The Food and Drug Administration (FDA) has authorized the emergency use of the bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 Vaccines as a single booster dose at least 2 months following the primary or booster vaccination with any authorized or approved monovalent COVID-19 vaccine.
The bivalent vaccines contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the omicron variant. Most cases of COVID-19 in the US are currently caused by the BA.4 and BA.5 lineages and are predicted to circulate this fall and winter.
The Moderna COVID-19 Vaccine, Bivalent is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older. According to today’s authorization, the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older.
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The authorizations for each bivalent vaccine were based on the totality of available evidence, including extensive safety and effectiveness data for each of the monovalent mRNA vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent vaccine, and nonclinical data obtained using a bivalent vaccine.
The efficacy and safety of the Moderna COVID-19 Vaccine, Bivalent was evaluated in a clinical study that included approximately 600 individuals 18 years of age and older who had previously received a 2-dose primary series and 1 booster dose of monovalent Moderna COVID-19 Vaccine. Findings showed that the bivalent vaccine achieved higher immune responses against BA.1 vs the monovalent vaccine after 28 days.
The efficacy and safety of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent was evaluated in a clinical study that included approximately 600 adults older than 55 years of age who had previously received a 2-dose primary series and 1 booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine. Findings showed that the bivalent vaccine achieved higher immune responses against BA.1 vs the monovalent vaccine after 1 month.
The safety of each bivalent vaccine was consistent with that seen with the monovalent vaccines because these vaccines are manufactured using the same process. The FDA will evaluate future data and submissions to support authorizations of bivalent COVID-19 booster vaccines for additional age groups.
“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. “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.”
Reference
Coronavirus (COVID-19) update: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 Vaccines for use as a booster dose. News release. US Food and Drug Administration. 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
This article originally appeared on MPR
