US FDA reverses course, will review Moderna's revised flu vaccine application

Feb 18 (Reuters) - Moderna said on Wednesday the U.S. drug regulator will review its modified flu vaccine application, a week after rejecting the original submission and fueling industry concerns over shifts in the agency's decision-making under the current administration.

Shares of the vaccine maker MRNA.O rose more than 6% in early trading on the news.

The company said the U.S. Food and Drug Administration has accepted its revised application seeking full approval for the shot for adults aged between 50 and 64, and accelerated approval for those aged 65 and above.

Moderna has also agreed to conduct a post-marketing study in older adults.

The regulator's initial refusal had amplified concerns about a sharp shift in U.S. vaccine policy under the Trump administration, which has contributed to falling vaccination rates and reshaped the regulatory landscape for new shots.

U.S. Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic and a prominent critic of the mRNA technology, used in Moderna's and most other COVID‑19 vaccines, recently oversaw the cancellation of a $600 million government contract to develop mRNA shots for bird flu and other high‑risk strains.

Citi analyst Geoff Meacham said the "about-face" by the FDA on Moderna's experimental shot review "potentially brings back a revenue stream which had been in limbo".

The regulator had rejected Moderna's application, saying the company should have given a higher-strength vaccine to older patients in the control arm of its trial.

FDA Commissioner Dr. Marty Makary said on Tuesday that the agency had advised the company to give people aged 65 and older in its control group, the standard of care, which according to the Centers for Disease Control and Prevention's recommendation should be a high-dose flu vaccine for people in that group.

The HHS, which oversees the FDA, was not immediately available for comment.

"Such a public airing of a dispute between a sponsor and the Agency is uncommon, but the quick reversal of FDA's initial position should be a tailwind for bulls who argue Moderna can effectively leverage public pressure against" mRNA skeptics at the FDA, Leerink Partners analyst Mani Faroohar said.

The regulator is expected to make a decision on the candidate by August 5.

"Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu," Moderna CEO Stéphane Bancel said.