FDA Fully Approves New COVID Shot
The U.S. Food and Drug Administration (FDA) has officially approved Novavax’s COVID-19 vaccine, but with limitations on who can receive it. The approval applies to adults aged 65 and older, as well as individuals between the ages of 12 and 64 who have at least one underlying medical condition that increases their risk of severe illness from COVID-19.
Novavax’s vaccine stands out as the only protein-based COVID-19 vaccine currently available in the United States. Until now, it had been authorized for emergency use only in individuals 12 years and older. In contrast to the widely used mRNA vaccines developed by Pfizer and Moderna, which are approved for broader age groups, Novavax’s vaccine will now be available only to more targeted populations.
The FDA did not publicly provide a reason for the narrower approval, but the decision appears consistent with broader political sentiments from some figures in the current administration who have taken a more cautious stance toward widespread vaccination. Despite this, Novavax’s leadership views the approval as a meaningful advancement, particularly for groups most likely to benefit from a seasonal vaccine.
CEO John Jacobs emphasized that the company is focused on serving older adults and those with health vulnerabilities, noting that data from the CDC and market studies support this strategy. Though Novavax had hoped for broader approval based on clinical trial results involving 30,000 participants, the FDA has instead requested additional studies. These include investigations into potential heart-related side effects and the effectiveness of the vaccine in generally healthy individuals between 50 and 64.
Meanwhile, the Centers for Disease Control and Prevention (CDC) is preparing to make recommendations on who should receive annual COVID-19 vaccinations. The FDA’s decision on Novavax may reflect broader federal plans on future vaccine guidelines.
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