Story at a glance

  • Vaccine maker Pfizer and its German partner BioNTech have submitted a request to the U.S. Food and Drug Administration (FDA) to open their COVID-19 booster to all adults 18 and older.
  • “Today, Pfizer has submitted a request to @US_FDA to amend the Emergency Use Authorization for our and BioNTech’s COVID-19 vaccine booster dose,” the company tweeted.
  • "This request is based on results from a randomized Phase 3 trial with >10,000 participants,” Pfizer added.

Vaccine maker Pfizer and its German partner BioNTech have submitted a request to the U.S. Food and Drug Administration (FDA) to open their COVID-19 booster to all adults 18 and older. 

“Today, Pfizer has submitted a request to @US_FDA to amend the Emergency Use Authorization for our and BioNTech’s COVID-19 vaccine booster dose. This request is based on results from a randomized Phase 3 trial with >10,000 participants,” Pfizer tweeted on Tuesday

The trial data suggested the boosters were safe and had an efficacy of 95 percent against symptomatic Covid-19 compared with the two-dose vaccine.

The Centers for Disease Control and Prevention (CDC) authorized the company’s vaccine for use in children ages 5 to 15 last week, expanding vaccine coverage to 28 million kids across the U.S. 

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The FDA and CDC in September authorized boosters for adults 65 and older and for younger at-risk adults. 

Approximately 13.1 percent of eligible Americans have received their third dose of the Pfizer-BioNTech vaccine. Around 58.5 percent of the total U.S. population is fully vaccinated. 


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Published on Nov 09, 2021