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FDA to require clinical trials for COVID boosters

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FDA tightens requirements for COVID vaccine, adding trials for healthy adults
The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting them to older adults and those at risk of developing severe illness.

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Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials
FDA to limit future Covid-19 shots to older people and those at risk of serious infection
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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F.D.A. Poised to Restrict Access to Covid Vaccines
Annual COVID-19 Shots For Healthy Younger Adults, Children Will No Longer Be Routinely Approved
FDA Approves New Covid Vaccine
Novavax Chief Corporate Affairs and Advocacy Officer Silvia Taylor said in an interview that the company had been notified of its approval late on Friday night after substantial back-and-forth with r...

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Novavax Shares Rise on FDA License Application Approval for Nuvaxovid
Novavax jumps as FDA clears COVID-19 vaccine
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.
FDA to Unveil Covid Shot Policy as RFK Jr. Eyes More Tests
President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.
Novavax Stock Rockets. FDA Finally Had Good News for the Covid-19 Vaccine Maker.
Novavax finally won approval of a Covid-19 vaccine after facing setback after setback that caused the stock to plunge more than 50% in the past year.The stock surged 20% to $8.10 in early trading Monday.
Asianet Newsable on MSN1d
Novavax Wins FDA Approval For COVID-19 Vaccine: Retail Calls For Buyback And Bigger Moves
The pharma company secured FDA clearance to manufacture and distribute its COVID-19 vaccine Nuvaxovid for adults and at-risk groups, with no advisory committee hurdles.
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