Dáil Éireann Debate, Thursday - 2 March 2017
258. Deputy Robert Troy asked the Minister for Health if the manufacturer of the HPV vaccine failed to inform the US Food and Drug Administration and the European Medicines Agency regarding Gardasil vaccine research omitting data concerning ovarian failure and its implications for the current HPV vaccination programme administered by the HSE on behalf of his Department. [11138/17]
Amharc ar fhreagraIn Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. The HPRA and the European Medicines Agency (EMA) in Europe continually monitor adverse events to vaccination. Gardasil is the HPV vaccine used in the HSE schools immunisation programme its safety profile has been continuously monitored since it was first authorised. In Ireland more than 660,000 doses of Gardasil have been administered and almost 250,000 girls have been vaccinated against HPV. Over 205 million doses of the HPV vaccine Gardasil have been distributed worldwide, either as part of national immunisation programmes or by private doctors.
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The EMA granted market authorisation for Gardasil on 20 September 2006. I am not privy to interactions between vaccine manufacturers and the EMA so cannot answer the Deputy's question in that regard.
The Food and Drug Administration (FDA) is a federal agency of the Government of the United States of America and has no role in the approval of vaccines for use in the EU.
