FDA Updates Moderna, Pfizer-BioNTech EUA to Include Use of Bivalent Vaccine as Booster Dose

The current emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 vaccines have been amended by the FDA, the agency announced, to authorize the bivalent formulations of each vaccine “for use as a single booster dose at least 2 months following primary or booster vaccination.”¹

These bivalent or “updated” boosters, the news release noted, contain 2 mRNA components of the SARS-CoV-2 virus: one, the original SARS-CoV-2 strain, and the other, the common strain in the BA.4 and BA.5 lineages of the omicron variant.

Currently, the BA.4 and BA.5 lineages of the omicron variant are the cause of most cases of COVID-19 in the United States; these lineages are also predicted to be the primary lineages circulating throughout the fall and winter.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants,” said Peter Marks, MD, PHD, director of the FDA Center for Biologics Evaluation and Research, adding that the agency sought input from outside experts on the inclusion of the omicron component in COVID-19 booster vaccines.

“We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently,” Marks continued. “The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations.”

These updates come after a June meeting of the Vaccines and Related Biological Products Advisory Committee, where a vote was “overwhelmingly” in favor of including an omicron component in booster vaccines. The final decision for each vaccine made by the FDA was based “on the totality of available evidence,” which included extensive safety and effectiveness data of the monovalent vaccines; safety and immunogenicity data from the bivalent COVID-19 vaccine containing mRNA from omicron variant BA.1; and nonclinical data from a bivalent COVID-19 vaccine containing mRNA of the original strain and mRNA in common from the BA.4 and BA.5 omicron lineages.

The agency anticipates that the bivalent vaccine will provide increased protection against the current omicron variant in circulation. Of note, the EUA updates do not authorize monovalent vaccines as booster doses for individuals aged 12 and older.

Currently, individuals aged 18 or older are eligible to receive a single booster dose of the bivalent Moderna COVID-19 vaccine if it has been 2 months since completion of their primary vaccination series or since they received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. Individuals aged 12 and older are eligible for a single booster dose of the bivalent Pfizer-BioNTech COVID-19 vaccine if it has been at least 2 months since completion of their primary vaccination series or since they have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Reference

1. Coronavirus (COVID-19) update: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as booster dose. News release. FDA. August 31, 2022. Accessed August 31, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use