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FDA approves Novavax COVID-19 vaccine

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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.

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WebMD · 8h
FDA Approves Novavax COVID Vaccine With Restricted Use
FDA approves Novavax COVID-19 shot but with unusual restrictions
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...

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Annual COVID-19 Shots For Healthy Younger Adults, Children Will No Longer Be Routinely Approved
US regulators say annual COVID-19 shots for healthy younger adults and 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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F.D.A. Poised to Restrict Access to Covid Vaccines
FDA to limit future Covid-19 shots to older people and those at risk of serious infection
BioSpace3h
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.
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.
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.
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.
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.”
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