The Food and Drug Administration announced this week that it has amended the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. The FDA action includes authorizing the current bivalent vaccines to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. This change does not affect Novavax and Janssen COVID-19 vaccinations (both of which are monovalent). All remaining Janssen doses in the country expire May 6, 2023. Highlights of the FDA amendment include:
- Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.
- Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA has indicated the agency intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.
- Individuals 65 years of age and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months following their initial bivalent dose.
- Most individuals with certain types of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least two months following a dose of a bivalent COVID-19 vaccine, and additional doses may be administered at the discretion of, and at intervals determined by, their healthcare provider. However, for immunocompromised individuals six months through four years of age, eligibility for additional doses will depend on the vaccine previously received.
- Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
- Children six months through five years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (six months through five years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (six months through four years of age). Children who are five years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- Children six months through five years of age who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history.
In June, the FDA is planning to hold a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the strain composition of the COVID-19 vaccines for fall of 2023 (similar to the annual influenza vaccine) Once the specific strains are selected for the COVID-19 vaccines, the FDA expects manufacturers to make updated formulations of the vaccines for availability this fall.
--Karen Braman