
STAT News · Feb 18, 2026 · Collected from RSS
The FDA reversed course and told Moderna it would review its application for a new flu vaccine, after refusing to do so earlier this month
By Ed SilvermanFeb. 18, 2026 Pharmalot Columnist, Senior Writer Hello, everyone, and welcome to the middle of the week. You made it this far, so why not continue, yes? Perhaps a cup or two of stimulation is in order. Our choice today is maple bourbon. As you know, a prescription is not required. So feel free to indulge as you attack the laundry list of meetings and deadlines that await. Meanwhile, we have once again assembled a list of tidbits for you to peruse and help you on your way. Hope you have a smashing day and, as always, do drop us a line when you hear something interesting. … The U.S. Food and Drug Administration reversed course and told Moderna it would review its application for a new flu vaccine, STAT writes. The agency told Moderna earlier this month that it would not review the submission because of a dispute over the design of a clinical trial, sparking an industry backlash and raising questions about broader decision-making at the FDA. The decision was made by top agency official Vinay Prasad, who STAT previously reported had overruled career scientists in the vaccine center. Moderna is trying to secure approval for an mRNA flu vaccine for adults 50 and older. The FDA will now review the product in adults 50 to 64 through a regular pathway, and adults over 65 via accelerated approval with a requirement to run a post-marketing study. The agency will aim to review the vaccine by Aug. 5, according to the company. Two of U.S. Health and Human Services Secretary Robert F. Kennedy Jr.’s top lieutenants struck decidedly different tones at a forum held Tuesday by the pharmaceutical industry group PhRMA, STAT tells us. The administrator of the U.S. Centers for Medicare and Medicaid Services, Mehmet Oz, had a friendly on-stage conversation with Pfizer chief executive officer and PhRMA board chair Albert Bourla in which he spoke of the benefits of vaccines, welcomed the idea of closed-door meetings with executives to hammer out policy ideas, and even suggested industry leaders should consider government jobs, despite Kennedy’s own criticism of the “revolving door” between government and industry. FDA Commissioner Marty Makary, on the other hand, was grilled by former CNBC reporter Bertha Coombs about the agency’s more skeptical approach to the regulation of vaccines, including Prasad’s initial decision not to review Moderna’s application for a new flu shot. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe