US EditionAnti-vaccine sentiment may derail vaccines already awaiting FDA approval, experts fear
- In April 2025, the FDA delayed granting full approval of Novavax's COVID-19 vaccine in the US after missing the April 1 decision deadline.
- The delay followed former FDA Biologics director Peter Marks’s resignation and the agency’s request for more data despite Novavax’s completed responses.
- Novavax’s application includes robust Phase 3 clinical data showing safety and efficacy for people aged 12 and older using protein-based technology.
- Novavax stated their application is ready for approval and called their vaccine an important alternative to mRNA vaccines, while HHS affirmed review is solely scientific.
- The delay and leadership changes occur amid anti-vaccine advocacy by HHS Secretary Kennedy Jr. And ongoing concerns that such factors may hinder vaccination efforts.
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Voices: As LDS women of faith, we’re distressed by pullback from vaccines. You should be, too.
“Our greatness is not measured by how fiercely we protect our own but by how faithfully we care for our neighbors in our global community,” write Emma Petty Addams and Jill Fairholm with Mormon Women for Ethical Government.
The Norfolk Daily News
FDA Delays Final Approval of Novavax COVID Vaccine
Key Takeaways
The drug regulator delays approval of a Novavax covid-19 vaccine
The U.S. drug regulator failed to meet the deadline for granting full approval to Novavax’s covid-19 vaccine, the company reported Wednesday, amid major changes in health agencies under President Donald Trump’s mandate. In a document sent to the financial market regulator and viewed by the AFP, the U.S. drug manufacturer Novavax said he was still awaiting a response from the Food and Drug Administration (FDA), which had promised to make a decisi…
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