The approval was based on the positive opinion for full marketing authorisation from the Committee for Medicinal Products for Human Use of the European Medicines Agency
EC grants Nuvaxovid full marketing authorisation in the EU. (Credit: Novavax)
American biotechnology company Novavax announced that the European Commission (EC) has granted full marketing authorisation (MA) for Nuvaxovid (NVX-CoV2373) in the European Union (EU).
Nuvaxovid is a protein-based vaccine developed by generating copies of the surface spike protein of SARS-CoV-2 that causes Covid.
The vaccine is now completely authorised for use as a primary series in people 12 and older and as a booster dose in adults 18 and older to prevent Covid-19.
Nuvaxovid was initially given a conditional MA in the EU for these indications. The full authorisation replaces this conditional authorisation, which is said to be the first for Novavax in the EU.
The approval was based on the positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Novavax president and CEO John Jacobs said: This marketing authorisation establishes the foundation for all future regulatory approvals for updated versions of our Covid vaccine, a necessity to ensure we can quickly get our vaccine to individuals in the EU.
“In addition to the EU, we are preparing to file for full approval in the US as well as other markets and are committed to ensuring protein-based options are available worldwide. Vaccine choice remains an integral part of public health measures.”
Nuvaxovid’s safety profile, efficacy as a primary series in adults, immunogenicity and safety as a booster dose in adults, and efficacy and safety as a primary series in people 12 years of age and older were all demonstrated in Phase 3 PREVENT-19 trial, the biotechnology firm said.
PREVENT-19 was a randomised, placebo-controlled, observer-blinded trial.
The primary endpoint was the first occurrence of polymerase chain reaction (PCR)-confirmed symptomatic Covid-19 with onset at least seven days post the second dose in 29,960 participants aged 18 and older at baseline without protocol violations before the illness.
The secondary endpoint was defined as the prevention of PCR-confirmed, symptomatic moderate or severe Covid-19.
The Nuvaxovid vaccine is packaged as a ready-to-use liquid formulation and is already authorised in more than 40 markets around the world.