Calls rise for FDA to fully approve COVID-19 vaccines

Calls are rising from some experts for the Food and Drug Administration (FDA) to move faster to fully approve the COVID-19 vaccines, in what could be a key step to address vaccine hesitancy.

As the vaccination rate lags, with the country on pace to miss President Biden’s goal of vaccinating 70 percent of adults by July 4, polling indicates full approval could help convince some of the remaining unvaccinated people to get the shots. 

Some unvaccinated people view the current emergency use authorizations for the vaccines as an indicator they are still experimental and not fully tested, despite the rigorous process that went into those authorizations. 

Pfizer began submitting data for full approval May 7, but it is unclear when the FDA will act, leading to calls to pick up the pace. Moderna applied later, on June 1, for full approval for its vaccine.  

The rise of the highly transmissible delta variant means unvaccinated people are at increased risk, highlighting the urgency for getting shots to more people. 

Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, said that while there should not be “political pressure” on the FDA, “I would be interested in knowing what the holdup is.”

“It could have a big impact on people getting [vaccinated] if it is FDA approved,” she said. “I think it’s worth asking why it hasn’t happened yet.”

Ashish Jha, dean of the Brown University School of Public Health, was more direct. “1 out of 3 American adults still unvaccinated,” he wrote on Twitter. “Pfizer initiated request on May 7. It’s 6 weeks later. Data is in. Vaccines are safe and effective. It’s time for full approval.”

Asked to respond, an FDA spokesperson said the agency cannot comment on individual applications before it. Pfizer declined to comment. 

Other experts said the agency has a large amount of data to sort through, which simply takes time. 

“If they hurry it up and don’t complete their review very carefully, that will actually have the opposite effect,” said Jesse Goodman, a former FDA chief scientist now at Georgetown University. “I think that would really undermine confidence.”

He said the agency was striking the right balance. “They’re moving quickly but they’re requiring a careful review,” he said, saying he thinks the review could take “three or four months” and be completed sometime this summer.  

Nancy Allen LaPointe, faculty fellow at the Duke-Margolis Center for Health Policy, likewise said it is important for confidence in the vaccines that there is not “any perception or actuality of cutting a corner” in the FDA review for full approval. 

Still, full approval could have a significant impact. 

President Biden pointed to the step during a stop in North Carolina on Thursday to urge people to get vaccinated, though he did not call on the FDA to move faster. 

“I predict, as soon as we go from temporary approval to permanent approval, which just takes time … it’s going to increase the number of people willing to move as well,” Biden said. 

A Kaiser Family Foundation poll in May found that about a third of unvaccinated people — 32 percent — said they would be more likely to get the shots if a vaccine received full approval. That was a higher percentage than those saying paid time off, a free ride to the vaccination site, or getting $100 from the state would make them more likely to get vaccinated. 

Gronvall, the Johns Hopkins professor, said the issue of full FDA approval “comes up all the time” in her discussions with unvaccinated people. 

“It’s got this experimental veneer to it” for some people under the emergency use authorization, she said. 

Experts noted that the FDA should have even more confidence for full approval in that more than 170 million doses of Pfizer’s vaccine have already been administered in the U.S. — and more than 130 million for Moderna — with a superb record of safety and efficacy. That is far more real-world data than the FDA would have for many other drugs with much smaller populations. 

Even under the emergency use authorization (EUA), the FDA first required strong safety and efficacy data. A full approval adds in other elements like examining manufacturing practices. But the perception of the emergency authorization among some unvaccinated people is that it is an unreliable standard. 

Full approval is also likely to lead to more employers requiring the vaccine for their employees, which could further boost vaccination numbers. 

Even in the health care field, major hospital systems in Boston on Thursday announced they would require their employees to be vaccinated, but only once the vaccines get full approval. 

“Because we know that some of our staff would feel more comfortable getting a COVID vaccine after it has been formally licensed by the FDA, we won’t require it unless and until the EUA is lifted,” said Kevin Tabb, president and CEO of Beth Israel Lahey Health, a major hospital system in Massachusetts. “After the EUA is lifted, it will be a requirement that all staff be vaccinated against COVID as a condition of employment.”

Eric Topol, a professor of molecular medicine at Scripps Research, pointed to the FDA’s controversial approval of an Alzheimer’s drug this month, despite doubts that it works, to contrast the COVID-19 vaccines from Pfizer and Moderna, known as mRNA vaccines. 

“Trying to figure out how @US_FDA approved the alzheimer’s drug [without] adequate evidence, against their Advisory Committee, but has yet to approve full licensure for mRNA vaccines—which could save lives, prevent the toll of the delta variant, and promote durable US containment,” he tweeted.