The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children aged 5 years and older as a single dose, regardless of their SARS-CoV-2 vaccination history. Additionally, the CHMP has recommended the vaccine for children between 6 months and 4 years.
Readiness for Distribution and EC Approval
Pfizer and BioNTech are prepared to ship the updated vaccine in anticipation of the European Commission (EC) following the CHMP’s recommendation to approve the vaccine. The companies aim to have the product available ahead of the fall and winter seasons this year, aligning with the needs for seasonal vaccination campaigns.
Implications for Pediatric Vaccination
The positive opinion from the CHMP is a significant step towards expanding vaccination options for children in the face of evolving SARS-CoV-2 variants. The approval of the Omicron-adapted Comirnaty vaccine could provide an additional layer of protection for pediatric populations across Europe.-Fineline Info & Tech
