FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

The FDA has issued an update to its emergency use authorization of both the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines, stating that the bivalent vaccines, the original and the Omicron BA.4/BA.5 strains, can be used for all doses administered to individuals aged 6 months and older, including as an additional dose(s) for certain populations.

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Because of the new action, the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines 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,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, said in a statement. “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….The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

Because of the update, individuals, depending on age, who were previously vaccinated with a monovalent COVID-19 vaccine and have not received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine. Most individuals who received a single dose of the bivalent vaccine are not eligible for another dose.

However, individuals aged 65 years and older who have received a single dose of a bivalent vaccine can receive 1 additional dose at least 4 months after their initial bivalent dose. Most individuals who are immunocompromised and have received a bivalent vaccine may receive an additional vaccine following 2 months after their bivalent dose. Additional doses may be administered at the discretion of their physicians.

The eligibility of those who aged 6 months through 4 years who are immunocompromised depends on the vaccine previously received.

Furthermore, most unvaccinated individuals may receive a single dose of a bivalent vaccine. However, children aged 6 months through 5 years may receive a 2-dose series of the Moderna bivalent vaccine or a 3-dose series of the Pfizer-BioNTech vaccine.

Those who are aged 5 years may receive 2 doses of the Moderna vaccine or 1 dose of the Pfizer-BioNTech vaccine.

Furthermore, 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 doses they receive depends on their vaccination history and the vaccine type.

In June 2023, the FDA will hold a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the strain composition of the COVID-19 vaccines for fall 2023, similar to the influenza vaccines. When the strain(s) is selected, the FDA expects manufacturers to update the formulations for the fall.

The efficacy and safety of the Moderna vaccine is based on the agency’s previous analyses of clinical trial data of the monovalent Moderna COVID-19 vaccine in individuals aged 6 months and older and an investigational bivalent vaccine (original and omicron BA.1) in individuals aged 18 years and older.

Additionally, the effectiveness of a single dose is supported by the FDA’s analysis of immune response data from clinical studies of those who had a prior COVID-19 infection and those who were not infected but had 2 doses of the monovalent Moderna COVID-19 vaccine. Investigators found that the immune response after 1 does among those with a prior infection was comparable to the immune response after 2 doses among individuals without evidence of a prior infection.

The efficacy and safety of the Pfizer-BioNTech COVID-19 vaccine was based on previous analyses of clinical trials data of the bivalent vaccine (original and omicron BA.4/BA.5) for those 6 months and older, and immune response data for individuals aged 6 months to 4 years, an investigational bivalent vaccine (original and omicron BA.1) for those aged 55 years and older, and the monovalent vaccine for those aged 6 months and older.

Additionally, the effectiveness of a single dose was supported by data from England on the effectiveness of the monovalent vaccine. Among those aged 12 to 17 years who had received 1 does of the monovalent vaccine, those who had a previous infection with the Alpha, Delta, or Omicron variants had increased protection against symptomatic Omicron infection compared with those without a previous infection.

Reference

Coronavirus (COVID-19) update: FDA authorized changes to simplify use of bivalent mRNA COVID-19 vaccines. US Food and Drug Administration. 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?utm_medium=email&utm_source=govdelivery