AIFA and the European Medicines Agency (EMA) have authorised 11 vaccines for seasonal influenza immunisation. As every year, the authorisation concerns the updating of viral strains based on the antigenic characteristics of the strains circulating in the last season, in accordance with the World Health Organisation (WHO) recommendations. 

The vaccines authorised for the 2025-2026 influenza campaign are:  

• Efluelda and Efluelda Tetra (Sanofi Winthrop Industrie), suspension for injection: indicated for the active immunisation of adults aged 60 years and over.
• Fluad (Seqirus Netherlands B.V.), adjuvanted, suspension for injection: indicated for the active immunisation of adults (aged 50 years and older).
• Fluarix and Fluarix Tetra (Glaxosmithkline S.p.A.), suspension for injection: indicated for the active immunisation of adults and children from 6 months of age.
• Flucelvax (Seqirus Netherlands B.V.), suspension for injection: indicated for the active immunisation of adults and children from 6 months of age.
• Fluenz (Astrazeneca AB) nasal spray: indicated for active immunisation in children and adolescents from 2 years to 18 years of age. 
• Influvac S and Influvac S Tetra (Viatris Healthcare Limited), suspension for injection: indicated for the active immunisation of adults and children from 6 months of age.
• Vaxigrip and Vaxigrip Tetra (Sanofi Winthrop Industrie): suspension for injection: indicated for the active immunisation of adults, including pregnant women, and children from 6 months of age. Maternal vaccination of pregnant women extends protection to infants from birth and up to 6 months of age (passive protection).

Influenza vaccines have been used for years in vaccination campaigns and have a well-established safety profile. The Agency monitors vaccine safety and collects and analyses reports of suspected adverse reactions from healthcare professionals and citizens, through the National Pharmacovigilance Network (RNF) and with the support of the Regional Pharmacovigilance Centres (CRFV). Data are also shared with the European Medicines Agency (EMA) to ensure coordinated monitoring at European level. 

The Ministry of Health - in its Circular “Influenza prevention and control: recommendations for the 2025-2026 season” of 25 July 2025 - recommended “conducting regional influenza vaccination campaigns from the beginning of October and offering vaccination to eligible persons at any time during the influenza season”. 

Vaccination is recommended and offered actively and free of charge to people aged 60 and over, pregnant and postpartum women, children between 6 months and 6 years, people suffering from chronic diseases that expose them to a greater risk of complications in case of influenza, people admitted to long-term care facilities, family members of subjects at high risk of complications, workers in public services of primary collective interest, such as doctors and health and social-welfare personnel, police and firefighters.

Not all authorised vaccines are automatically available on the market. Each year, the Regions decide, through tenders for supply, which of the products available on the market will be used during vaccination campaigns offered free of charge by the National Health Service. 

Vaccination is the most effective form of prevention against influenza and its complications. AIFA recalls that, in addition to vaccination-based protection and care measures and the possible use of antiviral medicines, good hand and respiratory hygiene (e.g. regular and frequent hand washing with soap and water; cover mouth and nose with a tissue when coughing or sneezing and then throw the used tissue in the trash; regularly ventilate rooms), is an important measure in limiting the spread of influenza.

Published on: 09 September 2025