US says that it will review Moderna flu vaccine it previously declined

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In February 2026, the FDA reversed its earlier decision and agreed to review Moderna's application for its new flu vaccine. The application seeks full approval for use in adults aged 50-64 and expedited approval for those over 65. Moderna CEO Stephane Bancel expressed optimism that the vaccine could be available later in the year. The FDA's initial rejection, citing the lack of a high-dose comparator in Moderna's trial, had raised concerns within the pharmaceutical industry, especially given the Trump administration's stance on vaccine guidelines and safety. Moderna stated the initial rejection did not identify any safety or efficacy concerns. The FDA's decision to review the application now offers hope for a new flu vaccine option.
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