The European Commission in the European Union (EU) has granted full marketing authorization for Novavax’s Nuvaxovid COVID-19 vaccine.
The decision follows positive opinion for full marketing authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19. Nuvaxovid, also known as NVX-CoV2373, was originally granted conditional marketing authorization in the EU for these indications.
“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,” says John C. Jacobs, president and CEO of Novavax, in a 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.”
The phase 3 PREVENT-19 trial demonstrated Nuvaxovid’s reassuring 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’s COVID vaccine is authorized for use in more than 40 markets around the world.
Authorized Use of the Novavax COVID-19 Vaccine in the US
The trade name Nuvaxovid has not yet been approved by the US Food and Drug Administration (FDA). The Novavax COVID-19 vaccine has not been approved or licensed by FDA but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent (COVID-19 as a primary series in individuals 12 years of age and older.
The Novavax COVID-19 vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 vaccine, adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Photo caption: Nuvaxovid COVID-19 vaccine
Photo credit: Novavax