(Tiper Stock Exchange) – The EMAdrug supervisory authority europera, recommended the clearance of vaccine to mRna Comirnaty produced by Pfizer/biotech adapted to the subvariant Omicron XBB.1.5. The vaccine is to be used for prevent COVID-19 in adults and children from 6 months of age.
In line with previous recommendations from EMA and the European Center for Disease Prevention and Control (ECDC), adults and children aged 5 and over who need to be vaccinated should receive a single dose, regardless of their history vaccine against COVID-19. Children aged 6 months to 4 years may receive one to three doses depending on whether they have completed a primary vaccination course or have had COVID-19.
In the decision to recommend clearance, all available data were considered on Comirnaty and other adapted vaccines, including data on safety, efficacy and immunogenicity. In addition, the Committee evaluated new laboratory data showing a strong response of the adapted vaccine against XBB.1.5 and related strains of the virus that causes COVID-19.