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The FDA Intergovernmental Affairs team would like to bring to your attention the following announcement by the FDA regarding its authorization of a second booster dose for older persons and certain immunocompromised individuals.. Please contact IGA@fda.hhs.gov for further information. Thank you!
 Today, 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
Good Day,
Today at 12:30 PM (ET) FDA will conduct a media call with Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research. You can listen in on the call via YouTube using this link: https://www.youtube.com/watch?v=2ENukDcykt8. The call will also be recorded and made available for future viewing if you cannot join the live broadcast.
Following the call, if you have any additional questions or concerns, please feel free to reach out to the Intergovernmental Affairs Team.
Akeisha Brown
Management Analyst
IGA@fda.hhs.gov
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