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September 27, 2002

INTERNATIONAL IMMUNIZATION NEWS

"TB Vaccine Shortage Affects Children in Britain"

Reuters Health Information Services (www.reutershealth.com) (09/26/02); Woodman, Richard

Powderject Pharmaceuticals voluntarily recalled its BCG tuberculosis vaccine in August because of uncertainties about the quality of some batches, and the British Department of Health says that the new vaccine, from Statens Serum Institute of Denmark, cannot yet be released, which means that the vaccination program for infants and children must be delayed.  The school immunization program usually starts in October and [is designed] to protect 600,000 children annually against tuberculosis; newborn babies in high-risk areas will also have to wait, according to a department spokesman.  The department says that Statens' vaccine has a U.K. product license and that its stocks are being tested to ensure uniform quality, and when it is released, the babies will be vaccinated before the school program starts.  Powderject withdrew its vaccine after finding that a few batches did not meet the end-of-shelf-life specifications, and, due to regulatory queries and the long manufacturing process, it will not be able to relaunch the vaccine this financial year.

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