Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older is filed at FDA
Pfizer Inc.and BioNTech SE announced the companies have submitted regulatory applications to the FDA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older
These filings follow guidance from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) to manufacture an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season.
The Omicron XBB sublineages currently account for nearly all COVID-19 cases in the U.S and are further antigenically distant from prior circulating SARS-CoV-2 variants, including Omicron BA.4/BA.5 and the original SARS-CoV-2 strain. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some protection against a range of outcomes from XBB-related COVID-19,evidence suggests that vaccines better matched to currently circulating sublineages can help further improve protection against symptomatic disease and severe COVID-19.
The U.S. regulatory applications are based on the full body of clinical, pre-clinical, and real-world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccines. Following guidance from regulatory authorities on the requirements for strain changes, the applications include data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates improved responses against circulating XBB sublineages, compared to the current Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
The companies have manufactured Omicron XBB.1.5-adapted monovalent COVID-19 vaccines at risk to ensure readiness ahead of the fall and winter season. Pending regulatory review and approval, the companies expect to be ready to ship Omicron XBB.1.5-adapted monovalent COVID-19 vaccines immediately. Pfizer and BioNTech have also submitted an application to the European Medicines Agency (EMA) and expect to initiate submissions to other regulatory authorities in the coming weeks.
The Pfizer-BioNTech COVID-19 Vaccines (Comirnaty) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original and Omicron BA.4/BA.5) in the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. BioNTech is also the Biologics License Holder for BNT162b2 (Original) in the United States.
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