Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron KP.2-adapted monovalent COVID-19 vaccine, Comirnaty KP.2. This recommendation is for active immunization to prevent COVID-19 in individuals aged 6 months and older.
The CHMP's positive opinion, issued on September 19, 2024, is based on non-clinical and manufacturing data for the KP.2-adapted vaccine, alongside clinical and real-world evidence supporting the safety and efficacy of previous COVID-19 vaccine formulations. Non-clinical data demonstrated a substantially improved immune response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, compared to the Omicron XBB.1.5-adapted vaccine.
The European Commission is expected to review the CHMP's recommendation and make a final decision soon. Following authorization, the Omicron KP.2-adapted vaccine will be available in European Union member states that have specifically ordered this formulation, contributing to Pfizer's ongoing COVID-19 vaccine supply.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.