New phase-III data demonstrate that MF59 adjuvanted influenza vaccine, Fluad, was highly efficacious in protecting infants and young children against seasonal influenza. This is the first efficacy study of an adjuvanted seasonal influenza vaccine in any paediatric population and the largest randomized, controlled efficacy study of influenza vaccination in children between 6 months and six years of age. These data were presented at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA) held in Vancouver, Canada. Fluad is not currently licensed for this age group.
The pivotal trial enrolling more than 4,700 children met its primary endpoints. Fluad demonstrated 89 percent efficacy against vaccine-matched strains over two influenza seasons compared with 45 percent for the non-adjuvanted seasonal influenza vaccines group. Results also showed that the MF59 adjuvanted vaccine has an acceptable tolerability profile, similar to the non-adjuvanted influenza vaccines used in the study. These data have the potential to support the suitability of the MF59 adjuvanted vaccine for use in the paediatric population, a population at high risk of influenza infection and transmission.
"Infants and children are particularly susceptible to influenza, partially due to their still maturing immune systems, and they can transmit the virus easily to those around them. Immunization is a critical component of protecting our families and communities against the potentially devastating effects of influenza," said Andrin Oswald, Division head of Novartis Vaccines and Diagnostics. "As a leader in the field of influenza vaccines, Novartis is committed to developing next-generation vaccine technologies to combat the global threat of seasonal and pandemic influenza."
Severe influenza complications, such as pneumonia, are most common in children younger than two years of age, and may result in serious illness or death. Each year an average of 20,000 children under the age of five in the United States (US) are hospitalized because of influenza complications. The associated annual public health cost burden can reach up to 250 million US dollars.
Novartis MF59 adjuvant has been designed to improve immune response to vaccine antigens.
Fluad is the only commercially-available, inactivated, subunit seasonal influenza vaccine containing the Novartis MF59 adjuvant.