Coronavirus Briefing: An FDA green light for Pfizer’s vaccine

A panel of experts formally recommended that the agency authorize the vaccine.
Coronavirus Briefing

December 10, 2020

An informed guide to the pandemic, with the latest developments and expert advice about prevention and treatment.

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Pfizer’s vaccine gets the green light

A panel of experts at the Food and Drug Administration formally recommended today that the agency authorize the vaccine. The agency is likely to do so within days, clearing the way for health care workers and nursing home residents to begin receiving it early next week.

My colleagues Katie Thomas and Noah Weiland report that the F.D.A. is expected to grant an emergency use authorization for the vaccine on Saturday, though it could be pushed to Sunday or later. Although the F.D.A. doesn’t have to follow the advice of the panel — composed of scientific experts, infectious disease doctors, and industry and consumer representatives — it usually does.

Noah, who covers health care for The Times, told me the vote was the most important step yet for regulators and was “the kind of stamp of approval that federal health officials believe was needed to help convince the public that the vaccine is safe to receive.”

Pfizer submitted its application on Nov. 20. Since then more than 100 F.D.A. employees have worked nearly round the clock, including on Thanksgiving, to review the application. The F.D.A. also sent teams to visit Pfizer’s production facilities and clinical trial sites to verify the records that the company sent to federal regulators.

Dr. Peter Marks, the top vaccine regulator at the F.D.A., said: “Among all global regulators, we are the ones that actually don’t just look at the company’s tables. We actually get down and dirty and we look at the actual adverse event reports, the bad spelling errors that are made by physicians sometimes, et cetera.”

If the F.D.A. authorizes the vaccine within the next few days, as expected, Noah told me, some health care workers and possibly nursing home residents could be getting it early next week.

“But the supply of the Pfizer vaccine is severely limited at first,” Noah said. “Only about three million people will receive it initially. It will take months before we eventually see the kind of wide distribution that could put a serious dent in Covid cases.”

Record deaths in the U.S.

The New York Times

Lillian Blancas was a spirited prosecutor and public defender in El Paso who was in a runoff election for a municipal judgeship. But when election results came in on Nov. 3, Ms. Blancas was at home asleep, too sick with the coronavirus to learn that she had finished in first place.

The U.S. recorded more than 3,000 deaths yesterday, a daily record, soaring past the spring peak of 2,752. Yesterday was one of the deadliest days for the U.S., with the virus killing more Americans than the Sept. 11 attacks, or the attack on Pearl Harbor.

The new deaths reflect infections that took place several weeks ago and come as the country continues to report record numbers of new cases and hospitalizations. Experts say that surging infection and death counts will not abate until more people follow mask and social-distancing rules.

“The worst is yet to come in the next week or two,” said Catherine Troisi, an infectious disease epidemiologist at UTHealth School of Public Health in Houston. “What happens after that,” she added, “is going to depend on our behavior today.”

Resurgences

What else we’re following

What you’re doing

I’m a shut-in shut in. My daily routine has not changed much at all, except for the fact that now I am shut in my room as well as my house. I am 81 years old with multiple comorbidities, so my family (that I live with) is very careful, and so am I. I emerge from my room to make lunch or play the piano when the children are in school. Other than that, I get visits at my doorway. Thank God for video phone calls!

— Pauline Reynolds, Chula Vista, Calif.

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