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FDA approves Novavax's Covid-19 vaccine

CBS News on MSN · 5h

Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials

"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.

CNN on MSN · 2d

After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk

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.

PharmExec · 7h

FDA Grants Full Approval to Novavax’s Nuvaxovid COVID-19 Vaccine

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

5h

FDA sets new COVID booster guidelines for healthy adults under 65

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

When the FDA requires a large vaccine trial, who pays?

In the Phase 2 study of patients with chronic kidney disease, the highest dose of the drug lowered by 86% the levels of ...

1don MSN

RFK Jr. pledged not to upend US vaccine system, but big changes are underway

WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by ...

5don MSN

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

6h

Annual COVID-19 Shots For Healthy Younger Adults, Children Will No Longer Be Routinely Approved

The upcoming changes raise questions about people who may still want a fall COVID-19 shot but don't clearly fall into one of the categories.

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