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After delays, Novavax Covid vaccine is on track for full FDA approval [1]
['Jennifer Sandlin']
Date: 2025-04-25
Rejoice, fellow vaccine enthusiasts—it looks like there's good news on the horizon for Novavax, everyone's favorite scrappy, highly effective, Matrix-M adjuvanted, protein-based, non-mRNA COVID-19 vaccine, which also has the fewest side effects, to boot. The company announced yesterday that, after some delays that spurred patients and consumers to double down on their advocacy efforts, the COVID-19 Novavax vaccine looks to be on track to move from emergency authorization to full approval from the Food and Drug Administration—which means Novavax will be able to provide the vaccine indefinitely. AP News provides more details about the pending decision and the holdup:
At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax's license by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters. But FDA's acting commissioner, Dr. Sara Brenner, directed the agency's lead official overseeing the vaccine to pause the decision, according to one of the people. The delay, first reported by The Wall Street Journal, sparked concerns of political interference under Robert F. Kennedy Jr., who spent decades leading antivaccine groups before joining the federal government as health secretary.
After initial approval was delayed, advocates for access to vaccines, and to Novavax in particular, jumped into action, and ramped up their communication to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP). Reuters explains that Organizing for a Better Tomorrow, an advocacy group that focuses on COVID-19, long COVID, Novavax, and other related issues, helped organize more than 3,200 people to call and email the FDA and to contact ACIP to leave comments encouraging the full approval of Novavax. The advocacy seems to have worked, as Novavax reported that the FDA has asked them to create a plan to collect and present additional clinical data from people who have received the shot. AP News reports that the company "said it is 'engaging with the FDA expeditiously' in hopes of receiving approval 'as soon as possible.'"
Advocates who have been working hard for this outcome are continuing their efforts, and remain cautiously optimistic. Reuters quotes Paul Hennessy, who volunteers with Organizing for a Better Tomorrow, who stated, "It's reassuring to see an update, but we're not celebrating just yet."
I want to personally thank everyone who has been working so tirelessly on behalf of all of us to get Novavax full FDA approval, including Don Ford, Friesein, Pauly Pandemic, and many others who are part of Organizing for a Better Tomorrow. And if you want to get more involved in COVID education and advocacy, check out Organizing for a Better Tomorrow, which hosts the Brace for Impact show, which meets most Tuesdays and Thursdays from 5:30-7:00 pm Pacific time "to talk about science, politics, and activism through the lens of a COVID conscious community."
Previously:
• RFK Jr.s lawyer petitions to ban Polio vaccine
• 2024-2025 COVID-19 vaccine approved. Now go get it!
• RFK Jr.'s scary fiction: Measles vaccine 'causes blindness…and death'
• 'Signs of liver damage' RFK Jr's anti-vaccine propaganda hurts kids
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