Some experts urge FDA to move more quickly to fully approve COVID-19 vaccines

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. Peter Sullivan TheHill

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.” ...