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FDA Authorizes Pfizer COVID-19 Booster For Seniors and High Risk Individuals

The Food and Drug Administration granted emergency use authorization Wednesday for the third dose of Pfizer and BioNTech’s COVID- 19 vaccine to be given to three groups — those 6 5 and older, those at high risk of developing severe COVID- 19, and those at risk of developing “serious complications” due to “frequent institutional or occupational exposure,” likely including frontline healthcare workers and prisoners.

The authorization makes the Biden administration’s plan to roll out booster shots this week at least partially possible.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer- BioNTech COVID- 19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers, and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” acting FDA Commissioner Janet Woodcock said in a statement.

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While the first two doses of the Comirnaty vaccine already have the FDA’s full approval for use in people 16 years and older, the regulator said it will now allow third shots for select portions of the American population. However, under federal agreements governing the use of the shots, most vaccine providers will still need to wait for a committee of vaccine advisers from the Centers for Disease Control and Prevention to formally recommend the third dose.

That group, the CDC Advisory Committee on Immunization Practices, met Wednesday to discuss the potential use of Pfizer’s booster shots.

It reviewed safety data collected from the millions of Americans who have already received additional doses of vaccines. The committee is expected to vote Thursday on its own guidelines for use of the shots.

 

Contact Jay Allen at [email protected]

 

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