Novavax Secures EC Approval for Updated 2024-2025 COVID-19 Vaccine

The leading global biotechnology company advancing protein-based vaccines, Novavax, announced that the European Commission has granted Marketing Authorisation for the company’s updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (NVX-CoV2705).

This authorisation permits its use in individuals aged 12 and older for the prevention of COVID-19 within the European Union (EU). The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

The authorisation of Novavax’s updated Nuvaxovid™ vaccine was based on non-clinical data demonstrating that it offers cross-reactivity against JN.1 and several other JN.1 lineage viruses, such as KP.2.3, KP.3, KP.3.1.1, and LB.1.1. The most common adverse reactions associated with Novavax’s previous prototype COVID-19 vaccine (NVX-CoV2373) included headache, muscle pain, joint pain, fatigue, and localized injection site reactions.

The vaccine is part of a broader global effort to respond to the ongoing COVID-19 pandemic. In addition to its approval in the EU, the updated Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) is also authorised in the United States and received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in August. 

U.S. Authorisation and Safety Information

In the U.S., the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is currently authorised for emergency use under an Emergency Use Authorization (EUA) for individuals aged 12 and older. Although not yet approved or licensed by the FDA, this EUA will remain in effect for the duration of the ongoing COVID-19 emergency, unless revoked earlier.

Key safety precautions for the vaccine include managing potential acute allergic reactions, heightened risks of myocarditis and pericarditis, and fainting (syncope) post-vaccination. It is also noted that the vaccine’s efficacy may be reduced in individuals with compromised immune systems, and like all vaccines, it may not provide protection for all recipients.

Healthcare providers are urged to report adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) and consult the full Fact Sheet for more detailed safety and administration information.

About the Novavax 2024-2025 Nuvaxovid™ Formula

The NVX-CoV2705 formula targets the JN.1 variant and is produced using Novavax’s proprietary recombinant nanoparticle technology. This protein-based vaccine mimics the SARS-CoV-2 spike protein to stimulate an immune response. Novavax’s Matrix-M™ adjuvant, made from saponin extracts, enhances the vaccine’s ability to induce a broader and more durable immune response. The ready-to-use liquid formulation is stored between 2°C and 8°C, allowing it to fit within existing supply chain infrastructures.

About Novavax

Novavax, Inc. is a biotechnology company dedicated to advancing innovative vaccines to prevent serious infectious diseases. Headquartered in Gaithersburg, Maryland, Novavax leverages its recombinant protein-based platform and patented Matrix-M™ adjuvant to develop vaccines that enhance immune responses. The company’s COVID-19 vaccine is part of its broader pipeline, which also includes a combination COVID-19-Influenza vaccine and a stand-alone influenza vaccine candidate. Novavax’s adjuvant is also used in the R21/Matrix-M malaria vaccine, developed in collaboration with the University of Oxford and the Serum Institute of India.


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