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FDA to Mandate Placebo-Controlled Trials for New Vaccines

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a policy shift that could reshape how immunizations are developed.

NBC News on MSN · 3d

FDA appears to be slow-walking vaccine approvals

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by imposing new regulatory hurdles on drugmakers, such as changing the requirements for approval or seeking additional clinical trial data.

Dermatology Advisor · 2h

Novavax COVID Vaccine Moves Closer to Full FDA Approval

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

COVID vaccine boosters called into question by FDA chief: ‘Void of data’

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

19hon MSN

HHS touts universal flu, coronavirus vaccine initiative while casting doubt on future of seasonal Covid-19 shots

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

STAT2d

How Marty Makary’s FDA is embracing a more skeptical view of vaccines

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

Scripps News on MSN1h

HHS, NIH announce development of universal vaccine for COVID-19 and influenza

Researchers aim to develop a universal vaccine platform that could protect against both COVID-19 and influenza without annual ...

2hon MSN

US government to require placebo testing of all new vaccines: How will it affect updated COVID shots?

The U.S. Health and Human Services Department says it will require placebo testing of "all new vaccines," raising questions ...

17hon MSN

Updated Covid vaccines for the fall may be in jeopardy under Kennedy's new rules

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

Fierce Pharma1d

FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

Chicago Tribune3d

FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded ...

1don MSN

Moderna Shares Fall on Vaccine Sales Miss, Delay in FDA Review

Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

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