COVID-19 Vaccine, Nuvaxovid, Gains EU Approval

Novavax announced on July 6, 2023 that the European Commission has granted the company’s COVID-19 vaccine, Nuvaxovid, full marketing authorization for use in the European Union. The vaccine can now be used as a primary series in people 12 years and older and as a booster in adults over 18 to prevent COVID-19. A conditional authorization was previously granted in the EU for the vaccine.

The decision was made after the European Medicines’ Agency’s Committee for Medicinal Products for Human Use recommended the vaccine for approval. A Phase III PREVENT-19 trial assured the “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 said in a press release.

"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," said John C. Jacobs, president and chief executive officer, Novavax, in the press release. "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."

Source: Novavax