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news.Preliminary results from clinical trials of Sanofi Pasteur's pre-pandemic avian flu vaccine have demonstrated a good immune response in a significant number of volunteers.
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The preliminary results showed that the vaccine was safe and well-tolerated in 300 healthy volunteers. A 30 microgram dose with an adjuvant in a two-dose regimen demonstrated an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine. Immune responses were also detected in a number of volunteers receiving lower doses.
Subsequent trials are planned to explore different dosages, which may be helpful in answering questions about dose-sparing strategies, something which is being widely discussed among the public health community.
The data will be submitted as part of the company’s “mock up” vaccine dossier to the European agency for the evaluation of medicinal products (EMEA). This process is expected to reduce the time necessary for approval of a pandemic vaccine in Europe once a strain is identified and a pandemic is declared.