Labour donor company withdraws TB vaccine

A pharmaceuticals company that caused controversy when it was awarded the Government contract to supply Smallpox vaccine is recalling its tuberculosis vaccine in the UK following the temporary suspension of its licence for the vaccine in Ireland.

PowderJect Pharmaceuticals Plc - the sole licensed supplier of the BCG vaccine in the UK - released a statement late last night saying that it is voluntarily withdrawing the vaccine in the UK as a precautionary measure following an interim suspension of the company's licence for the vaccine in Ireland.

PowderJect said it was being "extra cautious" in withdrawing the BCG vaccine, manufactured at its Liverpool factory, although it was assured that it was not unsafe.

The company was at the centre of controversy earlier this year when it emerged that it had been secretly awarded a contract to supply the Government with smallpox vaccine in case of a terrorist germ warfare attack.

The Government said the contract was not put out to open tender for security reasons but there was criticism over the fact that PowderJect's chairman and chief executive Paul Drayson was a substantial Labour Party donor.

The problem was initially identified in Ireland when a "small number" of batches approaching the end of their normal three-year shelf life were found to be below the normal required standards of potency.

Further testing identified a similar problem in a number of other batches at which point it was decided to order the recall.

Last night, PowderJect said: "The regulators are satisfied that there are no related safety implications, although the batches were potentially less potent than normal."

The company said it had consulted independent experts who had confirmed that the vaccine should still be effective because the potential reduced potency "is not of clinical relevance".

A Department of Health spokesman said the initial test results were received by the department on Thursday and yesterday and these had been discussed in detail with the company.

He said the schools vaccination programme should not be disrupted as it is not due to restart until October and that there was not thought to be a need for anyone to be recalled for re-vaccination.

"No concerns about the safety of the vaccine have been raised.

"We welcome the prudent and responsible course of action they have taken today in withdrawing the vaccine.

"The Department is currently making arrangements to ensure the continuity of the vaccine programme and to minimise any disruption. The school vaccine programme should not be affected as this is not scheduled to restart until October.

"The tests on the product are continuing. At this stage there is no need to recall people for re-vaccination but the situation is being kept under review."

However, he added: "All BCG vaccinations will have to be suspended as a result of this decision, but they will be re-started as soon as suitable vaccine does become available."

"The department is working to achieve this as soon as possible."

PowderJect said it was co-operating fully with the regulatory authorities to resolve any issues relating to the manufacture of the vaccine, specifically to ensure that in future each batch continued to comply with its shelf-life as stated in the product licence.

"PowderJect anticipates that due to the time required to answer the regulators' questions and the vaccine's lengthy manufacturing process, the company will not re-launch BCG vaccine during the current financial year.

"As an interim measure, PowderJect will offer its assistance to the Department of Health to secure vaccine supplies from an alternative source."