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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.

PharmExec · 6h

· 2d · on MSN

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

· 1d · on MSN

Novavax Stock Soars on FDA Approval for New COVID-19 Vaccine

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

The Food and Drug Administration will permit Covid vaccines for adults over 65 and those with certain medical conditions in the fall, according to new regulatory standards detailed on Tuesday by agen...

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

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

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...

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RFK Jr.’s FDA Severely Restricts COVID Vaccine Use

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FDA will limit COVID-19 vaccine to those over 65 or at high risk

BioSpace1h

FDA’s New Risk-Based Approach to COVID-19 Vaccines Aims to Ease ‘Public Distrust’: Makary, Prasad

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

32mon MSN

New Trump vaccine policy limits access to COVID shots

The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions

1BNTX, NVAX : Novavax Wins Limited FDA Nod For COVID Shot—Cleared Only For Seniors...

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.'s COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase risk of severe illness.

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.

US health authorities to stop recommending Covid-19 shots for children, pregnant women, WSJ reports

It's not clear if recommendation will be removed entirely or people will be told to consult their doctors. Read more at straitstimes.com. Read more at straitstimes.com.

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.”