Health
FDA Refuses to Review Moderna Flu Shot in Surprise Setback
A researcher works on bispecific antibodies at the Moderna Inc. headquarters in Cambridge, Massachusetts.
Photographer: Adam Glanzman/BloombergModerna Inc.’s shares fell after US regulators refused to review its novel mRNA flu vaccine, creating regulatory chaos for the pharmaceutical industry and offering another example of the Trump administration’s hard line on immunizations.
The US Food and Drug Administration rejected the company’s application, which was submitted in December, saying its studies didn’t compare the experimental shot to the “best-available standard of care,” Moderna said in a statement Tuesday.