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news.Novavax has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its updated Covid-19 vaccine for individuals aged 12 years and over.
The Covid-19 vaccine received recommendation from the US Centers for Disease Control and Prevention following receipt of FDA EUA. Credit: torstensimon from Pixabay.
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The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) [NVX-CoV2705] is now authorised for active immunisation against Covid-19.
Following the EUA, the vaccine is also recommended by the US Centers for Disease Control and Prevention (CDC).
Pre-filled syringes of the vaccine will soon be distributed across a variety of locations, including pharmacies and regional grocers, once the Center for Biologics Evaluation and Research approves the vaccine batches.
The CDC’s Advisory Committee on Immunization Practices unanimously recommended the use of the 2024-2025 COVID-19 vaccines for individuals as young as six months in June this year.
This recommendation applies to all vaccines authorised under EUA or approved via Biologics License Application, without preference for specific viral strains.
The decision to target the JN.1 strain, the parent of the most common variants currently in circulation, was based on public health benefits discussed during the June FDA Vaccines and Related Biological Products Advisory Committee meeting.
Novavax’s filing for the JN.1 lineage was in line with guidance from the FDA, the European Medicines Agency (EMA), and the World Health Organization.
The EUA for the Novavax vaccine was supported by non-clinical data demonstrating cross-reactivity against the JN.1 strain and its lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.1.
Headaches, nausea, muscle pain, and fatigue, among others were the most common adverse reactions to Novavax’s NVX-CoV2373 vaccine in clinical trials.
Novavax president and CEO John Jacobs said: “The 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.”
