When will the vaccines be fully approved by the FDA?



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The United States Food and Drug Administration (FDA) said Wednesday it is working to fully approve COVID-19 vaccines as coronavirus cases continue to rise and vaccination rates decline.

A Kaiser Family Foundation survey released this month found that among one-third of U.S. adults surveyed who are not vaccinated, 16% said the vaccine was too new, not tested enough, or too unknown.

While the FDA has yet to release a timeline for full vaccine approval, medical experts say full approval could come in the coming months.

An FDA official told CNN that the vaccines had already undergone a “comprehensive scientific evaluation” to “meet the FDA’s rigorous standards for safety, efficacy and manufacturing quality” when vaccine makers applied for emergency use authorization last year.

The time it takes for a vaccine for priority review to be fully approved by the FDA is typically around six months. The FDA says it is trying to complete its priority review for Pfizer and Moderna much faster than that.

Dr Anthony Fauci, chief medical adviser to the White House, said he expected the Pfizer vaccine to be fully approved by August and the Moderna vaccine to follow soon after.

Pfizer applied for full vaccine approval on May 7, almost three months ago, and Moderna applied for June 1 about two months ago.

The FDA has defended its process, a spokesperson telling ABC News it is “working as quickly as possible to review requests for full approval.”

The spokesperson added that the current “emergency use authorization” for these vaccines has been conducted extensively, even though an authorization is not an FDA approval.

Stories related to vaccines:

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Delta Variant Update: Pfizer Says Booster Strongly Protects Against Strain

Will we need a 3rd COVID shot? What we know now

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