Increasingly, some academics and physicians have pushed back on the popular narrative that the FDA is needlessly delaying full approvals for the Pfizer and Moderna coronavirus shots — and spurring vaccine hesitancy by doing so. While full approvals might encourage a handful of Americans to finally get vaccinated, they argue, it’s more important for the agency to make clear that the eventual approvals are motivated by science and not by public pressure.
“I’m not sure that it’s helpful for us to be advocating from the outside, saying: Hey, please approve, please approve,” said Céline Gounder, a physician and epidemiologist who advised President Biden’s transition team on Covid-19 policy. “I think the FDA is aware of the urgency.”
The FDA’s critics, though — a list that includes Brown University’s Ashish Jha, former Trump administration surgeon general Jerome Adams, and the physician-researcher Eric Topol — have publicly accused the agency of dragging its feet. The alleged delay, they argue, is fostering unnecessary hesitancy among people who still view the vaccines as experimental, despite data that shows them to be overwhelmingly safe and effective.
Adding to their urgency: the plummeting rate of new vaccinations in the U.S., the fast-spreading Delta variant, and pockets of the country with low vaccination rates that are now experiencing new outbreaks.
“Some people who understand that the ‘E’ in ‘EUA’ stands for ‘emergency’ are waiting for full FDA approval before they receive a shot,” Topol argued last week in a New York Times op-ed. He and others have urged the agency to quickly issue full approvals, which they say would help to assure Americans that being vaccinated is in their best interest.
Early during the coronavirus pandemic, the FDA faced immense pressure from President Trump to authorize questionably effective treatments like hydroxychloroquine or blood plasma, and later, vaccines.
As they did in 2020, many of the agency’s defenders say the pressure could prove harmful to the agency’s credibility — even if the people doing the pressuring are different.
“In the long term, a careful, thorough FDA review will probably benefit us more,” said Dorit Reiss, a law professor at the University of California, Hastings, who focuses on vaccine issues. “The people who have concerns won’t be reassured by something that looks like a hasty approval.”
Ensuring the FDA’s decision appears politics-free is especially important when considering the biggest remaining group of unvaccinated Americans, Gounder said: Voters in red states who did not support Biden’s campaign and aren’t inclined to trust his administration.
“The people who we haven’t been able to reach with educational outreach or trusted messengers or incentives are largely white Republican voters,” Gounder said. “This is a group for which I think it’s really important that the FDA approval process does not appear to be contaminated by outside pressure or political interference, because this is so much about building trust.”
Still, both Gounder and Reiss agreed that the FDA should move swiftly, and that the eventual approval would mark a positive step in the country’s ongoing vaccination campaign. Beyond broadly helping to spur confidence, they said, it could also help to debunk a fringe anti-vaccine talking point.
For months, some far-right activists have highlighted the distinction between a full approval and an emergency use authorization, which the federal government has used to distribute the Pfizer and Moderna vaccines since December. Rep. Marjorie Taylor Greene (R-Ga.), a known conspiracist who has likened the federal vaccination campaign to the Holocaust, accused Biden this week of “pushing a vaccine that is NOT FDA approved” and labeled the vaccines a “human experiment.”
More practically, a full authorization could give businesses, universities, and government agencies more confidence when it comes to imposing vaccine mandates for students or employees.
The Department of Defense, already, has said explicitly that it’s willing to impose a vaccine mandate for military servicemembers — but only once the FDA issues full approval.
“It is not FDA-approved,” John Kirby, a Department of Defense spokesperson, said last week. “Therefore, it is still a voluntary vaccine.”
Regardless of how big an impact full FDA approval might have, it’s also not clear the agency is at fault for the perceived delay. Typically, even an accelerated approval for a vaccine can take as long as six months; Pfizer announced it had begun its “rolling” application for full licensure in early May, and Moderna did so a month later.
In a statement to STAT, a Pfizer spokesperson said the company had provided the FDA with all the information it needed, meaning the FDA could proceed at its discretion with a full approval. A Moderna spokesperson, however, acknowledged the company has not yet submitted all of the necessary information the FDA would need to move forward.
“The average time from submission [for a vaccine] to approval is 12 months, and the shortest we’ve had in the past is 10 months,” said Reiss, the UC Hastings law professor. “This isn’t the same situation: First, we have a lot of data because we’ve given it to so many millions, and second, we’re in a pandemic. But I’m not sure we can call this a delay.”
Still, the agency has acknowledged the need to move quickly.
“The FDA recognizes that vaccines are key to ending the Covid-19 pandemic and is working as quickly as possible to review applications for full approval,” FDA spokesperson Abby Capobianco told STAT in a statement.
In a separate New York Times letter to the editor, Peter Marks, a top FDA regulator, also pushed back explicitly on Eric Topol’s prior criticism.
“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy,” he wrote.