HQ Team
September 1, 2024: The US Food and Drug Administration cleared Novavax’s Covid-19 vaccine, targeting the JN.1 strain, for people 12 years of age and older, according to a statement from the regulator.
The emergency use of the shot includes “a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.”
The virus has claimed the lives of more than seven million people globally.
“Today’s authorization 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,” said John C. Jacobs, President and Chief Executive Officer, Novavax.
Headache, nausea
“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.”
Pre-filled syringes of the vaccine in retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research release of vaccine batches, according to a company statement.
The emergency use authorization was based on non-clinical data that showed Novavax’s updated vaccine provides “cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.”
In clinical trials, the most common adverse reactions associated with Novavax’s prototype Covid-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
Covid-19-influenza combination
The company’s portfolio includes its Covid-19 vaccine and its pipeline includes Covid-19-Influenza combination and stand-alone influenza vaccine candidates.
Novavax filed for JN.1 in line with guidance from the USFDA, European Medicines Agency and the World Health Organization to target the JN.1 lineage this fall.
On August 22, the USFDA granted emergency use authorisation to the Covid-19 vaccine made by Pfizer Inc., and ModernaTX Inc., which incorporates a new component to fight a variant of the virus. The approval included a monovalent component to combat the KP.2 strain of the Omicron variant.
The updated vaccines are expected to provide protection against Covid-19 caused by the currently circulating variants.
