In a somewhat surprise announcement, the Food and Drug Administration (FDA) has approved the first US influenza vaccine built on Moderna's mRNA technology that gave us one of the most administered COVID-19 shots during the pandemic.
Known as mFlusiva (mRNA-1010), the vaccine marks a first for the US but comes with some caveats as to who will have access to it for the upcoming flu season. Adults over 50 will qualify, with those aged 65 and over receiving accelerated approval based on immune responses. Access for those aged 65 and over remains dependent on an ongoing clinical trial assessing specific needs of this demographic.
The announcement came on Wednesday, August 5 – which happens to be exactly a year since Health and Human Services Secretary Robert F. Kennedy Jr. cut around US$500 million of funding for 22 research projects into mRNA vaccine development.
And as of writing, we're unable to actually use the FDA as a source as there's no news of the vaccine to be found on the agency's site.
What people may not know is that this is not the world's first mRNA flu jab; in April, Moderna was given the green light in Europe for its combined COVID-19 and influenza vaccine, mCombriax.
"Looking ahead, we expect mFluvisa to be available in the United States for eligible adults during the 2026–2027 respiratory virus season," Moderna said in a statement.
The FDA voted unanimously to make mFluvisa available for those in the 50-64 age bracket based on the drug's most recent Phase 3 results.
It demonstrated it was 26.6% more effective, compared with current influenza vaccines, and had earlier met all safety thresholds. Side effects were shown to be in line with current flu shots, with symptoms like fatigue, headache and nausea the most reported.
Despite influenza being a major killer worldwide, vaccine technology hasn't changed a great deal. And there have been issues with adapting seasonal vaccines when expected strains surprise us with unexpected mutations.
As we've covered many times, mRNA vaccine technology is well suited to be quickly adapted for emerging flu strains, potentially putting us in a proactive rather than reactive position each season.
And no, there are still no nano-robots in mRNA vaccines designed for mind control; the nanoparticles used as vectors in these biologics deliver the instruction manual to the immune system so it can create virus-specific antibodies. These nanoparticles are then quickly flushed out of the body.
Nonetheless, mFlusiva looks set to remain restricted to all but a small – but vulnerable – segment of the US population for the time being.
Source: Moderna
