Moderna's mRNA flu vaccine, mFlusiva (also known as mRNA-1010), has received unanimous support from a US Food and Drug Administration (FDA) advisory committee, with votes of 9-0 in favor of its benefits outweighing risks for both adults aged 50-64 and those 65 and older. This recommendation is a major step towards potential FDA approval, which is expected by August 5, 2026. The FDA typically follows its advisory committees' recommendations, suggesting a positive outcome for Moderna's application, despite prior regulatory hurdles.
The unanimous backing is a significant turnaround for Moderna, as the FDA had initially declined to review the application due to concerns about the study design, particularly regarding a lack of adequately controlled trials and limited efficacy data in certain older and immunocompromised populations. However, public backlash and subsequent meetings led the FDA to reverse its stance. Panelists highlighted the robustness of Moderna's presented studies, which showed the vaccine reduced flu cases by approximately 27% compared to other standard vaccines in a trial of 40,000 people aged 50 and older. Moderna has also committed to a confirmatory trial involving up to 800,000 participants over two flu seasons to address the FDA's initial concerns.
Analysts have reacted positively to the news, viewing the unanimous vote as a significant de-risking event for Moderna ahead of the PDUFA date. Shares of Moderna rose 3.5% to $63.96 at market open on June 18 following the vote, up from a market close of $61.80. Citi analysts noted the "clear positive and meaningful de-risking event," while William Blair analysts anticipate a positive read-through for Moderna's dual flu/Covid vaccine candidate. This potential approval would mark the first seasonal influenza mRNA vaccine on the market, representing a major advancement in vaccine technology and potentially improving vaccine effectiveness for seasonal flu. biopharmadive.com pharmaceutical-technology.com
