The European Medicines Agency announced that manufacturers have started submitting data on influenza A (H1N1) vaccines under an accelerated and rolling review process, with preliminary results from human trials expected beginning in September. The agency noted that the EU has already approved a total of four mock-up vaccines by GlaxoSmithKline, Novartis and Baxter based on earlier data generated with the H5N1 influenza virus.

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Monika Benstetter, a spokesperson for the EMEA, said the agency will be evaluating data as it becomes available, and “by the time an actual application is filed, it can be looked at in a very short time frame because basically we have already seen most of it.” With regard to the mock-up vaccines, the agency said the candidates have already been tested in more than 8000 people and that “experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine, as will apply with the change from H5N1 to H1N1…should not substantially affect the safety or level of protection offered.”

The agency added that a number of other pandemic influenza vaccines are also currently under development, and preliminary data from GlaxoSmithKline and Sanofi Pasteur, the vaccines division of sanofi-aventis, are being assessed by the EMEA’s Committee for Medicinal Products for Human Use on a fast-track basis. However, Benstetter noted that these products will be produced “from scratch and that [will] take longer for the vaccines to become available” than those developed through the mock-up route.

Source: FirstWord

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