Written answers

Tuesday, 3 July 2018

Department of Health

Vaccination Programme

Photo of Bobby AylwardBobby Aylward (Carlow-Kilkenny, Fianna Fail)
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370. To ask the Minister for Health the position regarding his engagement with the advocacy groups and families representing the young women who claim to have suffered adverse health effects shortly after having received a vaccine (details supplied); the steps he has taken to ensure a clinical care pathway appropriate to the medical needs of this group in line with previous commitments; the number of doses of vaccine administered to date; and if he will make a statement on the matter. [29205/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. It operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions through this system. All Reports received by the HPRA are routinely transmitted to the European Medicines Agency’s adverse reaction database for inclusion in global signal detection and monitoring activities.

The HPRA and the European Medicines Agency continually monitor adverse events to vaccination. HPV is one of the most closely studied and monitored medicinal products. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. Mild and temporary reactions to any kind of vaccination are not unusual.

Over 230,000 Irish girls have safely received the HPV vaccine and over 227 million doses of the HPV vaccine have been given around the world. No serious side effects in any country can be scientifically attributed to this vaccine. Furthermore the safety and effectiveness of the vaccine is endorsed by all national and international regulatory bodies including the HPRA in this country.

As information concerning the number of doses of HPV vaccine administered to date is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy. I have also asked the HSE to respond in relation to providing a clinical care pathway for this cohort and on any engagement they have had with advocacy groups.

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