for which manufacturing has been permanently discontinued. Under section 506J, manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing. The publication of these lists allows for transparency to the public and stakeholders about devices shortages and manufacturing that has been permanently discontinued.
• The FDA issued Yale School of Public Health an EUA for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step.
• The CDC continues to update its dashboard with new guidance documents and details, and I highly encourage exploring the newest toolkits. A few of the most recent additions include:
  • Information for pediatric health care providers
  • When to quarantine
  • People with moderate to severe asthma
  • Operational Considerations for Immunization Services during COVID-19 in Non-US Settings Focusing on Low-Middle Income Countries
• The CDC also updated their increased risk page today to reflect recent data supporting increased risk of severe COVID-19 among individuals with cancer.
• The USDA reported that minks at two Utah fur farms have tested positive for the virus that causes COVID-19 in humans, announcing the first U.S. cases in a species that has been widely culled in Europe following outbreaks there.
• Negotiations for an additional coronavirus supplemental have fallen apart. Speaker Pelosi is standing firm at $2 trillion and the White House and Republican-led Senate have rejected the figure. For a more detailed description of what's on (or off, at this point) the table, and for a review of the broader COVID-19 legislative landscape, please refer to Sierra Fuller's COVID-19 Legislative Update (email sfuller@cgagroup.com to subscribe).

• President Trump’s national security adviser, Robert O’Brien, has tested positive for COVID-19. He is the most senior White House official known to have contracted the virus.
• The Moderna/NIH vaccine candidate has entered a Phase 3 clinical trial. The trial, which will be conducted at 89 U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19. Read more here.
  • If you're interested in learning more about all of the vaccine candidates, the New York Times has a very helpful tracker to follow vaccine development. It contains a list of 19 of the most-talked-about treatments for COVID-19.
• The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing. The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand use of the test to anyone, after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population. Additionally, the reissuance includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation. Sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more samples to be evaluated quicker.
• The FDA continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has posted a do-not-use list of dangerous hand sanitizer products, which is being updated regularly.
• A new FDA Voices, tilted FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability, describes how FDA has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.
• FDA delivered written testimony to the Senate Subcommittee on Manufacturing, Trade, and Consumer Protection. The statement, titled Protecting Americans from COVID-19 Scams, was by Catherine Hermsen, FDA’s Assistant Commissioner, Office of Criminal Investigations, Office of Regulatory Affairs.
• On July 29th at 12:15 PM, the FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
• HHS and DoD announced an agreement with Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine in the U.S. following the vaccine’s successful manufacture and approval. The agreement also allows the U.S. government to acquire an additional 500 million doses. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the U.S. if the product receives EUA or licensure from the FDA after completing demonstration of safety and efficacy in a large Phase 3 clinical trial. Read more here.
• Over the weekend, the FDA reissued an EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples. Read more about the announcement and sample pooling here.
• Tomorrow, July 21st, at 12 PM, the FDA, along with the CDC's National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host a webinar on Respirators for Health Care Personnel Use during the COVID-19 Pandemic. During this webinar, representatives from the FDA, the CDC, and OSHA will answer questions from webinar attendees in an open question and answer format.
• On July 22nd at 12:15 PM, the FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
• In a new FDA Voices, titled FDA Protects Patients and Consumers from Fraud During COVID-19, agency leaders explain that the FDA’s consumer protection work is a cornerstone of the agency’s mission and a critical component of its pandemic response efforts. In another new FDA Voices, titled FDA’s Continued Commitment to the Safety and Security of Our Laboratories, agency leaders explain that laboratory safety is of the highest priority in all of the agency’s scientific research and analytical facilities.
• Today, the FDA implemented and issued a guidance intended to help expand the availability of transport media used to transport certain clinical specimens for testing during the COVID-19 public health emergency. The FDA also posted answers to frequently asked questions relating to the development and use of transport media during the pandemic.
• Energy and Commerce Committee Chairman Frank Pallone (D-NJ), Health Subcommittee Chairwoman Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) wrote to FDA Commissioner Stephen Hahn regarding the agency’s work to determine the accuracy of COVID-19 diagnostic and serological tests. In their letter, the members raised similar concerns about serological tests, which are used to determine the presence of antibodies to the coronavirus. In March, citing the relative simplicity of serological tests, FDA allowed some serological tests to be used without first receiving an EUA, under certain conditions. As a result, a flood of unauthorized tests, which were later found to provide unreliable results, inundated the market. While FDA has since revised its guidance on serological tests, requiring developers to request an EUA, dozens of unreliable and unauthorized tests remain on the market.
• Democratic Leader Senator Chuck Schumer (D-NY) and Senator Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a white paper laying out a number of proposals from Senate Democrats to make sure COVID-19 vaccines are safe, effective, high quality, produced at scale, allocated in a manner that optimizes public health and reduces health disparities, free and accessible to everyone, and widely embraced by the public in order to end the COVID-19 pandemic and set the country on a path for economic recovery.
• Last week, the U.S. Surgeon General and HHS released a PSA ahead of the Fourth of July weekend imploring Americans to take action and to remember: COVID Stops With Me. The PSA from Surgeon General Jerome Adams reminds everyone to do their part to stay healthy by following a few simple instructions that will in turn, help prevent the spread of SARS-CoV-2, the virus that causes COVID-19. While we've passed the Fourth of July holiday, the message remains relevant.

• Last week, in an effort to prepare for the upcoming flu season during the COVID-19 pandemic, the FDA issued an EUA for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of having COVID-19 by their healthcare provider to the CDC.
• The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts.
• The FDA issued an EUA for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2. This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens. This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate, or waived complexity testing, meaning it can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument.
