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Sept. 26

— By Richard Woodman

LONDON (Reuters Health) - Britain's Department of Health said on Thursday that a key vaccination program to protect thousands of babies and schoolchildren against tuberculosis faces indefinite delays while a new vaccine undergoes stringent tests.

British biotechnology firm Powderject Pharmaceuticals Plc voluntarily recalled its BCG vaccine in August as a precautionary measure after doubts were raised about the quality of some batches. The department says that the new vaccine, from Danish company Statens Serum Institute, cannot be released yet.

A spokesman said he could not say when the BCG school immunization program, which normally starts in October and protects 600,000 10- to 15-year-olds a year against TB, would resume.

He said vaccination of newborn babies in high-risk areas such as inner London, where TB rates are three times the national average, was also affected by the lack of supplies.

"We are trying to get a new supply as quickly as possible. At the moment it is not a major worry so long as the new supply comes on stream."

Tuberculosis, an infectious lung disease, is a major killer in developing countries where 95% of cases occur but is also a growing concern in the west, where it is linked with immigrant communities, social deprivation and the spread of HIV.

It is the second time Britain's BCG program has been halted. In 1999, vaccination was suspended because of manufacturing problems suffered by Celltech Medeva.

In a statement, the department said the Danish company's vaccine had a UK product license and stocks were "currently undergoing stringent tests before they can be released.

"Once BCG supplies are available, the priority will be to vaccinate those at highest risk of TB--principally newborn babies whose parents are from higher risk communities or who live in higher risk areas. The schools program will then follow on afterwards.

"The current unavailability of BCG vaccine is not ideal but we have to ensure any new vaccine meets UK safety and effectiveness standards. We do not expect there to be any long-term shortage of BCG."

Powderject has said it withdrew its vaccine after testing in Ireland revealed a small number of batches did not meet the end-of-shelf-life specification. It would not be able to re-launch BCG this financial year due to the time needed to answer regulators' questions and lengthy manufacturing processes.

The Health Department spokesman said samples of the new Danish vaccine were being checked to ensure there was no variation in the quality of different batches.

Tuberculosis, 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 and after a national vaccination program was introduced in 1953.

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