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The FDA has reversed course on Moderna’s mRNA influenza vaccine filing, agreeing to review an amended application after previously issuing a refusal-to-file letter. Moderna said the change followed a meeting with the agency on Tuesday and results in a split regulatory approach by age.
Moderna is seeking approval for an mRNA-based influenza vaccine for adults over 50. Under the revised approach described by Moderna, the FDA will review the product for adults ages 50 to 64 through the traditional approval pathway, while adults 65 and older will be considered under accelerated approval with a requirement for a post-marketing confirmatory study. Moderna said it agreed to conduct the additional study in older adults if the vaccine is approved. The FDA is aiming to complete its review by August 5.
The reversal follows an unusually public disagreement over trial design and the choice of comparator. In the refusal-to-file letter signed by biologics center head Vinay Prasad, the FDA said it did not consider Moderna’s study adequate and well-controlled, citing that the trial’s control arm did not reflect what the agency regarded as the prevailing standard of care at the time. The agency’s concern focused on older participants, where high-dose or adjuvanted influenza vaccines are recommended, while Moderna used a licensed standard-dose influenza vaccine as the comparator. Moderna publicly released the letter and said the FDA had previously indicated the study design was acceptable when the study began about 18 months earlier, a characterization the agency disputed publicly.
Sources: Reuters, Stat
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