http://www.guardian.co.uk/world/2009/jul/26/fast-tracked-swine-flu-vaccine
The rest of the article is in the above link.
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.
The US government is taking a more cautious approach, calling for several thousand volunteers to be injected with the vaccine in tests beginning in August to assess its safety. Officials say the results should be ready in time for the vaccination programme to roll out in October.
But some US officials believe the European approach is the best option. "The consequences of not having a vaccine if this virus gets worse are very high," said Leonard Marcus, a public health expert at Harvard University. "If [regulatory authorities] took all the time that was necessary to make sure there are no side effects, ironically, in the effort to save a few lives, many lives could be lost."
The rest of the article is in the above link.
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.
The US government is taking a more cautious approach, calling for several thousand volunteers to be injected with the vaccine in tests beginning in August to assess its safety. Officials say the results should be ready in time for the vaccination programme to roll out in October.
But some US officials believe the European approach is the best option. "The consequences of not having a vaccine if this virus gets worse are very high," said Leonard Marcus, a public health expert at Harvard University. "If [regulatory authorities] took all the time that was necessary to make sure there are no side effects, ironically, in the effort to save a few lives, many lives could be lost."