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Pfizer-BioNTech COVID-19 Vaccine Gets FDA Advisors' Nod

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Pfizer-BioNTech COVID-19 Vaccine Gets FDA Advisors' Nod

Pfizer Inc (NYSE: PFE and BioNTech SE (NASDAQ: BNTX) have got the green light on their COVID-19 vaccine from an external panel of experts that advise the United States Food and Drug Administration.

What Happened: The Vaccines and Related Biological Products Advisory Committee (VRBPAC)  voted by a large majority of 17 to 4 in favor of giving emergency use authorization (EUA) to the companies' coronavirus vaccine. There was one absentation. 

The negative votes and absentation were in part a result of the inclusion of 16 and 17-year-olds in the EUA as some members of the VRBPAC expressed serious concerns on that front, Stat noted.

Panel member Paul Offit, a vaccinologist from Children’s Hospital of Philadelphia, said that it was a big problem that tens of millions of people in America could be too afraid to get inoculated because they had a history of severe allergies.

The panel touched on a wide range of issues including dosage, vaccination during pregnancy or lactation, and vaccine hesitancy. 

An issue that also cropped up during the meeting was whether volunteers who participated in the Pfizer trials and received a placebo should get the vaccine once a EUA is issued.

Why It Matters: The panel’s decision is not binding on the FDA but it is expected to adhere to its recommendation and clear the pathway for emergency use of Pfizer’s COVID-19 vaccine in the United States, as per Stat.

Doran Fink, deputy director of the FDA’s vaccine division, clarified during the proceedings that the agency could grant multiple EUAs if a product is in short supply.

The United Kingdom was the first nation to authorize the Pfizer-BioNTech vaccine on an emergency basis.

See Also: Pfizer Applies For Emergency Approval For COVID-19 Vaccine In India: Media Reports

As mass inoculation began in the U.K., it emerged the vaccine isn’t advisable for people with a history of serious allergic reactions.

One of the VRBPAC members, James Hildreth, said last weekend that the EUA for Pfizer-BioNTech vaccine is likely to come by Friday.

Price Action: Pfizer shares rose nearly 2.8% in the after-hours session on Thursday to $42.88 after closing nearly 0.3% lower. On the same day, BioNTech shares closed almost 5.5% higher at $129.54 and rose 3.44% in the after-hours session to $134.

 

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Posted-In: Covid-19 Pandemic VaccinesBiotech News FDA General Best of Benzinga

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