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UK swine flu vaccine 'approved' | UK swine flu vaccine 'approved' |
(20 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 and tested in 6,000 people. | |
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 | 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. | The number of new cases of swine flu in England has almost doubled over the last seven days to 9,000, official figures show. |
In Scotland, the new weekly figures showed a slight increase from 6,180 to 7,034. | |
Although the figures are rising, they are still far short of the 100,000 cases a week seen in July. | 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. | Officials are still predicting a second wave of swine flu as winter approaches. |
But they hope to begin a vaccination programme sometime next month. | But they hope to begin a vaccination programme sometime next month. |
High-risk individuals and front-line NHS staff have been prioritised for the vaccine. | |
Those eligible include anyone aged between six months and 65 years who usually gets the seasonal flu jab because of a chronic illness such as asthma, pregnant women, and people who live with those whose immune systems are compromised, such as cancer patients or people with HIV/AIDS. | |
It will also be offered initially to people aged 65 who are at high-risk of complications because of an underlying illness. | |
A further decision on who else may be vaccinated once these groups have been targeted is yet to be made. | |
A spokesman for the Department of Health said: "We are pleased that the European regulator has recommended that the GSK vaccine should be granted a licence by the European Commission. | |
"This is a positive step towards getting full licences for vaccine to protect the public. | |
"The European Commission must now consider the recommendations and we hope for their decision as quickly as possible." | |
Safety | |
Concerns have been raised about the safety of the vaccines given the speed of the approval process. | |
But the EMEA stressed that decades of experience with seasonal influenza vaccines indicate that adding a new strain in should not substantially affect safety. | |
Further clinical trials are being done and Pandemrix is being tested in 9,000 children, elderly and healthy adult volunteers. | |
The first results from a trial of the vaccine in Germany suggested a good response after one dose. | |
The EMEA added that with all medicines, adverse events may be detected once the vaccine is used in large numbers of people. | |
UK regulators have set up a special portal on the website for reporting any problems with swine flu medicines and vaccines when they begin to be used. |