• HHS announced an agreement to secure large supplies of the drug remdesivir for the U.S. from Gilead Sciences through September, allowing American hospitals to purchase the drug in amounts allocated by HHS and state health departments. Supplies will be allocated in the same way that Gilead’s donation of approximately 120,000 treatment courses of remdesivir were allocated: HHS allocates product to state and territorial health departments based on COVID-19 hospital burden, and health departments allocate it to hospitals. The delivery of the purchased remdesivir will be streamlined, going directly to the hospital, per the state’s allocation decision, rather than going first to the state health departments for subsequent delivery to hospitals.
• You can view the FDA's daily COVID-19 roundup here.
• The CDC today highlighted considerations for wearing cloth face coverings. Emerging evidence from clinical and laboratory studies that shows cloth face coverings reduce the spray of droplets when worn over the nose and mouth. Wearing a mask is critical to protecting your own health and the health of others.
• The CDC continues to update its dashboard with new guidance documents and details, and I highly encourage taking a look at the succinct answers provided to frequently asked questions. Over the weekend and today, the agency updated considerations for restaurants and bars, strategies for optimizing the supply of face masks, and the newest travel recommendations by country.
• OSHA, the CDC, and the FDA released joint coronavirus-related interim guidance for employers and workers performing seafood processing operations in onshore facilities and aboard vessels offshore. The guidance includes recommended actions employers can take to reduce the risk of exposure to the coronavirus.
• President Trump signed a proclamation temporarily suspending work visas and barring more than half a million foreigners from coming to work in the U.S. in an effort to limit entry into the country during the pandemic. The restrictions would block entry into the U.S. under the H-1B visa program for high-skilled workers, and would also affect several other categories of visas, although it would exempt health care professionals and farm workers, among others.
• A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 has been stopped by NIH. A data and safety monitoring board (DSMB) met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19. After its fourth interim analysis, the DSMB, which regularly monitors the trial, recommended to the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, to stop the study.
• CMS has instructed Medicare Administrative Contactors and notified Medicare Advantage plans to cover COVID-19 laboratory tests for nursing home residents and patients. This instruction follows the CDC's recent update of COVID-19 testing guidelines for nursing homes that provides recommendations for testing of nursing home residents and patients with COVID-19 symptoms, as well as for asymptomatic residents and patients who have been exposed. Original Medicare and Medicare Advantage plans will cover COVID-19 lab tests consistent with CDC guidance.
• House Speaker Nancy Pelosi (D-CA) has asked committee leaders to invoke the chamber’s rule on decorum to prevent members who choose not to wear face coverings from taking part in hearings within the committee meeting rooms. House lawmakers are now required to wear masks during in-person committee meetings, but it will be up to the chairmen and chairwomen of those panels to decide on enforcement. The decision comes on the heels of updated guidance from attending physician Brian Monahan.
• Today, the FDA published the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry. Clinical trials and development across investigational product areas have been impacted by public health measures to control the COVID-19 virus; this guidance shares recommendations on statistical considerations to address the impact of COVID-19 on meeting objectives of clinical trials. This guidance applies to clinical trials of human medical products and animal drugs.
• The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents. This page answers questions about adverse event reporting for medical devices distributed under EUAs or that are the subject of COVID-19-related guidance documents and points out a number of adverse event reporting-related resources.
• The NIH has posted updated guidelines for COVID-19 treatment. Some of the key updates to existing sections include considerations for children and potential antiviral drugs under evaluation, and there are a few new sections on acute kidney injury and renal placement therapy and testing for the virus.
• Here is this week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• At its first full briefing in over three months, the CDC released new guidance regarding COVID-19. The agency is urging organizers of large gatherings to "strongly encourage" the use of face masks. The new guidance also provides information about how to reduce risk of illness during everyday activities. The audio recording of today's telebriefing is available here.
• The CDC updated its dashboard with 22 new guidance documents and details today. Most recently, the agency posted updated guidance for deciding to go out and going out, some additional considerations for gatherings, and update guidance on caring for your family.
• The Office for Civil Rights (OCR) at HHS issued guidance on how the HIPAA Privacy Rule permits covered health care providers to contact their patients who have recovered from COVID-19 to inform them about how they can donate their blood and plasma containing antibodies to help other patients with COVID-19.
• FDA issued an FDA Voices, titled Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19, which explains that the FDA’s work to advance treatments for rare diseases and help ensure continuity of care for patients with those diseases continues to be a top priority during the COVID-19 public health emergency.
• The CDC continues to update its dashboard with new guidance and details. Today, the agency posted updated guidance for pets and other animals, travel recommendations by country, and staffing resources for strengthening the public health workforce.
• The FDA posted FAQs to address questions related to the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 public health emergency.
• The FDA issued an EUA to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology. The FDA authorized the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. Using next generation sequencing means that the test can generate information about the genomic sequence of the virus present in a sample, which can be also used for research purposes.
• FDA Commissioner Stephen Hahn said today that the CDC and the White House task force will be issuing guidance that “will have a lot of specificity” around how to use coronavirus tests.
• The FDA and the NIH have made updates to the CURE ID crowd-sourcing app to make it easier for healthcare providers to share their experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial. CURE ID’s web-based repository lets providers share experiences with novel uses of existing drugs in treating difficult-to-treat infectious diseases. Healthcare providers worldwide are encouraged to share their COVID-19 treatment experiences via CURE ID.
• In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the FDA is reissuing certain EUAs to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the Agency has decided that certain respirators should not be decontaminated for reuse by health care personnel.
• The CDC continues to update its dashboard with new guidance and details. Today, the agency posted updated guidance for Administrators in parks and recreation facilities, additional resources for health departments, and details for investigating a COVID-19 case.
