WASHINGTON: US biotech company Novavax Inc was granted full marketing authorisation on Thursday by the European Commission for the use of the coronavirus vaccine Nuvaxovid in the European Union, the company said, reported German news agency (dpa).
The decision follows a positive opinion for a full marketing authorisation from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).
The vaccine is now fully authorised for use as a primary series in individuals, aged 12 and older, and as a booster dose in adults, aged 18 and older, for the prevention of Covid-19.
Nuvaxovid was originally granted a conditional marketing authorisation in the EU for these indications.
The company said the Phase 3 Prevent-19 trial demonstrated Nuvaxovid’s reassuring safety profile, as well as efficacy as a primary series in adults, the immunogenicity and safety as a booster dose in adults, and the efficacy and safety as a primary series in individuals aged 12 and older.
Novavax’s coronavirus vaccine is authorised for use in more than 40 markets around the world.-Bernama
