The Food and Drug Administration (FDA) has authorized the use of the mRNA bivalent (original and Omicron BA.4/BA.5) COVID-19 vaccine (Moderna and Pfizer-BioNTech) for all doses administered to individuals 6 months of age and older. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the US.
The update is intended to simplify the COVID-19 vaccination schedule for most individuals. “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 vaccination,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
According to available data, almost all of the US population 5 years of age and older now has antibodies against SARS-CoV-2 as a result of vaccination or infection. As the monovalent vaccine is no longer authorized, for most unvaccinated individuals, a single dose of bivalent vaccine may be administered rather than multiple doses of the original monovalent vaccine.
With regard to child vaccination, the recommendations include the following:
- Unvaccinated children may receive a 2-dose series of the Moderna bivalent vaccine (6 months through 5 years) or a 3-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years). Children who are 5 years old may receive 2 doses of Moderna bivalent vaccine or a single dose of Pfizer-BioNTech bivalent vaccine.
- Children 6 months through 5 years who have received 1, 2, or 3 doses of monovalent vaccine may receive a bivalent vaccine; the number of doses depends on the vaccine and vaccination history.
- For immunocompromised children 6 months through 4 years, eligibility depends on the vaccine previously received.
For individuals 5 years of age and older with certain kinds of immunocompromise, a single additional dose of bivalent vaccine may be administered at least 2 months following the initial dose of a bivalent vaccine. Additional doses may be administered at the discretion of the health care provider, taking into consideration the individual’s clinical circumstances.
For individuals 65 years of age and older, an additional dose of bivalent vaccine may be administered at least 4 months following the initial bivalent dose in order to boost protection. Individuals younger than 65 years of age who have already received the bivalent vaccine are currently not eligible to receive another dose.
The FDA’s Vaccines and Related Biological Products Advisory Committee intends to meet in June to discuss future vaccination and the strain composition for the COVID-19 vaccines for fall of 2023. Additional information is available in the updated Moderna and Pfizer-BioNTech bivalent COVID-19 fact sheets.
Coronavirus (COVID-19) Update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. News release. Food and Drug Administration. April 18, 2023. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-changes-to-simplify-use-of-bivalent-mrna-covid-19-vaccines-301800433.html.