World's first mRNA flu vaccine approved

The messenger RNA, or mRNA, technology that became widely known during the COVID-19 pandemic is now entering a new chapter. In a landmark move, the US Food and Drug Administration has approved the world's first mRNA-based seasonal influenza vaccine, opening the door to a faster and more flexible way of protecting people against one of the world's most common viral infections.

The vaccine, called mFlusiva, has been developed by Moderna and is approved for adults aged 50 years and older in the United States. Scientists believe this new technology could transform how seasonal flu vaccines are made because influenza viruses constantly change from year to year. Unlike conventional vaccines that often take months to produce, mRNA vaccines can be designed and manufactured much more quickly, allowing health authorities to respond faster if new influenza strains emerge.

Although the approval currently applies only to the United States, experts say it represents a major milestone in vaccine science and could eventually influence how influenza vaccines are developed across the world, including in countries like India.

The US FDA has approved Moderna's mFlusiva for adults aged 50 years and above.

The approval includes:

. Full approval for adults aged 50 to 64 years.

. Accelerated approval for adults aged 65 years and older. Moderna must conduct additional studies to confirm long-term clinical benefits in this age group.

This is the first seasonal influenza vaccine to use mRNA technology instead of the traditional egg-based or cell-based manufacturing process.

Unlike conventional flu vaccines, which contain weakened or inactivated parts of the influenza virus, an mRNA vaccine works differently.

It delivers genetic instructions that tell the body's cells to temporarily produce a harmless influenza protein. The immune system recognises this protein as foreign and builds antibodies and immune cells that can fight the virus if the person is exposed



later.

Importantly, the vaccine cannot cause influenza because it does not contain the live virus.

The same technology was successfully used in COVID-19 vaccines, helping scientists develop effective vaccines in record time.

The FDA's decision was based on a large Phase 3 clinical trial involving more than 40,000 adults aged 50 years and older.

According to Moderna, the study showed that the vaccine:

. Reduced laboratory-confirmed influenza cases by 26.6 per cent compared with a standard licensed flu vaccine.

. Produced stronger immune responses than Sanofi's high-dose influenza vaccine in older adults.

However, additional studies are still required to determine whether the stronger immune response translates into better real-world protection among adults aged 65 years and above.

Moderna is continuing post-approval studies across multiple influenza seasons.

Scientists believe this approval is important not only because it introduces a new vaccine but because it demonstrates that mRNA technology can be used beyond COVID 19.

The success of mRNA vaccines has already encouraged research into vaccines against several infectious diseases and even certain cancers.

If future studies continue to show strong protection, mRNA-based flu vaccines could eventually become a key part of annual influenza vaccination programmes worldwide.

The approval of mFlusiva marks a significant step forward in vaccine science. It is the first time an mRNA-based vaccine has been approved for routine seasonal influenza prevention, offering the possibility of faster vaccine updates as flu viruses evolve.

While the vaccine is currently approved only for adults aged 50 years and older in the United States, the decision signals a new era in influenza prevention. As researchers continue to study its long term effectiveness, this breakthrough could shape the future of seasonal flu vaccination for millions of people across the world.