Second COVID-19 Booster Shot Approved for People 50 Years of Age and Older
The FDA approved a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. 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 previously authorized a single booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization, and death.
The authorization applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines. The FDA’s authorization of a single booster dose for other age groups with these vaccines remains unchanged.
The details of the FDA’s new approval for a second booster are as follow:
- A second booster dose of the Pfizer-BioNTech 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 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.
Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals, the FDA notes. 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. The agency has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations.