September 25, 2009

UK swine flu vaccine 'approved'

The European drugs regulator has given the go-ahead for one of the UK's swine flu vaccines.
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An expert committee agreed that Pandemrix, made by GlaxoSmithKline, can be used in adults and children over six months old and pregnant women.
The decision removes one of the last obstacles to getting the immunisation programme under way although licensing still needs to be formalised.
The UK has bought 60 million doses of the vaccine.
In addition, there are contracts for an as yet unapproved vaccine, Celvapan, produced by Baxter.
It means the UK has provision for up to 132 million doses - enough for every person in the country.
A vaccine made by Novartis, Focetria, has also been recommended for licensing by the European Medicines Agency - but this is not planned to be used in the UK.
Final marketing authorisation for the vaccines still needs to be signed off by the European Commission and is expected "as soon as possible".
The EMEA said they were working with Baxter on some ongoing issues about their vaccine but hoped to be able to resolve those next week.
The vaccines have undergone an accelerated approval process as "mock-ups" of the vaccine had already been developed in preparation for a pandemic and tested in 6,000 people.
Manufacturers have worked quickly to add the swine flu H1N1 strain to the mock versions.
Early trial data had suggested good immune responses with just one dose of the vaccines.
However, the EMEA is recommending two doses are given three weeks apart for both vaccines, but may revisit that decision as more clinical trials are carried out.

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