"The FDA recently refused to review an mRNA flu vaccine application-despite a 40,000-person clinical trial showing it outperformed standard flu shots in older adults."
"You cannot make a return on investment,' he said, 'if you don't have access to the U.S. market.'"
The European Medicines Agency approved a new Moderna mRNA flu vaccine, showing strong protection for older adults. In contrast, the FDA initially refused to review a similar application in the U.S., leading to a significant decline in investment in mRNA vaccines. Moderna's CEO indicated that without access to the U.S. market, pursuing new trials is unfeasible. The political scrutiny surrounding mRNA medicines has resulted in halted projects, such as NTx Bio's manufacturing facility in Texas, while other countries advance their own mRNA strategies.
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