Vaccine will be rushed out before results of health checks are known
The first doses of swine flu vaccine will be given to the public before full data on its safety and effectiveness become available, doctors confirmed yesterday.
The aim is to provide maximum protection against the pandemic in the shortest possible time. But, unlike seasonal flu vaccine, the pandemic version will be spread over two doses in a higher quantity, and one brand is expected to contain a chemical additive to make it go further, potentially increasing the risk of side-effects.
Children, who are most vulnerable to swine flu and are likely to be among those first in line for the jab, may get the vaccine more than a month before trial results are received.
The pressure to protect the population from the growing pandemic, and the short time available for production and testing of the vaccine since the H1N1 virus was identified in May, mean the licensing process is to be accelerated.
A previous vaccine against swine flu turned out to be worse than the disease. An outbreak in the US in 1976 infected 200 soldiers at a military camp in New Jersey, of whom 12 were hospitalised and one died. But before it was over 40 million people had been vaccinated, 25 of whom died and 500 of whom developed Guillain-Barre syndrome, an inflammation of the nervous system which can cause paralysis and be fatal.
The Government has placed advance orders for up to 132 million doses of vaccine with two manufacturers, GlaxoSmithKline and Baxter. The manufacturers have tested and licensed in advance three “core” vaccines in preparation for a pandemic. These are vehicles into which the H1N1 pandemic strain of the virus is inserted.
A spokesman for the EMEA said the first samples of the fully functional pandemic vaccine were expected by the end of July and a decision on whether to approve them would be taken within five days. Trials involving 200 to 400 patients would be conducted, but the vaccine would be made available for use by the NHS before the results came in.
“What the manufacturers will be submitting will not have any clinical trial data. We expect the interim adult data from September and the first paediatric data from October onwards,” he said.
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