Pfizer Inc. and BioNTech SE 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) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The European Commission (EC) is expected to make a final decision soon. Following the EC decision, the vaccine will be shipped to European Union (EU) member states that have specifically ordered this formulation.
The CHMP recommendation is based on non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine, as well as clinical and real-world evidence supporting the safety and efficacy of prior COVID-19 vaccine formulas by Pfizer and BioNTech. Non-clinical data demonstrated that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, compared with the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine.
Previous Authorizations
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 sublineages, 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.
Availability
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.
US Approval
In the United States, the U.S. Food and Drug Administration (FDA) approved the companies’ Omicron KP.2-adapted COVID-19 vaccine for individuals 12 years of age and older and granted emergency use authorization for individuals 6 months through 11 years of age on August 22, 2024. Pfizer and BioNTech will continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas as the data support and as regulatory agencies recommend.
Vaccine Technology
The COVID-19 vaccines (Comirnaty) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for Comirnaty and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
