The Pharmaceutical Journal
Vol 269 No 7211 p203
17 August 2002

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PowderJect Pharmaceuticals (more)

Supply of BCG vaccines halted following recall

All batches of BCG (tuberculosis) vaccine manufactured by Evans Vaccines, part of PowderJect Pharmaceuticals, have been recalled after a number of batches were found not to comply with the requirements of their registered specifications for potency throughout their shelf-lives (see p212). The recall also follows notification of suspension of the company's licence for BCG vaccine in Ireland.

A spokesperson for Evans Vaccines told The Journal that the vaccine is not expected to be made available again until April next year and that the company is assisting the Department of Health in finding an alternative source for obtaining supplies. However, the company adds that regulators are satisfied that there are no related safety implications and that “the vaccine should still be effective because the potential reduced efficacy is not of clinical relevance”.

The Irish Medicines Board, which ordered the suspension of the company’s contract to supply the BCG vaccine to the Irish Republic, says it is now reviewing the licences for all products the company supplies to the Irish market.

The suspension of the contract for the vaccine in Ireland follows a recall of one batch of the BCG vaccine in Ireland last month. Tests revealed it had a lower potency than usual, and was therefore less effective. That prompted an inspection of the company’s manufacturing facility at Speke, Liverpool by the Irish Medicines Board. Dr Joan Gilvarry, medical director, Irish Medicines Board, commented: “The board was dissatisfied with the procedures adopted in producing the vaccine”. The inspection revealed “inconsistencies” in the potency of the vaccines and that some batches were less effective than others. While there was no public safety threat, a decision to suspend the contract was taken as a precautionary measure. An alternative supplier has been found in Denmark.

The Irish Medicines Board says that it has expressed concern to the Medicines Control Agency over the inconsistency in the quality of the vaccine supplied by Evans Vaccines and has asked for its co-operation in investigating the plant. A further, more detailed, inspection of the Speke facility is planned.