Pfizer, BioNTech Obtain Positive CHMP Opinion For Omicron XBB.1.5-adapted COVID-19 Vaccine In EU

(RTTNews) - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Pfizer Inc. (PFE) and BioNTech's (BNTX) Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history, the companies said in a statement on Wednesday.

The companies said that the Committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.

The recommendation is based on pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which continue to dominate globally.

The European Commission will review the CHMP's recommendation and is expected to make a final decision soon. Following a decision from the Commission, the updated vaccine will be ready to ship to applicable EU member states immediately, the companies said.

Pfizer and BioNTech stated that they have also filed an application with the U.S. Food and Drug Administration (FDA) requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months of age and older. A decision is expected in the coming days. The companies have submitted data for the updated COVID-19 vaccine to other regulatory authorities around the world.

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