Dr. Joan Gilvarry:

First, before any vaccine comes to the market, it must meet very clear pre-defined standards of quality, safety and efficacy before it gets its licence. Gardasil is licensed since 2006. We monitor the safety of the vaccine after it comes to the market by health care professionals telling us of adverse reactions or suspected adverse reactions they have seen. Similarly, we hear from patients, carers, public health doctors when they are out in the schools. We also put all of these adverse reactions that we get into the European database which gives us a much bigger global database of adverse reactions. One can interrogate that database much better than a small Irish database and look for signals. We also look at published literature, new clinical trials, any new epidemiology trials.

Also, the manufacturers of the vaccine must submit what we call a periodic safety update report to us. In the case of Gardasil, that has been submitted to the regulatory authorities and to the European agency every year since it was licensed. The product is now licensed in 130 countries worldwide and 72 million people have been vaccinated. This involved approximately 200 million doses because the girls get two-to-three doses, depending on their age. We have a vast amount of knowledge about this particular vaccine.

Specifically about Denmark and Japan that Deputy Billie Kelleher talked about, in mid-2015, Denmark did see some cases of chronic fatigue syndrome, chronic regional pain syndrome and POTS, as Professor Karina Butler has referred to, and the regulatory authority in Denmark asked the Commission to trigger a European-wide review. That was done via the European agency and its safety committee. The safety committee of the European agency is made up of expertise from all the member states including doctors, nurses and scientists. They reviewed every piece of data that was available. They pulled in experts on vaccines and on epidemiology. They talked to the patient groups. In fact, on the Pharmacovigilance Risk Assessment Committee, PRAC, which is the safety committee, there are patient groups and health care professional representatives. They came to the conclusion by consensus - every member state and every patient on the committee agreed - that there was no evidence to support a causal relationship between the syndromes that were being seen and the vaccine. That recommendation went from that committee at the European agency to the licensing committee, which we call - without giving the committee too much technical jargon - the CHMP, and it agreed with that recommendation, also by consensus. The European Commission, in early 2016, issued a legally binding decision that there was no causal relationship with this. The product has not been withdrawn worldwide by any regulatory authority. The Government of Japan has taken the product out of its immunisation programme, but not in agreement with the regulatory authority, and it continues to be used continuously in Denmark. The Danes accept the recommendation. They were a party to the recommendation from Europe.

There was another question on pandemics and whether there was a rush to licensing. There was no rush to licensing, but I must admit it was a different situation. Everyone was prepared at some stage for a pandemic. We, on the Irish pandemic group, were preparing for years previously because we were expecting a pandemic. What we did, from a European regulatory point of view, is license mock-up vaccines. We did not know what the strain would be and for the years before, the companies submitted to the European agency mock-up so-called "dossiers" - it was with the H5N1 - so that we were ready. These mock-ups were licensed by the European Commission for all the member states in 2007 so that when the pandemic was declared, and we knew it was H1N1, what needed to be done was to vary that licence and, essentially, take out the H5N1 and dip in the H1N1 that was then identified. There was then active surveillance. They were licensed, probably at the end of October 2009, and there was active surveillance. We were in constant communication on a weekly basis on any new data or any new adverse effects that were appearing. The immunisation programme here in Ireland ended at the end of March 2010. The first signal that came on narcolepsy was from the Finnish agency in August 2010 and nobody could have predicted it. There was no rush to judgment. In fact, as soon as Finland brought that to attention, a European-wide referral and review was started. However, it had really no impact on our programme because it was finished here in Ireland at that stage.