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FDA Authorizes Novavax’s Updated Covid Vaccine for Emergency Use in Ages 12 and Up

BusinessFDA Authorizes Novavax’s Updated Covid Vaccine for Emergency Use in Ages 12 and Up

The Food and Drug Administration (FDA) has granted emergency use authorization for Novavax’s updated Covid-19 vaccine for individuals aged 12 and older. This approval positions Novavax’s protein-based vaccine to compete with the mRNA vaccines from Pfizer and Moderna during the upcoming fall and winter seasons.

Novavax’s vaccine specifically targets the omicron subvariant JN.1, which gained traction in the U.S. earlier this year. However, according to recent data from the Centers for Disease Control and Prevention (CDC), JN.1 currently accounts for only 0.2% of Covid cases nationwide. Despite this, Novavax has emphasized that its vaccine provides robust protection against the more dominant descendants of JN.1 circulating in the U.S., including variants such as KP.2.3, KP.3, KP.3.1.1, and LB.1.

John Jacobs, CEO of Novavax, stated that the updated vaccine targets JN.1, considered the “parent strain” of several currently circulating variants. He noted that the vaccine has demonstrated strong cross-reactivity against these lineage viruses, making it a viable option for broader protection this season.

Novavax’s vaccine stands out as a protein-based alternative to the mRNA vaccines produced by Pfizer and Moderna. Unlike mRNA vaccines, which use newer technology to instruct cells to produce proteins that trigger an immune response, Novavax’s approach utilizes protein-based technology, a method that has been used for decades in vaccines for hepatitis B and shingles. This traditional approach may appeal to individuals hesitant to receive mRNA vaccines.

The FDA’s decision follows its recent approval of new mRNA vaccines from Pfizer and Moderna, which target another JN.1 offshoot, KP.2. Last year, Novavax’s vaccine was authorized nearly a month after its competitors, placing the company at a disadvantage. However, the timely approval this year could level the playing field, allowing Novavax’s vaccine to be more readily accessible.

Novavax expects its vaccine to be available in thousands of locations across the U.S., including retail and independent pharmacies, as well as regional grocery stores. Following the FDA announcement, Novavax’s shares saw a notable increase of over 8%.

While the demand for Covid vaccines this fall remains uncertain, with only 22.5% of U.S. adults receiving the previous round of shots, Novavax’s protein-based vaccine offers an alternative option for those seeking a different approach to Covid protection.

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