• HHS posted a fact sheet titled, "HHS Initiatives to Address the Disparate Impact of COVID-19 on African Americans and Other Racial and Ethnic Minorities."
• HHS announced new guidance that specifies what additional data must be reported to HHS by laboratories along with COVID-19 test results. The guidance standardizes reporting to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19. The requirements including reporting based on race, ethnicity, age, and sex of individuals tested for the virus. The announcement acknowledges that, as the country begins to reopen, access to clear and accurate data is essential to communities and leadership for making decisions critical to a phased reopening.
• Agriculture Sec. Sonny Perdue today announced the USDA Farm Service Agency (FSA) has approved more than $545 million in payments to producers who have applied for the Coronavirus Food Assistance Program. FSA began taking applications May 26th, and the agency has received over 86,000 applications for the program.

• CMS posted the first set of underlying COVID-19 nursing home data. On April 19th, the agency announced the requirement that nursing homes must inform residents, their families, and their representatives of COVID-19 cases in their facilities. Also, nursing homes are required to report COVID-19 cases and deaths directly to the CDC. Today CMS made this data publicly available. As part of today’s announcement, CMS is also posting the results from the targeted inspections announced on March 4th to allow inspectors to focus on the most serious health and safety threats like infectious diseases and abuse during the pandemic. Links to all of the data can be found in the agency's announcement.
• HRSA awarded $15 million to 52 Tribes, Tribal organizations, urban Indian health organizations, and other health services providers to Tribes across 20 states to prepare, prevent, and respond to COVID-19 in rural tribal communities. View the list of awards here.
• The FDA is hosting a virtual Town Hall on June 3rd at 12:15 PM for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for COVID-19.
• Vice President Mike Pence met with members of the American Camp Association by phone and led a discussion with camp owners and operators across the country to discuss the approach to safely and responsibly reopening summer camps amid COVID-19. A brief readout is available here.
• The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.” The guidance provides a mechanism for FDA-regulated establishments (human food facilities and farms) to voluntarily notify the agency of temporary closures and significant reductions in operations and to request assistance from FDA on issues that might affect continuity of their operations during the pandemic.
• The FDA issued a guidance document entitled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications” to provide answers to frequently asked questions. The agency is providing answers concerning certain aspects of sponsor requests for formal meetings with industry, user fee applications goals and timelines, and prioritization of drug and biological application reviews.
• HHS has delivered an 81-page COVID-19 Strategic Testing Plan to Congress. The report outlines the national-level testing strategy, and recommends that states test at least two percent of their population by the end of June. The linked document outlines a state-by-state approach to COVID-19 testing, rather than a centralized national effort.
• In response to the recent acceleration in the number COVID-19 cases in Brazil, President Trump has restricted U.S. entry for arriving travelers who have been to Brazil in the past 14 days. The list of international travel restrictions into the U.S. now includes: China, Iran, the European Schengen area, the U.K., the Republic of Ireland, and Brazil.
• Many government agencies were pretty quiet over the long weekend, but the CDC continued to churn out updated guidance and publish new COVID-19 documents to its dashboard. Over the last few days, the CDC published steps for evaluating and testing persons for COVID-19, new information about CDC diagnostic tests, and helpful information about antibody tests (among other resources). All CDC PSAs can be viewed here.
• Here is this week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The CDC has posted interim guidance for communities of faith after President Trump referred to places of worship as essential services and said he would overrule governors who disagreed that places of worship should be allowed to reopen.
• The CDC continues to update and publish new COVID-19 documents to its dashboard. Today, the CDC published steps for how to discontinue home isolation, an updated FAQ for COVID-19 and children, and further considerations for travelers in the U.S. (among other resources). Importantly, the CDC has also revised its guidelines about how the coronavirus spreads. According to the newest guidance, it does not spread easily on surfaces.
• HHS announced it has begun distributing $4.9 billion in additional relief funds to skilled nursing facilities (SNFs) to help them combat the effects of COVID-19. The announcement points out that nursing homes play a pivotal role in providing skilled care to vulnerable seniors. During this pandemic, nursing homes have faced unique challenges as their population of high risk seniors are more vulnerable to respiratory pathogens like COVID-19. This funding, which supplements previously announced provider relief funds, will be used to support nursing homes suffering from significant expenses or lost revenue attributable to COVID-19.
• Agriculture Sec. Sonny Perdue announced that the Department is making available up to $1 billion in loan guarantees to help rural businesses meet their working capital needs during the COVID-19 pandemic. Additionally, agricultural producers that are not eligible for USDA Farm Service Agency loans may receive funding under USDA Business & Industry (B&I) CARES Act Program provisions included in the CARES Act.
• FDA posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending EUA request or issued EUA. The FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16th and updated on May 4th, continue to be located on the notification list pending review of their EUA request.
• The FDA issued the guidance “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” to help foster the continued availability of medical. Per the guidance, the FDA does not intend to object to limited modifications to the design and manufacturing of devices approved through either a PMA or HDE without prior submission of a PMA or HDE supplement or 30-day notice for the duration of the public health emergency. The policy set forth in the guidance does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain issues resulting from the COVID-19 public health emergency or to any proposed changes described in a regulatory submission already received by the FDA.
• Through HRSA, HHS provided $225 million to Rural Health Clinics (RHCs) for COVID-19 testing.  These investments will support over 4,500 RHCs across the country to support COVID-19 testing efforts and expand access to testing in rural communities. RHCs are a special designation given to health care practices in underserved rural areas by CMS that help ensure access to care for rural residents. The funding is from the Paycheck Protection Program and Health Care Enhancement Act that was signed into law last month. A state-by-state breakdown of the funding is available here.
