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FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...
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 ...
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 ...
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 ...
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 ...
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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 ...
Fierce Pharma16h
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 ...
BioPharma Dive3d
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” ...
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the ...
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US is planning $500m project on 'universal vaccines;' WSJ
According to the WSJ, the universal vaccine project is being pioneered by two recently appointed senior scientists in the NIH ...
Novavax Falls on Report That FDA Wants New Covid Vaccine Trial
Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another ...
STAT5d
U.S. health officials inject new uncertainty into approval process for Covid boosters
01. Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend when the agency’s commissioner, Marty Makary ...