A new kind of flu vaccine moved a step closer to the U.S. market as federal health advisers recommended approval of the first made with the same mRNA technology that was key to ending the COVID-19 pandemic. The Food and Drug Administration is evaluating Moderna’s new shot, dubbed mFlusiva, for older Americans ahead of the winter flu season.
mRNA Technology
Moderna is seeking full approval for the vaccine’s use in people ages 50 to 64 — along with authorization for use in those 65 and older while it conducts additional testing. The FDA’s independent advisory committee evaluated Moderna’s studies of the vaccine and voted unanimously that its benefits appear to outweigh any risks for both age groups.
Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.
“Having this technology available puts us in a better position to be prepared for emerging strains in the future,” said Dr. Flor Munoz-Rivas of Texas Children’s Hospital, one of FDA’s advisers.
In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared with those given another routinely used vaccine brand. In a smaller study of people 65 and older, Moderna’s shot also generated a strong protective immune response compared to a high-dose flu vaccine already recommended for that age group.
Original reporting: Dallas TX News (HLL/CB) — read the source article.