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FDA Authorizes Second COVID-19 Booster Dose

FDA Authorizes Second COVID-19 Booster Dose

On March 29, 2022, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization, and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.

The agency amended the emergency use authorizations as follows:

  • A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
  • A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
  • A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.

The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.

For the entire FDA press release, click here.

Emergency Use Authorizations:
Pfizer Vaccine: Pfizer-BioNTech COVID-19 Vaccine Information | CDC
Moderna: Moderna COVID-19 Vaccine Information | CDC
Janssen: Johnson & Johnson’s Janssen COVID-19 Vaccine Information | CDC