NewsWorld
PredictionsDigestsScorecardTimelinesArticles
NewsWorld
HomePredictionsDigestsScorecardTimelinesArticlesWorldTechnologyPoliticsBusiness
AI-powered predictive news aggregation© 2026 NewsWorld. All rights reserved.
Trending
AlsNewsFebruaryMajorDane'sResearchElectionCandidateCampaignPartyStrikesDigestSundayTimelinePrivateCrisisPoliticalEricBlueCreditFundingRamadanAdditionalLaunches
AlsNewsFebruaryMajorDane'sResearchElectionCandidateCampaignPartyStrikesDigestSundayTimelinePrivateCrisisPoliticalEricBlueCreditFundingRamadanAdditionalLaunches
All Articles
STAT+: Pharmalittle: We’re reading about an FDA reversal on a Moderna vaccine, the U.K. life sciences sector, and more
STAT News
Clustered Story
Published 4 days ago

STAT+: Pharmalittle: We’re reading about an FDA reversal on a Moderna vaccine, the U.K. life sciences sector, and more

STAT News · Feb 18, 2026 · Collected from RSS

Summary

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

Full Article

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


Share this story

Read Original at STAT News

Related Articles

NPR News4 days ago
FDA reverses course on Moderna flu shot

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the company's application to market the new kind of influenza vaccine.

negocios.com4 days ago
FDA da marcha atrás y revisará la vacuna de gripe ARNm de Moderna urgentemente

Published: 20260218T201500Z

newswise.com4 days ago
FDA Reopens Review of Moderna mRNA Flu Shot

Published: 20260218T193000Z

endocrinologyadvisor.com4 days ago
FDA Declines to Review Moderna mRNA Flu Vaccine Application

Published: 20260218T193000Z

inquirer.com4 days ago
FDA reverses course and will review Moderna mRNA - based flu shot

Published: 20260218T190000Z

Al Jazeera4 days ago
US says that it will review Moderna flu vaccine it previously declined

The pharmaceutical giant expressed optimism that its new flu shot would be available this year, after approval concerns.