If the Trump administration tries to push out a novel coronavirus vaccine before it’s fully tested, there are three committees of independent experts who could stand in its way. It’s a testament to the massive stakes of this kind of work that some of their names are effectively kept secret.
These committees—two in government and one in the private sector—keep tabs on vaccine-testing, sign off on new drugs and vaccines, and advise the government on how to deploy a new inoculation. But it remains to be seen just how much clout they have if the government decides to skirt science and rush out an Election Year miracle.
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In recent decades, the committees have proved their worth as scientific gatekeepers. They’ve halted the rollout of unproven and potentially unsafe drugs and, even when overruled, have at least drawn attention to government efforts to push risky medical products for political purposes.
But for all the committees’ influence in recent decades, none of them is an insurmountable obstacle if President Donald Trump or his closest allies in the administration are determined to ram through an untested vaccine, experts said.
Instead, the faceless experts might prove to be mere speed bumps.
The outside advisory groups that matter the most in the United States’ contributions to the global effort to develop and deploy a coronavirus vaccine are the pharma industry’s 10- to 15-member Data and Safety Monitoring Board (DSMB), the 15-member Vaccines and Related Biological Products Advisory Committee (VRBPAC) at the U.S. Food and Drug Administration, and the Advisory Committee on Immunization Practices (ACIP), which also has 15 members and falls under the umbrella of the U.S. Centers for Disease Control and Prevention (CDC).
Each committee is made up of scientists, medical doctors, statisticians, and health experts, and wields influence at a different stage of the vaccine-development process.
The DSMB monitors trials in order to ensure they’re safe—and can halt trials if it decides they’re not. The VRBPAC endorses—or doesn’t—a new vaccine right after the FDA approves it for public use. And the ACIP helps the CDC decide who should get a vaccine, and in what order.
The experts The Daily Beast spoke with all placed a great deal of faith in these groups’ ability to guide a vaccine through trials and deployment with objectivity, fairness, and genuine concern for Americans’ well-being. “I don’t think any vaccine is going to be put in the hands of the American public without a robust safety portfolio,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a former VRBPAC member, told The Daily Beast.
“The majority of time, the government certainly follows what the advisory committees do, and at times when it doesn’t, that can be cause of real controversy,” added Peter Lurie, president of the Washington, D.C.-based Center for Science in the Public Interest and a former member of the VRBPAC.
Of course, it’s possible the Trump administration doesn’t care about the controversy that might result from pushing a vaccine before it’s ready. Even if all three committees voted against a vaccine, the FDA might approve and distribute the vaccine, anyway. The administration has steadily been consolidating control over the vaccine-approval process, all while Trump continues to promise a vaccine before most experts expect one to be ready.
The problem is that the advisory committees mostly derive their authority from government agencies’ rules—and the same agencies can, with varying degrees of effort, change those rules. “The FDA and CDC advisory committees are that—advisory,” Lurie said. “There’s no requirement for them to follow them.”
The FDA confirmed that it’s under no obligation to its outside advisers, and could grant a vaccine a preliminary Emergency Use Authorization (EUA), which would allow the agency to begin distributing a vaccine before testing is complete, without the committees’ approval.
“The FDA has also stated that it plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of an EUA for any COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization,” an FDA spokesperson told The Daily Beast. “The committee provides independent advice to the agency. The FDA generally follows an advisory committee’s recommendations, but is not bound to do so.” (Requests for comment from the other two boards were redirected to the FDA.)
The National Institutes of Health (NIH) requires the pharmaceutical industry to form the first board in the approval process, the DSMB, which Dr. Anthony Fauci—the longtime director of the U.S. National Institute of Allergy and Infectious Diseases—has touted as a key safety valve. In the case of the novel coronavirus, there is one consolidated DSMB for all the companies receiving significant funding from Operation Warp Speed, the White House’s $13-billion vaccine-accelerator.
Earlier this month, a separate DSMB-like entity in the United Kingdom ordered a pause in large-scale, Phase 3 trials of a coronavirus vaccine candidate from British pharma AstraZeneca after a test subject in the U.K. suffered spinal inflammation. The FDA also halted AstraZeneca’s U.S. trials.
It’s unclear what role the American coronavirus DSMB played in that decision. AstraZeneca didn’t respond to requests for comment.
The members of the U.S. coronavirus DSMB are anonymous, with one exception: Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham, was publicly named chair of the board by Fauci. (Whitley did not respond to a request for comment.)
Whitley aside, the DSMB members’ anonymity protects them from pressure from the government and industry. “It’s not foreseeable that they could have influence on the DSMB, because they don’t know who the participants are,” Lawrence Gostin, a Georgetown University global health expert, told The Daily Beast.
The second key committee, the VRBPAC, is organized by the FDA. It normally meets after the FDA approves a new medical device, drug, or vaccine, and only then decides whether to endorse it, Lurie said. It’s rare for the FDA to move forward with a new product without the committee’s approval, he stressed.
But it has happened. In late 2013, the FDA approved Zohydro, a powerful new painkiller, despite the VRBPAC voting against the drug on the grounds that it might worsen America’s opioid addiction crisis. In the end, Zohydro didn’t sell very well, rendering it all but irrelevant. “It was a huge battle, in the end, over not very much,” Lurie said.
It should go without saying that a similar conflict over a coronavirus vaccine would be a big deal. If the FDA approves a vaccine but the VRBPAC rejects it, “the agency is going to have a lot of work to do to go against that,” Lurie explained.
Finally, the CDC appoints members to the ACIP, which advises the agency on strategy—that is, who should be first to get an initially limited supply of a new vaccine. Should health-care workers be first? The elderly? The immune-compromised? Should the government prioritize certain regions as well as specific vulnerable populations?
“That’s going to be a huge question,” Lurie said.
While the DSMB works in secrecy, the VRBPAC and ACIP don’t. The VRBPAC is even planning to hold a public hearing on Oct. 22. The goal? “To reassure the public about the vaccine for COVID-19,” Gostin said.
Given their limited power, the committees are mostly relying on norms—the expectation that the government should honor the groups’ recommendations. “A lot of the institutional and normative guardrails are weak and breaking,” Gostin said. “My hope is they will bend, but not break.”
A conflict between industry, the FDA and the CDC on one hand, and the advisory committees on the other hand, would be bad enough. But there’s an even more alarming possibility: that the FDA itself, rather than its outside advisors, rejects a vaccine because it’s unsafe or ineffective —and the Trump administration ignores the agency.
Even if the FDA decides a vaccine is unreleasable, Alex Azar, Trump’s health secretary, “could approve it anyway,” Offit said, rendering the boards’ expertise—and the agency ostensibly guiding the process along—moot.
“To me, that would be a nuclear option,” Offit said, “to actually override FDA career scientists.”
