The KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the U.S. during the 2024-2025 fall and winter season, if feasible.¹ Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention (“CDC”) recommendations remains important, particularly in light of COVID-19 cases on the rise again.² This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. beginning in the coming days.

The approval is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and effectiveness of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and non-clinical data showing that the KP.2-adapted vaccine generates a substantially improved response against currently circulating Omicron JN.1 sublineages, including KP.2, KP.3 and LB.1, compared with the companies’ Omicron XBB.1.5 adapted COVID-19 vaccine^.3

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY^® and its adapted vaccines (COMIRNATY^®(COVID-19 Vaccine, mRNA); COMIRNATY^® Original/Omicron BA.1; COMIRNATY^® Original/Omicron BA.4-5; COMIRNATY^®Omicron XBB.1.5; COMIRNATY^® JN.1; COMIRNATY^® KP.2) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.