In a move that seemed out of reach just six months ago, the Food and Drug Administration approved Moderna’s influenza vaccine for older adults on Wednesday, the first licensed flu shot made using messenger RNA technology.
In February, Vinay Prasad, the FDA’s head of biologics at the time, overturned the recommendation of career staff and issued a rare “refusal-to-file” notice to the company, saying the agency wouldn’t review the vaccine based on the available data package. A week later — after Moderna disclosed the FDA’s decision as well as its own displeasure over the agency’s position — Prasad’s decision was reversed. He left the FDA at the end of April.
The vaccine will be marketed as mFlusiva. It is Moderna’s fourth vaccine to enter the U.S. market.
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation,” Moderna CEO Stéphane Bancel said in a statement.
Moderna said it expects to have some doses of the vaccine available for administration in advance of the coming flu season.
