With these bivalent vaccine authorizations, the monovalent mRNA COVID-19 vaccines are still not authorized as booster doses for individuals 12 years of age and older.
Officials with the FDA have authorized Moderna and Pfizer-BioNTech’s bivalent COVID-19 vaccines for use as a single booster dose at least 2 months following primary booster vaccination. The updated boosters include the original SARS-CoV-2 strain as well as a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The updated Moderna booster vaccine is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech booster is authorized for use as a single booster dose in individuals 12 years of age and older.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, MD, in a press release. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
Both vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19, as well as an mRNA component to provide better protection against COVID-19 caused by the Omicron variant. The BA.4 and BA.5 lineages of the Omicron variant are currently causing most cases of COVID-19 in the United States and are predicted to circulate during the upcoming fall and winter, according to a press release.
The FDA based its decision on the totality of available evidence, including extensive safety and efficacy data for each of the monovalent mRNA vaccines; safety and immunogenicity data from a clinical study of a bivalent vaccine; and nonclinical data obtained using a bivalent COVID-19 vaccine. Based on the data supporting each of these authorizations, the bivalent vaccines are expected to provide increased protection against the currently circulating Omicron variant.
“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’s Center for Biologics Evaluation and Research, in the press release. “We sought input from our outside experts on the inclusion of an Omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently.”
With these authorizations, the monovalent mRNA COVID-19 vaccines have not been authorized as booster doses for individuals 12 years of age and older, according to the press release. The FDA will work to evaluate future data and submissions to support authorization of bivalent COVID-19 booster vaccines for additional age groups, as applications are received.
“We are confident in the evidence supporting these authorizations,” Marks said in the press release. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness, and manufacturing quality standards for emergency use authorization.”
Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a 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