Pfizer, BioNTech Seek EU Approval for KP.2 Vaccine

Pfizer and BioNTech announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for their Omicron KP.2-adapted monovalent COVID-19 vaccine. If approved, the vaccine, COMIRNATY KP.2, will be used for active immunization to prevent COVID-19 in individuals aged six months and older.

The CHMP’s recommendation, made on Sept. 19, 2024, is a critical step in the European Union’s review process. The final decision, which is expected soon, will be made by the European Commission (EC), as reported by Pfizer. Upon approval, the vaccine will be distributed to EU member states that have placed orders for this specific formulation.

The recommendation is backed by non-clinical and manufacturing data for the KP.2-adapted vaccine, as well as clinical and real-world evidence from earlier versions of Pfizer and BioNTech’s COVID-19 vaccines. Data suggest that the KP.2-adapted vaccine provides a stronger immune response against currently circulating Omicron sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, when compared to the previous XBB.1.5-adapted vaccine.

In July 2024, the European Commission had already granted marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine, which demonstrated an enhanced response to Omicron sublineages, similar to the KP.2-adapted vaccine. The KP.2-adapted vaccine will provide an additional tool for countries managing the evolving landscape of COVID-19 variants.

In the United States, the Food and Drug Administration (FDA) approved the KP.2-adapted vaccine for individuals aged 12 and older and granted emergency use authorization for those aged six months through 11 years in August 2024. 

Pfizer and BioNTech’s COVID-19 vaccines are based on BioNTech’s mRNA technology and developed in collaboration with Pfizer. The vaccines are already authorized for use in multiple regions, including the United States and the European Union, with BioNTech serving as the marketing authorization holder. 

Pending approval, both the Omicron KP.2-adapted and JN.1-adapted vaccines will be available in the European Union, though distribution may vary by country depending on government requests and national health recommendations.