The Irish Medicines Board (IMB)yesterday suspended a British company's licence to supply the BCG vaccine in the Republic as a result of concerns about the company's manufacturing procedures.
The BCG vaccine is normally administered to newborn babies, older children and adults who are considered to be at risk of developing tuberculosis.
This follows last month's withdrawal of a batch of the vaccine produced by the company.
The incident has also prompted the IMB to conduct a review of all licences held by the company to supply vaccines to the Republic.
Following the withdrawal of a batch of the vaccine last month, the IMB carried out an examination of the plant in Britain. The board was dissatisfied with the procedures adopted in producing the vaccine and this led to the decision to suspend the licence.
Dr Joan Gilvarry, medical director of the IMB, said an inspection of the manufacturing facilities of Evans Vaccine Ltd UK revealed "inconsistencies" in the potency of the vaccine produced. This means some batches of the vaccine were less effective than others.
She said this poses no safety threat as the less potent vaccine was never circulated in Ireland. None of the vaccines used here "would have been sub-potent," she said. However, the decision to suspend the supplier of the vaccine was taken as a precautionary measure.
An alternative supplier in Denmark will supply the BCG vaccine while the British company is investigated.
Under an EU agreement, all investigations and inspections of manufacturers are carried out by the State agency responsible in each jurisdiction.
The body responsible for carrying out such work in Britain is the Medicines Control Agency (MCA).
The Irish Medicines Board has expressed concern to the MCA at the inconsistency in the quality of the vaccine supplied by Evans Vaccine and has asked for its co-operation in investigating the plant.
An inspection team from the IMB will travel to the plant, near Liverpool, to carry out detailed examinations of the data, facilities and reporting mechanisms there.
Dr Gilvarry said the failure of the British control agency to detect any problems with the vaccine being supplied by Evans has prompted the IMB to instigate a review of all licences for products held by this company which are supplied to the Irish market.