Updated bivalent COVID-19 boosters authorized by FDA
Recently authorized COVID-19 booster is recommended for select individuals by the CDC
- All states
The Food and Drug Administration (FDA) authorized, and the CDC has recommended, bivalent formulations of the vaccines for use as a single booster, or “updated booster,” for Pfizer-BioNTech and Moderna that includes a formula that has two components. The first component is designed to be effective for the original strain of the COVID-19 virus. The second component is designed to be effective for the Omicron variants of the virus that are now the dominant strain in the USA.
The original booster, like the COVID-19 vaccine primary series, is considered monovalent and now the updated booster is bivalent, because it has mRNA components that are designed to protect individuals from both the original and the Omicron variants of COVID-19.
Pfizer and Moderna booster details
- Moderna — A single booster dose administered at least 2 months following an individual’s primary or earlier booster vaccination. This booster is authorized by FDA for individuals ages 18+ who have had their primary doses of the COVID-19 vaccine
- Pfizer-BioNTech — A single booster dose administered at least 2 months following the primary or earlier booster vaccine. This booster is authorized by FDA for individuals ages 12+ who have had their primary doses of the COVID-19 vaccine
For individuals 12 years and older, the FDA has removed the emergency use authorization for certain monovalent COVID-19 vaccines when used as a booster. The FDA has instructed anyone that has an appointment who is 12+ (Pfizer-BioNTech) or 18+ (Moderna) to schedule their vaccine appointment to receive the updated bivalent booster.
However, these monovalent vaccines continue to be authorized by FDA and recommended by the CDC for use for administration of a primary series for individuals at least 6 months old, as described in the letters of authorization.
Additionally, a single Pfizer-BioNTech monovalent booster dose continues to be authorized by FDA and recommended by the CDC for individuals 5–11 years old at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.
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