Novavax has submitted an application to the US Food and Drug Administration (FDA) seeking approval for an updated JN.1 version of its protein-based Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

The company has sought an amendment to its emergency use authorisation to the Covid-19 vaccine.

The move aligns with recommendations from the FDA, European Medicines Agency (EMA), and the World Health Organization (WHO) to target the JN.1 lineage for the upcoming fall season.

In June 2024 the FDA’s Vaccines and Related Biological Products Advisory Committee recommended the development of an updated Covid-19 vaccine to target the JN.1 variant for 2024 to 2025.

The JN.1 vaccine by Novavax has shown promising results, with broad cross-neutralising antibodies effective against variant strains including KP.2 and KP.3. These findings suggest the vaccine could offer protection against evolving variants.

According to nonclinical studies, Novavax’s JN.1 vaccine elicits a comprehensive neutralisation response to JN.1 lineage viruses, including those with the F456L and R346T mutations, and to the variants FLiRT and FLuQE.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The updated NVX-CoV2705 specifically targets the parent strain of the KP.2 and KP.3 variants.

Novavax plans to have the doses ready for distribution in the US by mid-July 2024, subject to the FDA authorisation and CDC recommendation.

The company is poised to deliver promptly to US customers and is engaging with other global regulatory bodies for the vaccine’s authorisation or approval.

NVX-CoV2705 is an enhanced version of Novavax’s initial Covid-19 vaccine, NVX-CoV2373, formulated to combat the JN.1 variant.

The vaccine’s ready-to-use liquid formulation and storage requirements of 2° to 8°C facilitate integration with existing vaccine supply chains and cold chain infrastructure.

Novavax president and CEO John Jacobs stated: “Novavax is committed to having a protein-based Covid-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates.”