Pfizer and BioNTech Secure EMA Backing for Omicron KP.2-Adapted COVID-19 Vaccine

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have received a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorization for their Omicron KP.2-adapted COVID-19 vaccine, COMIRNATY® KP.2. This vaccine is designed for individuals aged six months and older to prevent COVID-19 caused by the SARS-CoV-2 virus. The European Commission is expected to issue a final decision soon. Following approval, Pfizer and BioNTech’s vaccine will be available in European Union (EU) member states that have ordered this specific formulation.

The CHMP recommendation, dated September 19, 2024, is based on non-clinical and manufacturing data, as well as the safety and efficacy of previous Pfizer-BioNTech COVID-19 vaccines. The Omicron KP.2-adapted vaccine has shown an improved immune response against several currently circulating Omicron sublineages, including KP.2, LB.1, and KP.3. This follows the earlier approval of Pfizer-BioNTech’s Omicron JN.1-adapted vaccine in July 2024.

In the United States, the Omicron KP.2-adapted vaccine has already received full FDA approval for individuals 12 years and older and emergency use authorization for those aged 6 months to 11 years. Pfizer and BioNTech continue to adapt their vaccine strategies in response to the evolving COVID-19 landscape, ensuring readiness for further modifications as needed.