FDA Grants Emergency Use Authorization for Novavax's Updated COVID Shot Targeting JN.1 Strain

The Food and Drug Administration (FDA) has granted emergency use authorization for an updated version of Novavax's Covid-19 vaccine, which is now authorized for individuals 12 years and older and targets the JN.1 strain of the virus. Following this announcement, shares of Novavax experienced a 9% increase during late afternoon trading.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, emphasized the significance of this authorization, stating, "Today’s authorization provides an additional Covid-19 vaccine option." The company confirmed that doses are expected to be available as early as the end of next week.

Earlier this month, the FDA approved updated Covid vaccines from Pfizer and Moderna, which target the KP.2 variant. While the JN.1 strain was dominant in the United States earlier this year, it is estimated to account for only 0.2% of cases over a two-week period ended Aug. 31, according to data from the Centers for Disease Control and Prevention (CDC). In contrast, the KP.2 variant accounts for 3.1% of cases, with the KP.3.1.1 variant now being the dominant strain at 42.2%.

In June, the FDA revised its strain recommendation for 2024-25 Covid shots, urging manufacturers to update the vaccines to target the KP.2 variant, if feasible, instead of the previously targeted JN.1 lineage.

Diverse Vaccine Technologies

Novavax's traditional protein-based shot provides an alternative to the messenger RNA-based vaccines developed by Moderna and Pfizer/BioNTech. Despite a recent increase in Covid-related hospitalizations and deaths in the United States, the demand for vaccines has significantly decreased since the peak of the pandemic. Novavax anticipates that overall demand for Covid vaccines in the United States will remain similar to last year, but it expects better performance compared to the previous year, as stated by the company earlier this month.