Novavax has announced that the Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA).
The authorisation allows for its use in actively immunising individuals aged 12 and older against Covid-19.
Additionally, the vaccine is featured in the recommendations released by the US Centers for Disease Control and Prevention (CDC) in June 2024.
Novavax’s updated Covid-19 vaccine includes a monovalent component that targets the Omicron variant JN.1 strain of SARS-CoV-2.
Its EUA application, filed in June, sought approval as the only protein-based Covid-19 vaccine available in the US for individuals aged 12 and older.
However, it is not yet approved or licensed by the health agency.
This authorisation comes after the FDA’s recent approvals and authorisations of updated mRNA Covid-19 vaccines for 2024-2025 from ModernaTX and Pfizer against currently circulating variants.
The EUA is supported by non-clinical data demonstrating its effectiveness and cross-reactivity against JN.1 and various JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.1.
Clinical trials of Novavax’s earlier prototype Covid-19 vaccine (NVX-CoV2373) reported common adverse reactions such as headache, nausea or vomiting, muscle pain, joint pain, tenderness and pain at the injection site, fatigue, and malaise.
Novavax president and CEO John Jacobs said: “Today’s authorisation enables Novavax to launch our updated Covid-19 vaccine in the US in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide.
“Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”
In June, the CDC’s Advisory Committee on Immunization Practices recommended the use of 2024-2025 Covid-19 vaccines authorised under EUA or approved via biologics licence application for individuals aged six months and older, irrespective of specific viral strains.
The US-based biotechnology company plans to distribute the pre-filled syringes of the vaccine to retail and independent pharmacies as well as regional grocers, once the Center for Biologics Evaluation and Research releases the vaccine batches.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “Today’s authorisation provides an additional Covid-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorisation.”
