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COVID-19 Vaccine from Pfizer and BioNTech Receives CHMP Approval for Omicron JN.1 Adaptation

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Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY® JN.1, for active immunization in individuals aged 6 months and older. This recommendation is based on pre-clinical and epidemiological data showing an improved immune response against multiple JN.1 sublineages.

The European Commission (EC) will review the CHMP’s recommendation, with a final decision expected soon. Upon authorization, Pfizer and BioNTech will immediately ship doses to applicable EU member states. The companies have been manufacturing the vaccine at risk to ensure supply readiness for the anticipated increase in demand during the fall and winter seasons.

The CHMP’s recommendation is supported by extensive clinical, non-clinical, and real-world evidence of the safety and efficacy of Pfizer-BioNTech COVID-19 vaccines. The updated vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages compared to the previous Omicron XBB.1.5-adapted vaccine.

Pfizer and BioNTech Seek FDA Approval for Omicron KP.2-Adapted COVID-19 Vaccine

Pfizer and BioNTech are starting rolling applications with the U.S. FDA, requesting approval for their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals aged 6 months and older. They will continue to monitor COVID-19 epidemiology and prepare to meet global public health needs.

COMIRNATY® (COVID-19 Vaccine, mRNA) is used for active immunization against COVID-19 in people 12 years and older. The vaccine should not be administered to individuals who have had severe allergic reactions to previous doses or any ingredients in the vaccine. There is a remote chance of severe allergic reactions, myocarditis, and pericarditis, especially in adolescent males. Common side effects include injection-site pain, fatigue, headache, muscle pain, and fever. Individuals with weakened immune systems may have a reduced response to the vaccine.

COVID-19 Vaccine

Pfizer and BioNTech Advance COVID-19 Vaccines with CHMP Positive Opinion for Broader Access

Pfizer and BioNTech developed the COVID-19 vaccines using BioNTech’s proprietary mRNA technology. BioNTech is the Marketing Authorization Holder for COMIRNATY® in the U.S., EU, UK, and other countries. The companies continue to advance the development of COVID-19 vaccines to address emerging variants and public health needs.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) plays a critical role in the scientific evaluation of medicines for use in the European Union. The positive opinion from CHMP is a significant step towards broader access to the updated COVID-19 vaccine across Europe.

This release includes forward-looking statements about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer, and the development and potential benefits of their COVID-19 vaccine programs. These statements are subject to risks and uncertainties, including clinical trial outcomes, regulatory approvals, and manufacturing and distribution challenges. Pfizer assumes no obligation to update forward-looking statements as a result of new information or future events.

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Resource: Pfizer, June 27, 2024

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