Quality | 2009.09.25
Swine flu vaccine gets go-ahead for use in the UK
Swine flu vaccination programme expected to be rolled out next month
The first of the swine flu vaccines for use in the UK have been approved for a licence, opening the way to a roll-out of the vaccination programme next month, it was announced today.
The European Medicines Agency (EMEA) has recommended two vaccines for approval following an expedited procedure based mainly on mock-ups of how the vaccines were expected to behave if bird flu rather than swine flu had sparked a pandemic.
The EMEA says it is satisfied that inserting the new strain into the vaccine "should not substantially affect the safety or level of protection offered".
It has asked manufacturers actively to investigate and monitor any side-effects from the vaccine "so that action can be taken as early as possible if a safety issue emerges". It points out that, "as with all medicines, rare adverse reactions may only be detected once the vaccines are used in large numbers of people". The manufacturers have agreed to conduct post-licensing safety studies on 9,000 people for each vaccine.
One of the two vaccines given approval is Pandemrix, made by the British company GlaxoSmithKline, which the UK government contracted to buy before the outbreak and which is already beginning to be stockpiled in warehouses in Britain. The other is Focetria, made by the Swiss company Novartis.
The Department of Health said it could not yet say when the first vaccinations would take place, but the EMEA\'s recommendation, which will be rubber-stamped by the European Commission, will allow the programme to begin next month as the chief medical officer, Sir Liam Donaldson, had anticipated.
The EMEA is recommending two doses of vaccine, at an interval of three weeks. It says it recognises there is evidence that one dose may be enough, and may change its advice later. The vaccines are approved for use in pregnant women and children over the age of six months.
The clinical trials on which approval was based involved more than 6,000 people for each vaccine, each of whom received a version which was basically the same as the one to be rolled out, but originally contained an avian flu (H5N1) strain – which had been expected to cause a pandemic – instead of H1N1.
The EMEA said: "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 committee\'s recommendation to authorise these two vaccines is based on the information on the quality, safety and immunogenicity, including information on clinical trials in more than 6,000 subjects, generated at the time of the authorisation of the mock-up vaccines, as well as on information relating to the change in strain from H5N1 to H1N1."
For more information, please visit
http://www.guardian.co.uk/society/2009/sep/25/swine-flu-vaccination-uk
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