Emergency Use Authorization for Novavax’s Updated COVID Vaccine

By Sriparna Roy

(Reuters) – The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for an updated version of Novavax (NASDAQ:NVAX) COVID shot.

The updated vaccine targets the JN.1 strain and is authorized for individuals aged 12 and older. Following the announcement, shares of Novavax rose by 2.2% in extended trading after an 8.6% increase in regular trading.

“Today’s authorization provides an additional COVID-19 vaccine option,” stated Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Doses are expected to be available by the end of next week. The vaccine is designed to target the ‘parent strain’ of circulating variants and has shown strong cross-reactivity against several lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1, according to CEO John Jacobs.

Earlier this month, the FDA approved updated vaccines from Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) targeting the KP.2 variant. The JN.1 strain was dominant earlier this year but now constitutes about 0.2% of cases as of late August, according to CDC data. Meanwhile, the KP.2 subvariant accounts for approximately 3.1%, with KP.3.1.1 reaching 42.2%.

In June, vaccine makers were advised by the regulator to focus on the KP.2 strain for 2024-25 vaccines. Novavax’s protein-based shot offers an alternative to the mRNA-based vaccines from Moderna and Pfizer/BioNTech.

COVID-19-related hospitalizations and deaths have risen over the last three months in the U.S., although vaccine demand has significantly declined since the pandemic’s peak. Novavax expects steady overall demand for COVID vaccines in the U.S. but plans for improved performance than last year.