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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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. <\/p>\n
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.<\/p>\n
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