Dr. Joan Gilvarry:

I will give a few facts on the licensing of the vaccine worldwide before I go into the adverse events. Gardasil has been licensed across the European Union since 2006 and is used in most of the 27 member states in their immunisation programmes. It is also approved in about 130 countries worldwide, including by the FDA, the TGA in Australia and Health Canada. More than 110 million doses have been distributed, which equates to the vaccination of around 33 million children or adolescents with the three-dose schedule. When a vaccine comes to market there must be evidence that it works. A licence is given for the vaccine on the basis of the benefits versus the risks. The benefits of Gardasil, and the licensed indications, are the prevention of pre-malignant genital lesions and cervical cancer. That licence is based on evidence across the European Union. I have said it a hundred times, and we have heard it here today, that no medicine or vaccine is without risks. That is why we have an extensive post-marketing monitoring programme at the Irish Medicines Board, across the European Union and worldwide. When the vaccine was first introduced into the immunisation programme in 2010 the Irish Medicines Board issued a special drug safety newsletter advising of the benefits but also of the risks and the adverse reactions we knew of at that time, and it asked health care professionals to report any adverse reactions they were seeing. In terms of transparency, as the programme proceeded every month we updated our website to indicate the reactions we were seeing and the number of such reactions. In the first year of the programme we saw more than 450 reactions, while in the second year of the programme the number decreased to 150. The vast majority of the adverse reactions we saw were as expected and were non-serious. They were syncopes and faints in young girls in school, sometimes before the injection rather than after it, headaches, malaise, muscle pains and gastrointestinal upset - nothing that was extremely worrying.

To answer one of the questions posed, when 33 million children are vaccinated worldwide with three doses of the vaccine, one will see unexpected side effects with a temporal association with the vaccine but not necessarily a causal relationship. To date across the European Union and worldwide we have identified no risks additional to those that were known when the vaccine was licensed, and the benefits still far outweigh any risks to this vaccine.