CHMP positive opinion for Omicron KP.2-adapted COVID-19 vaccine in the European Union

The European Commission (“EC”) will review the CHMP’s recommendation and is expected to make a final decision soon. Following the EC decision, Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine will ship to European Union (“EU”) member states that have specifically ordered this formulation.

The CHMP recommendation dated September 19, 2024, is based on the non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine and the clinical and real-world evidence supporting the safety and efficacy of prior formulas of the COVID-19 vaccines by Pfizer and BioNTech. The non-clinical data showed that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sub-lineages, including KP.2, LB.1, KP.3, and KP.3.1.1, compared with the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine.

In July 2024, the EC granted marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine. This authorization was based on evidence showing that the JN.1-adapted COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sub-lineages, including KP.2, LB.1, KP.3, and KP.3.1.1, as compared with the companies’ Omicron XBB. 1.5-adapted COVID-19 vaccine. 

Pending authorization of the Omicron KP.2-adapted vaccine by the EC, both the Omicron KP.2-adapted vaccine and the Omicron JN.1-adapted vaccine will be available across the EU, though availability will vary based on individual country government requests and national recommendations.