FDA’s slowness on vaccine isn’t the issue

The U.S. Food and Drug Administration’s meeting to evaluate whether the PfizerBioNTech vaccine should be authorized for emergency use is scheduled for Thursday, but it’s already controversial. The meeting comes three weeks after Pfizer submitted its data, and some critics have suggested that this delay has cost lives. A similar issue is likely to arise with other vaccines.

How hard is the FDA is working, really? That question is the focus of the debate, which defines the options as either granting an immediate emergency use authorization, known as an EUA, or waiting.

There is, however, a simpler frame: Since the vaccines exist and are ready for distribution, the question is whether somebody should receive them in the meantime, while the FDA’s full review is pending. Call it a partial rollout — or better yet, a continuation of the Phase III trial.

One argument against proceeding this way is that the vaccines are still too dangerous. Yet thousands of people have already received these same vaccines in Phase III trials. What’s more, by all indications the results were very positive, and a large number of Americans would likely benefit from taking the vaccine. (I for one would gladly be first in line, and the same is true for many other informed people I know.)

A second reason for reluctance springs from public opinion. What if more vaccines were to become available before full FDA consideration, and they turned out to have unforeseen problems? Wouldn’t more Americans then turn against vaccines altogether?

Again, compare distributing additional vaccines to continuing the Phase III trial. What if the Phase III trial had gone badly and harmed some of the vaccine recipients? That too could have turned public opinion against vaccines.

And if public relations are a concern, then the vaccine distribution could be portrayed as part of a special program over the last few weeks of the trial. Health-care workers, national-security officials, some nursing-home patients, members of the military or others could get vaccinated — with a PR campaign making it clear that this is another phase of the public-health response. This experience could be used to generate further useful information about vaccine safety and efficacy, such as whether being vaccinated limits your transmissibility to others as a potentially asymptomatic carrier.

Nobody would be forced to take the vaccine, and they could be provided with the same information and consent forms that individuals receive for the Phase III trials. If significant and problematic side effects emerged, the FDA could delay or withdraw the vaccine approvals.

By far the most likely result of such a program would be to save lives. The American economy, and Americans’ social life, could recover and resume earlier than otherwise. Yes, something could still go wrong. But a few more weeks of FDA scrutiny of the data might not find those problems. Some number of (willing) Americans would be in the position of having volunteered for an experiment just as America was about to run a slightly safer version of essentially the same experiment.

Not everyone would benefit. One loser would be the FDA, which would have a more complicated set of PR issues to manage, as well as heavier oversight burdens. The vaccine makers also might be worse off, as their task would have a greater number of steps and therefore additional logistical and reputational risks. Note that since the vaccine makers have been prepaid by the federal government, they do not have the same incentives for rapid distribution as a private company might in a more traditional market setting.(1)

In this debate, then, it may seem obvious that “saving American lives and jobs” is far preferable to “protecting the FDA and Big Pharma.” But maybe not. Maybe those institutions are capable of managing only so much stress. Speeding up the process might prove counterproductive and limit their capabilities to handle the rollout later.

Nonetheless, those urging delay are coming down on the side of protecting institutions rather than the public. The debate should be presented in such terms, rather than with bromides about “safety first.” Under a true “safety first” policy, I could get a jab tomorrow — or better yet, with proper planning and preparation, I could have gotten one a few weeks or even months ago.

(1) Disclaimer: Pfizer has been a donor to the university and research center where I work.