Michael Healy-Rae
Question:471. Deputy Michael Healy-Rae asked the Minister for Health if he will address matters (details supplied) in relation to the HPV vaccine; and if he will make a statement on the matter. [3107/19]
View answerTuesday, 22 January 2019
Questions (471)
Written answers
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. HPV is one of the most closely studied and monitored medicinal products.
All medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. Taking into account the totality of the available information, the benefits of the HPV vaccines continue to outweigh their risks. The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.
The initial authorisation of Gardasil was supported by the results from the study known as Future II. This study concluded that in young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
Subsequently the results from Future III updated the product information for Gardasil in relation to the vaccination of women up to 45 years old.
The trials for Future II or Future III were not conducted in Ireland and therefore the HPRA did not have access to the original clinical trial submissions, however, the results of the studies are publically available at www.ema.europa.eu/documents/scientific-discussion/gardasil-epar-scientific-discussion_en.pdf).
In both the Future II and Future III studies participants were randomised to either a vaccine group or placebo group. The currently licensed quadrivalent Gardasil product contains 0.225 mg amorphous aluminium hydroxyphosphate sulfate per 0.5 ml dose. Placebo product used in the control arms of the referenced studies contained the same amount of aluminium-containing adjuvant. The use of the aluminium-containing adjuvant in the placebo group is stated in the study documents referenced above.
A placebo arm is an important aspect of many clinical studies and supports the evaluation of the true overall effect of the experimental drug under study. There is a strong rationale for using a placebo in large pivotal studies as it is widely considered to be the most rigorous method of evaluating the efficacy of treatment or prevention interventions. The only difference in composition between the placebo and vaccine in the above-mentioned Gardasil trials was the absence of active substances (HPV virus type proteins) in the placebo. This allows the effects observed in the clinical study to be attributed to the vaccine product.