 Health Care | Health Care |
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FDA refuses Moderna's mRNA flu vaccine application |
The Food and Drug Administration (FDA) has refused to review an application by Moderna for its influenza mRNA vaccine, not due to issues with the shot itself but what the agency claims was substandard care in the company's clinical trial. |
In a press release Tuesday, Moderna said the FDA's Center for Biologics Evaluation and Research (CBER) told the company it would not be initiating a review of its investigational mRNA vaccine. Moderna specified that the letter did not identify any "specific safety or efficacy concerns" with its vaccine candidate. "The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC recommended flu vaccine to compare safety and efficacy," FDA Commissioner Marty Makary said in a statement Wednesday. "Moderna exposed participants, age 65 and over, to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA career scientists." Refusing to file does not mean the application has been rejected and is not a result of evaluating the drug itself. Moderna argued in its press release that this reasoning for refusing to file is not reflected in relevant regulations and guidance. CBER Director Vinayak Prasad reportedly overruled FDA staff reviews when deciding to reject Moderna's application. FDA officials did not respond to this when asked on Wednesday. When asked if Moderna could resubmit the same data, a senior FDA official said it was "entirely feasible that if they come back, maybe even show some humility." In response to these claims by the FDA, Moderna said in a statement to The Hill: "The FDA reviewed and cleared the trial design as adequate before the study began 18 months ago. The industry depends on clear, transparent rules that are applied consistently in order to make the long-term investments that benefit Americans." |
Welcome to The Hill's Health Care newsletter, I'm Joseph Choi — every week we follow the latest moves on how Washington impacts your health. |
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How policy will be impacting the health care sector this week and beyond: |
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Gallup will no longer track presidential approval ratings after more than eight decades doing so, the public opinion polling agency confirmed to The Hill on Wednesday. The company said starting this year it would stop publishing approval and favorability ratings of individual political figures, saying in a statement it "reflects an evolution in how Gallup focuses its public research and thought leadership" ... |
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The U.S. will participate in the World Health Organization’s (WHO) upcoming meeting on the composition of the influenza vaccine despite officially withdrawing from the global group last month. The WHO will meet on Feb. 26 in Turkey to discuss the composition of the 2026-2027 flu vaccine for the northern hemisphere. “The vaccine composition meeting will be taking place later this month. The U.S. will participate … |
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Sens. Elizabeth Warren (D-Mass.) and Josh Hawley (R-Mo.) are teaming up to "break up big medicine." The lawmakers introduced legislation to crack down on health care conglomerates that own multiple parts of the industry — including pharmacy benefit managers (PBMs), which act as a conduit between insurers and drug manufacturers, and pharmacies themselves. Warren and Hawley's "Break Up Big Medicine Act" proposes prohibiting parent … |
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Branch out with a different read from The Hill: |
Attorney General Pam Bondi went toe to toe with lawmakers in a heated hearing on Wednesday as the country's top lawyer appeared before the House Judiciary Committee for the first time since taking office.
Bondi fielded questions on issues ranging from pending investigations into adversaries of President Trump to immigration, but the most tense exchanges came amid questions into the Epstein files. |
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A MESSAGE FROM COALITION TO STRENGTHEN AMERICA'S HEALTHCARE |
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Local and state headlines on health care: |
- State House halts health care provider conscience exemption bill (South Dakota Searchlight)
- Health officials detect 'rhino tranq' in illegal drugs around Southern Nevada (KSNV)
- New Iowa health initiative calls for increase in state's cigarette tax (1040 WHO)
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Health news we've flagged from other outlets: |
- CMS wants more 'catastrophic' health plans in ACA exchanges (MedPage Today)
- WHO director-general calls plans for U.S.-funded vaccine trial 'unethical' (Stat)
- Pharma companies left out of Trump's drug-pricing deals look for way in (Reuters)
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Opinions related to health submitted to The Hill: |
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You're all caught up. See you tomorrow! |
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