As calls for the Food and Drug Administration to fully approve COVID-19 vaccines grow louder, the agency itself has little to say. This is a mistake. The agency insists it is “working as quickly as possible” and has suggested that full approval may come for at least one vaccine by the end of summer. The public is left wondering: What’s taking so long?
This isn’t just a minor nuisance. It undermines trust in the vaccines and damages the FDA’s most valuable asset — its credibility.
The drug regulators have good reason to insist on thoroughly reviewing many months of clinical trial data before fully licensing any medicine. The emergency use authorizations for the vaccines now administered in the U.S. were based on just two months of follow-up data — enough to be confident that the vaccines are safe, effective, and fit for use in response to a pressing need, but relying on a faster analysis than the FDA requires for its full approval process. To fully approve the vaccines, the FDA looks at more data and satisfies itself on a range of other issues, including developing detailed guidance on use.
This two-track system, allowing flexibility when circumstances demand it, makes sense. To many outside the agency, however, it seems contradictory. Late last year, the FDA pronounced the mRNA vaccines safe and effective enough for emergency use; many months later, it hasn’t fully licensed them. So are the vaccines safe and effective or not? That’s a reasonable question — and the agency has failed to answer it clearly.
With the delta variant racing through the population and the pace of vaccination in the U.S. still too slow, many observers, including some infectious disease professionals, have accused the FDA of dragging its feet. Without transparent communication from the agency itself, it’s impossible to know whether that charge is correct. On Friday, an agency official said it was making further efforts to speed its review, making one wonder why every effort hadn’t already been made. The FDA traditionally hasn’t explained its ongoing work in detail, but hesitancy over the COVID-19 vaccines makes that reticence unacceptable.
If it’s now in a position to affirm that six months’ worth of clinical trial data provides stronger confirmation that the shots work safely, it should do so, and announce that the licenses will soon be forthcoming. It should also explain what further steps are involved, and how long they’ll take. This would reassure Americans that the shots are indeed safe and that anyone who hasn’t yet gotten them should go ahead without delay. It would assure businesses that requiring vaccinations for their employees right away is wise. And it would discourage states from forbidding vaccine mandates until the shots are fully approved.
One more thing. Right now, at a moment of exceptional stress, the FDA is hobbled by its lack of a permanent leader. After more than six months in office, President Joe Biden has yet to make the appointment. The agency’s professionals are surely aware of the urgency on vaccines. They know it would be a mistake to bow to pressure by cutting corners. Competently led, they can be more effective — and help restore public trust — simply by explaining what they’re doing.
