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How the swine flu vaccines were approved

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The two pandemic flu vaccines to be given to UK patients have now been approved by the European Medicines Agency and licensed by the European Commission.

Pandemrix, manufactured by GlaxoSmithKline and approved in September, and Celvapan, manufactured by Baxter and approved last week, have both been fast-tracked to be ready in time for this years’ flu season.

Both products were approved using the so-called “mock-up” approach in order to save time. This meant the vaccines were initially developed using a different flu strain – an H5N1 in this case. Once the actual pandemic strain, A(H1N1)v, was identified by the World health Organization, the manufacturers added it to their mock-up.

The EMEA has stated this is a process with a good safety record. “Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine should not substantially affect the safety or level of protection offered,” the agency said.

The EMEA has said that clinical trials on the two vaccines are ongoing, with more results expected to become available later this month and during November.

The agency has also instructed the manufacturers to “actively investigate ad monitor the safety” of the vaccines as soon as they are in use. As part of this they have also committed to carry out post-approval safety studies in 9,000 patients each.

 

Evidence centre:
Information, including trial data, on swine flu vaccines that have been approved by the European Medicines Agency
Interim results from a pilot study, run by the University of Leicester, looking at the safety of the Novartis vaccine MF59 in 175 adults, have been published online in the New England Journal of Medicine
Information from the five UK trial centres looking at swine flu vaccine safety and efficacy in around 900 children
Specific information on the development and testing of Pandemrix manufactured by GlaxoSmithKline

 

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Readers' comments (1)

  • i would like to read more about swine flu vaccine, lots of us in our nursing home is having it yesterday but i changed my mind.I want to see what's the side effect and i want to make sure am having this vaccine to be healthy,still i want some more weitten about it.

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