The Food and Drug Administration on Wednesday approved the U.S.’s first flu shot that uses mRNA technology: mFlusiva, from drugmaker Moderna.The FDA granted approval for two age groups: adults 50 to 65 and adults 65 and up, on the condition that Moderna run an additional clinical trial in the older group, the company said in a release.In a late-stage trial, mFlusiva was found to be about 27% more effective than a standard flu shot.
Many scientists and public health experts have touted the idea of an mRNA-based flu vaccine, which uses the same messenger RNA platform as the Covid vaccines from Moderna and Pfizer.That’s because mRNA vaccines can be manufactured much faster than traditional vaccines, allowing scientists to better match circulating influenza strains.Moderna said it takes two to three months from picking the strain to rolling out its flu shot, compared with about six months for traditional flu shots.“If you’re choosing the strain half a year before, how good can we be at sharpshooting?” said Dr.
Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital.The flu puts hundreds of thousands of people in the hospital every year, according to the Infectious Diseases Society of America, and there can be tens of thousands of deaths.
Young children and older adults are more likely to get very sick from the flu.The traditional flu shot ranges in effectiveness from 22% to 56%, according to the Mayo Clinic.
“We wish it were higher, quite frankly,” Levy said.Even though mFlusiva outperformed the traditional flu shot in a late-stage clinical trial, its approval was not a sure thing.
Health and Human Services Secretary Robert F.Kennedy Jr.
— an anti-vaccine activist — has repeatedly criticized mRNA technology, calling the Covid vaccines “the deadliest vaccine ever made.” Last year, HHS under Kennedy canceled nearly $500 million in funding for mRNA vaccine research.The FDA initially refused this year to review Mo...