FDA Greenlights Updated Novavax COVID Vaccine

The FDA granted emergency use authorization for Novavax's updated COVID-19 vaccine targeting the JN.1 strain. Approved for individuals 12 and older, the vaccine offers an alternative to mRNA-based vaccines. Novavax aims to meet demand as COVID hospitalizations and deaths rise, despite falling overall vaccine demand.

The U.S. Food and Drug Administration (FDA) granted emergency use authorization for an updated version of Novavax's COVID-19 vaccine on Friday. The new vaccine, targeting the JN.1 strain of the virus, is authorized for use in individuals aged 12 and older.

Following the announcement, Novavax shares rose 9% in late afternoon trading. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, stated that this authorization provides an additional option for COVID-19 vaccination.

Novavax confirmed that doses could be available by the end of next week. Earlier, the health regulator approved updated vaccines from Pfizer and Moderna targeting the KP.2 variant.

The JN.1 strain was dominant earlier this year but now accounts for only 0.2% of cases, according to CDC data. The KP.2 variant accounts for 3.1%, while KP.3.1.1 is the current dominant strain at 42.2%.

In June, the FDA revised its strain recommendation for 2024-25 COVID-19 shots, urging manufacturers to target the KP.2 variant. Novavax's traditional protein-based vaccine offers an alternative to the messenger RNA-based vaccines from Moderna and Pfizer-BioNTech.

While COVID-19-related hospitalizations and deaths have increased over the past three months, overall demand for the vaccines has decreased since the pandemic's peak. Novavax expects demand to remain similar to last year, anticipating better performance for its own vaccine.

(With inputs from agencies.)