Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for their Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2). This vaccine is designed for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six months and older. The European Commission (EC) is expected to review the recommendation soon and make a final decision. Once approved, the vaccine will be shipped to European Union (EU) member states that have placed orders for this formulation.
The CHMP recommendation, dated September 19, 2024, is based on non-clinical and manufacturing data for the Omicron KP.2-adapted vaccine, along with clinical and real-world evidence supporting the safety and effectiveness of previous Pfizer and BioNTech COVID-19 vaccines. Non-clinical data indicates that the KP.2-adapted vaccine produces a significantly enhanced immune response against several circulating Omicron sublineages, such as KP.2, LB.1, KP.3, and KP.3.1.1, compared to the companies’ earlier Omicron XBB.1.5-adapted vaccine.
In July 2024, the EC granted approval for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine, which also showed improved efficacy against multiple Omicron JN.1 sublineages. Once the Omicron KP.2-adapted vaccine receives authorization, both this and the JN.1-adapted vaccine will be available across the EU, though access will depend on individual government orders and national guidelines.
In the U.S., the Food and Drug Administration (FDA) approved the Omicron KP.2-adapted vaccine for individuals 12 years and older on August 22, 2024, while granting emergency use authorization for children aged 6 months to 11 years. Pfizer and BioNTech will continue to track the evolving COVID-19 landscape and are prepared to develop new vaccine formulations as needed, depending on data and regulatory guidance.
Pfizer and BioNTech’s COVID-19 vaccines, branded as COMIRNATY®, are based on BioNTech’s proprietary mRNA technology. BioNTech holds the marketing authorization for COMIRNATY® and its adapted versions in the U.S., EU, UK, and other countries, as well as emergency use authorizations or equivalents in partnership with Pfizer in various regions.
