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FDA Refusing to Review Moderna mRNA Flu Shot Application
- On Feb. 3, the U.S. Food and Drug Administration refused to review Moderna's mRNA-1010 application, which Moderna disclosed on Tuesday and said raised no safety or efficacy concerns.
- CBER determined the trials and comparator were insufficient, citing the FDA said the studies were not adequate and well controlled, and the comparator did not reflect the U.S. standard of care, including for older adults.
- The Phase 3 trials showed mRNA-1010 met efficacy goals with a good safety profile in global studies enrolling around 44,000 participants, comparing it to GSK's Fluarix and Sanofi's Fluzone for older adults.
- Moderna requested a meeting with the FDA after the refuse-to-file letter, while William Blair projected mRNA-1010 sales could top $1 billion in a $5 billion market, and analysts warn this may chill investment in mRNA-1083 and future research.
- This year’s severe flu season has sickened at least 22 million people and killed 12,000, while Health and Human Services under current leadership pulled $500 million in mRNA funding and last year canceled a $590 million Moderna contract.
42 Articles
42 Articles
"The real agenda is rejecting science": FDA unexpectedly nixes new Moderna flu vaccine
The U.S. Food and Drug Administration is cancelling development of a new flu vaccine from biotech giant Moderna, with one unnamed senior FDA official calling the clinical trial a “brazen failure.” In a rare move, the FDA refused to consider the mRNA vaccine, which could be more effective at preventing flu infections, per a press release from Moderna. A letter signed by director of the Center for Biologics Evaluation and Research, Dr. Vinay Prasa…
FDA Leader Accused of Sexual Harassment; RFK Jr.'s Toilet Comment; GLP-1s and Scurvy
(MedPage Today) -- Note that some links may require registration or subscription. FDA vaccine chief Vinay Prasad, MD, MPH, who made the controversial decision to refuse to review Moderna's mRNA flu vaccine, has been accused of sexual harassment...
Moderna Just Crushed Estimates While Everyone Was Looking the Other Way
Quick Read Moderna (MRNA) beat Q4 expectations with $678M revenue but total sales fell 29% as COVID vaccine demand declined. Moderna cut annual operating expenses by $2.2B and significantly exceeded its cost-reduction targets. The FDA declined to review Moderna’s flu vaccine application. This delays critical diversification beyond COVID vaccines. You can earn up to $1,500 in cash bonuses just for moving your savings; see how this limited-tim…
FDA’s Vaccine Upheaval Has Pharma Worried About the Flu Shot
Phelan M. Ebenhack/APA whirlwind of new vaccine directives from the Food and Drug Administration has pharmaceutical companies hesitating on new vaccine research — and anxiously waiting to see what the agency does next.Under increasingly urgent scrutiny are seasonal flu vaccines, which are designed for the following flu season in February and March each year. The FDA is set to release new guidelines describing what will be required for flu vaccin…
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