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When will the COVID-19 vaccines get full FDA approval?

UB's Chief of Infectious Diseases tells us everything we need to know.
Posted at 5:49 PM, Jul 27, 2021
and last updated 2021-07-27 18:16:50-04

BUFFALO, N.Y. — The Moderna, Pfizer, and Johnson and Johnson vaccines are FDA approved for emergency use, but the shots are not fully FDA approved.

To help give context on what this means, I turned to the Chief of Infectious Diseases with the University at Buffalo, Doctor Russo, and asked him some questions.

“People should be reassured that the approval in this country for a drug or a vaccine is the most rigorous in the world,” Russo said.

What’s the difference between FDA emergency use approval and full FDA approval?

“To get full licensing from the FDA, the main difference is you need six months of safety data versus two months of safety data,” Russo said.

Pfizer and Moderna have filed for full approval of the vaccine and have six months of data. Johnson and Johnson never applied.

How does the vaccine get approved?

Dr. Russo told me it's a multi-step process that starts by companies submitting clinical trial data. Then, that information is thoroughly examined by the FDA as well as an independent advisory committee.

“It’s a rigorous process with a lot of checks and balances,” Russo said. "The data may be made public at certain stages. The CDC also has an advisory committee that gives an opinion on who this vaccine should be used for.”

Pfizer submitted for full approval on May 7 and Moderna applied on June 1.

When will the vaccines be approved?

The FDA said in a statement that the goal date to get approval is by January 2022, but that does not mean approval will not happen before that time.

“Most people are expecting the full licensing of the Pfizer vaccine with the Moderna vaccine to follow soon after, probably no later than the beginning of September,” Russo said.

What’s going to change when the vaccines get approved?

A recent study shows about one-third of unvaccinated adults say FDA approval would make them more likely to get the vaccine.

“For the people on the fence waiting for full licensing, hopefully this will move them to wanting to get the vaccine,” Russo said. “However, I think the delta variant is being a good inspiration as well.”