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FDA report confirms the safety of Pfizer's COVID-19 vaccine, authorization expected in days ahead

FDA report confirms the safety of Pfizer's COVID-19 vaccine, authorization expected in days ahead
Posted at 9:42 AM, Dec 08, 2020
and last updated 2020-12-08 17:50:07-05
WASHINGTON —

U.S. health regulators posted a positive review of Pfizer's COVID-19 vaccine as they near a decision on whether to allow use of the shot.

The review posted online Tuesday by the Food and Drug Administration offers the world the first detailed look at the evidence behind the shot, which was co-developed with BioNTech.

The FDA review comes before a Thursday meeting where a panel of independent experts will scrutinize the data and vote on whether to recommend use of the vaccine.

The vote isn't binding but the FDA usually follows the group's guidance.

A U.S. decision to allow use of the vaccine is expected within days.

Food and Drug Administration Commissioner Dr. Stephen Hahn granted 7 Action News a 1-on-1 interview on the same day the FDA released its preliminary findings on Pfizer’s COVID-19 vaccine candidate.

The report, confirming Pfizer’s vaccine is 95% effective 7 days after a second dose is taken 21 days after the first.

Another significant finding is the first dose appears to be 52% effective in protecting against the coronavirus, leaving the United States in a quandary.

The distribution plan for Pfizer’s vaccine if authorized for emergency use allows for 50-million Americans to receive two doses of the 100-million doses procured by the federal government.

Former FDA commissioner Scott Gottlieb suggested this week the U.S. should instead get doses in as many arms as possible by giving the full allotment to 100-million Americans, then procure more to give the second dose.

“I think it's really important not to prejudge what’s going to come out of the vaccine advisory committee because that’s one factor that we will look at and judge and make a recommendation about,” said Dr. Hahn. “I think it’s another important point is that these doses were done with a 2-dose regiment. That’s where the data comes from.”