Why FDA shouldn’t rush full approval of COVID vaccines

It’s undoubtedly a coincidence, but two commentators I find most thoughtful and trustworthy both weighed in Wednesday on the question of whether the Food and Drug Administration should just go ahead and grant full formal approval to the COVID-19 vaccines being widely administered in the U.S.

They’re Kevin Drum, lately of Mother Jones, and Paul Campos of the University of Colorado law school and the Lawyers, Guns & Money group blog.

Unfortunately, they land on opposite side of the question.

Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would … affect public trust in the agency and do little to help combat vaccine hesitancy.

Drum advocates allowing the full approval process to play out, which means approval might not be granted until January or later. Campos argues that, given how much we already know about the safety and efficacy of the vaccines, the FDA should just go ahead and grant full authorization now.

I’m going to have to agree with Kevin on this one. It’s true that with a combined total of more than 300 million doses of the Pfizer-BioNTech and Moderna vaccines administered in the U.S. alone, the data on their safety and efficacy are copious indeed.

But it’s also true that the FDA has established a procedure for fully authorizing drugs that has served it well in the past. Tinkering with that procedure can only lead to a bad outcome.

Let’s examine the issues.

First, some background. The FDA issued emergency use authorizations for the three COVID-19 vaccines in use in the U.S. starting on Dec. 11, 2020, when it granted the EUA for the two-dose Pfizer vaccine. EUAs followed for the two-dose Moderna product on Dec. 18 and for a one-dose vaccine manufactured by Johnson & Johnson on Feb. 27 this year.

The EUA process isn’t casual or slapdash. It’s used to grant approval for medical products needed to address public health emergencies, the pandemic being a classic example.

EUAs still require manufacturers to submit extensive clinical data on the safety and efficacy of their products, and the FDA anticipates that the applicants will continue clinical trials of the products until they compile enough evidence for full authorization — often involving as many as tens of thousands of trial subjects followed over a period of months or even years.

That process is going on now for all three vaccines. Pfizer applied on May 7 for expedited review of its vaccine, which would shorten the FDA process to six months or so from the usual 10 months or more; Moderna made a similar application on June 1. Johnson & Johnson hasn’t filed its application yet.

So the bottom line is that the FDA is facing a lot of pressure to move as fast as possible.

As recently as Wednesday evening, President Biden said that scientists in his circle expected that the FDA would issue final authorizations “sometime maybe in the beginning of the school year — at the end of August, beginning of September, October.”

Biden said the decision would rest in the FDA’s hands and implied it would be based on science. But, whether deliberately or not, his words implicitly gave the FDA a working deadline.

That’s one indication that pressure on the agency to move swiftly isn’t based on science, but on politics.

The thinking underlying the push for prompt final authorization is that it will give policymakers, medical authorities and political leaders an additional tool to encourage vaccine holdouts to get their shots, including a stronger legal case for mandating vaccinations.

Whether final authorization alone will move the needle on vaccine resistance is debatable. In fact, it’s dubious. The chance that holdouts will be swayed by the upgrading of the vaccines from EUA to final authorization is plainly small.

The bigger risk is to the FDA’s own reputation.

As Drum points out, a vaccine approval that involves truncating a formal procedure would lead skeptics to “rightfully assume that this means the approval is political, not based on science. It would pretty much destroy the FDA’s credibility.”

He’s right. Following four years of its relentless manipulation by Donald Trump and his henchmen, the FDA has precious little credibility to squander.

The best thing the agency can do to ensure that the public sees that the vaccines are safe and effective is to put them through the same approval process that has made the U.S. drug market one of the safest in the world. Little can be gained by changing the rules, and far too much can be lost.

Michael Hiltzik is a Los Angeles Times columnist. © 2021 Los Angeles Times. Distributed by Tribune Content Agency.

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