• Agriculture Sec. Sonny Perdue announced today that households in 13 new states – Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, Ohio, Oklahoma, Pennsylvania, Tennessee, and Virginia – will soon be able to purchase food online with their SNAP benefits. Once operational, online purchasing will be available in 36 states and D.C., home to more than 90 percent of SNAP participants. Sec. Perdue also announced an expansion of independently owned and operated retail stores beyond those included in the original pilot. Soon, more SNAP authorized retailers, under multiple store banners, will be accepting SNAP benefits online.
• The GAO published a new Science & Tech Spotlight article focused on COVID-19 testing.
• Responding to the Senate Finance Committee, the GAO submitted a report on infection control in nursing homes. The study concluded that infection control deficiencies were widespread and persistent in nursing homes prior to the COVID-19 pandemic.
• Agriculture Sec. Sonny Perdue, Labor Sec. Gene Scalia, NIH Director Francis Collins, HRSA Administrator Thomas Engels, and FDA's Director of the Center for Biologics Evaluation and Research Peter Marks are all joining the White House Coronavirus Task Force. According to Vice President Pence, the task force is now focused on getting Americans back to work and allowing businesses to reopen.
• The White House announced the details of Operation Warp Speed, an effort to dramatically shorten the development timeline for COVID-19 vaccines, therapeutics, and diagnostics and get them to the front lines as quickly as possible. The project's chief operating officer will be four-star General Gustave Perna, and former head of GlaxoSmithKline's vaccine's division, Moncef Slaoui, will serve as chief scientist.
• Here is this week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• The CDC published a series of flowcharts to provide guidance to state and local governments, schools and child care services, restaurants, and others regarding when and how to safely relax social distancing measures for various aspects of society.
• The CDC will award $10.25 billion in funding to jurisdictions using funds from the Paycheck Protection Program and Health Care Enhancement Act. These funds will be directed to states, localities, and territories to develop, purchase, administer, process, and analyze COVID-19 tests, conduct surveillance, trace contacts and related activities
• The CDC continues to update and publish additional COVID-19 documents to its dashboard. Today, the CDC published updated information about worker safety and support, planning for colleges and universities, correctional and detention facilities, and an air travel toolkit for airline partners (among other resources).
• HHS has extended the deadline for healthcare providers fighting COVID-19 to attest to receipt of payments from the Provider Relief Fund and accept the Terms and Conditions. Providers will now have 45 days, increased from 30 days, from the date they receive a payment to attest and accept the Terms and Conditions or return the funds.
• To date, the FDA has issued 42 warning letters to companies making bogus COVID-19 claims, including one to a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, frequently referred to as “Miracle Mineral Solution” or “MMS,” as a treatment for COVID-19. After the seller refused to take corrective action, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product.
• Through HRSA, HHS awarded nearly $583 million to 1,385 HRSA-funded health centers in the U.S. to expand COVID-19 testing. Nearly 88 percent of HRSA-funded health centers report testing patients, with more than 65 percent offering walk-up or drive-up testing. Health centers are currently providing more than 100,000 weekly COVID-19 tests in their local communities. The funding for these centers is part of the “COVID 3.5” bill signed into law last month. Here is a list of award recipients.
• COVID-19 hearings in Congress this week (memos available upon request):
  • Today (5/7)
    • 10:00 AM – Senate Health, Education, Labor and Pensions (HELP) Committee Hearing: "Shark Tank: New Tests for COVID-19"
• COVID-19 hearings in Congress next week:
  • Tuesday (5/12)
    • 10:00 AM – Senate HELP Hearing: "COVID-19: Safely Getting Back to Work and Back to School"
    • 2:30 PM – Senate Judiciary Hearing: “Examining liability during the COVID-19 pandemic”
  • Wednesday (5/13)
    • 10:00 AM – Senate Commerce Hearing: "The State of Broadband Amid the COVID-19 Pandemic"
  • Thursday (5/14)
    • 10:00 AM – House Energy and Commerce Hearing: “Protecting Scientific Integrity in the COVID-19 Response”
• The FDA announced updates to its March 16^th policy on commercial manufacturers’ serology tests (antibody tests) for COVID-19. Under the new policy, FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of the updated policy publication date, or the date they notify FDA of their test validation, whichever is later.
• An internal report in the Trump Administration projects about 200,000 new cases and 3,000 deaths each day by the end of the May/beginning of June. So far, no agency or department has claimed authorship over the document that contained the new projections.
• The National Institute of Allergy and Infectious Diseases (NIAID) at the NIH is funding a study to help determine the rate of COVID-19 infection in children and their family members in the U.S. The study, called Human Epidemiology and Response to SARS-CoV-2 (HEROS), has started to enroll patients. HEROS will help determine what percentage of children infected with SARS-CoV-2, the virus that causes COVID-19, develop symptoms of the disease. In addition, the HEROS study will examine whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not.
• The Senate has returned to D.C. (with skeleton staffs) and are jumping right in with hearings. The slated COVID-19 hearings are:
  • Wednesday (5/6)
    • 10:00 AM – House Appropriations, Labor-HHS: “COVID-19 Response.” Notably, the White House denied the Committee’s request for Dr. Tony Fauci to testify at this hearing and have since announced that no members of the White House Coronavirus Task Force will be allowed to testify before Congress this month.
    • 2:00 PM– Senate Homeland Security and Governmental Affairs Committee Hearing: "Roundtable - COVID-19: How New Information Should Drive Policy."
    • 2:30 PM – Senate Commerce, Science and Transportation Hearing: "The State of the Aviation Industry: Examining the Impact of the COVID-19 Pandemic."
