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

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,” 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, said yesterday, 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 (EUA) granted in December (DID, Dec. 14, 2020). 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 (DID, Aug. 2).

Fauci noted that some members of the public who have resisted getting vaccinated have pointed to that lack of full FDA approval for the available vaccines.

“A certain percentage have said when the vaccines get the full approval of the FDA, I would feel more comfortable in doing that … [and] when you get full approval, local authorities will feel more comfortable in doing local mandates for vaccine.”

A national mandate is unlikely, he said.

Fauci has also said that he is “cautiously optimistic” that children under age 12 will be able to get a COVID-19 vaccine by Thanksgiving. — Martin Berman-Gorvine