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  TB jabs halted after vaccine recall
10th August 2002

ll vaccinations against tuberculosis have been suspended after the firm that supplies the vaccine recalled it in Britain following the discovery of a failed batch in Ireland.

Biotechnology firm PowderJect Pharmaceuticals Plc said it was voluntarily recalling its BCG tuberculosis vaccine in Britain as a precautionary measure after its licence for the vaccine in Ireland was suspended after tests.

The decision "follows testing that revealed a small number of batches did not meet the end-of-shelf-life specification," PowderJect said in a statement.

A spokesman for the Department of Health said the recall meant all vaccinations would have to be suspended.

"All BCG vaccinations will have to be suspended as a result of this decision. They will be restarted as soon as a suitable vaccine does become available and the department is working to achieve this as soon as possible," he said.

But the spokesman stressed: "No concerns about the safety of the vaccine have been raised".

British schoolchildren have been routinely vaccinated against TB for many decades and the department said that since schools are on summer breaks, this programme should not be affected as it is not due to restart until October.

It added: "At this stage there is no need to recall people for revaccination but the situation is being kept under review."

PowderJect said it was cooperating fully with the regulatory authorities and would offer advice to the Department of Health to secure supplies of the vaccine from an alternative source.

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

Britain was forced to suspend its routine immunisation of children against TB for two years from September 1999 because manufacturing problems led to a shortage of the BCG vaccine.

TB, which usually affects the lungs and is spread by coughing, sneezing or spitting, was once a major killer in Britain. It declined steadily in the 20th century as living standards improved. A national vaccination programme was introduced in 1953.

The health department said in its statement that BCG vaccination can be delayed without increasing a person's chance of catching TB.

PowderJect said its vaccine recall would have no impact on its revenues but could cut expected pre-tax profit by five million pounds ($7.64 million) from its original forecast of 25 million pounds.

"PowderJect should still achieve its target to exceed 160 million sterling of revenues for the current financial year," it said. "However, due to the one-off costs associated with the vaccine recall, such as inventory write off, the company's pre-tax profit will be approximately five million sterling below the original expectation of over 25 million sterling."

PowderJect's BCG vaccine accounts for revenues of approximately 10 million pounds per annum.

 

     
 
©2002 Associated New Media Limited
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ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.