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UK swine flu vaccine 'approved' | UK swine flu vaccine 'approved' |
(10 minutes later) | |
The European drugs regulator has given the go-ahead for one of the UK's swine flu vaccines. | The European drugs regulator has given the go-ahead for one of the UK's swine flu vaccines. |
An expert committee agreed that Pandemrix, made by GlaxoSmithKline, can be used in adults and children over six months old and pregnant women. | 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 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. | 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. | 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. | 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 approved by the European Medicines Agency. | A vaccine made by Novartis, Focetria, has also been approved by the European Medicines Agency. |
Final marketing authorisation for the vaccines will be signed off by the European Commission and is expected shortly. | Final marketing authorisation for the vaccines will be signed off by the European Commission and is expected shortly. |
The vaccines have undergone an accelerated approval process as "mock-ups" of the vaccine had already been developed in preparation for a pandemic. | The vaccines have undergone an accelerated approval process as "mock-ups" of the vaccine had already been developed in preparation for a pandemic. |
Manufacturers have worked quickly to add the swine flu H1N1 strain to the mock versions. | 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 vaccine. | Early trial data had suggested good immune responses with just one dose of the vaccine. |
However, the EMEA is recommending two doses are given three weeks apart, but may revisit that decision as more clinical trials are carried out. | However, the EMEA is recommending two doses are given three weeks apart, but may revisit that decision as more clinical trials are carried out. |
Rising cases | |
The number of new cases of swine flu in England has almost doubled over the last seven days to 9,000, official figures show. | |
Although the figures are rising, they are still far short of the 100,000 cases a week seen in July. | |
Officials are still predicting a second wave of swine flu as winter approaches. | |
But they hope to begin a vaccination programme sometime next month. |