  • Thursday (5/7) 10:00 AM – Senate Health, Education, Labor and Pensions Committee Hearing: "Shark Tank: New Tests for COVID-19."

• The FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.
• The FDA published Q&A about COVID-19 and pets.
• The federal government is reportedly initiating an effort called “Operation Warp Speed” to speed the development and production of countermeasures against COVID-19, including vaccines. The program will reportedly provide liability protection and funding for vaccine developers. Operation Warp Speed has not officially been announced by the government.
  • It is unclear how much money will be allocated to this program, but the goal is reportedly to manufacture hundreds of millions of treatment/vaccine doses by the end of 2020.
• The CDC continues to update their dashboard. Today, they notably updated the social media toolkit and guidance for contact tracing. Recently, they updated and published the most recent reopening guidelines for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools, and Homes.
• Betsy DeVos announced today that nearly $1.4 billion in additional funding will be directed to Minority Serving Institutions (MSIs), including Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), as well as institutions serving low-income students to help ensure learning continues during the coronavirus national emergency. This funding is part of the Higher Education Emergency Relief (HEER) Fund authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
• The White House released the Opening Up America Again Testing Overview and Testing Blueprint to facilitate state development and implementation of the testing plans and rapid response programs described in the President’s Opening Up America Again Guidelines. The blueprint describes a partnership between federal, state, local, and tribal governments, and the private sector. The overview and blueprint do not specify how states will be able to test at least 2 percent of their populations every month, which is what administration officials had promised.
• President Trump signed the interim emergency relief fund package last week, which replenishes the SBA Paycheck Protection Program (PPP), and includes funding for hospitals, testing, and disaster loan programs. You can view the bill text here and a section by section summary here. With Congress set to return next Monday, May 4^th, discussion of a fourth COVID supplemental funding package has continued. For a more thorough update on the federal legislative landscape, please refer to the COVID-19 Legislative Update from Sierra Fuller which is published every Monday, Wednesday, and Friday. If you do not already receive that update and would like to subscribe, please email sfuller@cgagroup.com.
• The CDC has been busy uploading new guidance and updated resources for COVID-19 on their dashboard. On Sunday, the agency posted an interim guidance document for meat and poultry processing workers and employers. Today, there is more information about contact tracing, new symptoms associated with COVID-19, and a toolkit for transportation partners to inform road travelers.
• Yesterday, CMS announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program (AAP) and suspending its Advance Payment Program to Part B suppliers effective immediately. Since expanding the AAP programs on March 28^th, CMS approved over 21,000 applications totaling $59.6 billion in payments to Part A providers, which includes hospitals. For Part B suppliers, including doctors, non-physician practitioners, and durable medical equipment suppliers, CMS approved almost 24,000 applications advancing $40.4 billion in payments.
• President Trump signed the interim emergency relief fund package Friday April 24, which includes $310 billion to replenish the SBA Paycheck Protection Program (PPP), $60 billion for separate disaster loans to small businesses ($50 billion for the Economic Injury Disaster Loan program and $10 billion for the Emergency Economic Injury Grant program), $75 billion in emergency funds for hospitals, and $25 billion for testing. You can view the bill text here and a section by section summary here. For a more thorough update on the federal legislative landscape, please refer to the COVID-19 Legislative Update from Sierra Fuller which is published every Monday, Wednesday, and Friday. If you do not already receive that update and would like to subscribe, please email sfuller@cgagroup.com.
• Here is this week’s COVIDView from CDC, a weekly summary and interpretation of key indicators that have been adapted to track the COVID-19 pandemic in the U.S.
• Sens. Mitt Romney (R-UT) and Kyrsten Sinema (D-AZ) wrote a letter to CDC Director Robert Redfield expressing concern that federal public health officials are “behind the curve in assessing public health threat levels, because they lack immediate visibility into population health data.” In the letter, they press the CDC to implement a real-time national system for tracking COVID-19.
• The Trump Administration released a new toolkit for states to help accelerate adoption of broader telehealth coverage policies in the Medicaid and Children’s Health Insurance Programs (CHIP). The toolkit will help states identify policies which may impede rapid deployment of telehealth services, such as pediatric considerations, coverage and reimbursement policies, and technology requirements.
• Education Sec. Betsy DeVos announced the availability of more than $13.2 billion in emergency funding to support continued learning for K-12 students impacted by COVID-19. Education leaders will have flexibility to use these funds from the Elementary and Secondary Education Relief Fund (ESSER Fund) for immediate needs.
  • State education agencies (SEAs) must allocate 90% of their ESSER funds to local education agencies (LEAs), including public charter schools, in proportion to the  amount of FY 2019 funds the LEA received under Title I, Part A of the Elementary and Secondary Education Act.
• The Senate passed more than $480 billion in interim emergency relief this afternoon. The legislation includes $310 billion to replenish the SBA Paycheck Protection Program, $60 billion for separate disaster loans to small businesses ($50 billion for the Economic Injury Disaster Loan program and $10 billion for the Emergency Economic Injury Grant program), $75 billion in emergency funds for hospitals, and $25 billion for testing. The House is expected to vote on the measure as soon as Thursday. For a more thorough update on the federal legislative landscape, please refer to the COVID-19 Legislative Update from Sierra Fuller which is published every Monday, Wednesday, and Friday. If you do not already receive that update and would like to subscribe, please email sfuller@cgagroup.com.
• President Trump announced that he would be ordering a temporary ban on immigration to the U.S. He has backed down from his original plan to also suspend guest worker programs. The order will be in place for 60 days, with the potential to be extended longer if deemed necessary.
