WASHINGTON — The Food and Drug Administration is aiming give full approval to Pfizer-BioNTech’s COVID-19 vaccine as soon as Monday, several news outlets reported Friday.
A green light from the FDA would make the two-shot Pfizer vaccine the first to receive full approval from the federal government, The New York Times reported.
The story was first reported by Politico.
Breaking News: The FDA is aiming to give full approval to Pfizer’s Covid-19 vaccine on Monday, according to people familiar with the agency’s planning. The move is expected to pave the way for a series of vaccine mandates. https://t.co/fAPMWec5MC
— The New York Times (@nytimes) August 20, 2021
The Pfizer vaccine has been in use in the U.S. under an emergency authorization since December 2020. Pfizer applied for full approval three months ago, according to Politico. The vaccine is available to people 12 years old and older.
The White House referred questions to the FDA, which did not immediately respond to requests for comment.
>> FDA authorizes Pfizer’s COVID-19 vaccine
Regulators were working to finish the process by Friday, but were delayed by paperwork and negotiations with Pfizer, the Times reported.
The FDA had unofficially set a Labor Day deadline to give full approval to the vaccine.
Public health experts have argued that the FDA’s move to grant full approval will be a key moment in the fight against the COVID-19 pandemic, according to The Washington Post. Health officials believe that the approval would make it easier for employers to issue mask mandates, the newspaper reported.
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