Vaccine maker Moderna said on Wednesday that the US Food and Drug Administration (FDA) had approved its new influenza vaccine, nearly six months after the regulator initially rejected the company’s application for review.
The company’s first mRNA-based flu vaccine, mFLUVISA, has been approved for use among adults aged 50 and above, Moderna said in a statement, reports AFP.
“Moderna expects to have mFLUVISA available for eligible populations in the US for the 2026–2027 respiratory virus season,” the company said.
Moderna announced in February that federal vaccine regulators had deemed its clinical trial data inadequate and rejected its application for review of the new vaccine.
However, the FDA reversed its position a week later following what Moderna described as a “constructive” meeting with the regulator.
The vaccine uses mRNA technology, which has faced criticism from US Health Secretary Robert F Kennedy Jr, a prominent vaccine sceptic. Under his leadership, federal research grants supporting mRNA development were cut.
During the administrations of Kennedy and US President Donald Trump, the FDA has called for a review of approval procedures for some vaccines, including influenza vaccines. Proposed federal policy changes have raised concerns among public health and medical experts.
During his first term, Trump described mRNA technology as a “modern-day miracle”.
The technology was used during the Covid-19 pandemic to rapidly develop vaccines against the fast-spreading virus and was credited with saving millions of lives.
Global health authorities consider Covid-19 vaccines safe and effective, and say they provide protection against severe forms of the disease.
