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# FDA OKs 2nd Covid Booster for Some People
- URL: https://www.fdaweb.com/fda-oks-2nd-covid-booster-for-some-people/
- Published: 2023-04-18T12:00:00.000Z
- Updated: 2026-09-14T18:26:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154233

FDA has amended the emergency use authorizations for the Moderna and Pfizer/BioNTech Covid-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals and permit a second booster for certain at-risk populations. An agency [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/3559331?ref=fdaweb.com) lists these key changes:

- most individuals, depending on age, previously vaccinated with a monovalent Covid-19 vaccine who have not received a dose of bivalent vaccine may receive a single bivalent dose;
- most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose;
- individuals aged 65 and older who have received a single dose of bivalent vaccine may receive one additional dose at least four months following their initial bivalent dose;
- most individuals with certain kinds of immunocompromise who have received a bivalent Covid-19 vaccine may receive a single additional dose of bivalent Covid-19 vaccine at least two months following a dose of bivalent Covid-19 vaccine, and additional doses may be administered at the discretion of and intervals determined by their healthcare provider;
- most unvaccinated individuals may receive a single dose of bivalent vaccine, rather than multiple doses of the original mRNA monovalent vaccines, which are no longer authorized for use in the U.S.;
- children six months through five years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer/BioNTech bivalent vaccine, while children who are five years old may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer/BioNTech bivalent vaccine; and
- children six months through six years of age who have received one, two, or three doses of a monovalent Covid-19 vaccine may receive a bivalent vaccine, with the number of doses depending on the vaccine and their vaccination history.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent Covid-19 vaccines, and the agency believes that this approach will help encourage future vaccinations,” says CBER director **Peter Marks**.

The changes were discussed with the FDA Vaccines and Related Biological Products Advisory Committee on 1/26\. The notice says the committee recommended harmonizing the strain composition of Covid-19 vaccines used in the U.S. and also supported simplifying the vaccine dosing schedule.