The Food and Drug Administration (FDA) on Wednesday approved the first influenza jab in the United States to use mRNA technology.

The jab, called mFLUSIVA, was manufactured by COVID-19 jab maker Moderna.

Moderna received approval for the jab in all adults 50 years and older.

“The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform,” said Moderna CEO Stéphane Bancel.

“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. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible,” he added.

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Initially the F.D.A. had refused to even review Moderna’s application for approval earlier this year, but quickly reversed course after a public outcry. The flu kills more than 300,000 people worldwide each year and was particularly harsh in the 2024-25 season, with an estimated 45,000 deaths in the United States, including at least 297 reported cases in children, according to the Centers for Disease Control and Prevention.

The new vaccine is authorized for people ages 50 to 64. The F.D.A. issued an accelerated approval for adults 65 and older, which allows widespread use and can be converted to a full approval if the results of a follow-up study are deemed acceptable.

The company said it expected to have the vaccine ready for the 2026-27 respiratory virus season.

“The FDA’s approval of mFLUSIVA in adults 50 through 64 years of age is based on results from a randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024), which enrolled 40,805 adults aged 50 years and older across 11 countries. The primary objectives in this study were to evaluate the safety and reactogenicity of mFLUSIVA, and to evaluate relative vaccine efficacy (rVE) of mFLUSIVA versus a standard dose (SD) active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains,” Moderna stated in a release.

“Use in adults 65 years of age and older was granted accelerated approval based on results from a randomized, observer-blind, active-controlled clinical trial (ClinicalTrials.gov Identifier: NCT05827978), which enrolled 2,992 adults 65 years of age and older in the United States. The primary objective in this study was to evaluate the immunogenicity of mFLUSIVA versus a high-dose (HD) inactivated influenza vaccine comparator. The effectiveness of mFLUSIVA in adults 65 years of age and older is also supported by the descriptive analysis of rVE in the randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024). Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial,” it added.

NBC News shared further:

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.

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