Daijiworld Media Network – Washington
Washington, Aug 6: The US Food and Drug Administration (FDA) has approved the world's first messenger RNA (mRNA)-based seasonal influenza vaccine for older adults, marking a major milestone in vaccine science. Developed by Moderna, the vaccine, named mFlusiva, has been authorised for adults aged 50 years and above, becoming the first mRNA vaccine approved for routine seasonal influenza prevention.
The approval is considered significant because influenza viruses mutate frequently, requiring vaccines to be updated every year. Conventional influenza vaccines are largely manufactured using egg- or cell-based methods, a process that takes several months. Scientists believe mRNA technology could substantially reduce production timelines, enabling vaccines to be updated more rapidly if circulating influenza strains change unexpectedly.
The decision also comes as seasonal influenza continues to impose a major global health burden. According to the World Health Organization (WHO), annual influenza epidemics cause an estimated 3–5 million cases of severe illness and up to 650,000 respiratory-related deaths worldwide each year.
The FDA has granted traditional approval for adults aged 50 to 64 years and accelerated approval for those aged 65 years and above. Under the accelerated approval pathway, Moderna must conduct additional studies to confirm the vaccine's long-term clinical benefits in the older age group.
Unlike conventional influenza vaccines, which contain weakened or inactivated viral proteins, mRNA vaccines deliver genetic instructions that enable the body's cells to temporarily produce influenza proteins. The immune system recognises these proteins as foreign and generates protective antibodies and immune responses without causing influenza infection.
The technology gained global prominence during the COVID-19 pandemic and is regarded as offering several advantages, including faster vaccine design, manufacturing and adaptability.
The approval is based on findings from a Phase 3 clinical trial involving more than 40,000 adults aged 50 years and older.
According to Moderna, mFlusiva reduced laboratory-confirmed influenza cases by 26.6 per cent compared with a standard licensed influenza vaccine. The vaccine also generated stronger immune responses than Sanofi's high-dose influenza vaccine among older adults, although further studies are required to determine whether this results in improved real-world protection for people aged 65 years and above.
The company is continuing post-marketing studies to evaluate the vaccine's effectiveness across multiple influenza seasons.
Researchers believe mRNA technology could transform seasonal influenza vaccination by enabling quicker production, faster updates to match emerging virus strains and potentially stronger protection for populations at greater risk of severe disease, particularly older adults.
The approval also marks an important step in Moderna's efforts to expand its vaccine portfolio beyond COVID-19.
The FDA's decision currently applies only to the United States and does not alter India's influenza vaccination programme. India already has several licensed seasonal influenza vaccines recommended for high-risk groups, including older adults, pregnant women, healthcare workers and people with chronic illnesses, in line with national and international guidelines.
Availability of mRNA-based influenza vaccines in India will depend on future approvals by Indian regulatory authorities.
Experts believe the FDA's approval of the first mRNA-based seasonal influenza vaccine represents a major advancement in vaccine technology and could pave the way for faster, more adaptable influenza vaccines capable of providing improved protection against constantly evolving virus strains in the years ahead.