Moderna said on Wednesday that the U.S. Food and Drug Administration has agreed to review a revised application for its flu vaccine, reversing an earlier rejection that occurred about a week prior. The company reported that shares jumped by more than 6% in early trading following the announcement.
In its filing, Moderna is asking the FDA for full approval of the vaccine for adults aged 50 to 64, and for accelerated approval for adults 65 and older. The company also said it has agreed to carry out a post-marketing study focused on older adults as part of the regulatory package.
The FDA’s initial refusal to review Moderna’s application had heightened industry concern about a notable change in U.S. vaccine policy under the Trump administration, a development that the article said has been associated with lower vaccination rates and a changed regulatory environment for new shots. The company and regulators publicly sparred over the design of Moderna’s trial, with the agency saying the company should have administered a higher-strength vaccine to older participants in the control arm.
U.S. Health Secretary Robert F. Kennedy Jr., described in the material as a longtime vaccine skeptic and a vocal critic of the mRNA technology used in Moderna’s and many COVID-19 vaccines, recently oversaw the cancellation of a $600 million government contract to develop mRNA vaccines for bird flu and other high-risk strains. That development was cited as part of the broader backdrop to the initial rejection.
Citi analyst Geoff Meacham characterized the FDA’s reversal as an "about-face" that "potentially brings back a revenue stream which had been in limbo." Leerink Partners analyst Mani Faroohar noted that public disputes between a sponsor and the agency are uncommon, and that the rapid reversal should be "a tailwind for bulls who argue Moderna can effectively leverage public pressure against" mRNA skeptics at the FDA.
FDA Commissioner Dr. Marty Makary said the agency had advised Moderna to give people aged 65 and older in its control group the standard of care. According to the statement, the Centers for Disease Control and Prevention’s recommendation for that group should be a high-dose flu vaccine, and the agency’s initial position was that Moderna’s trial control arm did not reflect that standard.
The U.S. Department of Health and Human Services, which oversees the FDA, was not immediately available for comment, the company said. The regulator is expected to issue a decision on Moderna’s candidate by August 5.
Moderna Chief Executive Stéphane Bancel said the company looks forward to making the vaccine available later this year, pending FDA approval, so that "America’s seniors have access to a new option to protect themselves against flu."
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