Pfizer, BioNTech report positive CHMP opinion for Omicron XBB.1.5 vaccine

Pfizer (PFE) and BioNTech SE (BNTX) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, marketed as “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 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 European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. Following a decision from the EC, the updated vaccine will be ready to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase,” the companies said.