CHMP Backs Pfizer-BioNTech Omicron KP.2 COVID-19 Vaccine in EU

NEW YORK, NY, USA and MAINZ, Germany – September 20, 2024 – Pfizer Inc. and BioNTech SE have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their new COVID-19 vaccine, COMIRNATY® KP.2. This vaccine is designed to combat the Omicron KP.2 variant of the virus and is recommended for individuals aged six months and older. The European Commission is expected to review this recommendation and make a final decision soon. Once authorized, the Omicron KP.2-adapted vaccine will be shipped to EU member states that have placed specific orders for it.

The CHMP's recommendation, dated September 19, 2024, is based on comprehensive non-clinical and manufacturing data for the Omicron KP.2-adapted vaccine. Additionally, it considers clinical and real-world evidence supporting the safety and efficacy of previous COVID-19 vaccines developed by Pfizer and BioNTech. The data indicates that the KP.2-adapted vaccine elicits a significantly improved immune response against multiple 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.

Back in July 2024, the European Commission had granted marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine. This earlier authorization was based on evidence showing that the JN.1-adapted vaccine also generated a markedly improved immune response against various Omicron JN.1 sublineages, including KP.2, LB.1, KP.3, and KP.3.1.1, outperforming the Omicron XBB.1.5-adapted vaccine.

Pending the European Commission's authorization of the KP.2-adapted vaccine, both the Omicron KP.2-adapted and the previously authorized Omicron JN.1-adapted vaccines will be made available across the EU. However, their availability will differ based on individual country requests and national health guidelines.

In the United States, the Food and Drug Administration (FDA) approved the Omicron KP.2-adapted COVID-19 vaccine for individuals aged 12 and older and granted emergency use authorization for those aged 6 months to 11 years on August 22, 2024. Pfizer and BioNTech will continue to monitor the evolving epidemiology of COVID-19 and stay prepared to develop new vaccine formulas as needed, based on data and regulatory recommendations.

The COVID-19 vaccines, known as COMIRNATY®, developed by Pfizer and BioNTech, utilize BioNTech’s proprietary mRNA technology. BioNTech holds the marketing authorization for COMIRNATY® and its adapted vaccines in various regions, including the United States, the European Union, and the United Kingdom. BioNTech is also the holder of emergency use authorizations or their equivalents in these and other countries, in collaboration with Pfizer.

COMIRNATY® is intended for active immunization to prevent COVID-19 in individuals aged 12 and older. The safety profile of the vaccine has been well-documented, although individuals are advised to consult their healthcare providers about any medical conditions prior to vaccination. Various side effects have been reported, and individuals are encouraged to report any adverse effects to the appropriate health authorities.

The companies remain committed to advancing global health and continuing to address the challenges posed by COVID-19 through innovative solutions and collaborative efforts with health authorities and governments worldwide.