FDA Clears Moderna's First mRNA-Based Flu Vaccine for Older Adults

Image- Collected

The US Food and Drug Administration (FDA) has approved Moderna's first mRNA-based influenza vaccine, marking a key regulatory milestone after the agency initially declined to review the application earlier this year.

Moderna announced on Wednesday that the vaccine, branded as mFLUSIVA, has been authorised for use in adults aged 50 and older. The company said it expects the vaccine to be available in the United States for the 2026–2027 respiratory virus season.

The approval comes nearly six months after the FDA rejected Moderna's application, citing concerns over the adequacy of its clinical trial data. However, the regulator reversed its position following what the company described as a constructive meeting held a week later.

The newly approved vaccine is based on mRNA technology, which gained global prominence during the Covid-19 pandemic. The technology has since faced criticism from US Health Secretary Robert F. Kennedy Jr., who has questioned mRNA vaccines and previously halted federal research grants supporting their development.

Under the administrations of President Donald Trump and Health Secretary Kennedy, the FDA has also called for a review of approval procedures for certain vaccines, including influenza vaccines. Proposed changes to federal vaccine policy have raised concerns among public health experts and medical professionals.

During his first term, President Trump described mRNA technology as a "modern-day miracle." The technology enabled the rapid development of Covid-19 vaccines, which global health authorities continue to regard as safe, effective, and capable of preventing the most severe forms of the disease.