• House Majority Leader Steny Hoyer sent a letter to chairs of the House Administration and Rules Committees urging them to consider a set of recommendations to enable remote voting and committee work, and that also prepare Congress to work remotely even when back in Washington to comply with social distancing guidelines.
• Agriculture Sec. Sonny Perdue announced today that Arizona and Illinois have been approved to operate Pandemic Electronic Benefit Transfer (EBT), a new program authorized by the Families First Coronavirus Response Act (FFCRA) which provides assistance to families of children eligible for free or reduced-price meals dealing with school closures.
• FDA Commissioner Dr. Stephen Hahn, Director of the Center for Biologics Evaluation and Research Dr. Peter Marks, and Director of the Center for Drug Evaluation and Research Dr. Janet Woodcock wrote an article for the FDA’s Coronavirus Treatment Acceleration Program (CTAP).
• HHS announced an ongoing partnership with Oracle, including Oracle's donation to HHS of the Therapeutic Learning System, an online platform designed to collect real-time medical data related to COVID-19. The Therapeutic Learning System is a safe, secure web portal designed to gather crowd-sourced, real-time information from doctors and other clinicians about how patients are responding to possible therapeutics to treat COVID-19. The data will not be owned by Oracle or any other private entity.
• SAMHSA has begun to release emergency grants to strengthen access to treatments for substance use disorders and serious mental illnesses during the COVID-19 pandemic, according to an announcement this afternoon.
• Agriculture Sec. Sonny Perdue announced the Coronavirus Food Assistance Program (CFAP). The $19 billion USDA program will take several actions to assist farmers, ranchers, and consumers in the response to COVID-19. CFAP will use the funding and authorities provided in the CARES Act, the Families First Coronavirus Response Act (FFCRA), and other USDA existing authorities to provide direct support to farmers and ranchers, and partner with regional and local distributors to purchase produce, dairy, and meat.
• Senate Finance Committee Ranking Member Ron Wyden (D-OR) along with 11 Democratic members of the Senate Finance Committee sent a letter to HHS Sec. Alex Azar calling on him to distribute the remaining COVID-19 aid to health care providers in an equitable and transparent way, claiming the first $30 billion dollars failed to deliver funds to where they are needed most.
• The NIH announced the launch of a public-private partnership to speed up the development of a COVID-19 vaccine and treatment options. Government and industry partners will provide infrastructure, subject matter expertise and/or funding (both new and in-kind) to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials. Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to COVID-19.
  • The government agencies involved are: NIH; ASPR; FDA; CDC; and European Medicines Agency.
  • The industry partners are: AbbVie; Amgen; AstraZeneca; Bristol Myers Squibb; Evotec; GlaxoSmithKline; Johnson & Johnson; KSQ Therapeutics; Eli Lilly and Company; Merck & Co., Inc.; Novartis; Pfizer; Roche; Sanofi; Takeda; and Vir Biotechnology.
• The White House released guidelines for Opening Up America Again. The guidelines recommend that states document a “downward trajectory” in cases of COVID-19 and flu-like illnesses before relaxing stay-at-home orders. States could then proceed into a three-phase reopening process, according to the guidelines. The guidelines recommend that employers develop and implement social distancing practices, temperature checks at workplaces, testing for the virus, and increased sanitation and use of disinfection. President Trump said today that governors could begin reopening businesses, restaurants, and other elements of daily life by May 1^st or earlier.
• The President also hosted a call with a bipartisan group of members of Congress who will serve on the “Opening Up America Again Congressional Group.” The list of members can be found here.
• The FEMA Healthcare Resilience Task Force created a COVID-19 Hospital Resource Package. The document contains guidance and resources for hospital administrators, hospital emergency planners and infection control practitioners in the following topical areas: hospital surge, crisis standards of care, staffing surge and resilience, workforce protection, regulatory relief, equipment supply surge and telemedicine.
• The CDC has posted multiple new guidance documents on its COVID-19 dashboard, including considerations for pharmacies, guidance for training for healthcare professionals and the newest travel guidelines.
• Senators released two documents today, A Roadmap to Reopening by Ensuring a Speedy and Ubiquitous Lab Testing System (RESULTS) and a report from DPCC: U.S. Lags the World in Testing, Leads the World in COVID-19 Cases. The reports outline Democrats' proposals to rapidly expand testing capacity. Democrats note in the report that the U.S. is testing around one in every 273 people for COVID-19, while South Korea and Germany have been testing one in every 100 people.
• Rep. Raja Krishnamoorthi (D-IL) sent a letter to Philips North America Corporation requesting information and documents regarding its foreign sales of ventilators, after entering into contract with HHS to provide ventilators to the U.S. stockpile. In the letter, Rep. Krishnamoorthi says Philips has been selling ventilators to foreign clients at much higher prices than what it would have received from HHS.
• Democratic Whip Dick Durbin (D-IL) led a letter signed by 37 senators to President Trump urging him to automatically extend work authorizations for Deferred Action for Childhood Arrivals (DACA) and Temporary Protected Status (TPS) recipients and other impacted immigrants.
• Energy and Commerce Committee Chairman Frank Pallone (D-NJ) sent a letter to CMS Administrator Seema Verma today urging the agency to release demographic data on the health outcomes of COVID-19 based on race, ethnicity, and gender.  His letter comes after multiple data sources continue to show that COVID-19 disproportionately affects individuals from racial and ethnic minority communities. In New York City, Latino and African American residents had double the age-adjusted death rates as compared to white residents. In Chicago, 64.6 percent of deaths and 49.6 percent of total cases are among African American residents, despite African Americans only making up approximately 30 percent of the city’s population.
