FDA Amends Moderna, Pfizer EUAs to Simplify Use of Bivalent COVID-19 Vaccines

The FDA has amended the emergency use authorizations (EUAs) of both the Moderna and Pfizer-BioNTech bivalent mRNA COVID-19 vaccines, according to an agency news release.¹

The newly amended EUAs simplify the vaccination schedule for most individuals, authorizing the current bivalent vaccines—original and Omicron BA.4/BA.5) to be used for all doses for all individuals aged 6 months and older, and as an additional dose for certain patient populations. The monovalent vaccines from these manufacturers are no longer authorized for use in the United States.

“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 Center for Biologics Evaluation and Research. “Evidence is now available that most of the US population 5 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.”

These updated EUAs follow discussions that took place during the January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). During that meeting, the committee unanimously recommended “harmonizing the strain composition of COVID-19 vaccines” in the United States, as well as supported simplifying the vaccine dosing schedule. Safety and effectiveness of both the Moderna and Pfizer-BioNTech vaccines are based on previous FDA analyses of clinical trial data of the respective monovalent vaccines.

The amended EUAs have led to the following updates:

• Most individuals who were previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a bivalent vaccine dose may receive a single dose of a bivalent COVID-19 vaccine
• Most individuals who have already received a single dose of a bivalent COVID-19 vaccine are not currently eligible for an additional dose.
• Adults aged 65 years or older who have received a single dose of a bivalent COVID-19 vaccine may receive 1 additional dose, at least 4 months after their initial bivalent dose.
• Most immunocompromised individuals (those with certain kinds of immunocompromise) who have received 1 dose of a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following the previous bivalent COVID-19 vaccine dose. Additional doses may be administered at the discretion of—and at intervals determined by—the patient’s health care provider.
• Eligibility for immunocompromised individuals aged 6 months through 4 years will depend on the vaccine previously received.
• Most unvaccinated individuals may receive 1 single dose of a bivalent COVID-19 vaccine, rather than multiple doses of the original monovalent vaccine.
• Children aged 6 months through 4 years who are unvaccinated may receive a 2-dose series of the Moderna bivalent vaccine
• Children aged 6 months through 5 years who are unvaccinated may receive a 3-dose series of the Pfizer-BioNTech bivalent vaccine
• Children who are 5 years of age may receive either 2 doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine
• Children aged 6 months through 5 years who have received 1, 2, or 3 doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine; however, the number of vaccines they receive will depend on the vaccine and their vaccination history.

“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,” Marks said. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

Additional discussions around future vaccination, as well as vaccine strain composition, will be take place during a VRBPAC meeting in June, where the FDA will seek input on which variants and lineages of SARS-CoV-2 are most likely to circulate during the upcoming year. Once these decisions have been made, the FDA expects vaccine manufacturers to make updated vaccine formulations with availability in the fall.

Reference

1. Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. News release. FDA. April 18, 2023. Accessed April 18, 2023. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines