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FDA Will Approve COVID-19 Vaccine

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· 5d · on MSN

FDA approves Novavax's COVID-19 vaccine with limitations

The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

STAT · 1d

FDA gives Covid vaccine manufacturers instructions for next fall’s shot

PharmExec · 3d

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

MIT Technology Review · 1d

The FDA plans to limit access to covid vaccines. Here’s why that’s not all bad.

Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk.

Alaska Dispatch News · 1d

Opinion: The FDA’s new covid vaccine policy is clear as mud

wtvr · 1d

FDA advisory committee meets on COVID-19 vaccine after putting new restrictions on approvals

6don 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.

Novavax: Nuvaxovid FDA Approval Unlocks Several Bullish Stimuli

Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating their protein-based vaccine technology. The approval positions Novavax as the only non-mRNA COVID-19 vaccine with full FDA approval, offering a differentiated alternative amid growing mRNA fatigue.

5don MSN

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

Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.

BioSpace5d

FDA Grants Narrow Approval of Novavax’s COVID Shot as Makary Teases Changes to Vaccine Approval Framework

The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”

FDA advisers recommend updating COVID shots to JN.1 strain

Moderna (MRNA), and Novavax (NVAX) agree as the FDA advisors recommend targeting JN.1 strain for updated COVID vaccines this fall. Read more here.

3don MSN

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.

5don 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.