RBC Capital sees FDA’s flu vaccine reversal as ‘clearly positive’ for Moderna

RBC Capital said the FDA’s decision to reverse course and review Moderna’s (MRNA) flu vaccine application comes with limited detail, but the firm’s read is that regulators and the company reached a compromise where the FDA may ultimately grant full approval in 50-65 years of age and accelerated approval in 65 and older. The PDUFA date is now August 5, 2026, implying the agency is granting priority rather than standard review, RBC noted. The firm expects debate over the comparator arm and notes most U.S. adults 65-plus receive a high-dose flu shot. Still, RBC highlighted that Moderna’s filing was accepted elsewhere, the vaccine outperformed the high-dose option, and the 43,808-patient trial met all primary endpoints. Overall, this is clearly positive for Moderna and if this FDA is willing to compromise even for politically sensitive topics like vaccines/mRNA, the firm wonders if the news should also have favorable readthroughs to other areas that are clearly less politically sensitive. RBC has a Sector Perform rating on the shares with a price target of $30.