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news.Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has obtained positive opinion for Humenza adjuvanted A(H1N1) monovalent influenza vaccine from Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).
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The CHMP has recommended the marketing authorisation of Humenza vaccine in EU countries for the active immunisation of persons 6 months of age and older against influenza disease caused by the pandemic A(H1N1) 2009 virus.
Reportedly, the positive opinion granted to Humenza vaccine through the European centralised marketing authorisation application process was based on a review of results from clinical trials on company’s A(H1N1) AF03-adjuvanted influenza vaccine candidate.
The trials, conducted in healthy children (6 months to 17 years of age), adults and the elderly, evaluated the safety of Humenza vaccine and its ability to elicit a sero-protective immune response to the A(H1N1) pandemic strain now circulating.
Sanofi Pasteur said that 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.
The trial results suggested, 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 A(H1N1) monovalent vaccine induced a high antibody response 21 days postvaccination that meets the three EMA immunological criteria and is considered sero-protective.