The U.S. Food and Drug Administration has authorized a second booster dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines for seniors and certain immunocompromised people.
The FDA previously authorized a single booster dose for certain immunocompromised people after completing 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 of severe illness, 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 modified the emergency use authorizations as follows:
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine may be given to people over 50 years of age at least 4 months after receiving a first booster dose of either authorized or approved COVID-19 vaccine.
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to people 12 years of age and older with certain types of immunosuppression at least 4 months after receiving a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone a solid organ transplant or are living with conditions that are considered to have an equivalent level of immune compromise.
- A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any licensed or approved COVID-19 vaccine to people 18 years of age or older with the same types of immunosuppression.
“Current evidence suggests some decline in protection over time against severe COVID-19 outcomes in older and immunocompromised people. “Based on an analysis of emerging data, a second booster dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase levels of protection for these highest-risk individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Furthermore, data show that an initial booster dose is critical to help protect all adults from the potentially serious outcomes of COVID-19. Therefore, those who have not received their initial booster dose are strongly encouraged to do so.”
The action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups.
The FDA-authorized Pfizer-BioNTech COVID-19 vaccine and the FDA-cleared Comirnaty can be used to provide authorized booster doses. Similarly, the FDA-authorized Moderna COVID-19 vaccine and the FDA-approved Spikevax are authorized to provide authorized booster doses.
