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Parliamentary questions
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14 October 2009
by Elena Oana Antonescu (PPE)
to the Commission

 Subject: Authorisation of vaccines against influenza A (H1N1) —‘swine flu’
 Answer in writing 

On 25 September, just a few months after the pandemic alert level was raised to phase 6 by the World Health Organisation, the European Medicines Agency (EMEA) recommended that the European Commission grant marketing authorisation for two vaccines against the influenza A (H1N1) virus.

In its press release EMEA/602582/2009, EMEA makes the following statements: the two vaccines recommended for approval, Focetria and Pandemrix, were developed on the basis of information resulting from experience with a different viral strain (H5N1); insertion of a new strain into a vaccine should not substantially affect the safety or level of protection offered; vaccines contain ‘adjuvants’ — substances that increase the immune response to viruses and have been widely used in vaccine production so far, having a tried-and-tested level of safety.

Who will be responsible for the consequences if the clinical tests that are to be carried out on broader population samples after the approval of these vaccines, which can show effects and interactions that are far more complex than those seen in the initial clinical trials, reveal new side effects? Will the Commission inform citizens about the risks they will run if they are vaccinated without having full and comprehensive information on side effects?

Original language of question: ROOJ C 10 E, 14/01/2011
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