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

The US Food and Drug Administration has fully approved a new COVID vaccine option specifically targeting high-risk individuals, including seniors. The protein-based Nuvaxovid vaccine, produced by Novavax,

"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.

The U.S. Food and Drug Administration approved Novavax's COVIDd-19 vaccine with age restrictions after a six-week delay.

(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 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.

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.

The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.

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%.