FDA approves first mRNA flu vaccine

The Food and Drug Administration (FDA) late Wednesday approved the nation’s first mRNA flu vaccine, manufactured by drugmaker Moderna. 

The agency approved the shot for two separate age groups; people age 50 to 64, and for 65 years and older. Moderna said it will conduct a postmarket clinical trial to confirm the effectiveness in the older group. 

“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”

According to the company, late-stage trials found the vaccine to be about 27 percent more effective than a standard-dose flu shot for people 50 and older. 

In a smaller study of people ages 65 and older, the mRNA shot generated a strong protective immune response compared with an existing high-dose flu vaccine already recommended for that age group.  

Moderna said it expects to have the vaccine available for eligible........

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