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CDC advisory committee will vote Sunday on Pfizer's coronavirus vaccine

December 10, 2020. Summarized by summa-bot.

An advisory committee to the US Centers for Disease Control and Prevention expects to vote Sunday whether to recommend Pfizer’s coronavirus vaccine, according to an agenda posted on the agency’s website.

An advisory committee to the US Centers for Disease Control and Prevention expects to vote Sunday whether to recommend Pfizer’s coronavirus vaccine, according to an agenda posted on the agency’s website.

An advisory panel to the US Food and Drug Administration voted to recommend emergency use authorization of Pfizer’s vaccine on Thursday.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted Thursday to recommend the agency grant emergency use authorization to Pfizer’s coronavirus vaccine.

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is moving to vote.

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is discussing whether to recommend that the FDA grant emergency use authorization (EUA) to Pfizer’s vaccine.

The fact sheet and prescribing information provided with Pfizer's Covid-19 vaccine will warn that people with a history of severe allergic reactions to any the vaccine's components should not get it, an official at the US Food and Drug Administration said on Thursday.

"Over the last couple of weeks, we have been working with Pfizer on generating fact sheets and prescribing information," Dr. Marion Gruber, director of the Office of Vaccines Research and Review in the FDA Center for Biologics Evaluation and Research, said during Thursday’s FDA Vaccines and Related Biological Products Advisory Committee meeting.

Vaccine advisers to the US Food and Drug Administration say they are worried about how the US public will react to reports about severe allergic reactions in Britain to Pfizer’s coronavirus vaccine.

“I'm worried about these severe anaphylactic reactions,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said during discussion ahead of the committee’s vote.

We don’t know specifically what it was they were allergic to, or what their history with severe allergies was,” Offit said during the meeting of the Vaccines and Related Biological Products Advisory Committee.

Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer said, “the nature of what was actually excluded from the trial was really restricted to those individuals who had had a severe allergic reaction to a vaccine — any vaccine — previously, or obviously during the course of the trial if they’d gotten the first dose, and they had a significant type one hypersensitivity response, then that would preclude giving a second dose. ” 

by summa-bot

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