FDA Refuses to File Moderna’s mRNA Flu Vaccine, Company Shifts Focus Ex-US
The FDA has refused to file Moderna's flu vaccine candidate mRNA-1010. The company will push forward outside the U.S. and pause its combination flu vaccine, while expressing disappointment over the decision's regulatory implications.
The U.S. Food and Drug Administration has issued a surprise refusal-to-file letter for Moderna’s seasonal flu vaccine candidate mRNA-1010, the company said. Moderna is now forging ahead with the jab in markets outside the United States and will hold off on advancing its combination flu vaccine toward submission.
The refusal-to-file letter was dated February 10. The company expressed disappointment and voiced concern about what the decision means for the broader drug regulatory landscape.
mRNA-1010 is an experimental seasonal flu vaccine for adults 50 and older. It uses the same mRNA technology that powered the company’s COVID-19 vaccines and is designed to better protect against influenza in older adults, who face higher risks of serious illness. An independent advisory panel had voted unanimously in June that the benefits outweigh the risks.
MRNA stock is down 23% this month.