KABUL (Pajhwok): The US Food and Drug Administration (FDA) has approved Moderna’s mRNA-based flu vaccine for people aged 50 and older, the company said, making it the first seasonal flu vaccine using messenger RNA technology to receive FDA approval.
The vaccine, mFlusiva, received traditional approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older, Reuters reported.
Moderna will conduct an additional study and submit more data on adults aged 65 and older to confirm the vaccine’s benefit in that age group.
The approval was based on a late-stage trial involving more than 40,000 adults aged 50 and older, which found the vaccine was 26.6 percent more effective than a licensed standard-dose flu vaccine.
Separate late-stage data showed mFlusiva generated stronger antibody responses than Sanofi’s high-dose flu vaccine in adults aged 65 and older.
The vaccine will compete with flu shots from Sanofi, GSK, CSL Seqirus and AstraZeneca.
Moderna said its mRNA technology could allow the vaccine to be updated more quickly to match circulating flu strains. Conventional flu vaccines are largely egg-based and contain viral proteins.
Analysts do not expect mFlusiva to generate significant revenue until the second half of 2027, as Moderna missed the contracting cycle for the 2026 US flu season.
The company is counting on the flu vaccine and a potential COVID-19-flu combination vaccine to offset declining COVID-19 vaccine revenue and demonstrate the commercial potential of its mRNA technology.
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