FDA Refuses to Review Moderna Flu Shot in Surprise Setback (4)

Moderna Inc.’s shares plunged 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.

The FDA’s move is a blow to the company, which generated enormous sales during the pandemic with its breakthrough Covid shot but has struggled since then to launch new products. ...