New document reveals scope and structure of Operation Warp Speed

WASHINGTON — When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”

The initiative — to accelerate the development of Covid-19 vaccines and therapeutics — lacks the scale, and the degree of secrecy, of the effort to build the atomic bomb. But Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact.

Now, an organizational chart of the $10 billion initiative, obtained by STAT, reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists.

The labyrinthine chart, dated July 30, shows that roughly 60 military officials — including at least four generals — are involved in the leadership of Operation Warp Speed, many of whom have never worked in health care or vaccine development. Just 29 of the roughly 90 leaders on the chart aren’t employed by the Department of Defense; most of them work for the Department of Health and Human Services and its subagencies.

Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January — and the military is intimately involved, according to Paul Mango, HHS’ deputy chief of staff for policy. It has already helped prop up more than two dozen vaccine manufacturing facilities — flying in equipment and raw materials from all over the world. It has also set up significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from “state actors who don’t want us to be successful in this,” he said, adding that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.

“This is a massive scientific and logistical undertaking,” said Mango. “We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”

Despite the military’s dominance, the chart also includes Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases who was almost fired by Trump in February for warning the public about the growing Covid-19 pandemic. Public health and drug industry officials told STAT that Messonnier and Gen. Paul Ostrowski, her direct superior, serve as the initiative’s main contacts on all questions related to the distribution of an eventual vaccine. One public health official said that Ostrowksi, an expert on military acquisition, defers to Messonnier on matters of public health.

The military’s extensive involvement in the development and distribution of a vaccine is a departure from pandemics of the past, but it is fitting for Trump, who has gushed about his love for “my military” and “my generals.” While the military was tangentially involved in public health crises like the H1N1 pandemic of 2009, some public health leaders have raised concerns about what they see as their marginalization during the pandemic.

One senior federal health official told STAT he was struck by the presence of soldiers in military uniforms walking around the health department’s headquarters in downtown Washington, and said that recently he has seen more than 100 officials in the corridors wearing “Desert Storm fatigues.”

“Military personnel won’t be familiar with the health resources available in a community,” said John Auerbach, CEO of Trust for America’s Health, a group closely aligned with public health departments. “They don’t know who the doctors are or where the community health centers are located or what resources they have. They don’t know where the pharmacies are. Public health people do know, that’s part of what they do.”

Military officials, however, contend that the U.S. Army excels at complex challenges — like distributing vaccines that might need to be transported at subzero temperatures.

“You know the old joke about, ‘You and what army,’ right?” said Andrew Hunter, a Defense Department expert at a Washington think tank, the Center for Strategic and International Studies. “They routinely do things that are more complex, even than this vaccine job, all the time.”

Mango told STAT the operation has kept some key personnel information under wraps out of concerns for the security of the entire vaccine supply chain, from the warehouses storing vaccines to the computer systems being used to coordinate the effort.

“The secretary has given us the order of being as transparent as we possibly can with one caveat: That we are not compromising anything that has to do with national security,” he said.

An HHS spokesperson declined to comment directly on the chart, citing precedent that the agency does not comment on leaked documents. But the spokesperson noted that at least 600 HHS officials are involved in Warp Speed. The majority of those employees are not captured by the chart obtained by STAT. Among the decision makers not included in the chart are Mango and HHS’ Assistant Secretary for Preparedness and Response, Bob Kadlec. Mango told STAT that he and Kadlec personally sign off on every business agreement made by HHS for Operation Warp Speed.

Mango also added that the vast majority of scientists working on Operation Warp Speed work for the companies the effort is funding.

“There’s really not a need for anyone to place scores of scientists inside HHS or DOD to get this done,” Mango said. “Quite honestly, we are not conducting any science whatsoever inside the government to support Operation Warp Speed, none.”

He also defended the military’s involvement in the initiative, though he insisted that it is primarily supporting efforts led by public health officials at the CDC.

“There are quite honestly certain logistical elements of this that the CDC has never, ever been asked to do, and why not bring the best logisticians in the world into the equation?” Mango said.

Beyond obtaining the internal document from a federal official, STAT interviewed companies funded by Warp Speed and more than a dozen key officials who have worked closely with the organization’s leaders. The reporting sheds light on the high degree of organization and specialization within the organization, as well as the extreme demands the initiative is placing on the companies it funds.

Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January. The initiative has poured $10 billion into the clinical development and manufacturing of potential vaccine candidates, and it has stockpiled hundreds of thousands of doses of as-yet-unproven immunizations. Warp Speed has deals with six major drug companies hoping to develop Covid-19 vaccines and may seek more, the group’s chief adviser, Moncef Slaoui, told STAT earlier this month.

Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, approvingly called Operation Warp Speed a “talent show.”

“If you go through the organizational boxes of Operation Warp Speed, they’re very, very impressive,” Fauci told STAT in an interview Friday.

Tom Inglesby, the director of the Johns Hopkins Center for Health Security, with whom STAT shared the organizational chart, agreed that the initiative appears well-positioned to achieve its ambitious goals — and under a tight timeline.

“There is deep knowledge of science and on how to manage complex government operations,” said Inglesby. “It’s clearly operating in a challenging pandemic and political environment, and we won’t know if we have a safe and effective vaccine until the trials are finished. But it’s a highly competent group of people working to make it happen.”

Though HHS Secretary Alex Azar and Defense Secretary Mark Esper are at the top, the two key leaders are Slaoui, the formal civilian leader of the project, and Gen. Gustave Perna, the military lead who is the chief operating officer for Operation Warp Speed.

Under Slaoui are two major pillars, “Vaccine” and “Therapeutics.” Under Perna are three pillars, for “Plans, Ops and Analysis,” “Security and Assurance,” and “Supply, Production and [Distribution].”

But the complexity of the organization makes it difficult as an outsider to discern who is reporting directly to who, experts in business management who reviewed the chart told STAT.

“It’s confusing for sure,” said Robert Huckman, the chair of Harvard Business School’s health care initiative, who studies health care management and organization. Huckman added that the chart was more complex than most he’s seen. “It is more complex, but it’s a more complex endeavor, too … it may be that it simply reflects the complexity of what Operation Warp Speed is trying to do.”

“I can only imagine the headache that comes with trying to coordinate these different production processes,” said Raffaella Sadun, a professor of business administration at Harvard Business School who studies CEO behavior.

Slaoui’s tenure thus far at Warp Speed has been marked by outside concerns over his personal financial stake in some of the companies he is now overseeing. Slaoui, who holds roughly $10 million in GSK stock, is not bound by federal ethics rules because he is employed by an outside contractor, not the federal government. Slaoui has agreed to donate any increase in the value of that stock, although that agreement hasn’t placated critics.

“The first person to be fired should be Dr. Slaoui,” Sen. Elizabeth Warren (D-Mass.) said at a hearing last week. “The American people deserve to know that Covid-19 vaccine decisions are based on science, and not on personal greed.”

But Slaoui knows firsthand, perhaps better than anyone else, what it takes to dramatically speed up the search for a vaccine. He played a pivotal role in GSK’s sprint to develop an Ebola vaccine in 2015. The effort ultimately failed, but he is so well-regarded at GSK that the company named its vaccine research center after him in 2016.

Perna, meanwhile, is a four-star Army general who previously managed virtually all of the Army’s logistics. He was even inducted into the Army’s own logistics hall of fame. He most recently served as head of Army Materiel Command, a sprawling job that handles virtually all of the Army’s equipment. The organization’s slogan is: “If a Soldier shoots it, drives it, flies it, wears it, communicates with it, or eats it — AMC provides it.”

During his tenure, Perna constantly pushed the Army to move faster, and to be more ready to go to war at a moment’s notice.

Below Perna and Slaoui are a team of military and civilian experts like Ostrowski, a former special forces soldier who handles the supply and distribution of an eventual vaccine, and Matt Hepburn, the initiative’s go-to vaccine coordinator. Hepburn cut his teeth working on high-tech military projects, including an initiative that developed sensors that could be implanted into soldiers to detect certain illnesses before the men and women ever showed symptoms. Hepburn also has a reputation for driving even the most accomplished scientists to work harder than they’ve ever worked before.

“If Matt is still the Matt I know, he will be on these people with a foot on their neck, making them go go go,” said Geoffrey Ling, Hepburn’s former boss at the Defense Advanced Research Projects Agency.

There are government outsiders deeply involved in the project, too. Larry Corey, one of the country’s leading AIDS researchers, describes himself as an “ex-officio” member of Warp Speed. Corey runs the Covid-19 prevention network, an assortment of existing HIV trial networks that now are running at least three of the Phase 3 Covid-19 clinical trials. While he’s not formally on the organizational chart, he takes part in thrice-weekly calls with Warp Speed. Corey, who is based in Seattle, is in constant cross-country coordination with one of the NIH’s top vaccine researchers, John Mascola, a formal member of the organization.

