FDA to Prioritize Full Approval for Pfizer COVID Vaccine

FRIDAY, July 16, 2021 — Pfizer Inc. announced on Friday that the U.S. Food and Drug Administration has granted priority review to its COVID-19 vaccine, positioning the vaccine for full approval by January.

The Pfizer vaccine has been administered to more Americans than any other shot so far in the U.S. vaccination campaign. According to data from the U.S. Centers for Disease Control and Prevention, some 85 million people have been fully vaccinated with the two-dose Pfizer regimen.

A full approval for the Pfizer vaccine could help boost U.S. vaccination efforts. Some people who have been reluctant to get a shot have said they are unwilling to get an experimental medication, and an approval could also make it easier for employers, school districts and others to mandate vaccination, Bloomberg News reported.

Of the three vaccines approved for use in the United States, Pfizer and Moderna have begun their applications for full approval from the FDA. Johnson & Johnson has said it intends to file for full approval, but had not done so as of Friday, Fox News reported.

Right now, the Pfizer vaccine is only authorized on an emergency basis for people aged 12 and over. Pfizer said it would apply for full approval in those aged 12 to 15 once the required six months of data following second vaccine doses are available.

A recent Kaiser Family Foundation survey showed that 31% of U.S. adults who have yet to be vaccinated would be more likely to get a vaccine that is fully approved by the FDA, Fox News reported. About 20% of U.S. adults who have not been vaccinated said it’s because they believe the vaccine is too new.

Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said during a White House COVID-19 briefing recently it would be “most unusual” for the FDA to refuse full approval for coronavirus vaccines being used under emergency use authorization.

“You never want to get ahead of the FDA, but it would really be a most unusual situation not to see this … get full approval,” Fauci said, Fox News reported. “I believe it’s going to happen.”

The typical priority review process allows six months, but FDA approval could come before January, CNN said.

Andy Slavitt, former White House senior adviser for the COVID-19 response, told CNN earlier this month that approval could even come in July, but acknowledged it’s a complicated process.

“There’s a lot of moving pieces. It’s not as easy,” Slavitt told CNN. “Hopefully in the next four to five weeks, and I think that will be very, very good news.”

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Posted July 2021

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