"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.

A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions. Novavax can finally breathe a sigh of relief – at least a small one.

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

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.

(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.

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.

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%.

China on Sunday announced anti-dumping duties as high as 74.9% on imports of POM copolymers, a type of engineering plastic, from the United States, the European Union, Japan and Taiwan.