The U.S. Food and Drug Administration (FDA) has authorized Novavax’s updated Covid-19 vaccine for emergency use in individuals aged 12 and older, marking a significant development as the fall and winter vaccination campaigns approach. This authorization positions Novavax’s vaccine to compete with offerings from Pfizer and Moderna during the upcoming season.
Novavax’s updated vaccine targets the omicron subvariant JN.1, which emerged earlier this year and is currently circulating in the U.S., although it accounts for only 0.2% of current cases according to recent data from the Centers for Disease Control and Prevention (CDC). Despite the limited prevalence of JN.1, Novavax asserts that its vaccine remains effective against several JN.1 descendants, including KP.2.3, KP.3, KP.3.1.1, and LB.1.
John Jacobs, CEO of Novavax, emphasized the vaccine’s broad protective capabilities, stating, “Our updated vaccine targets JN.1, the ‘parent strain’ of currently circulating variants, and has demonstrated robust cross-reactivity against JN.1 lineage viruses.”
The vaccine will be available at thousands of locations across the U.S., including retail pharmacies, independent drugstores, and regional grocery stores. Following the FDA’s decision, Novavax’s stock saw a significant increase, rising over 8% on Friday.
This announcement follows the FDA’s recent approval of new mRNA-based vaccines from Pfizer and Moderna, which target an offshoot of JN.1 known as KP.2. Last year, Novavax’s vaccine was authorized about a month after its mRNA competitors, placing the company at a competitive disadvantage.
Public health experts view Novavax’s protein-based vaccine as a valuable alternative for individuals preferring not to use mRNA vaccines. The protein-based technology employed by Novavax is a long-established method used in vaccines for diseases such as hepatitis B and shingles.
With uncertainty surrounding the uptake of new Covid-19 vaccines, past data indicates that only about 22.5% of U.S. adults received the latest vaccine updates last fall.
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