FDA Vaccine ‘No’ Votes Needs to Be Explained
(Bloomberg Opinion) -- Thousands watched remotely last Thursday as the U.S. Food and Drug Administration’s vaccine advisory committee deliberated the merits of issuing an emergency use authorization for Pfizer Inc. and BioNTech SE’s Covid-19 vaccine, a potential game-changer in the pandemic fight. The companies led off the proceedings with their findings, and then the FDA panel followed with its analysis of the efficacy and safety data for the vaccine. The public had a chance to say its piece, after which the committee of experts again debated the data. So far so good, and pretty standard practice.
The meeting came to a head about nine hours in, when the panel was asked to vote on whether it would recommend that the FDA authorize the vaccine with the following indication: “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” Everyone held their breath during the two minutes that the votes were counted and then came the result: 17 said yes, four said no and one abstained. The next day, the FDA granted the emergency use authorization, launching one of the biggest vaccination efforts in U.S. history. But what about those no votes?
It is perhaps not ideal to see any dissent in a vote like this, but it is realistic. Some experts tend to think differently. But what did the dissenters think? This is where the whole thing went wrong. We don’t know. The normal process is to ask the panelists who voted no to explain why. But the meeting was closed immediately after the vote instead of taking the extra 10 to 20 minutes to discuss it. This is unfortunate, especially given the reservations many in the U.S. have about vaccines. Without a full explanation, it’s impossible to know if the no votes reflect real concern about the shot or, as is more likely, they indicate some more granular questions about use among a particular group.
If ever there was a time for full disclosure and transparency, this is it. And it didn’t happen. The FDA has a chance to do better this week, when the panel meets again to review Moderna Inc.’s Covid-19 vaccine data on Thursday. Let’s hope we get to hear the committee’s views, including any reasons for voting against early approval.
As for last week’s proceedings, I believe — having listened to the whole meeting — that a vast majority of experts on the panel agrees the vaccine is safe and effective for most people, including the more vulnerable older population and those with pre-existing conditions that put them at higher risk of severe Covid-19. The key point of contention appeared to be that there were only 153 participants between the ages of 16 and 18 in the trial. It is very likely the dissenters were reluctant to recommend approval for this younger group without more data. All we needed was to hear this for sure, or any other reasons they may have had. Instead, the panel unwittingly gave some ammunition to those who disparage the use of vaccines on principle.
The reality is that 16-year-olds are biologically not that much different from 18-year-olds, at least from an immunological perspective. Also, any dissenters worried about this younger cohort had no reason to believe that 18 years was a better cutoff because the data didn’t reveal how many 18- or 19- or 20-year-olds were in the trial — only that there were 14,690 people between the ages of 18 and 65 in the trial with a median age of 46 who got the vaccine. But we should have heard their arguments. Finally, it doesn’t matter if the emergency approval is granted for those 16 or 18 because these people are at the end of the line when it comes to being offered a vaccine. By the time they are up for vaccinating, we will very likely have data from both the Pfizer-BioNTech and Moderna trials studying adolescents specifically.
In the grand scheme of things, those four no votes didn’t hold up the vaccine’s approval and may not keep many Americans from getting in line for a shot. It just would have been a lot better to have let that last discussion run its course.
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
Sam Fazeli is senior pharmaceuticals analyst for Bloomberg Intelligence and director of research for EMEA.
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