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.
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