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Updated Covid vaccines for the fall may be in jeopardy under Kennedy’s new rules
The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
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 ...
BioSpace7h
HHS To Require Placebo-Controlled Trials for All New Vaccines in ‘Radical Departure’ From Past
The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...
STAT1d
8 possible indicators of how RFK Jr.’s HHS will handle vaccine policy
Here are eight possible indicators of how health secretary Robert F. Kennedy Jr. may handle U.S. vaccine policy in coming ...
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
Fierce Pharma8h
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 ...
Why is there pushback to RFK Jr.‘s plan to test new vaccines vs. placebos?
Per the Post, which first reported the story, “‘All new vaccines will undergo safety testing in placebo-controlled trials ...
Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline
The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...
BioPharma Dive1h
Moderna combination flu, COVID shot delayed amid FDA scrutiny
Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.
Mercury News3d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
WASHINGTON (AP) — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus ...