The U.S. Food and Drug Administration has authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for 50 years of age and older people and certain immunocompromised individuals.
Previously, the regulator had authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.
As per the latest data, 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 latest FDA authorization will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death.
The amendments to the emergency use authorizations or EUAs to include a second booster dose were granted to Pfizer Inc. and ModernaTX Inc.
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty, as well as the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax, can be used to provide the authorized booster dose.
The FDA action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines. The authorization of a single booster dose for other age groups with these vaccines remains unchanged, the agency noted.
As per the changes, 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.
The agency also approved a second booster dose of the Pfizer-BioNTech COVID-19 Vaccine to 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.
Further, the FDA also authorized a second booster dose of the Moderna COVID-19 Vaccine to 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.
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