CHMP Endorses Pfizer-BioNTech's Omicron KP.2 COVID-19 Vaccine in EU

Pfizer Inc. and BioNTech SE have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for their Omicron KP.2-adapted COVID-19 vaccine, named COMIRNATY® KP.2. This vaccine is intended for active immunization against COVID-19 for individuals aged six months and older. Following this recommendation, the European Commission (EC) is expected to make a final decision soon. Once approved, the vaccine will be distributed to European Union (EU) member states that have ordered this specific formulation.

This recommendation from the CHMP, dated September 19, 2024, is based on a combination of non-clinical and manufacturing data from the Omicron KP.2-adapted vaccine, as well as clinical and real-world evidence from previous COVID-19 vaccines developed by Pfizer and BioNTech. Non-clinical data showcased that the KP.2-adapted vaccine generates a significantly improved response against various circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, compared to the companies' Omicron XBB.1.5-adapted COVID-19 vaccine.

Earlier in July 2024, the EC had authorized Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine. The authorization was granted based on data demonstrating that the JN.1-adapted vaccine also generated a substantially improved response against the same Omicron JN.1 sublineages. Similar to the KP.2-adapted vaccine, the JN.1-adapted vaccine will be available in the EU, contingent upon individual country requests and national guidelines.

In the United States, the Omicron KP.2-adapted COVID-19 vaccine received approval from the U.S. Food and Drug Administration (FDA) for individuals aged 12 and older, with emergency use authorization granted for those aged six months through 11 years, effective August 22, 2024. Pfizer and BioNTech will keep monitoring the evolving COVID-19 epidemiology and are prepared to develop new vaccine formulations as required by emerging data and regulatory recommendations.

The COMIRNATY® COVID-19 vaccines, developed jointly by Pfizer and BioNTech, employ BioNTech’s proprietary mRNA technology. BioNTech holds the marketing authorizations for the vaccine and its adapted versions in the U.S., EU, UK, and other regions, including emergency use authorizations in specific jurisdictions.

In terms of safety, the vaccines have been associated with rare instances of myocarditis and pericarditis, particularly in adolescent males aged 12 to 17, typically occurring within a few days post-vaccination. Additionally, other side effects ranging from severe allergic reactions to mild symptoms such as injection site pain, fatigue, and headache have been reported.

Pfizer and BioNTech continue to collaborate closely to ensure the vaccines are widely accessible and are committed to meeting global health needs during the ongoing pandemic. They emphasize the importance of vaccination in controlling the spread of COVID-19 and preventing severe outcomes associated with the virus.