Health officials have approved the first-ever flu vaccine made using the same controversial technology used in Covid shots.
The Food and Consumer Product Safety Authority (FDA) announced Wednesday the approval of mFLUSIVA, which is manufactured by Modern and uses mRNA technology used in Covid vaccines from Moderna and Pfizer.
The shot is approved for adults ages 50 to 64 and is intended to tackle fast-spreading flu strains that often evade traditional vaccines, which are only about 40 percent effective.
The FDA also plans to approve it for people over age 65, who are particularly susceptible to serious illness flu symptoms and death due to a naturally weakened immune system, provided Moderna will conduct further studies 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 to April.
Previous clinical data shows the new vaccine may be about 27 percent more effective than traditional flu vaccines in protecting against the disease.
However, the researchers believe that side effects were more common than with older vaccines, with up to two-thirds of patients reporting pain, fatigue and headache at the injection site. This is approximately twice as much as with older recordings.
The approval of mFLUSIVA comes after the 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 several states.
Moderna has developed the new flu shot mFLUSIVA for adults aged 50 to 64, with plans to further study it in people over 65
On average, influenza causes tens of millions of infections in the US each year.
At least 32 million illnesses were reported during last year’s flu season, along with 380,000 hospitalizations and 24,000 deaths, the majority of which involved young children and older adults.
Stéphane Bancel, CEO of Moderna, said: “Flu remains a significant public health challenge, and mFLUSIVA offers an important new option for American seniors.
“This approval also reflects the continued potential of our mRNA platform to address important public health challenges through continued scientific innovation.”
mRNA technology causes some cells in the body to produce small fragments of a virus, triggering an immune response that leads to long-term protection.
White blood cells attack the proteins and then remain in the body, ready to spring into action when the real virus appears.
Department of Health and Human Services (HHS) Secretary Robert F Kennedy Jr. had previously petitioned the FDA to withdraw mRNA Covid vaccines from the market. HHS also canceled $500 million in federal research contracts for mRNA vaccines.
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 increase 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 injection turned out to be 27 percent more effective than older vaccines, but also came with more side effects
For flu vaccines, scientists believe mRNA is an advance over traditional vaccines, which take months to prepare using decades-old technology, some of which require the virus to develop in aged fertilized eggs.
Moderna has said the faster approach will help move away from the current process that focuses on one strain of flu each season.
“Having a flu vaccine that does not have to go through the archaic process of using chickens and eggs will greatly benefit public health,” said Dr. Georges C. Benjamin, CEO of the American Public Health Association. told The New York Times.
“It will allow us to quickly adapt to rapidly emerging new flu variants, a capacity we have not had before.”
Moderna’s studies involved nearly 41,000 people between the ages of 50 and 64. About 21,000 people took the Moderna vaccine, while the same number received a similar, approved control shot.
Within six months, 411 Moderna recipients came down with the flu, compared to 557 of those who got the other shot, translating to a 27 percent greater effectiveness.
However, about two-thirds had pain at the injection site, 45 percent reported fatigue and 38 percent experienced headaches. These percentages were about twice as high as those of the other vaccine.
Serious events reported included one case of fainting, one case of low blood pressure leading to a three-day hospital stay and one case of pericarditis and myocarditis.
Moderna’s new vaccine will take about two to three months to produce 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 against a virus that sends hundreds of thousands of Americans to the hospital and claims thousands of lives every year,” 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.”
