By Daily Mail (U.S.) | Created at 2026-08-06 18:37:59 | Updated at 2026-08-06 21:08:42
3 hours ago
Health officials have approved the first-ever flu vaccine made using the same controversial technology found in Covid shots.
The Food and Drug Administration (FDA) announced Wednesday the approval of mFLUSIVA, which is manufactured by Moderna and uses mRNA technology used in Covid vaccines from Moderna and Pfizer.
The shot is approved for adults ages 50 to 64 and is meant to target rapidly spreading strains of influenza that often evade traditional vaccines, which are only about 40 percent effective.
The FDA is also planning to approve it for people over 65, who are especially prone to severe flu symptoms and death due to naturally weakened immune systems, on the condition that Moderna will run further trials in this group over the course of two flu seasons.
The shot is expected to be rolled out ahead of this respiratory virus season, which typically runs from September through April.
Previous clinical data shows the new shot may be about 27 percent more effective than traditional flu vaccines in protecting against the disease.
However, the researchers believe side effects were more common than with older vaccines, with up to two-thirds of patients reporting injection site pain, fatigue and headaches. This is about twice the rate compared to older shots.
mFLUSIVA's approval comes after the US faced a brutal flu season this past winter caused by a particularly virulent strain, which caused more severe symptoms and led to record-high cases in multiple states.
Moderna has developed the new flu shot mFLUSIVA for adults ages 50 to 64, with plans to further study it in people over 65
On average, flu causes tens of millions of infections every year in the US.
During last year's flu season, at least 32 million illnesses were reported, alongside 380,000 hospitalizations and 24,000 deaths, the majority of which were in young children and older adults.
Stéphane Bancel, Moderna’s chief executive, said: '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.'
mRNA technology works by causing some cells in the body to create small fragments of a virus, sparking an immune response that leads to long-lasting protection.
White blood cells attack the proteins and then remain in the body, ready to act when the real virus appears.
Department of Health and Human Services (HHS) Secretary Robert F Kennedy Jr had previously petitioned the FDA to pull mRNA Covid vaccines off the market. HHS has also cancelled $500 million in federal mRNA vaccine research contracts.
Kennedy has argued that mRNA is ineffective against upper respiratory infections and can cause serious health risks, including paralysis, heart inflammation and death.
Covid vaccines using mRNA technology have been shown to raise the risk of the rare but serious complications myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the sac-like lining around the heart. They occur in about one in 50,000 cases.
The shot was found to be 27 percent more effective than older vaccines, but it also came with more side effects
For flu vaccines, scientists believe that mRNA is an advance from traditional vaccines that take months to prepare using decades-old technology, some of which requires the virus to develop in out-of-date fertilized eggs.
Moderna has said the quicker approach will help shift away from the current process that focuses on one flu strain each season.
'Having a flu vaccine that does not have to go through the archaic process of using chickens and eggs will benefit the public health enormously,' Dr Georges C Benjamin, chief executive of the American Public Health Association, told The New York Times.
'It will allow us to rapidly adjust to rapidly emerging new flu strains, a capacity we have not had before.'
Moderna's trials involved nearly 41,000 people between 50 and 64 years old. About 21,000 took the Moderna vaccine while the same number took a similar licensed control shot.
Within six months, 411 Moderna recipients got the flu compared to 557 of those who got the other shot, which translated to 27 percent greater effectiveness.
However, about two-thirds had injection site pain, 45 percent reported fatigue and 38 percent suffered headaches. These rates were about twice that of the other vaccine.
Serious events reported included one case of fainting, one case of low blood pressure leading to a three-day hospitalization and one case of pericarditis and myocarditis.
Moderna's new vaccine takes about two to three months to manufacture and roll out.
'The Food and Drug Administration’s approval of a new mRNA flu vaccine is welcome news and provides another important option to help protect people from a virus that sends hundreds of thousands of Americans to the hospital each year and claims thousands of lives,' Ronald G Nahass, president of the Infectious Disease Society of America, said in a statement.
'As we prepare for flu season, the most important message is simple: Vaccination saves lives.'
