Pfizer and BioNTech Granted Favorable CHMP Assessment for Omicron XBB.1.5-adapted COVID-19 Vaccine in the EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommendation is grounded in pre-clinical data indicating that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine elicits an enhanced immune response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which continue to be dominant on a global scale. Pending authorization by the European Commission, the vaccine doses can be swiftly made available for shipment to eligible EU member states.

Pfizer Inc. and BioNTech SE announced that the CHMP of the EMA has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5). This vaccine is proposed for use as a single dose for individuals aged 5 years and older, irrespective of their prior COVID-19 vaccination status. The CHMP has also recommended the updated vaccine for children aged 6 months to 4 years, either as part of or the entirety of the primary three-dose vaccination regimen, depending on their prior vaccination history, or as a single dose for those with a documented history of completing a COVID-19 primary vaccination series or previous SARS-CoV-2 infection.

The European Commission (EC) is slated to review the CHMP’s recommendation and is expected to make a final decision shortly thereafter. Once approved by the EC, the updated vaccine will be poised for immediate shipment to eligible EU member states. Pfizer and BioNTech have taken the proactive step of manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine in advance, ensuring a readily available supply as the demand for COVID-19 vaccinations is anticipated to rise during the approaching autumn and winter seasons.

Albert Bourla, Chairman and Chief Executive Officer at Pfizer, stated:

“This season’s vaccine is prepared for distribution as soon as the final regulatory verdict is rendered, allowing people across Europe to safeguard themselves more effectively against COVID-19 as the risk escalates. It has been nearly a year since many European Union citizens were initially vaccinated against COVID-19, and the revised formulation offers them an opportunity to receive a vaccine better matched to the current sublineages.”

Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, emphasized,

“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain dedicated to providing COVID-19 vaccines that are better suited to the prevailing circulating variants or sublineages, supporting vaccination efforts in the upcoming fall and winter season. The Omicron XBB-related sublineages are antigenically distinct from previous Omicron strains and continue to account for the majority of COVID-19 cases worldwide. The updated COVID-19 vaccine aims to further enhance protection against severe illness and hospitalization.”

The CHMP’s recommendation rests on a comprehensive body of prior clinical, non-clinical, and real-world evidence endorsing the safety and efficacy of COVID-19 vaccines developed by Pfizer and BioNTech. Additionally, the application includes pre-clinical data illustrating that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine provokes a markedly improved immune response against various XBB sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the previously adapted bivalent COVID-19 vaccine for Omicron BA.4/BA.5. Further pre-clinical data demonstrate that serum antibodies induced by the updated COVID-19 vaccine effectively neutralize the globally predominant and recently designated variant of interest EG.5.1 (Eris), in contrast to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

The COVID-19 vaccines (COMIRNATY®) developed by Pfizer and BioNTech are founded on BioNTech’s proprietary mRNA technology and were jointly created by both companies. BioNTech holds the Marketing Authorization for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada, and various other countries. Additionally, BioNTech possesses emergency use authorizations or equivalents in the United States (in conjunction with Pfizer) and multiple other nations.

Original Source: Press Release from August 30, 2023, (BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE including multimedia content, please follow this link:

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