• The CDC has posted multiple new guidance documents on its COVID-19 dashboard, including useful information about how to wear a cloth face covering and how COVID-19 spreads.
• The Supreme Court announced it will hear arguments, including cases on subpoenas, over the phone during six days in May.
• Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products are available for patients:
  • Today, the FDA published product-specific guidances to support generic drug development for these drugs.
  • The FDA is currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
• The FDA issued a Consumer Update: How You Can Make a Difference During the Coronavirus Pandemic. It explains ways to help, such as donating blood, protecting yourself and others, saving protective equipment for front line workers, and reporting fraudulent products to the agency.
• The FDA added new questions and answers to the webpage Q&A for Consumers: Hand Sanitizers and COVID-19. These new questions focus on unintentional ingestion of hand sanitizer by children, as there has been an increase in calls to Poison Control for unintentional ingestion of hand sanitizer during the COVID-19 pandemic.
• HHS announced they are beginning the delivery of the initial $30 billion in relief funding to providers in support of the national response to COVID-19 as part of the distribution of the $100 billion provider relief fund provided for in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The initial $30 billion in immediate relief funds started being delivered to providers today.
• The CDC announced the extension of a no sail order for cruise ships. The order says it shall continue in operation until the earliest of (1) the expiration of the HHS Sec.’s declaration that COVID-19 constitutes a public health emergency; (2) the CDC Director rescinds or modifies the order based on specific public health or other considerations; or (3) 100 days from the date of publication in the Federal Register. The agency has reported that there are 100 cruise ships at sea off of U.S. coasts, with 80,000 crew members on board. Twenty ships at port or anchorage in the U.S. have known or suspected cases of COVID-19.
• The CDC has published this week’s “COVIDView,” a weekly surveillance summary of U.S. COVID-19 activity.
• The CDC updated its travel recommendations by country.
• CMS is proposing a rule to continue their efforts to strengthen Medicare by aligning payments for inpatient psychiatric facilities (IPFs) with the costs of providing care. The proposed rule would update Medicare payment policies and rates for the IPF Prospective Payment System (PPS) for Fiscal Year (FY) 2021. CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for IPFs on an annual basis.
• CMS issued a proposed rule [CMS-1737-P] for Fiscal Year (FY) 2021 that updates the Medicare payment rates and the quality programs for skilled nursing facilities (SNFs).
• Education Sec. Betsy DeVos said today she was moving to "immediately distribute" the $6 billion in coronavirus economic stimulus money that has been earmarked for emergency financial aid grants to college students. The funding is the first tranche of the nearly $31 billion of overall education aid that was included as part of last month’s stimulus package. The bill makes available aid for college students for things like technology, course materials, food, shelter, and health care. Allocations are available here.
• CMS announced this on April 8th that they have temporarily suspended a number of rules so that hospitals, clinics, and other health care facilities can boost their frontline medical staffs. The changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and “perform work to the fullest extent of their licenses.”
• CMS has updated their Q&A to assist Medicare providers to a more recent version.
• The Office for Civil Rights (OCR) at HHS announced that it will exercise its enforcement discretion and will not impose penalties for violations of the HIPAA Rules against covered entities or business associates in connection with the good faith participation in the operation of COVID-19 testing sites during pandemic response. The notification was issued to support certain covered health care providers, including some large pharmacy chains, and their business associates that may choose to participate in the operation of a Community Based-Testing Site (CBTS), which includes mobile, drive-through, or walk-up sites that only provide COVID-19 specimen collection or testing services to the public.
• The CDC released interim guidance on March 8 that details how essential employees can go back to work even if they have been exposed to people infected by COVID-19 as long as they do not feel sick and follow certain precautions. Per the guidance, employees can return to work if they take their temperature before heading to their workplaces, wear a face mask at all times, and practice social distancing while on the job.
• The CDC removed guidance for doctors on how to prescribe hydroxychloroquine and chloroquine, drugs recommended by President Donald Trump to treat COVID-19 that lack evidence to support their efficacy.
• HHS announced the first contract for ventilator production rated under the Defense Production Act (DPA) to General Motors (GM). GM’s contract, at a total contract price of $489.4 million, is for 30,000 ventilators to be delivered to the SNS by the end of August, with a production schedule allowing for the delivery of 6,132 ventilators by June 1^st.
• Soon after, HHS announced the second contract for ventilator production rated under the DPA to Philips. Philips’s contract for $646.7 million is for a production schedule allowing for the delivery of 2,500 ventilators to the SNS by the end of May, and a total of 43,000 ventilators to be delivered by the end of December.
• On Monday April 7 White House press briefing, President Donald Trump criticized the WHO for being slow to respond to the pandemic and accused the organization of being “China-centric.” He followed that by saying the U.S. will be putting a hold on giving money to the WHO.
• President Trump removed Glenn Fine, the Pentagon’s acting inspector general, who had been tasked with overseeing the $2 trillion stimulus package spending. In his place, the President has named the EPA’s inspector general, Sean O’Donnell, as the new acting inspector general for the DoD.
• The CDC released several new guidance pages and resources today including: PPE burn rate calculator, guidelines for running essential errands, interim additional guidance for outpatient and ambulatory care settings, and more.
• Today, the FDA approved an Abbreviated New Drug Application (ANDA) for 200mg hydroxychloroquine tablets. The agency had recently posted information about hydroxychloroquine shortages due to a significant surge in demand, and is working with manufacturers to get supply under control.
• The FDA continues to update its COVID-19 Q&A page here and has published its April 7^th roundup here.
• CMS announced it has delivered near $34 billion in the past week to frontline health care providers battling COVID-19. The funds have been provided through the expansion of the Accelerated and Advance Payment Program.
