The Food and Drug Administration (FDA) has approved the first messenger RNA (mRNA) vaccine for seasonal influenza, following a prior rejection earlier this year. The vaccine, known as mFLUSIVA and developed by Moderna, is intended for individuals aged 50 and older.
Moderna announced the approval on Wednesday, emphasizing the potential of its mRNA technology to address critical public health challenges. The company expressed gratitude to the participants, investigators, and regulators involved in the clinical trials that contributed to this milestone.
Unlike traditional flu vaccines, which utilize inactive or weakened viruses or viral proteins, mRNA vaccines instruct cells to produce a harmless protein that triggers an immune response. The FDA initially declined approval in February, citing concerns regarding the clinical trial’s use of an appropriate comparator for adults aged 65 and older. This led to further discussions between Moderna and federal regulators, prompting the company to adjust its regulatory strategies and submit a revised application.
The approval included a provision for adults 65 and older under accelerated review, contingent upon a post-marketing study that will span two flu seasons. The FDA mandated that Moderna conduct this additional trial as a condition of continued approval for this demographic.
This approval comes amidst ongoing scrutiny of mRNA technology. Health and Human Services Secretary Robert F. Kennedy Jr. has publicly criticized the approach, questioning its efficacy in preventing upper respiratory infections and asserting that it may present greater risks than traditional methods. His administration has redirected funding away from mRNA vaccine research, focusing instead on conventional vaccine platforms.
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