The U.S. government, over the past few weeks, has made three important decisions on vaccines without consulting independent panels of experts. On Nov. 19, the Food and Drug Administration authorized boosters for all adults — regardless of their job or any underlying health conditions. On Nov. 29, the Centers for Disease Control and Prevention announced that everyone 18 and above should get a booster shot, a revision of previous guidance that strongly recommended boosters only for those 50 and older. Then, on Dec. 9, the FDA authorized booster shots (of Pfizer) for 16- and 17-year-olds, moving the age of eligibility down from 18.
Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it and vote. That did not happen in these cases, meaning that the costs and benefits of these policy moves, from a medical perspective, were not fully aired publicly and discussed in advance.
One of us is the former deputy director of the FDA’s Office of Vaccines Research and Review; the other is a former acting chief scientist at the FDA. We believe that much is lost when decisions like these are made without consulting outside experts — whatever one believes about the merits of the policies in question.
At this point in the pandemic, the world faces a host of new questions related to vaccines and boosting. The recommendations of experts on the outside advisory committees are needed more than ever — so the scientific community can understand the empirical bases for decisions, and so the public can be assured that science, not politics, is driving vaccine policy.
In each of the recent decisions we’ve mentioned, at least some experts would probably have voiced opposition (based on earlier scientific debates and votes the two committees had taken, which supported different conclusions). That these experts were not given a chance to make their cases could hurt the credibility of these agencies. (In a poll published in May, conducted by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health, 75 percent of American adults said they trusted the FDA a great deal or somewhat, with 24 percent saying they felt not much trust or none.)
This area of research is fast-moving, and much changed between the most recent meetings of the expert committees (on the booster question) and the FDA’s decision to authorize boosters for 16- and 17-year-olds — notably the emergence of the omicron variant. Still, the lack of involvement of the FDA’s expert panel on that question was striking, and observers noticed. Helen Branswell, a senior writer for the health and science publication STAT News, tweeted that the FDA had “authorized Pfizer booster shots for 16- & 17-years olds, without asking its vax expert panel for advice.” She added, “This approach sidesteps what would likely have been lengthy discussion about myocarditis” — an uncommon side effect of the mRNA vaccines, which had drawn careful study in earlier steps of the approval process.
In a news release, the FDA explained that it didn’t convene the outside committee because approving boosters for 16- and 17-year-olds “does not raise questions that would benefit from additional discussion by committee members.” But that is unpersuasive, given the previously expressed views of panel members. The CDC has not explained why it did not convene its own panel of vaccine experts for its recent decision.
The FDA and the CDC need their experts. This is a particularly challenging time in the pandemic, as scientists try to understand how omicron changes the picture. Some people, including us, predict that the original two-shot vaccination regimen for the existing mRNA vaccines will continue to offer substantial protection against serious disease in people who aren’t at high risk, even with the new variant’s emergence. There are significant questions about how effective boosting with a non-omicron-specific vaccine will be or how long any effect will last. Others argue that boosters for all are absolutely essential. Still others are saying that not only is a third shot needed but probably a fourth one as well.
Emergency situations call for rapid high-stakes decision-making with limited data. Exigency might be offered as an excuse for bypassing the advisory process, but that’s the exact circumstance when expert discussion and interpretation of the data can make the biggest difference. Both the CDC and the FDA are able to convene their advisory committees on short notice, so there is no need to go without the benefit of these meetings. If for some reason these processes are bypassed, it is critical that the reasons are made clear and public.
Many people were appropriately outraged when the FDA, under the Trump administration, made important decisions, including authorizations of hydroxychloroquine and convalescent plasma for covid-19, under what appeared to be extreme political pressure and without advisory committee input. We should apply the same standards to the Biden administration.
As a country, we are weaker when we bypass our scientific experts. Although some may find it convenient to make policy without their input, the long-term consequences will hurt public health.