Dáil Éireann Debate, Tuesday - 11 October 2016
475. Deputy Michael Fitzmaurice asked the Minister for Health if there are any ongoing studies here to examine any adverse reaction to the Gardasil vaccination, not just directly after the injections but for at least five years afterwards; his plans to implement a strategy in this regard; and if he will make a statement on the matter. [29795/16]
View answer493. Deputy Clare Daly asked the Minister for Health the number of longitudinal studies of girls vaccinated against HPV in the past five years that have been performed and their results. [29876/16]
View answerI propose to take Questions Nos. 475 and 493 together.
In the past ten years the safety of the HPV vaccine has been reviewed frequently by many international bodies including the European Medicines Agency (EMA), the Global Advisory Committee on Vaccine Safety of the World Health Organisation and the Centres for Disease Control and Prevention in the US. These Committees have continually concluded that the vaccine is safe.
The Global Advisory Committee on Vaccine Safety of the World Health Organisation has systematically investigated safety concerns raised about HPV vaccines and has issued several reports in this regard. In December 2015, WHO reported that, it has not found any safety issue that would alter its recommendations for the use of the vaccine. In January 2016 the EU endorsed the use of HPV vaccines in all countries in the EU. This was following a European Medicines Agency (EMA) report on a review of HPV vaccine.
There have been numerous studies published in the past 5 years on the HPV vaccine which have observed those girls vaccinated with the HPV vaccine since it was licensed in 2006. The findings of almost 30 of these studies that I am aware of can be summarised as follows:
- HPV vaccines are highly efficacious (>90%) at preventing infection with targeted HPV types (types 16 and 18 and for the quadrivalent vaccine also types 6 and 11) and related cervical intraepithelial neoplasia. The quadrivalent vaccine has proven efficacy and against HPV16/18/6/11 related vulvar, vaginal, and anal intraepithelial neoplasia and genital warts.
- The vaccines have some, although lower levels of, cross-protection against related type HPV31. The bivalent vaccine also has some cross-protection against types 33, 45, 51 and 52. The bivalent vaccine produces higher antibody titers than the quadrivalent vaccine.
- Following three doses, antibody tirtres plateau by 48 months but are then sustained (bivalent>quadrivalent) for more than 9 years, with no indication of waning protection.
- Two doses of vaccine spaced six months or more apart are as immunogenic in females aged under 15 years as three doses in older women.
- Following population-based vaccination programs, significant declines in genital warts, HPV infection and cervical intraepithelial neoplasia have been observed.
- Herd protection of males against genital warts has been observed following female HPV vaccination programs.
- With over 230 million doses distributed globally, HPV vaccines have been repeatedly assessed as safe. The vaccines are not associated with any increased risk of disease including autoimmune, neurological or thromboembolic disease.
I can provide Deputies with detailed references of these studies.
Worldwide there is no scientific evidence that HPV vaccines cause any long term illness. The Health Products Regulatory Authority (HPRA), the authority regulating the HPV vaccine has never advised that there is any concern about the safety of the HPV vaccine. The HPRA continues to monitor each vaccine and medicine during the life time of its license.
