FDA's Vinay Prasad, controversial CBER chief, to depart
https://misryoum.com/us/trending/fdas-vinay-prasad-controversial-cber-chief-to-depart/
WASHINGTON — Vinay Prasad, a top official at the Food and Drug Administration who has been at the center of recurring public controversies, is exiting the agency for a second time. Prasad will leave the FDA at the end of...
#FDAs #Vinay #Prasad #controversial #CBER #chief #depart #US_News_Hub #misryoum_com
The U.S. Food and Drug Administration is
refusing to consider Moderna’s application for a new flu vaccine
made with Nobel Prize-winning mRNA technology.
The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.,
particularly those using mRNA technology,
which he has criticized before and after becoming the nation’s top health official.
Moderna received what’s called a “refusal-to-file” letter from the FDA
that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.
The letter from FDA vaccine director Dr. #Vinay #Prasad said the agency doesn’t consider the application to contain an
“adequate and well-controlled trial”
because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.”
Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow
According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen
— but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study.
Still, Moderna said, the FDA did agree to let the study proceed as originally planned
The company said it also had shared with FDA additional data from a separate trial
comparing the new vaccine against a licensed high-dose shot used for seniors.
The FDA “did not identify any safety or efficacy concerns with our product”
and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,”
Moderna CEO Stephane Bancel said in a statement.
https://apnews.com/article/moderna-vaccine-flu-mrna-2fc551cb2fb45735e67db0a4e2e2b0fb
The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA technology. The company announced the news on Tuesday. The FDA's decision reflects heightened scrutiny under Health Secretary Robert F. Kennedy Jr., who has criticized mRNA technology. Moderna received a “refusal-to-file” letter, objecting to its clinical trial methods. The FDA said the trial didn’t compare the new shot to the best available standard of care. Moderna has requested an urgent meeting with the FDA and noted it has applied for approval in Europe, Canada and Australia.
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