U.S. FDA authorizes changes to simplify COVID-19 vaccine use in the United States

The U.S. Food and Drug Administration (FDA) has simplified the COVID-19 vaccination schedule for most individuals by amending the emergency use authorizations for the Moderna and Pfizer-BioNTech COVID-19 vaccines. The current bivalent vaccines (original and omicron BA.4/BA.5 strains) are now authorized to be used for all doses administered to individuals six months of age and older, including for an additional dose or doses for certain populations. In addition, the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.1 Read: New Omicron XBB.1.16 variant reaches second place on U.S. COVID-19 list The FDA highlighted the following key changes to COVID-19 vaccination in the United States: 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 will 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 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 two months following a dose of a bivalent COVID-19 vaccine. 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 (6 months through 5 years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 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.1 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research stated that “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.” He also commented that “Evidence is now available that most of the U.S. population five years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization and death.”1 The manufacturers have updated the healthcare professional fact sheets for the Pfizer and Moderna bivalent COVID-19 vaccines in the United States, to reflect these changes.2,3 Reference 1. U.S. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. April 18, 2023. (accessed April 26, 2023). 2. BioNTech/Pfizer. Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization of Pfizer-BioNTech COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5). April 18, 2023. (accessed April 26, 2023). 3. Moderna. Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization of Moderna COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5). April 18, 2023. (accessed April 26, 2023).

U.S. FDA authorizes changes to simplify COVID-19 vaccine use in the United States

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