FDA authorises Novavax's updated Covid-19 vaccine targeting JN.1 strain
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The US Food and Drug Administration on Aug 30 granted emergency use authorisation for an updated version of Novavax's Covid-19 shot.
PHOTO: REUTERS
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WASHINGTON - The US Food and Drug Administration on Aug 30 granted emergency use authorisation for an updated version of Novavax's Covid-19 shot.
The updated vaccine is authorised for use in individuals 12 years of age and older and will target the JN.1 strain of the virus.
Shares of the company were up 2.2 per cent in extended trading after closing 8.6 per cent higher.
"Today’s authorisation provides an additional Covid-19 vaccine option," said Mr Peter Marks, director of the FDA's Centre for Biologics Evaluation and Research.
Doses are on track to be available as early as the end of next week, the company said in an emailed response.
The updated vaccine targets 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, said CEO John Jacobs.
Earlier in August, the health regulator approved updated Covid-19 vaccines made by Pfizer and Moderna that target the KP.2 variant.
JN.1 was the dominant strain in the United States earlier in 2024.
While it is no longer as prevalent, it is estimated to account for 0.2 per cent of cases over a two-week period ended Aug 31, the Centres for Disease Control and Prevention’s data showed.
The KP.2 subvariant, on the other hand, is estimated to account for 3.1 per cent, with KP.3.1.1 now becoming dominant at 42.2 per cent.
In June, the health regulator asked Covid-19 vaccine makers to target the KP.2 strain for 2024 to 2025 Covid-19 vaccines.
Novavax’s traditional protein-based shot offers an alternative vaccine technology to those that are based on messenger RNA - Moderna’s Spikevax and Comirnaty, which is jointly developed by Pfizer and BioNTech.
Covid-19-related hospitalisations and deaths have increased over the past three months in the United States.
Demand for the shots, however, has fallen sharply since the peak of the pandemic.
Novavax expects overall demand for Covid-19 vaccines in the United States to remain similar to 2023, but anticipates its own performance to be better, it said earlier in August. REUTERS
