Covid-19 Live Updates: Expert Panel to Vote on Whether to Recommend Pfizer Vaccine to F.D.A.

3 min readDec 10, 2020

The U.S. surpasses 3,000 daily deaths, shattering the record after only a week. Overcrowded hospitals indicated numbers were unlikely to dip soon. Wealthy nations are being accused of hoarding vaccines. Ellen DeGeneres said she tested positive for the virus.

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Virginia imposes a curfew and strengthens mask rules as cases rise.

Here’s what you need to know:

An expert panel will decide Thursday whether to recommend that the F.D.A. authorize the vaccine made by Pfizer and BioNTech.

If the Food and Drug Administration’s vaccine advisory panel votes in favor of the Pfizer vaccine, it will clear the way for the F.D.A. to authorize the vaccine within days.Credit…Pool photo by Jeff J. Mitchell

The Food and Drug Administration’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, as well as industry and consumer representatives, is meeting all day on Thursday to discuss whether the Pfizer-BioNTech Covid-19 vaccine should be authorized by the agency. Although the F.D.A. does not have to follow the advice of the panel, it usually does.

If the experts vote in favor of the vaccine, it will clear the way for the F.D.A. to authorize the vaccine within days and for some health care workers and nursing home residents to begin receiving it early next week.

Earlier this week, career scientists at the F.D.A. published more than 100 pages of analysis of clinical trial data from the companies that showed the vaccine was safe and effective across a variety of demographic groups and also began to show effectiveness after the first of two doses.

Panel members are likely to discuss how a broad authorization of the vaccine — the vote is whether it should be allowed in adults 16 and older — might affect the clinical trial, which will continue. Some experts have argued that, ethically, trial volunteers who received a placebo trial should be offered the real vaccine once it is authorized, but others worry this could tarnish the long-term results of the trial.

Experts could also bring up concerns over possible allergic reactions to the vaccine after two health care workers in Britain, who had histories of severe allergies, developed such reactions after they received the Pfizer-BioNTech vaccine. British regulators have recommended that people with a history of severe allergies not receive the vaccine while these reactions are investigated.

The formal blessing of this expert panel would be the high point of a contentious year for the agency, which has spent months fending off political interference from the White House as infections and deaths have surged to record highs. When public distrust of the vetting process grew over the summer and fall, the agency issued guidelines vowing to listen to the panel, whose deliberations are public, before making its decision.

If the vote is in favor of authorization, it would also be a milestone for Pfizer and its German partner, BioNTech, which began working on the vaccine 11 months ago, shattering all speed records for vaccine development, which typically takes years.

The vaccine has already been given to people in Bahrain and Britain, where it was authorized on Dec. 2. Canada approved it on Wednesday.

Covid-19 Live Updates: Expert Panel to Vote on Whether to Recommend Pfizer Vaccine to F.D.A.

Here’s what you need to know:

An expert panel will decide Thursday whether to recommend that the F.D.A. authorize the vaccine made by Pfizer and BioNTech.

Written by Hhelpaswdfs