FDA authorizes booster dose of Pfizer-BioNTech COVID-19 vaccine for some groups

Sept. 23, 2021

The U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow the use of a single booster dose for some groups of people.

The agency granted the EUA for the use of the booster dose, to be administered at least six months after completion of the primary series, for people who are: 

  • 65 years of age and older
  • 18 through 64 years of age if they are at high risk of severe COVID-19
  • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

As the next step in the regulatory process, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will issue recommendations, which likely will include rules about who fits into each of the groups authorized by the FDA. The committee met Wednesday and is scheduled to meet Thursday. CDC officials would then decide whether to accept the recommendations of the committee.

The FDA authorization applies only to the Pfizer-BioNTech vaccine.

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