BSE Risk? - Polio Vaccine Made
From Banned Cattle Products
Given To Hundreds Of Thousands Of People
By David Derbyshire
Medical Correspondent
The Telegraph - London

The drugs safety watchdog was criticised yesterday for allowing polio vaccines made from banned cattle products to be given to hundreds of thousands of people.
Prof Sir Liam Donaldson, the Chief Medical Officer, said the Medicines Control Agency should have taken extra care and acted more proactively to stop the potential contamination with BSE infected material in the late 1990s.
Although he stressed that there was no health risk, he accused drugs companies of giving inaccurate information about vaccines and called on the MCA to monitor the industry more carefully.
His report investigated a brand of oral polio vaccine recalled in October 2000 after fears that it could be contaminated with BSE.
The vaccine, one of two used in Britain, was made using British foetal calf serum dating from the mid 1980s.
Sir Liam said the health risk from the vaccine was "incalculably small" and that all vaccines since 2000 had been made with serum from BSE-free countries. That conclusion was backed up by a report from the Committee on Safety of Medicines, also published yesterday.
However, Sir Liam said: "Of more significance and concern is the fact that this problem was not identified by the MCA. The agency is very reliant on information supplied to it by pharmaceutical companies. A more proactive approach might have identified the problem with the oral polio vaccine."
When the MCA became aware of the problem, "there was not a sufficient awareness of the potential seriousness of the situation and of the importance of reviewing rapidly the need for precautionary action", he said.
In 1989, the MCA asked all pharmaceutical companies about their stocks of bovine material. Wellcome, the original manufacturer of the polio vaccine, told the MCA that its supply of British calf serum used for vaccines would have been used up by 1994.
Production of the vaccine changed hands during the late 1990s, passing to Evans Medical, which changed its name to Medeva before being sold to Celltech. In 2000 an audit revealed that British calf serum was still being used in the vaccine. By then, the product had been banned.
"It was apparent to many that the transfer of oral polio vaccine manufacture from Wellcome to Evans could be problematic," said Sir Liam. "The MCA might have been expected to know this and to have taken extra care."
The MCA should review its procedures for checking on the validity of information from drugs companies, he said.
If a company makes an important health product and is being taken over, information on the manufacturing process should be disclosed to the new buyers - even if there is no legal duty, he said.
Following the report, the Government admitted that it had given "incorrect or misleading" information to the House of Commons over whether vaccines complied with guidance.
Hazel Blears, the public health minister, said "inaccurate advice" from the MCA was to blame. Contrary to earlier advice, the guidelines had never ruled out the use of UK derived bovine material, she said. Statements that the MCA would not licence any product that did not comply with the guidelines were also wrong. In fact, the MCA could licence products that did not fully comply.
And despite earlier reassurances to the contrary, some highly processed fats from cattle were found in finished vaccines, although there was no health risk, she said.
Calf foetal serum is used as a culture medium in vaccine production. It is is "washed out" in the final stages and should not be present in the vaccine given to patients. Vaccines now use bovine material from Australia, New Zealand, the US or Canada.


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