Nuvaxovid receives positive CHMP opinion for full marketing authorization for the prevention of COVID 19 in the EU
Novavax, Inc. announced that Nuvaxovid (NVX-CoV2373) has been recommended for full Marketing Authorization (MA) 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 (EU) following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
The European Commission will review the CHMP recommendation and is expected to make a final decision on the MA.
"The positive CHMP Opinion for full Marketing Authorization for our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall," said John C. Jacobs, President and Chief Executive Officer, Novavax.
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 III PREVENT-19 trial, Phase II trials and in real-world evidence. Novavax's COVID vaccine is authorized for use in more than 40 markets around the world. In the EU, Nuvaxovid has been conditionally authorized as a two-dose primary series in adults and adolescents, and as a booster dose in adults.
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