FDA to Review Moderna's mRNA Flu Vaccine After Initial Rejection
The FDA's Vaccines and Related Biological Products Advisory Committee is set to review Moderna's investigational mRNA flu vaccine next month. This follows a previous refusal by the FDA to accept Moderna's application due to concerns over the control group used in the pivotal trial, which did not align with the best-available standard of care. The upcoming meeting will focus on the safety and efficacy of the vaccine, particularly for individuals aged 50 and above. The FDA's initial rejection led to significant industry backlash and prompted a review of the application, which is now seeking regular approval for adults aged 50 to 64 and accelerated approval for those 65 and older. 
