The Food and Drug Administration (FDA) has approved Moderna’s experimental mRNA influenza vaccine, reversing an earlier decision that blocked the application over concerns about the company’s clinical trial design.
The approval marks a significant turnaround after regulators, under Health and Human Services Secretary Robert F. Kennedy Jr., initially refused to even review Moderna’s submission.
Officials at the time said that the company had failed to compare its vaccine against what officials considered the best available standard of care.
Back in February, FDA vaccine chief Dr. Vinay Prasad concluded that Moderna’s study was not “adequate and well-controlled” because it used GlaxoSmithKline’s Fluarix Quadrivalent vaccine as its comparator rather than a stronger-performing alternative.
Hellbound and Down 