A serious European-wide shortage of tuberculosis vaccinations for new-born babies is expected to last well into the new year, the Health Service Executive has confirmed.
Up to recently, the HSE had believed that a delivery of new stocks of the BCG TB vaccination originally expected in early November would finally arrive in early January.
However, the HSE told Labour deputy leader Joan Burton this week: "The latest information we have is that stocks will not be available before the middle of February at the earliest."
The vaccination is normally given to babies within one month of birth, and it was administered to 94 per cent of all babies born in the State, according to the latest health statistics figures.
The HSE imports its supplies of the tuberculosis vaccine from the sole European licensed supplier, the Danish-based Statens Serum Institut (SSI).
This company warned the HSE national immunisation office on October 9th that there were problems about the delivery due in November.
Unlike other vaccines, the Bacille Calmette-Guerin (BCG) vaccine, which contains live, weakened bacteria similar to the tuberculosis bacterium, has a very short shelf life that prevents the storage of large reserve stocks.
The Irish Medicines Board (IMB) requires that BCG batches used in Ireland must be first tested and analysed by an EU-approved official medical control laboratory before it is imported into Ireland.
However, a Norwegian laboratory used by SSI "has experienced severe problems with their test results" which means that it cannot give the EU stamp of approval required by the Irish Medicines Board (for the time being). "The HSE has also sought alternative supplies of SSI BCG from other countries, so far without success, and is in regular contact with SSI to secure stocks as soon as possible," the HSE said.
HSE executives met the Danish supplier on November 20th "to express serious concern" about the vaccine shortage. The Danish company has promised to notify the HSE when EU approval is available.
All hospitals were informed in early October of the supply problems "and asked to manage their limited stocks". Each HSE area then had about one month's stock in hand in multi-dose vials.
"All mothers of newborn babies due BCG have been advised of the current BCG shortage and the local HSE local health office will contact them with an appointment when new stocks arrive. "As of today [December 3rd] the latest information we have from the company is that stocks will not be available before the middle of February at the earliest," the HSE told Ms Burton.
