Pivotal Study Finds Novartis Adjuvanted Flu Vaccine 89% Effective in Infants and Children

A pivotal trial evaluating Novartis’ MF59®-adjuvanted flu vaccine Fluad® in infants and young children found it to be 75% more effective than nonadjuvanted vaccines at preventing seasonal influenza over two separate seasons. Data from the study in over 4,700 children aged between six months and six years showed Fluad vaccination was 89% effective at preventing infection by vaccine-matched flu virus strains, and 86% effective against all circulating flu strains. The respective figures for nonadjuvanted influenza vaccines were 45% and 43%.

Fluad is the only inactivated subunit seasonal influenza vaccine containing Novartis’ MF59 adjuvant to have been approved in any population. Although not yet sanctioned anywhere for use in infants or children, Fluad has been approved in 13 European countries and 10 other territories in Asia-Pacific and Latin America for active immunization against seasonal influenza in individuals aged 65 years and older. The vaccine has yet to be licensed in the U.S. and Canada.

Novartis’ marketed flu vaccines include Fluad, Agrippal, Begrivac, Optaflu, Fluvirin, and the A(H1N1) flu pandemic vaccine Focetria. In July the firm reported that it had started shipping its Fluvirin seasonal flu vaccine to the U.S. in advance of the 2010–1011 flu season. It will supply the U.S. market with some 40 million doses of Fluvirin, which has been FDA-approved for patients aged four years and older. Under WHO recommendations, this year’s Fluvirin vaccine includes the A/California/7/2009 (H1N1)-like virus responsible for pandemic flu during the previous season.

Novartis points out that this flu season also represents the first year that the Centers for Disease Control and Prevention (CDC) has recommended routine influenza vaccination for all people aged six months and older, including all adults aged between 19 and 49 years. CDC had previously recommended vaccinating high-risk individuals, a category encompassing infants and children up to 18 years, people aged 50 years or older, and adults of any age at risk of flu-related health complications.