FDA, COVID-19 and vaccines
Digest more
The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials.
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.
President Donald Trump's tax cut and spending bill faces a critical stress test on Wednesday as Republicans in the U.S. House of Representatives try to overcome internal divisions about cuts to the Medicaid health program and tax breaks in high-cost coastal states.
The FDA has approved Nuvaxovid to prevent COVID-19 in adults 65 years and older and high-risk individuals 12 through 64 years.
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 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.
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.