Federal Updates - Washington D.C. Archives

December 2020

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:

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:
    • 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.
  • 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:
  • 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:
  • 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:
  • 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.
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