FDA Rejects Moderna Shot over GSK’s Fluarix Comparator in 65+ Trial
FDA refused to file Moderna’s mRNA-1010 application solely because it used GSK’s Fluarix Quadrivalent as the comparator in participants aged 65 and older. Fluarix Quadrivalent is FDA-approved but not CDC-recommended for the 65+ group, highlighting potential market challenges for the product.
1. FDA Refusal Cites Fluarix Comparator
The FDA’s Center for Biologics Evaluation and Research issued a refusal-to-file letter for Moderna’s mRNA-1010 influenza vaccine because the trial used GSK’s Fluarix Quadrivalent as the comparator in participants aged 65 and older rather than a high-dose vaccine, citing this choice as the sole basis for refusal.
2. Fluarix Approval versus CDC Recommendations
Although Fluarix Quadrivalent holds FDA approval for all age groups, it is not among vaccines recommended by the CDC for adults aged 65 and over, where high-dose or adjuvanted formulations are preferred to enhance immune response.
3. Potential Impact on GSK Flu Business
The FDA’s critique may prompt GSK to consider seeking expanded labeling or marketing efforts for high-dose alternatives; failure to adapt could reduce Fluarix uptake and pressure revenue from the senior influenza vaccine segment.