“We are sacrificing our time and energy on Operation Warp Speed. We have taken the pivot from everything else that we have done in our lives,” Corey said, regarding him and Mascola. Corey described waking up at 5 a.m. each day to get on calls with Warp Speed leaders at 5:30 a.m., and then enduring a deluge of conference calls until 6 p.m. When the day’s work is done, he turns to planning for the following day, which keeps him working until 11 p.m. He’s in bed by midnight.

“I don’t think his day is any different than my day,” Corey said of Mascola. Both, he was sure, are sleep-deprived.

Operation Warp Speed is much more than a splashy name for an initiative focused on doling out purchase orders. The benefits for companies who land a Warp Speed contract go far beyond just money, according to one of the companies with a contract.

SiO2 Materials Science, an Auburn, Ala.-based company that is making vials for the effort, used its status as an Operation Warp Speed grantee to force a vendor to cut production time from 75 days to just seven. It also leveraged its contract with Warp Speed to get its power turned on in the midst of a massive outage in just minutes — others had to wait days, according Lawrence Ganti, the company’s chief business officer. Operation Warp Speed also covered the costs of installing 32 new security cameras around the company’s facility after an assessment found the company’s physical security was lacking.

SiO2 received $143 million from Operation Warp Speed, a fraction of what larger companies have received, but the company still is required to provide monthly status reports to the government. The reports typically run up to 60 pages and are coupled with a four-hour meeting attended by multiple Warp Speed officials, according to Ganti. That’s in addition to biweekly “risk reports” and weekly site visits from the Army Corps of Engineers.

A second company funded by Warp Speed confirmed similar reporting requirements.

“Everybody has — or at least I had a stereotype of how the government operated. Nine-to-five, slow, kind of what you’d expect at the DMV … this is not that in any way,” said Ganti. “They seem to be working 24/7.”

The organizational chart also underscores which agencies are not as closely involved in the leadership of the effort: namely, the Centers for Disease Control and Prevention, which took a leading role in coordinating vaccine distribution for other past pandemics, like the H1N1 pandemic of 2009. There are at least three staffers from each of the administration’s other major health agencies, like the Biomedical Advanced Research and Development Authority or the National Institutes of Health.

Mango, the HHS deputy chief of staff, said the CDC has a more central role than the personnel chart implies. He personally interacts with Messonier multiple times a week, and there are frequent meetings between the DOD and CDC with 15-20 of her deputies, he said.

“What General Perna says at the start of every meeting, and he means it, is we are here for one reason, to support the CDC,” Mango said. “Anyone who is watching what is going on a daily basis would say the CDC is leading and the DOD is enabling and supporting.”

Chief Pentagon Spokesperson Jonathan Hoffman struck a similar tone.

“The Department of Defense has been clear in its role in Operation Warp Speed: We are providing the bandwidth of logistical expertise, including program management and contracting proficiency to this all-of-America effort,” he said in a statement. “The development and delivery of over 300 million vaccine doses harnesses public-private partnerships, academia, and industry – no one entity can do this alone.”

The Pentagon also declined to comment on the chart obtained by STAT, saying they do not comment on leaked documents.

The Food and Drug Administration is also largely absent from the organizational chart, though that is by design. Most FDA officials are barred from participating formally in Operation Warp Speed over concerns that their involvement would conflict with their mission to impartially review eventual vaccine applications. The one major exception is Janet Woodcock, who took a temporary leave as head of FDA’s drug center to lead the initiative’s efforts on therapeutics.

BARDA plays perhaps the most head-scratching role in Operation Warp Speed. The organization’s acting director, Gary Disbrow, a camera-shy bureaucrat who was catapulted into the job after the ouster of his boss, Rick Bright, is listed as co-leading the vaccine effort alongside Hepburn, and a number of other BARDA leaders are included in the chart.

But three sources told STAT that Disbrow, and BARDA more generally, are playing a marginal role in Warp Speed. “BARDA has been largely sidelined in all of this,” one pharmaceutical industry source told STAT.

Ganti of SiO2, however, told STAT that the company deals primarily with BARDA for all of its Warp Speed-related questions. Mango also told STAT BARDA officials meet with Warp Speed officials daily “to make sure contracts are moving along.”

BARDA also appears to be fronting a large chunk of the funding for the Warp Speed initiative, alongside the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

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