FDA, COVID-19 vaccine
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Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.
Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions -- 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.
Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating their protein-based vaccine technology. The approval positions Novavax as the only non-mRNA COVID-19 vaccine with full FDA approval, offering a differentiated alternative amid growing mRNA fatigue.
Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
Novavax had expected full approval for broader use by April 1, after the FDA reviewed data from a 30,000-person clinical trial showing the vaccine was safe and effective. But instead of a broad approval, the FDA asked the company to conduct more research.
Key Takeaways Novavax received Food and Drug Administration approval for its new, protein-based COVID-19 vaccine.The shot, Nuvaxovid, is designed for older adults and those between the ages of 12 and 64 who have underlying conditions that puts them at higher risk from the disease.
WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.