LYON, France — Sanofi Pasteur announced Feb. 19 that its adjuvanted H1N1 influenza vaccine Humenza has received a positive opinion from the scientific committee of the European Medicines Agency.
The Committee for Medicinal Products for Human Use is recommending the marketing authorization of Humenza vaccine in European Union countries for the active immunization of people 6 months of age and older against the pandemic H1N1 2009 flu virus.
The recommendation was based on a review of results from clinical trials on Sanofi Pasteur’s H1N1 AF03-adjuvanted influenza vaccine candidate. These trials — conducted in healthy children from 6 months to 17 years old, adults and the elderly — evaluated the safety of the vaccine and its ability to elicit a sero-protective immune response to the H1N1 pandemic strain now circulating.
Humenza vaccine’s safety profile is satisfactory in all age groups in the studies and similar to that of adjuvanted pandemic influenza vaccines already licensed. In all age-groups — children 6 months to 17 years of age, adults and the elderly — immune response measurements showed that a single dose of Humenza influenza H1N1 monovalent vaccine induced a high antibody response 21 days post-vaccination that meets the three EMA immunological criteria and is considered sero-protective.
Humenza is manufactured at Sanofi Pasteur’s facility in Val de Reuil, France, using the same process as Sanofi Pasteur’s seasonal trivalent influenza vaccine licensed in Europe.
This vaccine is not intended to be distributed in the United States, where Sanofi Pasteur produces another H1N1 pandemic vaccine licensed by the U.S.’ Food and Drug Administration.