Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for their Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2). This vaccine is intended for active immunization against COVID-19 caused by SARS-CoV-2 in individuals aged six months and older. The European Commission is set to review this recommendation and is expected to make a final decision shortly. Once authorized, the vaccine will be distributed to EU member states that have placed orders.
The CHMP’s favorable opinion, dated September 19, 2024, is based on non-clinical and manufacturing data, as well as clinical evidence demonstrating the safety and efficacy of previous Pfizer-BioNTech COVID-19 vaccines. Non-clinical data indicate that the KP.2-adapted vaccine elicits a significantly improved immune 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.
In July 2024, the European Commission granted marketing authorization for the Omicron JN.1-adapted vaccine, which also showed enhanced responses against several Omicron JN.1 sublineages.
Pending final authorization from the EC, both the Omicron KP.2 and Omicron JN.1-adapted vaccines will be accessible throughout the EU, with availability varying by country based on governmental requests and recommendations.
In the U.S., the Food and Drug Administration approved the Omicron KP.2-adapted vaccine for individuals aged 12 and older and granted emergency use authorization for those aged six months to 11 years as of August 22, 2024. Pfizer and BioNTech continue to monitor the evolving COVID-19 landscape and are ready to adapt their vaccine formulations as necessary, based on emerging data and regulatory guidance.
The COVID-19 vaccines (COMIRNATY®) developed by Pfizer and BioNTech utilize BioNTech’s proprietary mRNA technology. BioNTech holds the Marketing Authorization for COMIRNATY® and its adaptations in the U.S., EU, U.K., and other regions.
Indications and Important Safety Information
Indication:
COMIRNATY® (COVID-19 Vaccine, mRNA) is authorized for individuals aged 12 and older to protect against COVID-19.
Important Safety Information:
Do not receive COMIRNATY® if you have had a severe allergic reaction to a prior dose of COMIRNATY or any Pfizer-BioNTech vaccine. Severe allergic reactions may occur within minutes to an hour after vaccination; monitoring post-vaccination is advised. Symptoms of severe reactions may include difficulty breathing, facial and throat swelling, rapid heartbeat, widespread rash, dizziness, and weakness.
Myocarditis and pericarditis have been reported in some individuals following mRNA vaccinations, particularly among adolescent males aged 12 to 17. Symptoms usually appear within days of vaccination. Seek immediate medical attention if experiencing chest pain, shortness of breath, or rapid heartbeat, especially within two weeks of receiving the vaccine.
Individuals with weakened immune systems may have a reduced response to the vaccine, and it may not protect all recipients.
