On August 31, 2022, the FDA amended the Emergency Use Authorization (EUA) of both the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least 2 months following primary or booster vaccination. The bivalent vaccines, which will also be referred to as “updated boosters,” contain two mRNA components of SARS-CoV-2 virus—one of the original strains of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2.

Individuals aged 18 years and older are eligible for a single booster dose of the Moderna COVID-19 vaccine, bivalent, if it has been at least 2 months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

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

For each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence. This included extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from Omicron variant BA.1 lineage that is comparable to each of the vaccines being authorized, and nonclinical data obtained using a bivalent COVID-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the Omicron variant.

Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating Omicron variant. Individuals who receive a bivalent COVID-19 vaccine may experience adverse effects commonly reported by individuals who receive authorized or approved monovalent mRNA COVID-19 vaccines.

Due to the recent authorization for boosters, the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals aged 12 years and older. The FDA will work swiftly to assess future data and submissions to support authorization of bivalent COVID-19 boosters for additional age groups as they are received.

FDA Commissioner Robert M. Califf, MD, stated, “The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19. 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.”

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, stated, “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. 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. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations. 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.”

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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