FDA yesterday took a number of important steps to simplify the use of the bivalent mRNA COVID-19 vaccines. The Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines (original and omicron BA.4/BA.5 strains) should now 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 in the United States, FDA said. Other actions included the following:
- 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 eligible for another dose. The FDA 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 or 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 kinds of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 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 6 months through 4 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 6 months through 5 years of age who are unvaccinated may receive a 2-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) OR a 3-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of age). Children who are 5 years of age may receive 2 doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- Children 6 months through 5 years of age who have received 1, 2, or 3 doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses they receive will depend on the vaccine and their vaccination history.