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European Commission Approves Influenza A(H1N1) Vaccine NEW YORK -- October 07, 2009 -- The European Commission (EC) has granted marketing authorisation for a cell culture-based non-adjuvanted influenza A(H1N1) vaccine (CELVAPAN). The vaccine have already been received by a number of countries, including the United Kingdom and Ireland, for use in their national vaccination programs. The safety and immunogenicity of the vaccines is being confirmed in clinical trials and will supplement the licensure post-approval with data from its ongoing clinical trial program. Preliminary safety data from ongoing clinical trials in adults aged 18 years and older indicate the vaccine is well tolerated. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines. Immunogenicity data from the first vaccination in adults will be submitted to the European Medicines Agency within days. The 2 randomised, ongoing trials include 400 healthy adults aged 18 years and over and 400 children and adolescents. The trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5 mcg and 3.75 mcg. A large-scale observational study will also be conducted 9,000 people of different age groups, including children. SOURCE: Baxter International Inc. E-mail this page to a friend or colleague! To print, use this version