Gerry Adams
Question:885. Deputy Gerry Adams asked the Minister for Health the progress to date in identifying an alternative supplier for the BCG vaccine; and if he will make a statement on the matter. [30960/15]
View answerTuesday, 22 September 2015
Questions (885, 886, 888, 889, 912, 913, 914)
Gerry Adams
Question:886. Deputy Gerry Adams asked the Minister for Health the number of babies that have not received the vaccine to date; the projected final figure for non-innoculation; and if he will make a statement on the matter. [30961/15]
View answerGerry Adams
Question:888. Deputy Gerry Adams asked the Minister for Health if his Department is considering ending the universal availability of the BCG vaccination; and if he will make a statement on the matter. [30963/15]
View answerGerry Adams
Question:889. Deputy Gerry Adams asked the Minister for Health the specific concerns or risks associated with TB for babies born on farms; and if he will make a statement on the matter. [30964/15]
View answer
Ruth Coppinger
Question:912. Deputy Ruth Coppinger asked the Minister for Health the measures taken to ensure there is adequate supply of the BCG vaccine as soon as possible for new born children; and if he will make a statement on the matter. [31095/15]
View answerRuth Coppinger
Question:913. Deputy Ruth Coppinger asked the Minister for Health the number of BCG vaccines that are currently available here. [31096/15]
View answerRuth Coppinger
Question:914. Deputy Ruth Coppinger asked the Minister for Health the steps taken to find alternative sources of the BCG vaccine to ensure there was an adequate supply; and if he will make a statement on the matter. [31097/15]
View answerWritten answers
I propose to take Questions Nos. 885, 886, 888, 889 and 912 to 914, inclusive, together.
There is a worldwide shortage of BCG and Ireland is not the only country affected by this. There is only one licensed supplier of BCG vaccine to Ireland and to other countries within the EU.
The vaccine has not been available since the end of April 2015. Babies born after the last day of April have not been immunised, this equates to approximately 5,500 babies a month, so around 24,000 to-date. It is anticipated that the vaccine will be available near the end of the year so if vaccinations begin in January there will be approximately 44,000 babies to immunise. The exact backlog will clearly be dependent on when the vaccine becomes available.
Since this problem became apparent, the HSE National Immunisation Office has been in regular contact with the manufacturer of BCG and with the Health Products Regulatory Authority (HPRA) who licenses vaccines in Ireland as well as with other relevant stakeholders. The HPRA have been seeking to find an alternative supply of BCG that meets safety, quality and effectiveness standards and that could be used in Ireland. To date no appropriate alternative manufacturer of BCG vaccine has been found.
The HPRA confirmed that it was contacted by an Irish company in August 2015, which advised that it could procure some Infant BCG Vaccine from InterVax in Ontario, Canada. The HPRA highlights that the company InterVax is a distributor for this product rather than a manufacturer or marketing authorisation holder. The vaccine in question is currently not authorised for use in Ireland.
The HPRA followed up with both the Irish company and contacts within the regulatory network. The information which was made available to the HPRA in relation to this BCG vaccine was extremely limited and was not considered to be sufficient to allow for the assessment of the quality, safety and efficacy of the medicine. Consequently, the HPRA was not in a position, without further data, to undertake a comprehensive review or to approve the use of this medicine (which is primarily used for the vaccination of infants) in Ireland. The HPRA subsequently outlined its concerns to the Irish company involved, which acknowledged them.
This company was also advised that should it submit a regulatory submission, providing the necessary data on this BCG vaccine, the HPRA would be happy to assess the medicine for safety, quality and efficacy, in an expedited timeframe. The company indicated that it did not wish to pursue this option.
In early 2015 the HSE asked the HPRA to look at extending the shelf life of 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. Any new deliveries of BCG will have an 18 month shelf life.
The National Immunisation Advisory Committee (NIAC) and the National TB Advisory Committee have recommended stopping routine BCG vaccination of newborn babies and instead provide a selective vaccination of babies in high-risk babies groups. The Department of Health have requested the Health Information and Quality Authority (HIQA) to conduct a Health Technology Assessment (HTA) to review the implications of this change. HIQA commenced a public consultation on proposed changes to the BCG vaccination programme in Ireland on September 9th 2015.
Tuberculosis (TB) is a notifiable disease under the Infectious Diseases (Amendment) Regulations 2011 (S.I. No. 452 of 2011). In 2014, 328 cases of TB were notified to the Health Protection Surveillance Centre, giving a national TB notification rate of 7.1 per 100,000, the lowest rate reported since surveillance commenced. According to the World Health Organisation, the definition of a low incidence TB country is one with a national TB notification rate of less than 10 cases per 100,000, Ireland is in this category.
In Ireland the number of cases of TB has been falling and there were no cases of TB in young children in 2014. Most European countries, including the UK, Sweden, Norway, Denmark and Iceland do not give BCG vaccine to all babies. Babies are not at risk of TB because of the delay in getting BCG vaccine in Ireland.
Resolving the issue of the shortage of BCG remains a priority for the HSE.
Question No. 886 answered with Question No. 885.