Almost 55,000 children awaiting BCG injections

About 54,000 children are now awaiting BCG (Bacillus Calmette–Guérin) vaccinations with the HSE unable to find an alternative source for the drug which ran out 10 months ago. SSI Denmark is the only approved European manufacturer of the vaccine which prevents tuberculosis. Ireland’s stocks ran out at the beginning of last May. Since then, an estimated 5,500 to 6,000 children born in Ireland every month have been unable to avail of the vaccination.

According to documents obtained under Freedom of Information legislation, the delay at the producer “is due to a possible problem with the capping of the vials and qualification/validation activities that have to be performed following repair of central equipment”.

The correspondence between the HSE and the Department of Health last July explained: “Existing stock has been awaiting assessment in SSI for at least seven months. Production of new stock will not commence until February 2016 at the earliest.” SSI had advised the “delivery situation” would not be “normalised” until the second or third quarter of this year.

“The HSE has been in regular contact with SSI about the vaccine shortage and is liaising with the HPRA [Health Products Regulatory Authority] to see if there is an alternative supplier. To date none has been found.”

According to figure from the Central Statistics Office, 25 people died from TB in 2014. That year, 328 cases were notified in Ireland but the Health Protection Unit at the Department of Health said there were no cases in young children. TB rates here have been falling.

Many countries have ended universal vaccination. Ireland and Portugal maintain the blanket approach although the Health Information and Quality Authority (Hiqa) last December recommended to the Minister for Health that Ireland switch to selective vaccination of at-risk children only.

The HSE has been advising parents that children are “not at risk of TB because of the delay in getting the vaccine”.