Posted by Michael Wonder on 30 May 2023
Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU
26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of COVID-19 in the European Union following a positive opinion issued by the CHMP of the EMA.
Novavax has demonstrated the efficacy and safety of Nuvaxovid as a primary series, and the immunogenicity and safety of the vaccine as a booster in individuals aged 12 and older in the Phase 3 PREVENT-19 trial, Phase 2 trials and in real-world evidence.
