FDA Refuses to Review Moderna Flu Vaccine in Latest Setback

Moderna Inc.’s shares fell in late trading after US regulators refused to review its novel mRNA flu vaccine, dealing a major blow to the company as it seeks more products beyond its Covid shot.Author of the article:You can save this article by registering for free here. Or sign-in if you have an account.(Bloomberg) — Moderna Inc.’s shares fell in late trading after US regulators refused to review its novel mRNA flu vaccine, dealing a major blow to the company as it seeks more products beyond its Covid shot.Subscribe now to read the latest news in your city and across Canada.Subscribe now to read the latest news in your city and across Canada.Create an account or sign in to continue with your reading experience.Create an account or sign in to continue with your reading experience.The US Food and Drug Administration refused to start a review of 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.The rejection letter signed by Vinay Prasad, who leads the FDA division that oversees vaccines, cited the lack of an “adequate and well-controlled” study for mRNA-1010. Moderna said the FDA’s letter was “inconsistent with previous written communications” and noted that its studies compared the new shot to existing, approved vaccines for influenza.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againInterested in more newsletters? Browse here.The company is “seeking clarity from the FDA on what has changed” from the previous written guidance it received, Moderna President Stephen Hoge said in an interview. “It’s a total surprise” that the agency won’t review the application, he said, adding that “it’s not even clear to us what exactly they’re asking for.”The letter didn’t identify any safety or efficacy concerns, Moderna said. The agency did suggest that the new vaccine should be compared to specific shots preferred for older adults, which the company said it didn’t do. It has requested an urgent meeting to discuss the decision and figure out its next steps, Hoge said. The FDA didn’t immediately respond to a request for comment.Moderna shares fell as much as 11% in post-market trading before paring declines. The stock had risen 42% this year through Tuesday’s close.The company said it doesn’t expect the FDA’s decision to impact its 2026 financial guidance.Unusual MoveThe rare refusal to file appears to reflect Prasad’s longstanding criticism of control arms in clinical trials. As an academic before he joined the FDA, he was often harshly critical of the treatments drug companies chose for comparison purposes when testing new drugs for cancer and other diseases. He said that drug companies could make their new treatments look good by picking easy comparators. Now he’s putting those criticisms into practice as a top regulator at the FDA.In particular, Moderna said the FDA criticized the choice of control groups in its main flu vaccine trial, noting that it used a standard-dose vaccine for comparison purposes. The study included people over 65 years old, a group for whom high-dose flu vaccines are often recommended.Refusal-to-file letters are a rare way to reject a drug. The FDA historically uses the technique when an application is considered grossly inadequate, such as when it’s missing key parts. The move by Prasad to not even consider Moderna’s application signals a new aggressive phase to regulating drugs and forcing drugmakers to perform more rigorous studies.A 2021 study published in JAMA Internal Medicine found that only 4% of drug applications received refusal-to-file letters. Among the 2,475 applications that the FDA received during the study time frame, just 98 received such letters.The decision, “which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” said Moderna Chief Executive Officer Stéphane Bancel. “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on” before it started, he said.Vaccine PullbackAfter meeting with the FDA, Moderna can file the application again over protest if it chooses, the rejection letter says. One factor in Moderna’s favor is that while many doctors recommend the high-dose vaccine for older people, the standard dose is also approved for them.It’s unclear whether Moderna will decide to run another study. Moderna’s chief executive officer told Bloomberg last month that it doesn’t plan to invest in new late-stage vaccine trials because of growing opposition to immunizations from US officials.Moderna has also applied for approval of its flu shot in Europe, Canada and Australia. The US has been mired in a particularly bad flu season, with the current vaccines not well-matched to the circulating strain. Moderna says its mRNA technology can solve this problem because its vaccine can be more quickly updated.(Adds stock price in the first and sixth paragraphs, executive comments in fourth, fifth and 12th paragraphs, notes no immediate FDA comment in the fifth paragraph.)Postmedia is committed to maintaining a lively but civil forum for discussion. Please keep comments relevant and respectful. Comments may take up to an hour to appear on the site. You will receive an email if there is a reply to your comment, an update to a thread you follow or if a user you follow comments. 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