The full MA is based on positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use, and replaces the conditional Marketing Authorization.
As the EC has now granted full approval, the protein-based vaccine can be used as a primary series in people aged 12 and above for the prevention of Covid-19.
It can also be taken as a booster dose in adults aged 18 and older.
The Phase 3 PREVENT-19 study showed Nuvaxovid’s reassuring safety profile and 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 who are aged 12 and above.
The study was conducted in the US and Mexico.
Novavax’s COVID vaccine is authorised for use in more than 40 markets around the world.
Novavax president and CEO John C. Jacobs said: “This Marketing Authorization 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 is available as a ready-to-use liquid formulation and is to be stored at 2° to 8°C.