One of America’s biggest companies has teamed up with one of the country’s least-known federal agencies to make doses of a coronavirus vaccine. Lots of them.
The deal underscores the important role that the U.S. Biomedical Advanced Research and Development Authority, or BARDA, plays behind the scenes in protecting Americans—and everyone, really—from pandemics.
New Jersey pharmaceutical giant Johnson & Johnson, America’s 37th-biggest company by revenue, on Monday announced it was working with the Washington, D.C.-based BARDA to identify the best coronavirus vaccine and then produce a billion doses at a cost of around $1 billion.
The federal government and Johnson & Johnson are splitting the cost roughly down the middle.
Johnson & Johnson announced trials of its vaccine would begin in September. The goal is for the first batches of the vaccine to be available for emergency use in early 2021. That’s “a substantially accelerated time frame in comparison to the typical vaccine development process,” Johnson & Johnson boasted.
It’s a gargantuan deal for a new agency. BARDA formed in 2006 as a division of the U.S. Department of Health and Human Services. Its mission: to identify, help develop, and stockpile potential countermeasures against the most dangerous diseases and chemical, biological, radiological, and nuclear weapons.
With an overhead of just $500 million, BARDA employs fewer than 200 people. Isabel Jackson, the director of the Medical Countermeasure Program at the University of Maryland School of Medicine, described the agency as being understaffed.
BARDA did not respond to a request for comment.
The agency’s small size and budget belie its importance. Over the past 14 years BARDA has stockpiled vaccines and other treatments for anthrax, botulism, smallpox, nerve agents, and radiological “dirty bombs.”
But BARDA isn’t a science agency. It doesn’t employ big teams of researchers. Rather, it funds scientists working for universities and private companies on drugs that might not be very profitable for a big company such as Johnson & Johnson or Moderna.
After all, there’s not much of a market for, say, an Ebola vaccine except during an Ebola outbreak. And those, while devastating, aren’t frequent. “Without BARDA’s investment, it is unlikely that there would be interest in developing these drugs,” Jackson told The Daily Beast.
Not only does BARDA target unprofitable but lifesaving drugs, it also times its funding to arrive at a critical point in the research-and-development process—when early grants begin to run out but the drug isn’t quite ready to sell. “BARDA funding bridges the valley of death,” former BARDA head Robin Robinson wrote in the agency’s most recent strategic plan.
Current agency director Rick Bright took over from Robinson in 2016. In a 2019 presentation, Bright described a BARDA simulation of a flu pandemic—one that over three simulated months kills 10 million simulated people.
The pandemic war game underscored the importance of responding quickly to a fast-moving virus. “Speed is the critical component of response,” Bright wrote in his presentation. “Even the most advanced countermeasures fail unless present in sufficient quantities with minimal delay at the location of need.”
Does BARDA move fast enough? The response was mixed from researchers who have worked with the agency.
Herek Clack, a professor of civil and environmental engineering at University of Michigan, praised Bright’s staff at BARDA for their swiftness. Clack is working on new masks that could replace the current N95 that many doctors and nurses are wearing to protect themselves from the coronavirus, and which are in short supply.
“Even with the crush of inquiries they’re receiving now, including ours, they’ve responded generally within days to emails or to confirm document submissions,” Clark said of his BARDA contacts.
Jackson had a different perspective. “I would say that BARDA can be very slow, at times, due to understaffing,” she said.
And when a researcher does manage to get the agency’s attention, sometimes it gets too much attention. “You can end up with ‘analysis fatigue’ due to so many experts with varying opinions, and this can stall projects while you try to get everyone on the same page,” Jackson added.
“However, despite the delays this can cause, the projects always end up being stronger because you did have those sometimes intense discussions.”
Once all but unknown outside certain scientific circles, BARDA is now spending hundreds of millions of dollars to help produce potentially billions of doses of coronavirus vaccine.
The agency might be too small and it might occasionally trip over itself in its efforts to help researchers. But organizational hiccups aren’t necessarily the fault of the uncelebrated employees of an uncelebrated agency whose efforts could save millions of lives. “These guys are your true definition of public servants,” Jackson said.