Tuesday, 26 November 2019

Ceisteanna (60)

Michael Healy-Rae


60. Deputy Michael Healy-Rae asked the Minister for Health his views on the safety of the HPV vaccine (details supplied); and if he will make a statement on the matter. [48571/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As Minister for Health I have no responsibility for vaccine trials.

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. All HPV vaccines available in the EU are authorised by the European Medicines Agency (EMA).

The HPRA has advised that the specific HPV vaccine trial has not been identified in this query. This response is therefore only made in relation to the HPV vaccine that been chosen by the HSE for use in current HPV schools immunisation programme, which is Gardasil 9. The EMA website provides information on the authorisation of Gardasil 9 including information for the public and product information for healthcare professionals.

The safety of HPV vaccines have been studied for over 13 years. Over 1 million people have been studied during clinical trials since the vaccine was licensed in 2006. No country has raised concerns about the safety of the HPV vaccine. There is no scientific evidence in Ireland or in any other country that the HPV vaccine causes any long-term medical condition.

All international bodies have continually reported that the vaccines used in Ireland have no long-term side effects. Most people have no problems after the vaccine. The HPV vaccine has many of the same, mild side effects as other vaccines. Some people have an area of soreness, swelling and redness in their arm where the injection was given. This is nothing to worry about as this usually passes after a day or two. Some people may get a headache, feel sick in their tummy or have a slight temperature. If this happens, paracetamol or ibuprofen will help. Occasionally, some people may feel unwell and faint after getting their injection. To prevent this, they should sit down and rest for 15 minutes after the vaccination. Severe allergic reactions to vaccines are very rare. School vaccination teams are trained to treat any severe allergic reaction. If you are worried, you should talk to your GP or a member of the school vaccination team.

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.

The HPRA and the EMA continually monitor adverse events to vaccination. The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.