• The CDC is now urging all Americans to wear a face covering (ideally a non-medical mask or scarf covering their mouth and nose) when they leave their homes. They have published a Q&A page for cloth face coverings and have updated the prevention page to include guidance on the use of cloth face coverings as a means to mitigate spread of COVID-19.
• The FDA held a webinar with device manufacturers and industry partners to discuss its guidance on enforcement policy for PPE during COVID-19. Recording and transcript of the webinar can be found here.
• HHS also reported its planned purchase of the ID NOW COVID-19 rapid point-of-care test, developed by Abbott Diagnostics Scarborough Inc. The ID NOW test, which provides results in under 13 minutes, will be distributed to public health labs in every state and territory.
• CMS released a video providing answers to common questions about the Medicare telehealth services benefit.
• CMS approved a number of additional state waivers to address the COVID-19 pandemic, including Section 1135 Medicaid waivers, Appendix K waivers for programs that care for elderly, and blanket waivers that permit Medicare-enrolled Ambulatory Surgical Centers (ASCs) to temporarily enroll as hospitals.
• The CDC has started publishing “COVIDView,” a weekly surveillance summary of U.S. COVID-19 activity. The report summarizes and interprets key indicators including information related to COVID-19 outpatient visits, emergency department visits, hospitalizations and deaths, as well as laboratory data.
• The CDC has also released new guidance for how cruise ship passengers will be able to travel home. Previously, passengers who were exposed to COVID-19 but showed no symptoms were allowed to travel home on commercial flights if they had no fever. With the newly released guidance, cruise companies will have to charter flights to return passengers to their home cities. The decision was released as 1,000 passengers were going to disembark the Coral Princess, which docked in Miami on Saturday.
• HUD announced new CARES Act mortgage payment relief options for single family homeowners with FHA-insured mortgages who are struggling financially due to the coronavirus pandemic.
  • HUD also issued availability of regulatory waivers for Continuum of Care, Emergency Solutions Grant, Housing for Persons with AIDS, and Consolidated Plan requirements.
• Members of Congress are now looking ahead to a fourth supplemental funding package. House Dems are expected to take the lead on a fourth package, and Speaker Pelosi has indicated that the infrastructure framework from January will be the starting point of whatever bill they introduce. For a more thorough update on the legislative landscape, please refer to the COVID-19 Legislative Update from Sierra Fuller. If you do not already receive that update and would like to subscribe, please email sfuller@cgagroup.com.
• Rep. Adam Schiff (D-CA) is drafting legislation to establish a 9/11-style independent commission to review the country’s coronavirus response. The legislation is “very preliminary” and will likely not be released until the coronavirus crisis has subsided.

• The FDA approved the first test for coronavirus antibodies for use in the U.S. While current tests can tell if a person is still infected, the Cellex antibody test is the first to receive authorization and can tell whether a patient has ever been exposed and if they might have some immunity.
  • A similar test, created by BioMedomics, has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance the agency issued on March 16^th.
• The FDA has published guidance to address the need for blood during the pandemic.
• FEMA told the House Oversight Committee today that the 100,000 ventilators promised by President Trump will not be available until June. Following the release of this information, the President invoked the Defense Production Act, which directs General Electric Co., Hill-Rom Holdings Inc., Medtronic Public Limited Co., ResMed Inc., Royal Philips N.V., and Vyaire Medical Inc. to make ventilators. It also directs acting Homeland Security Sec. Chad Wolf and HHS Sec. Alex Azar to "use any and all authority available under the Act to facilitate the supply of materials" to these companies.
• Dr. Fauci has reportedly required increased security due to threats to his personal safety as well as unwelcome communication from fervent admirers.
• FEMA has a rumor control website to discern factual claims from fictional ones in regard to COVID-19.
• The FDA today announced multiple actions taken in the ongoing response effort to the COVID-19 pandemic, including the development of reference sequence data for the U.S., a constituent update regarding guidance for flexibility for chain restaurants, a warning letter to Neuro XPF (cannabidiol products), and a diagnostics update.
• The HHS Assistant Secretary for Health and U.S. Surgeon General issued an open letter to the health care community stressing the need to aggressively implement the following four measures:
  • Rigorous adherence to all social distancing measures, including limitations on gatherings and travel. This is the best way to reduce infections and thus demand for ventilators.
  • Optimize the use of mechanical ventilators, which includes canceling elective surgeries as well as transitioning other medical equipment for mechanical support for respiratory failure.
  • Judicious, data-driven requests and usage of the SNS of ventilators and equipment. To be able to allocate ventilators where they are most needed, all states must be data-driven in their requests based on the actual capacity for mechanical ventilation, including anesthesia machine conversions.
  • Increasing the capacity of the SNS through federal procurement. The SNS will receive at least an additional 20,000 mechanical ventilators by mid-May 2020.
• The FDA created the Coronavirus Treatment Acceleration Program (CTAP), as the federal government’s primary organization to develop and test COVID-19 treatments. CTAP will have a major focus on public private partnerships. CTAP is currently exploring antiviral drugs like remdesivir that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients. Work is also ongoing to evaluate whether existing therapies such as chloroquine and hydroxychloroquine (with or without other medications) help treat patients with COVID-19.
• President Trump on Sunday issued a major disaster declaration for Washington, D.C., marking the 22^nd state/territory to receive a major disaster declaration and federal assistance from FEMA. The declaration allows states and territories to access federal funds to combat the coronavirus.
• The Capitol Visitor Center and House and Senate office buildings will be closed to the public though May 1st.
• On Friday March 27, the House passed and the President signed the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act. The bill text is available here, and a section-by-section is here.