The FDA has approved Moderna’s new mRNA-based vaccine for influenza. The vaccine is to be used for adults over the age of 50.
“The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform,” said Stéphane Bancel, CEO of Moderna. “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible.”
The vaccine’s approval follows the results from a randomized clinical trial. “The Phase 3 program demonstrated an acceptable safety profile for mFLUSIVA, with no new safety concerns identified, consistent with previously reported studies of mFLUSIVA,” Moderna said in a press release.
In June, FDA reviewers said the flu vaccine made with mRNA technology is “effective.” The reviewers noted that the vaccine did run the risk of adverse reactions. “Solicited adverse reactions (ARs) within 7 days postvaccination were more frequent in mRNA-1010 recipients than in comparator recipients in both pivotal studies but were predominantly mild to moderate in severity with a median duration of approximately 2 days,” the document states. There were no cases of myocarditis or pericarditis within 42 days of postvaccination.
The FDA agreed to review an application from Moderna concerning its mRNA influenza vaccine after previously denying the company’s effort.
