Discrepancies of Pediatric Data of BNT162b2 mRNA Covid-19 Vaccine in the Assessment Report of the European Medicines Agency

Severe cases of Covid-19 predominantly occur in the elderly and subjects with underlying conditions. However, it is a mild disease in most of the affected people, particularly children and adolescents. This paper comments on the Assessment Report of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) (herein further referred to as Assessment Report) on the data of pediatric study; the Assessment Report served as a basis for authorization of Comirnaty vaccine for active immunization to prevent Covid-19 in individuals 12 to 15 years of age. By the legislation of the European Union, Assessment Report is a key document for an opinion of EMA regarding marketing authorization. Opinion of EMA provides a background for a decision of the European Commission to place a medicinal product for human use on the market.