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Around the nation: FDA will review Moderna's flu vaccine


FDA has agreed to review Moderna's application for its new flu vaccine after initially rejecting the application due to concerns over the controls used during the clinical trial, in today's bite-sized hospital and health industry news from Maryland, Massachusetts, and Washington. 

  • Maryland: The National Cancer Institute (NCI) will reportedly study ivermectin as a potential treatment for cancer. Ivermectin, which is primarily used to treat parasitic infections in humans and animals, gained popularity during the pandemic as a potential treatment for COVID-19, though clinical trials have found it to be ineffective. Previous laboratory research has also shown that ivermectin could have anticancer effects by promoting cell death and inhibiting the growth of cancer cells. However, there is currently no evidence that the medication can safely or effectively treat cancer in humans. According to KFF Health News, NCI's decision to study ivermectin has alarmed several career scientists at the agency. "I'm shocked and appalled," one NCI scientist said. "We are moving funds away from so much promising research in order to do a preclinical study based on nonscientific ideas. It's absurd." (Pradhan, KFF Health News, 2/10)
  • Massachusetts: FDA has agreed to review Moderna's application for its new flu vaccine after initially rejecting the application over concerns about the controls used in clinical trials. Earlier this month, Vinay Prasad, who heads FDA's biologics division, said the agency did not consider Moderna's clinical trial in the application to be "adequate and well-controlled" since the "control arm does not reflect the best-available standard of care in the United States at the time of the study." Although Moderna acknowledged that FDA previously said it would prefer the company use a different vaccine as a control in its clinical trial, the agency also said that "it would be acceptable to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study." However, FDA on Wednesday reversed its previous decision and said it would now review the vaccine application by Aug. 5. The agency will review the vaccine in adults ages 50 to 64 through its regular approval pathway and in adults ages 65 and older through its accelerated approval pathway. Moderna will also be required to run a post-marketing study for the vaccine in adults ages 65 and older. "We appreciate the FDA's engagement in a constructive … meeting and its agreement to advance our application for review," said Moderna CEO Stéphane Bancel. (Jewett/Robbins, New York Times, 2/10; Herper/Branswell, STAT+ [subscription required], 2/10; Jewett, New York Times, 2/11; Lawrence, STAT+ [subscription required], 2/18; Reuters/CNBC, 2/18)
  • Washington: Amazon One Medical has launched a new beta feature called Health Insights, which uses personalized analysis and recommendations to help members better understand the results of routine blood tests. The feature is currently available to members who are 18 years and older and have at least one blood test result from the last year. Those with certain conditions are excluded from using the feature. Health Insights analyzes over 50 biomarkers from standard bloodwork and organizes patients' results into different health categories, including cardiovascular, metabolic, and immune function. After completing a brief questionnaire, users will receive a personalized wellness score, biomarker breakdowns, and lifestyle recommendations for nutrition, physical activity, stress management, and sleep. According to Amazon One Medical, it plans to continue refining the feature based on member engagement, provider input, and health outcomes during the beta period. (Diaz, Becker's Health IT, 2/10)

Now is the time to move the needle on flu vaccinations

Learn how three healthcare providers are taking a new approach to increase flu vaccination rates ahead of an unprecedented influenza season.


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