There is a current shortage of the BCG vaccine in Ireland. This issue affects all of Europe, as one of the largest providers (SSI) of the vaccine has been unable to meet demand. There is only one brand of this vaccine licensed for use in Ireland, as no other suppliers have met the safety and validation requirements.
The Health Service Executive (HSE) have asked the Health Products Regualtory Authority (HPRA) to source an alternate supplier of the BCG vaccine, but it’s not an easy task as there are a limited number of companies manufacturing the vaccine. The HPRA are trying to find a company that can provide the vaccine in a safe manner which satisfies all of the safety and validation tests, procedures, and requirements. Once the HPRA successfully finds an appropriate supplier, they will licence the product for use in Ireland. This product must then be procured by the HSE.
The HSE currently have a contract of supply with a vaccination production organisation called Statens Serum Institut (SSI) in Denmark, who are unable to fulfil the contract requirements due to two factors. The first issue the company is having is related to a manufacturing process problem, and the other issue is related to a change in the organisation's management strategy. Both of these issues have meant that SSI have not been able to meet the HSE’s order for the BCG vaccine, and production is due to restart in the next couple of months, I believe. This batch of the vaccine will have to undergo the same high level of safety tests and validation proceudures as all licensed medicines and then will have to be allocated and distributed, so it will likely be next year before the vaccinations land in the local HSE health centres.
In Ireland, the number of cases of TB has been falling (328 in 2014) and there were no cases in young children in 2014. The rate of TB in Ireland for 2014 was the lowest since surveillance started in 1998. Most European countries do not give the BCG to all babies, only those who are in 'at risk' categories.
Even in the North of Ireland and the UK, the vaccine is not routinely given to every baby – only those considered at risk. In fact, it is only Ireland and Portugal who offer universal TB vaccination out of the western European countries. The vaccination offers a high level of protection from tuberculosis but not full (approximately up to 80% protection) so it is still possible to contract TB even after receiving the BCG.
The National Immunisation Advisory Committee, who are independent experts, have not voiced concern over the shortage of vaccines and the anticipated delay in the vaccination programme due to the low rates of TB in Ireland. The BCG is still, however, in the childhood vaccination schedule and so will be administered once it becomes available. The challenge will be for the HSE to deliver the vaccinations in a prompt and efficient manner. The HSE has advised that it will arrange appointments for clinics to facilitate vaccination once it has the stock. The vaccine itself is a intradermal injection. Each vial contains 20 doses for children under 12 months, or 10 doses for children over 10 months. So, group clinics will need to be organised for efficient use of resources.
On a personal note, as a parent with a baby due for vaccination, I feel there is no reason for major concern over this matter. The risk of children contracting tuberculosis in Ireland is very low. I am happy that the regulatory authorities are maintaining the necessary standards and requirements to ensure a safe vaccine is available for my child - effort is being made to procure one, and I don't see a way in which the process could be faster. I will follow the NIAC and HSE guidelines and get the vaccination when it is available, and in the meanwhile I will protect my child against more prevalent illnesses by participating in the rest of the childhood vaccination programme at the appropriate times. There is no need to delay vaccinating your child against other illnesses just because they have not received the BCG – in fact it would be detrimental to do so.
To learn more about the BCG and tuberculosis have a read of this: http://wonderbaba.ie/2015/08/07/tuberculosis-and-the-bcg-a-parents-guide/
For up-to-date information, it is important to talk to your public health nurse, who will inform you of any developments in the shortage and when you can expect your baby to receive the vaccine. They will contact you when they have vaccines in stock to arrange the vaccination of your baby.
This article was written using the most up-to-date information available from the HSE, HPRA, SSI,and NIAC in September 2015. If you have any further questions or would like up-to-date information, please don’t hesitate to contact me by private message on the WonderBaba facebook page (www.facebook.com/wonderbabacare).
