FDA Authorizes Second COVID-19 Booster Dose for Certain Groups

March 29, 2022
On March 29, the U.S. Food and Drug Administration announced the authorization of a second booster dose of the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people over 50 years old and certain immunocompromised individuals

According to a March 29 press release, the U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for individuals over 50 years of age and certain immunocompromised people.

In November, we reported that the FDA amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

The release states that “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.”

That said, “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.”

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research was quoted in the release saying that “Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals. Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

The decision only applies to the Pfizer-BioNTech and Moderna COVID-19 vaccines. The authorization for a single booster dose for other age has not changed but the agency will continue to evaluate data and information when considering a second booster dose in other age groups.

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