Fri Sep 20 12:10:00 UTC 2024: ## EU Recommends Authorization for Pfizer-BioNTech’s Omicron KP.2-Adapted COVID-19 Vaccine

**Mainz, Germany and New York, September 20, 2024** – Pfizer Inc. and BioNTech SE today 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 monovalent COVID-19 vaccine (COMIRNATY® KP.2). This recommendation, if approved by the European Commission, will make the vaccine available to individuals 6 months of age and older across EU member states.

The CHMP’s recommendation is based on non-clinical and manufacturing data, along with existing clinical and real-world evidence supporting the safety and efficacy of previous COVID-19 vaccine formulations from Pfizer and BioNTech. Non-clinical data demonstrated 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 vaccine.

This recommendation comes after the European Commission granted marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine in July 2024. Both the KP.2 and JN.1-adapted vaccines will be available across the EU, pending final authorization from the EC, though availability will vary based on individual country orders and recommendations.

In the United States, the U.S. Food and Drug Administration approved the 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 continue to monitor the evolving COVID-19 situation and are prepared to develop modified vaccine formulations as data and regulatory agencies recommend.

**About the Vaccine**

COMIRNATY® KP.2 is based on BioNTech’s proprietary mRNA technology. It is administered as a single dose for individuals aged 5 years and older. Infants and children from 6 months to 4 years of age may receive one or three doses depending on their vaccination history.

**About Pfizer and BioNTech**

Pfizer Inc. is a global pharmaceutical company committed to developing therapies that improve patients’ lives. BioNTech SE is a global immunotherapy company specializing in the development of novel therapies for cancer and other serious diseases.

**Note:** This news article has been summarized and rewritten from the original press release. It includes key information about the recommendation and its implications but may not include all details found in the original document.

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