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The BCG Shortage – The Full Story!

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green-update-button-clip-art16/10/2016 – Below you will find in black text my original review of the status of the BCG vaccination in Ireland and also a link to my full article on Tuberculosis.  I am also available to answer any queries you may have by private message on the WonderBaba facebook page.   I just wanted to update this information due to a recent statement made by the HSE.  The HSE are still struggling to obtain supply of the BCG vaccine – this is a problem being experienced all over Europe – not just in Ireland! The situation remains the same as described in my article below with no date mentioned for resolution of the issue.  The National Immunisation Advisory Committee and the Health Information and Quality Authority both advise that there is no longer a need for the vaccine to be given routinely to all babies in Ireland – just to certain at risk categories.  However it still remains on the new Childhood Immunisation Schedule.  The most important information out of this article is that TB has been at the lowest rates available on records in 2014 and 2015.  Most countries in Europe do not routinely vaccinate against TB they feel the risk is so low.  The best thing to do is follow the rest of the Childhood Vaccination Schedule as recommended and time will tell us what will happen about the BCG.  If it helps to alleviate worry…I have three children and only two have received the vaccine…There is no information that has made me feel concerned at this stage.

 

7/8/15 – The BCG Shortage – The Full Story!

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 who can provide the vaccine in a safe manner which satisfies all of the safety and validation tests, procedures, and requirements. Once the HPRA successfully find 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 contracts requirements due to two factors. The first issue the company are having is to do with a manufacturing process problem and the other issue is to do with a change in the organisations 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 have advised that they will arrange appointments for clinics to facilitate vaccination once they have the stock. The vaccine itself is a intradermal injection. Each vial contains 20 doses for children under 12months or 10 doses for children over ten 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  https://wonderbaba.ie/2015/08/07/tuberculosis-and-the-bcg-a-parents-guide/

This article was written using the most up to date information available from the HSE, HPRA, SSI,and NIAC on 7/8/15. 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) or through Milltown totalhealth Pharmacy on 01-2600262. I am always happy to help!

Ref:

http://www.hse.ie/eng/health/immunisation/news/BCG16.html

Author: WonderBaba Blog

My name is Sheena Mitchell and I'm a pharmacist with my own business Milltown totalhealth Pharmacy in Dublin 6. From working in the pharmacy I've realised that there are a lot of first time and experienced moms who might benefit from hints and tips from a pharmacist who can balance healthcare advice with real hands on experience from my important work as a mother of two! I hope to bring you regular advice and information and answer questions that you have! Being a mother and pharmacist are my two favorite things and I'm delighted to have this way of bringing my two worlds together! All questions and queries are gratefully received but otherwise sit back, relax, and let the solutions come to you!

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