COVID-19 Vaccine Approved with Shipments Arriving Soon

 Pfizer Inc. and BioNTech SE today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for the companies' LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults aged 65 years and older.

This FDA approval includes individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The company's approval application also included data from pre-clinical models showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the company's JN.1- and KP.2-adapted monovalent COVID-19 vaccines.

Importantly, this season's Pfizer-BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.

To date, 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, utilizing BioNTech's proprietary mRNA technology, which both companies jointly developed.

Please click here for complete Prescribing Information and Patient Information for COMIRNATY.