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http://news.independent.co.uk/uk/health/story.jsp?story=352648

Ministers criticised over failure to test smallpox vaccine

By Paul Waugh Deputy Political Editor

16 November 2002

Ministers were accused last night of putting lives at risk by failing to organise clinical trials of the smallpox vaccine.

The Government provoked controversy earlier this year by awarding an exclusive £32m contract for supplies of the drug to Powderject Pharmaceuticals, a firm run by a millionaire Labour donor.

In an attempt to prepare for a terrorist attack, ministers also put out a new tender for more supplies of the Lister strain of the vaccine last month, a contract that could also be won by Powderject.

John Hutton, a Health minister, has now confirmed in a written parliamentary answer that the vaccine will not be tested on humans because of fears of endangering Britain's smallpox-free status. He said trials were not compulsory for unlicensed vaccines.

Instead, the National Institute for Biological Standards and Control was checking the potency and quality of the new vaccine, the minister said.

Mr Hutton was attacked by Labour MPs on the Commons science and technology, and defence select committees, both of which are looking at the contract with Powderject. The MPs said a different strain of smallpox vaccine being used by the American government had been forced to go through clinical trials costing £88m.

Dr Ian Gibson, a microbiologist who chairs the science committee, said doctors, nurses and ambulance workers due to be inoculated first could refuse the vaccine if it had not been tested properly. "Every drug needs clinical trials. For the Government to claim that the vaccine cannot be tested because it does not exist in the population is complete rubbish. The Americans have tested their vaccine successfully under the same conditions," he said. "People who are given doses of an untested vaccine could suffer serious reactions or even die. But it seems the Government is determined not to budge on this matter."

Dr Gibson added: "We know that the Prime Minister is concerned about bioterrorism, but this does smack of panic. The testing of new drugs and vaccines is essential and to ignore this vital stage in the process could prove to be a fatal mistake."

Kevan Jones, the Labour MP for Durham North and a member of the defence committee, added: "I find it remarkable that while the Ame- ricans spend millions making sure their vaccine is safe, our Government doesn't think it's necessary. I'll be asking the Department of Health exactly what it thinks it's playing at."

A department spokesman said previous smallpox vaccinations had resulted in the death of one person in every million and the low immunity of the current population could make that figure higher. "There are other ways of testing for its safety that do not involve using human trials," he said.

The Government is facing an investigation by the National Audit Office for its award of the contract to PowderJect, owned by Paul Drayson. Mr Drayson gave £100,000 to the party, including a £50,000 gift weeks before winning the contract.

Ministers sought new supplies last November when it found that stocks totalled just three million doses for a population of 60 million.

The American authorities have ordered the Cambridge biotech firm Acambis to provide 209 million doses of a different "battle-strain" vaccine, which works against biological weapons developed by Iraq. Acambis said it was meeting the cost of the clinical trials in Washington.

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