Pfizer Coronavirus Vaccine: FDA Will Work ‘Rapidly’ to Issue Emergency Authorization

Pfizer Coronavirus Vaccine: FDA Will Work ‘Rapidly’ to Issue Emergency Authorization

RN Clinical Staff Educator Diane Mikelsons receives a mock Pfizer vaccine for the coronavirus during a staff vaccine training session at UW Health in Madison, Wisc., December 8, 2020. (John Maniaci/UW health/Handout via Reuters)

The U.S. Food and Drug Administration is “rapidly” working toward clearing Pfizer’s Covid-19 vaccine for emergency use after an advisory panel voted to recommend the shots, Commissioner Stephen Hahn said Friday.

“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” Hahn said in a statement.

“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” he added.

The FDA’s Vaccines and Related Biological Products Advisory Committee on Thursday voted 17-to-4 with one abstention to recommend the vaccine, which the company developed with BioNTech, for emergency authorization.

Health and Human Services Secretary Alex Azar said Friday morning that vaccinations could begin as early as Monday.

“So in the next couple of days probably as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine,” Azar continued.

The vaccine, which will be the first against the coronavirus in the U.S., was approved for use in the U.K. last week and immediately began being administered to British citizens.

An FDA internal review found that the shot showed “a favorable safety profile, with no specific safety concerns.”

The vaccine was 95 percent effective at preventing disease in a 44,000-person trial in the U.S., according to peer-reviewed results published in the New England Journal of Medicine on Thursday.

Members of the FDA advisory panel supported the vaccine’s authorization but raised questions over possible allergic reactions seen in two health care workers in the U.K. with serious, known allergies who experienced a reaction after they handled the shots.

Some of the experts unsuccessfully sought a more narrow authorization that would not include some teens and population groups at lower risk from the virus.

The virus has killed nearly 290,000 Americans and infected 15.4 million as the country heads into what experts warn could be a long winter as cases surge across the country.

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By: Brittany Bernstein

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