"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," the agency said in an article published by The New England Journal of Medicine, authored by FDA Commissioner Dr. Martin Makary and his new top vaccines official, Dr. Vinay Prasad.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

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.

In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it says.

The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to green-lighting shots that have been recommended broadly to the public.

(Reuters) -Novavax shares surged more than 17% before the bell on Monday, following the long-delayed approval of its COVID-19 vaccine from the U.S. health regulator, albeit with new conditions. The U.

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination trends.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.

Novavax Inc. jumped as US regulators fully approved its Covid vaccine, easing investors’ concerns after the clearance was delayed and US Health and Human Services Secretary Robert F. Kennedy Jr. raised doubts about its efficacy.

In the Phase 2 study of patients with chronic kidney disease, the highest dose of the drug lowered by 86% the levels of high-sensitivity C-reactive protein (hs-CRP), a measure of inflammation, through 90 days. Study participants treated with a placebo showed hs-CRP reductions of 15%.

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.