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FDA, COVID

FDA sets new COVID booster guidelines for healthy adults under 65

Makary and Prasad said they expect the FDA will be able to approve the boosters for adults over the age of 65 years based on data from tests that measure immune response in patients.

· 12h · on MSN

FDA sets new COVID booster guidelines requiring trials for approvals for healthy adults

· 11h

FDA set to unveil new Covid vax guidelines today

· 9h

US FDA advisers to consider if new COVID shots should target LP.8.1 subvariant

The U.S. Senate plans to vote this week to bar California's landmark plan to end the sale of gasoline-only vehicles by 2035 that has been adopted by 11 other states, Majority Leader John Thune said on...

· 11h

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

· 12h

US regulators say annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved

· 10h

FDA sets new COVID booster guidelines for healthy adults under 65

Vaccine makers have argued that because COVID vaccines have been changed annually to match the circulating strain of the virus, new placebo-controlled trials could delay availability of the shots unt...

· 5h

F.D.A. Poised to Restrict Access to Covid Vaccines

· 11h

FDA to limit future Covid-19 shots to older people and those at risk of serious infection

PharmExec12h

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.

10hon MSN

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.

McKnight's Long-Term Care News46m

Older adults gain new COVID vaccine option as FDA approves protein-based shot

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,

1don MSN

Novavax shares jump after long-awaited FDA approval of its COVID-19 vaccine

(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.

3hon MSN

The FDA is making it more difficult for Americans to get vaccinated for covid

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.

12hon MSN

FDA to limit covid shot approval to elderly, those with medical conditions

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.

3don MSN

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.

STAT14h

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 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%.

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 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.