Italian Medicines Agency Agenzia Italiana del Farmaco

Influenza: eight vaccines authorised for the 2024-2025 season - Influenza: eight vaccines authorised for the 2024-2025 season

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Influenza: eight vaccines authorised for the 2024-2025 season

Press release No. 14/2024 - AIFA and the European Medicines Agency (EMA) have authorised eight vaccines for seasonal influenza immunisation. As every year, the virus strains were updated according to World Health Organization (WHO) recommendations, based on the antigenic characteristics of the virus strains circulating in the last season.

The vaccines authorised by AIFA with mutual recognition and decentralised procedures (AIFA Resolution No 710/2024, published in the Italian Official Gazette on 13 September 2024) are as follows:

  • EFLUELDA TETRA (SANOFI PASTEUR), suspension for injection, indicated for the active immunisation of adults aged 60 years and over.
  • FLUARIX TETRA (GLAXOSMITHKLINE BIOLOGICALS S.A.), suspension for injection, indicated for the active immunisation of adults and children from 6 months of age.
  • INFLUVAC S (VIATRIS HEALTHCARE Limited), suspension for injection, indicated for the active immunisation of adults and children from 6 months of age. 
  • INFLUVAC S TETRA (VIATRIS HEALTHCARE Limited), suspension for injection, indicated for the active immunisation of adults and children from 6 months of age.
  • VAXIGRIP TETRA (SANOFI PASTEUR EUROPE), 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).

The vaccines authorised through centralised procedure (coordinated by EMA) are as follows:

  • FLUAD TETRA (Seqirus Netherlands B.V.), adjuvanted, suspension for injection, indicated for the active immunisation of adults (50 years and older).
  • FLUCELVAX TETRA (Seqirus Netherlands B.V.), suspension for injection, indicated for the active immunisation of adults and children from 24 months of age.  
  • FLUENZ (Astrazeneca AB) nasal spray, indicated for active immunisation in children and adolescents aged 24 months to 18 years. 

Not all vaccines authorised for use are necessarily available on the market. The Regions decide annually, through tenders for the supply of vaccines, the products that will be used during the vaccination campaigns, among the products available on the market.

The Ministry of Health has recommended conducting regional influenza vaccination campaigns from the beginning of October.

AIFA recalls that 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. 


Published on: 16 September 2024

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