FDA's Approval of Novavax's COVID Vaccine Has a Lot of Caveats

This weekend, the FDA released its recommendation for Novavax, a vaccine designed to combat COVID-19. That in itself is not unusual; with this approval, Novavax joins the likes of vaccines from Pfizer and Moderna that have a similar purpose. As the Associated Press’s Lauran Neergaard reported, this particular vaccine approval comes with a lot more caveats than its peers.

As the Associated Press noted, this approval replaces the emergency authorization that Novovax had previously been authorized under. However, the people it was approved for are a smaller group than expected: adults 65 and over, or people from the ages of 12 to 64 who have an underlying condition that makes them more susceptible to the disease.

Novavax isn’t the only COVID-19 vaccine out there, but — as Yale Medicine’s Kathy Katella pointed out — it is the only protein-based vaccine available in the U.S.; the Moderna and Pfizer vaccines are mRNA-based. As Scientific American reported in 2023, protein-based vaccines have shown evidence of having fewer side effects than their counterparts.

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In a followup to her earlier reporting written with Matthew Perrone, the AP’s Needham described the FDA’s unusual decision as part of a larger series of changes afoot at the agency with respect to vaccine approvals. Needham and Perrone wrote that this shift “[raises] uncertainty about next fall’s COVID-19 vaccinations.”

As someone who spent the better part of two weeks earlier this year with a mild case of COVID, I suspect that getting boosted regularly helped that case stay mild as opposed to something more severe; the prospect of fewer boosters being available in the future is especially unsettling.