{"id":15192,"date":"2026-08-06T08:54:19","date_gmt":"2026-08-06T08:54:19","guid":{"rendered":"https:\/\/nile1.com\/en\/?p=15192"},"modified":"2026-08-06T08:54:28","modified_gmt":"2026-08-06T08:54:28","slug":"fda-approves-modernas-first-mrna-seasonal-flu-vaccine-mflusiva","status":"publish","type":"post","link":"https:\/\/nile1.com\/en\/2026\/08\/06\/fda-approves-modernas-first-mrna-seasonal-flu-vaccine-mflusiva\/","title":{"rendered":"FDA Approves Moderna\u2019s First mRNA Seasonal Flu Vaccine mFlusiva"},"content":{"rendered":"

The U.S. Food and Drug Administration<\/a> has approved Moderna Inc.\u2019s seasonal influenza vaccine mFlusiva for adults aged 50 and older, marking the first commercial clearance of a messenger RNA flu shot in the United States.<\/p>\n

The regulatory decision grants full approval for adults between 50 and 64 years of age and accelerated approval for individuals aged 65 and older. The vaccine, also known as mRNA-1010, targets the four most common seasonal influenza strains responsible for up to five million severe illness cases and 650,000 respiratory deaths globally every year, according to World Health Organization<\/a> data.<\/p>\n

Approval was based on a Phase 3 clinical trial encompassing 40,805 adults across 11 countries, which evaluated mFlusiva against a licensed standard-dose comparator. Researchers found that “mRNA-1010 was superior to standard-dose licensed vaccines for prevention of… influenza-like illness in adults 50 years of age or older.” While solicited adverse reactions\u2014including injection-site pain, fatigue, headache, and myalgia\u2014were more frequent than with conventional flu shots, most were mild to moderate and transient.<\/p>\n

The clearance follows a sharp regulatory dispute. The FDA initially issued a refusal-to-file letter, arguing Moderna\u2019s trial should have used a higher-dose comparator shot better suited for elderly patients. The decision sparked intense scrutiny after reports revealed the FDA\u2019s drug approval director had overruled career scientists to block the filing.<\/p>\n

“It’s all pretext and obfuscation when the real agenda is rejecting conventional science and serving a predetermined anti-vaccine agenda,” law professor Richard Hughes IV said at the time.<\/p>\n

The FDA reversed its stance less than a week later, acknowledging it had previously issued written guidance telling Moderna that “it would be acceptable to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study.”<\/p>\n

The approval represents a major milestone in expanding mRNA technology beyond COVID-19 into seasonal respiratory diseases. Traditional influenza vaccines, which rely on egg- or cell-based manufacturing, often face reduced effectiveness due to mutations during production and long lead times. Messenger RNA vaccines bypass live virus manufacturing entirely, offering faster production schedules and greater agility to match shifting seasonal virus variants.<\/p>\n

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