Washington: The U.S. Food and Drug Administration (FDA) granted approval on Friday to Novavax’s COVID-19 vaccine, Nuvaxovid, but imposed new restrictions on the eligible recipients of the shot. According to the FDA approval letter, the vaccine’s use is limited to individuals aged 65 and older, as well as those aged 12 to 64 who have at least one underlying health condition that increases their risk of severe COVID-19 illness. The letter did not provide a detailed definition of what qualifies as an underlying condition.
Additionally, the FDA deferred the submission of pediatric studies involving children from birth to under 12 years of age, noting that those studies have not yet been completed.
Novavax CEO John Jacobs described the FDA’s approval as a “significant milestone” that paves the way for wider access to the vaccine.
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The vaccine’s future had been uncertain after the FDA missed its April 1 deadline to approve Nuvaxovid. Earlier that month, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. suggested in a CBS interview that the delay was related to the vaccine’s composition.
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Novavax’s protein-based vaccine, which employs an older technology compared to its competitors, missed out on the pandemic vaccine boom that benefited Moderna and Pfizer, both of which manufacture messenger RNA-based vaccines. The company’s progress was hampered by manufacturing challenges and regulatory delays.
