FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

By Sriparna Roy

The U.S. Food and Drug Administration on Friday granted emergency use authorization for an updated version of Novavax's COVID shot.

The updated vaccine is authorized for use in individuals 12 years of age and older and will target the JN.1 strain of the virus.

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Shares of the company were up 2.2% in extended trading after closing 8.6% higher.

"Today's authorization provides an additional COVID-19 vaccine option," said Peter Marks, director of the FDA's Center 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 this month, the health regulator approved updated COVID-19 vaccines made by Pfizer and Moderna targeting the KP.2 variant.

JN.1 was the dominant strain in the United States earlier this year. While it is no longer as prevalent, it is estimated to account for 0.2% of cases over a two-week period ended Aug. 31, the Centers for Disease Control and Prevention's data showed.

The KP.2 subvariant, on the other hand, is estimated to account for 3.1%, with KP.3.1.1 now becoming dominant at 42.2%.

In June, the health regulator asked COVID vaccine makers to target the KP.2 strain for 2024-25 COVID-19 vaccines.

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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 hospitalizations 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 vaccines in the United States to remain similar to last year, but anticipates its own performance to be better, it said earlier this month.