BCG VACCINE SSI 28.02.2005

Notice type: 3rd Party Publications

Date: 28/02/2005


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MIMS Publication February 2005

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Further to previous articles regarding BCG Vaccine SSI in Ireland (April 2003 and September 2004), this month’s item outlines the up to date experience and on-going monitoring activities including progress with the retrospective review of enhanced follow up of suspected ADR reports. 

Since BCG Vaccine SSI was first introduced, some 350,000 doses of the vaccine have been distributed in Ireland. BCG Vaccine SSI is the only BCG vaccine currently authorised for use here. Up to the end of December 2004, the IMB received a total of 151 suspected ADR reports associated with use of the product. Of these 9 were received in 2002, 50 in 2003 and 92 in 2004. 

In addition to monitoring national experience with use of the product, with healthcare professionals encouraged to report all suspected ADRs observed with use of BCG Vaccine SSI, the IMB has also closely monitored global safety data provided by the company, as well as seeking information on any concerns relating to its use from colleagues collaborating in the EU/WHO pharmacovigilance monitoring programmes. 

Retrospective Review of cases of ADRs – initial findings 

As outlined in the article included in the September 2004 issue of MIMS, healthcare professionals were informed of the intention to conduct an enhanced retrospective review of all ADRs notified to the IMB in association with use of BCG Vaccine SSI. 

To date, the IMB has distributed a total of 87 questionnaires to the original reporters for completion and has received a total of 43 responses so far. The questionnaires returned have provided extremely useful additional information relating to dosage, outcome/recovery data, treatment details etc. Further comments received highlight concerns regarding appropriate needle size, amount of diluent to be used, exact method of administration and the reactogenicity of the vaccine. Detailed information regarding the former points is addressed in the product information, while the strain of BCG vaccine used in BCG vaccine SSI is known to be more reactogenic than some other strains of BCG vaccine. 

The IMB would like to sincerely thank those healthcare professionals who have responded to the questionnaires, and would like to remind those who have not as yet done so to return the questionnaires in the post-paid envelope provided to them as soon as possible, to facilitate a comprehensive review of the issue. 

It is appreciated that healthcare professionals receiving the questionnaires are not the original vaccinators in many cases, however, the IMB is completely reliant on the initial reporters to provide further information on the cases, particularly with regard to management and outcome, as far as possible. If appropriate/known, contact details for original vaccinators may be provided in that section of the questionnaire and the IMB will follow up on those cases directly. 

A further update on the findings/outcome of the review will be provided, when completed. Any suspected ADRs should be notified to the IMB in the usual way. 

A version of the ADR report form is available to download from the HPRA’s website ( 
Downloaded forms may be completed and sent by freepost to the HPRA. 
Envelopes should be marked 
Pharmacovigilance Unit, 
Health Products Regulatory Authority, 
The Earlsfort Centre, 
Earlsfort Terrace, 
Dublin 2. 
Alternatively completed forms may be submitted by fax (01- 6762517). 
Post-paid report cards are also available from the Pharmacovigilance Unit at the HPRA (01- 6764971). 
References: IMB Page, MIMS Ireland, April 2003, September 2004

Background Information Or Related Documents:
BCG VACCINE SSI 28.02.2005 Document

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