Pfizer and BioNTech Receive EMA’s CHMP Positive Opinion Recommending Marketing Authorization for Omicron BA.4/BA.5- Bivalent Booster Vaccine
Shots:
- The EMA’s CHMP has adopted the positive opinion recommending marketing authorization for a booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children aged 5-11yrs. The EC’s final decision is expected shortly
- The recommendation was based on safety & immunogenicity data from the Omicron BA.1-adapted bivalent vaccine in individuals aged ≥12yrs., initially approved 10µg pediatric formulations of the COVID-19 vaccine, manufacturing data from pediatric formulation & preclinical data from Omicron BA.4/BA.5-adapted bivalent vaccine
- The P-II/III trial results showed that booster vaccine in adults aged ≥18yrs. elicited a strong immune response against BA.4 & BA.5 sublineages, safety & tolerability profile similar to the COVID-19 vaccine
Ref: Globenewswire | Image: BioNTech
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