Drugs firm in smallpox row recalls its TB vaccine

PowderJect, the pharmaceuticals company that caused controversy when it was awarded a government contract to supply the 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 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.

PowderJect, the sole licensed supplier of the BCG vaccine in the UK, released a statement saying that it is voluntarily withdrawing the vaccine in the UK as a precautionary measure.

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.

PowderJect said in a statement: "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 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.

The spokesman said: "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 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."

Shadow Health Secretary Dr Liam Fox said yesterday: "The Government must respond immediately to worries about the TB vaccine being provided by PowderJect. They must ensure supplies are made available especially to high-risk individuals. Failure in this area of immunisation is another example of how low a priority public health issues are for this Government."

PowderJect 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 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.