Ask PolitiFact: When will the COVID-19 vaccines get FDA approval?

Question: When will the COVID-19 vaccines get full Food and Drug Administration approval?

Answer: That’s a question on a lot of minds as the daily number of COVID-19 cases rise across the U.S., driven by a more contagious mutation of the coronavirus. More public and private institutions are considering or imposing vaccine mandates on their employees. And some, including the Department of Defense, say they will consider requiring employees be vaccinated once the Food and Drug Administration gives the vaccines final approval. 

When will that happen? The short answer — at least for one vaccine — is sometime between now and January 2022.

Pfizer and BioNTech, which developed one of the three COVID-19 vaccines available in the U.S., in May completed their application for full FDA approval for use in people ages 16 and older. They are the only companies to have completed an approval application so far. The FDA is giving the application priority review, which expedites the process by a few months, with a decision deadline of January 2022. But the agency says it expects to have a decision before January.

Moderna said in June that it had begun submitting parts of its application. Johnson & Johnson has not yet submitted an application, but plans to this year.

In the meantime, the three vaccines are all under what is known as emergency use authorization. Two of the vaccines, Pfizer/BioNTech’s and Moderna’s, got that designation as far back as December 2020. Johnson & Johnson’s vaccine received the authorization in February 2021.

The FDA requires even more information from the manufacturers before it grants full approval.

Some experts believe that once the vaccines get full licensure, confidence about their safety and effectiveness will grow among the sizable portion of the population who have not been vaccinated.

What’s the holdup?

Here’s what we know about where the process stands.

During public health emergencies, like the coronavirus pandemic, the FDA has the legal power to grant emergency use authorization to certain products if they meet specific criteria and when there’s no adequate, approved and available alternative to treat the malady. A goal of this authority is to make products available quickly, when people urgently need them. Scientists and physicians at the FDA decide whether to grant such authorization.

When COVID-19 was declared a pandemic in early 2020, there weren’t any approved vaccines for it. As manufacturers developed therapeutics for COVID-19 — such as testing kits, blood purification devices and vaccines — they sought emergency use authorizations from the FDA. The agency has published information about these products throughout the COVID-19 pandemic.

Under an emergency use authorization, products become available based on the best available evidence at the time and if the benefits outweigh any known or potential risks. An FDA approval depends on more substantial evidence that the product is effective and that its benefits outweigh its risks.

"An emergency use authorization has a slightly lower bar to cross than full approval, but has come about after a comprehensive review of the data," Seema Shah, a Northwestern University professor of medical ethics previously told PolitiFact.

The FDA has granted emergency use authorizations for diagnostic tests and treatments during other public health emergencies, including the H1N1 pandemic that started in 2009.

It’s up to companies to submit applications that would move their products from emergency use authorization to full approval.

Companies seeking FDA approval must submit to the agency a Biologics License Application, which includes technical information, at least six months of clinical data, non-clinical data on the development of the vaccine in the lab, detailed manufacturing information, and data on the safety of the vaccine.

Before granting approval for a vaccine, the FDA must determine whether clinical data and other information show that it is safe and effective and whether it can be manufactured according to federal quality and control standards.

The FDA ​​reviews and verifies data in detail, and full approval hinges on the information in a complete application, said Peter Marks, FDA’s Center for Biologics Evaluation and Research, in a letter to the editor published by the New York Times on July 9.

"This approach helps to ensure that the FDA has all the available data from clinical studies and provides the public with trust and confidence in the quality, safety and effectiveness of any vaccine that the agency approves," Marks said. Any approval without a high-quality review "would undermine the FDA’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy," he said.

The FDA on July 16 formally accepted Pfizer and BioNTech’s application for approval of the vaccine for people age 16 and older. The companies said they plan to request approval for people ages 12 to 15 once they have additional required data. They got an emergency use authorization for this age group in May.

Moderna said in June that it had started a "rolling" submission process with the FDA for approval of its vaccine on people ages 18 and up. Under a rolling review, a manufacturer can submit sections of the application for review as they are completed, rather than waiting to submit them all at once. Moderna also plans to request priority review. Under priority review, an FDA decision on approval is expected within six months of receiving a completed application, compared with 10 months for a standard review.

Johnson & Johnson has not submitted an application for approval. A spokesperson said Johnson & Johnson is continuing to gather data and plans to file a licensing application with the FDA "later in 2021."