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Fast-tracked swine flu vaccine will be safe, officials insist

David Batty
London Guardian [1]
Monday, July 27, 2009

The World Health Organisation has raised concerns about the fast-track production of the swine flu vaccine in Europe, where the treatment is due to be made available at least two months earlier than in the US. Britain is expected to be the first country in Europe to provide the vaccine, with the first of 132 million ordered doses due to be administered next month.

The European Medicines Agency (EMA), the drug regulatory body for the EU, is accelerating the approval process for the vaccine, and countries including Britain, Greece, France and Sweden plan to start using it as soon as it is cleared. The most vulnerable groups, such as pregnant women and young children, will be given priority.

To ensure the vaccine is available as soon as possible, the EMA is allowing companies to bypass large-scale human trials. Amid concerns about bird flu several years ago, the EMA designed a protocol to fast-track the approval of a vaccine. It let companies submit data for a “mock-up” vaccine, using H5N1 avian flu. The idea was to do most of the testing before a pandemic, so that when it hit, the drug companies could insert the pandemic virus into the vaccine.

When the first doses are ready, the EMA will approve them largely based on data from the bird flu vaccine, since both will have the same basic ingredients. The agency will then require regular reporting of the vaccine’s effects as it is being administered, monitoring that is normally done beforehand.

Full article here [1]