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BCG expiry date moved from 12 to 18 months

Last month it emerged that the HSE was experiencing significant delays with the supply of the BCG vaccine because of manufacturing difficulties.

A HSE spokesperson confirmed to MI that, “in early 2015 the HSE asked the Health Products Regulatory Authority (HPRA) to look at extending the shelf life of the BCG vaccine from 12 months to 18 months.”

The HPRA reviewed the necessary documentation and agreed to extend the shelf life of any new delivery of BCG vaccine to 18 months, the spokesperson said.

“However, the HSE has not received any delivery of BCG vaccine since December 2014. This BCG vaccine expired at the end of April 2015. Any new deliveries of BCG will have an 18-month shelf life.”

The spokesperson also confirmed that the HSE is still experiencing delays with the supply of BCG vaccine.

“This is a problem that is affecting most countries in Europe, not just Ireland. This is because there is only one licensed manufacturer of BCG vaccine, supplying BCG to countries within the EU.

“There is no alternative supplier of the BCG vaccine, which is a licensed product. The HSE continues to engage with the supplier (SSI) to seek an alternative supplier in the EU for the BCG vaccine,” the spokesperson said.

The BCG vaccine has not been available since 1 May 2015. Based on an estimated 5,500-6,000 babies being born every month this means that 16,500-18,000 babies are due to be vaccinated.

HSE staff will arrange appointments for BCG vaccination clinics when the BCG vaccine supply is restored, the spokesperson said.

They added that the vaccine manufacturer has “informed us that BCG vaccine will not be delivered into Ireland until October at the earliest”.

Meanwhile, HIQA was this week due to publish a draft health technology assessment, for consultation, on the clinical and cost-effectiveness of moving from universal to selective BCG vaccination for TB prevention in Ireland.

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