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BioPharma Dive11m
FDA set to meet this month on COVID vaccines
The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but will take place amid newly imposed scrutiny of COVID shots.
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 ...
Moderna study shows immune response in older adults for a combo flu and COVID-19 shot
A combination shot for flu and COVID-19 using messenger RNA generated antibodies in a study, but U.S. government regulators ...
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
If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...
Fierce Pharma6d
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 ...
RFK Jr. calls for 'new' vaccines to undergo placebo-controlled trials
A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...
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 ...