U.S. FDA Approves Pfizer's New COVID-19 Vaccine

Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older.

And the FDA granted emergency use authorization for individuals six months through 11 years of age for the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

This decision follows guidance from the FDA's Vaccines and Related Biological Products Advisory Committee, which recommended an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for this fall and winter season.

"With today's decision, an updated vaccine will shortly become available that helps address multiple Omicron XBB-related sublineages, which currently account for the vast majority of COVID-19 cases globally," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, in a press release on September 11, 2023.

The approval of this season's COVID-19 vaccine is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech.

Further, the application included pre-clinical data showing this season's vaccine substantially improved responses against multiple Omicron XBB-related sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent vaccine.

Additionally, pre-clinical (non-human) data demonstrate that serum antibodies induced by Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted bivalent vaccine, effectively neutralize the recently emerged Omicron BA.2.86 (Pirola) and the globally dominant Omicron-related EG.5.1 (Eris) subvariant.

This season's COVID-19 vaccine will be available in pharmacies, hospitals, and clinics across the U.S. following a recommendation by the U.S. Centers for Disease Control and Prevention.

In Europe, the Comirnaty Omicron XBB.1.5 vaccine was recommended on August 30, 2023.

Also, on September 11, 2023, Moderna, Inc. announced the FDA approved the supplemental Biologics License Application for Spikevax®. Moderna's updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older.