Freeze-Dried Glutamate BCG vaccine is a live attenuated vaccine indicated for the prevention of tuberculosis. It has two components, a freeze-dried vaccine and a diluent to be used to reconstitute the vaccine, presented in amber glass ampoules and colourless ampoules respectively.
The vaccine was prequalified on 1 January 1987 and supplied through direct and UN agencies.
In August 2019, WHO was made aware of the decision of Japan BCG Laboratory (JBL), the vaccine manufacturer, to prompt a recall procedure. The reason given was that during the packaging operation, a foreign matter was detected in one ampoule of diluent. Therefore, a visual inspection of the total number of this lot (89,992 ampoules) was conducted. As a result, two additional ampoules of foreign matter were found. In total, three ampoules were detected from the lot. A foreign particle was also detected in one ampoule out of 87,647 from another lot. The main component of the foreign matter is ethylene propylene rubber/styrene butadiene rubber, carbonate and inorganic silicon compound. These two lots of diluents were not supplied to any country.
The recall procedure was triggered by JBL in order to strictly adhere to Japanese pharmacopoeia requirements and to comply with Japan’s legislation.
However, it should be highlighted that recall procedure was triggered on all lots of diluent with remaining shelf-life in countries even though no particles could be found in the retained samples of the distributed lots. As of today, no complaint regarding foreign matter was reported from the lots distributed so far. Since the diluent is terminally sterilized, the sterility of the product is ensured, regardless of presence or absence of foreign matter. The incidence rate per lot was calculated as 0.0011% - 0.0033%, which, in the risk assessment analysis, is considered as an extremely low incidence (less than 0.01%). Evaluation of adverse drug reactions did not provide any evidence of a change in the safety profile of the vaccine. Finally, it should be emphasised that the presence of foreign particles is a visible defect and as such, it can be detected by the vaccinator.
On this basis, WHO considers that the impact on safety, if any, is negligible and that the benefit of immunization with the Freeze-Dried Glutamate BCG vaccine far outweighs the risks stemming from stopping BCG vaccination.