America’s Last Line of Defense for a Safe Vaccine

When the Food and Drug Administration ran into White House resistance to its proposed vaccine safety standards in early October, the agency took a bold step: It published the guidance on its Web site. The public could now see what vaccine manufacturers and the FDA’s own independent advisory panel would require to ensure a longer, scientifically rigorous process.

The two public health agencies responsible for overseeing the approval, distribution and use of a coronavirus vaccine—the FDA and the Centers for Disease Control and Prevention—have been undermined and politicized. The FDA’s proposed guidelines for emergency use of a coronavirus vaccine did finally clear the White House, but the well-publicized resistance has further undermined public trust in Operation Warp Speed just as the United States inches toward a viable vaccine. At a time when trust should be growing, the opposite is happening.

What should give Americans hope, however, is that both the FDA and the CDC have a last line of defense when it comes to approval and distribution of a vaccine: panels of outside experts who now merit the nation’s attention and unequivocal support. If, in the days ahead, either of these independent bodies are sidelined, ignored or in any way circumvented, a red line will have been crossed, and the safety and/or efficacy of a coronavirus vaccine can reasonably be questioned.

For the CDC, it’s the Advisory Committee on Immunization Practices, or ACIP, which next meets October 28–30. We each served terms on this committee at different times, and neither of us ever felt any political pressure during our tenures. The FDA equivalent is the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, which next meets October 22. Most Americans have never heard of either.

These panels of health experts, with expertise in vaccinology, immunology, pediatrics, internal medicine, infectious diseases and preventive medicine, among other disciplines, have been studying and assessing the myriad coronavirus vaccines under consideration. Each has been scouring data from phase I and phase II trials, and now are awaiting phase III data about some of the most promising vaccines in development.

The advisory panels operate with intentional transparency. The public has access, often in real time via livestream, to their discussions and discoveries, and public records document their work. The 15 voting members on each advisory committee all undergo conflict-of-interest reviews, with annual filings to safeguard compliance. Vaccine interests and financial attachments are disclosed, and members must recuse themselves from related votes. Whether for a coronavirus vaccine or other vaccines, these panels make recommendations as to whether a vaccine is safe, efficacious and ready to be licensed (FDA), as well as how and to which populations a vaccine should be distributed (CDC). Though the members on each committee surely understand the politics of the moment, they will never bend to it.

Today, despite regular political pressure being applied on FDA and CDC to meet arbitrary deadlines for a vaccine release, the time-tested vaccine vetting and approval system has held up since it was established nearly four decades ago. However, the threat to this system is real. Having both worked within it, we’ve identified several scenarios that would be troubling and even dangerous from a public health perspective.

First, it will be problematic if the advisory panels’ work is interrupted or circumvented. Each one has established protocols and defined responsibilities that must not be short-circuited or compromised. If the FDA commissioner or CDC director rejects or modifies the panels’ recommendations, which rarely occurs, the decision will merit close scrutiny and an accompanying strong justification. Second, FDA has now released strict guidance for approving vaccines for emergency use. If manufacturers fail to comply with this guidance, the panels may not have sufficient information to assess the safety of the vaccines. Third, if anyone in the executive branch of government were to override FDA or CDC decisions and guidance regarding coronavirus vaccines under consideration, this would be a red flag.

If ACIP and VRBPAC are each allowed to do their work unencumbered, and there is fidelity to this tried-and-true process, Americans should feel confident that the recommendations of the advisory panels were based on rigorous science showing both safety and efficacy. These committees’ work is not about politics, but people, and their evidence-based approach helps to counteract vaccine misinformation and disinformation. Today, only about half of adults in the U.S. say they would get a coronavirus vaccine if one became available this year. Unless public trust improves, the U.S. likely will see thousands of avoidable deaths and needless suffering. The pandemic itself will be given a longer life as we are forced to crawl toward herd immunity, which would require a vaccination rate well above 50 percent.

In many communities—particularly communities of color—the trust in government’s role in medical care was low even before this pandemic, with seeds sown over many generations because of violations of trust, systemic barriers and racist policies. Physicians across the nation, including in underserved communities, depend on the scientific integrity of ACIP and VRBPAC recommendations to determine whether they are confident in bringing a vaccine to their patients. We know that patients put trust in their physicians when it comes to determining whether to get a vaccine. That’s why it’s all the more imperative that this trust not be eroded by putting politics above science.

There is a reason the U.S. has had remarkable success with its vaccine programs and has been a global leader in disease control and prevention. We cannot let the trust developed over decades be diminished further during this pandemic. The preservation of that trust, after all, will serve us not just today, but for generations to come.

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