The U.S. Food and Drug Administration (FDA) has approved the first flu vaccine built on messenger RNA (mRNA) technology, months after the agency refused to even consider the application. The shot, called mFLUSIVA, is made by Moderna and was cleared on Wednesday.
Approval covers adults ages 50 to 64. Adults 65 and older fall under an accelerated approval, which permits broad use now and can be upgraded to a full approval if a follow-up study delivers acceptable results.
It's said to be superior to the current flu vaccines. Researchers compared rates of influenza diagnosis in more than 40 000 participants who received either Moderna’s trivalent mRNA-1010 vaccine or the standard flu jab over several months in the 2024-25 flu season. All participants were aged 50 or older.
The results showed that 2% (411 of 20 179) of people who had the Moderna vaccine and 2.8% (557 of 20 124) in the standard group developed flu. This equated to Moderna’s shot being 26.6% (95% confidence interval 16.7% to 35.4%) more effective than the standard dose flu shot from GSK (GSK.L), meeting the study’s criterion that Moderna’s jab should be at least as effective as existing approved vaccines.
Approval covers adults ages 50 to 64. Adults 65 and older fall under an accelerated approval, which permits broad use now and can be upgraded to a full approval if a follow-up study delivers acceptable results.
It's said to be superior to the current flu vaccines. Researchers compared rates of influenza diagnosis in more than 40 000 participants who received either Moderna’s trivalent mRNA-1010 vaccine or the standard flu jab over several months in the 2024-25 flu season. All participants were aged 50 or older.
The results showed that 2% (411 of 20 179) of people who had the Moderna vaccine and 2.8% (557 of 20 124) in the standard group developed flu. This equated to Moderna’s shot being 26.6% (95% confidence interval 16.7% to 35.4%) more effective than the standard dose flu shot from GSK (GSK.L), meeting the study’s criterion that Moderna’s jab should be at least as effective as existing approved vaccines.
