The US Food and Drug Administration (FDA) has changed its stance and will now proceed with the review of a new mRNA flu vaccine developed by Moderna, the pharmaceutical company announced on Wednesday.
Just two weeks prior, the FDA had communicated its refusal to accept the application for this groundbreaking seasonal flu vaccine, a decision that sparked concerns about potential setbacks for mRNA technology, which has faced scrutiny from some health officials during the Trump administration.
In its earlier correspondence, the FDA cited deficiencies in Moderna’s clinical trial, specifically stating that the control group did not represent the “best-available standard of care in the United States at the time of the study.” However, the agency did not voice any concerns regarding the safety or efficacy of the vaccine. Following this rejection, Moderna engaged in discussions with the FDA and introduced a revised regulatory strategy that includes different pathways based on age demographics.
The company is now pursuing full approval for adults aged 50 to 64 and seeking accelerated approval for those aged 65 and older. Additionally, it has committed to conducting an additional post-marketing study focused on older adults. Should the FDA grant approval, the vaccine could be made available to individuals aged 50 and up in time for the 2026-2027 flu season.
Moderna previously expressed that the initial FDA rejection was at odds with feedback they had received from the agency during earlier discussions. CEO Stéphane Bancel remarked on the recent developments, highlighting his appreciation for the FDA’s cooperation during a constructive Type A meeting and expressing optimism about making the flu vaccine accessible later this year for America’s seniors.
This potential vaccine could introduce a significant new option for older adults in their fight against the flu, aiming to enhance public health and broaden protective measures within this vulnerable demographic.
