Tipsheet

Pfizer Asks the FDA to Authorize Booster Shots for All Adults

On Tuesday, Pfizer and BioNTech announced that they asked the Food and Drug Administration (FDA) to authorize booster shots of their Wuhan coronavirus vaccine to all adults 18 and older. 

Tuesday’s announcement includes data that reportedly shows the need for boosters for this age demographic. Additionally, it notes that the Pfizer-BioNTech booster shot is currently approved for Emergency Use Authorization (EUA) for adults age 65 and older and for “high-risk” individuals – those who have underlying conditions or those who have jobs that put them at greater risk of contracting COVID-19.

As I covered Tuesday, The Washington Post reported this week that Pfizer and BioNTech planned to ask the FDA to authorize their booster shot for all adults. In August, the Biden administration first announced plans to move forward with a booster shot program for all adults, but their plans were derailed when an FDA panel formally rejected booster shots for the general public. Shortly after, the FDA said they would allow “mix-and-match” booster shots between the different COVID-19 vaccines.

Last week, the Centers for Disease Control and Prevention (CDC) signed off on a recommendation allowing a lower-dosage Pfizer-BioNTech vaccine to be administered to children ages 5 to 11. Days before, Oct. 29, the FDA approved Emergency Use Authorization for the Pfizer vaccine for that age group.

Pfizer’s data, which was compiled from a study of over 10,000 individuals, asks the FDA to amend its EUA of their booster shot. It does not mention boosters for children ages 5 to 11.