FDA Panel Endorses Pfizer Vaccine For Those 16 And Older
The benefits outweigh the risks, a committee of experts advised Thursday in a 17-4 vote, with one person abstaining. The FDA is likely to sign off soon; shots could begin going into arms in just days.
FDA Panel Supports Emergency Authorization For Pfizer COVID-19 Vaccine
In a 17-4 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended Thursday that the COVID-19 vaccine being developed by Pfizer and BioNTech be authorized for emergency use during the coronavirus pandemic. The vote in favor of the vaccine was taken to answer the agency's question: Do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people age 16 and older? The agency typically follows the advice of its expert advisers. (Hensley and Harris, 12/10)
The Wall Street Journal:
FDA Panel Endorses Covid-19 Vaccine
In its vote to approve, the panel said the benefits of the vaccine outweigh the risks for people 16 years of age and older. “The efficacy is overwhelming” for the vaccine, said Eric Rubin, a Harvard microbiologist, panel member and editor-in-chief of the New England Journal of Medicine. “It’s very strong.” (Burton and Hopkins, 12/10)
US Panel Endorses Widespread Use Of Pfizer COVID-19 Vaccine
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation. “This is a light at the end of the long tunnel of this pandemic,” declared Dr. Sally Goza, president of the American Academy of Pediatrics. (Neergaard and Perrone, 12/10)
The New York Times:
F.D.A. Panel Gives Green Light To Pfizer's Covid Vaccine
The vote caps a whirlwind year 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. It is also a triumph for the F.D.A., which has upheld its reputation as the world’s gold standard for drug reviews despite months of political pressure from President Trump, who has sought to tie his political fortunes to the success of a vaccine. (Thomas, Weiland and LaFraniere, 12/10)
FDA Panel Member Says She Voted Against Vaccine Authorization Because Of Limited Data On 'Younger Participants'
A member of a federal panel that voted Thursday to move forward with an emergency use authorization for Pfizer's coronavirus vaccine said that she voted against the candidate citing a lack of data on younger participants. Archana Chatterjee, Dean of the Chicago Medical School, told CNN anchor Erin Burnett during a panel segment on "OutFront" that she is for the use of a coronavirus vaccine in legal adults. (Choi, 12/10)
President-elect Joe Biden responds to the news —
Biden Says FDA Panel Vote On Pfizer Vaccine A 'Bright Light In A Needlessly Dark Time'
President-elect Joe Biden called a Food and Drug Administration (FDA) panel’s endorsement of Pfizer’s coronavirus vaccine on Thursday a “bright light in a needlessly dark time.” “We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,” Biden said in a statement shortly after the panel's vote. (Chalfant, 12/10)