Due to production issues and rehabilitation of the BCG production line at Statens Serum Institut (SSI), the SSI’s BCG vaccine against tuberculosis has been on back order for a substantial period of time, and the current outlook is that the SSI will remain unable to provide the vaccine at least until the end of 2016. Furthermore, there is a general lack of BCG vaccine on the world market, including in countries which have included the vaccine into their childhood vaccination programme.
Nevertheless, we have procured a consignment of BCG vaccine from a Japanese manufacturer (Japan BCG Laboratory), which we expect to be able to supply from the SSI as from the beginning of February. This BCG vaccine is currently also being used in Sweden.
Whereas the SSI’s BCG vaccine is provided as vials with 10 doses (20 infant doses) of lyophilised vaccine, the Japanese product comes in packages of 10 ampoules each counting 10 doses of lyophilised vaccine, i.e. 100 doses (200 infant doses). It is not possible to repack the vaccine into more limited volumes, which causes logistic challenges in ensuring prioritised supply to the clinics/hospitals that have the greatest need for the vaccine in order to minimise vaccine waste.
Therefore, and because the product is not registered in Denmark, it will only be possible to order BCG vaccine by calling the SSI Order Office (Ordremodtagelsen).
Furthermore, we urge general practitioners who find that there is indication for vaccination of a patient to consider referring the patient to a larger unit, e.g. a vaccination clinic or hospital department that administers more vaccinations and therefore may use more doses per package within the limited shelf-life period after opening and reconstituting the vaccine.
For more information, please see EPI-NEWS 4/16.
Source: Statens Serum Institut