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European Medicines Agency Reaffirms Efficacy, Safety of H1N1 Vaccines LONDON -- November 20, 2009 -- The European Medicines Agency has reviewed further data on the centrally authorised influenza A(H1N1) vaccines (Celvapan, Focetria and Pandemrix), and has reaffirmed their positive balance of benefits and risks in the context of the current H1N1 influenza pandemic. The data on 2 vaccines (Focetria and Pandemrix) indicate that a single dose of these vaccines is able to trigger an immune response that may be sufficient to give protection against the H1N1 virus in some age groups. For both vaccines, a single dose may be used in adults aged 18 to 60 years and in children and adolescents (from age 9 years for Focetria, and from 10 years for Pandemrix). Pandemrix may also be used as a single dose in the elderly. For certain groups, such as younger children and immunocompromised patients, the recommendation remains that 2 doses should be given, to ensure that their immune system responds adequately to the vaccination. Further data will become available in the coming months. Data on the third vaccine (Celvapan) are still being assessed. The Agency also concluded that the vaccines (Focetria and Pandemrix) can be co-administered with non-adjuvanted seasonal influenza vaccines. The Agency, together with the national competent authorities, is continuously monitoring the safety profile of H1N1 vaccines. To date, the side effects reported have mainly been mild symptoms such as fever, nausea, headache, allergic reactions, and injection site reactions, confirming the expected safety profile of the three vaccines. A very small number of cases of Guillain-Barré syndrome and foetal death have been reported in patients previously vaccinated with a pandemic vaccine. The Agency is still in the process of gathering all relevant information and evaluating the data. However, on the basis of the available information there is no evidence to link these to the vaccines. The Agency will continue to evaluate all information that becomes available and make further recommendations as necessary. SOURCE: European Medicines Agency E-mail this page to a friend or colleague! To print, use this version