Full Approval of the Pfizer-BioNTech COVID-19 Vaccine May Happen by Labor Day

August 6, 2021

Full FDA approval for the Pfizer-BioNTech COVID-19 vaccine may be just weeks away, as reports indicate an agency-wide push to meet that goal by Labor Day — if not sooner.

“I hope as we get into the middle of August that we’re almost there,” said Anthony Fauci, President Biden’s chief medical adviser and the director of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, adding that “again, I can’t predict, because that’s totally a regulatory decision.”

The vaccine has been distributed to millions of Americans under the FDA’s Emergency Use Authorization, which was granted in December. Last month, the agency granted the vaccine a priority review for full approval, and the agency has also reallocated staff resources and said it is taking an “all hands on deck” approach.

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