Minister says the HSE who have confirmed that as the Gardasil vaccine has been approved for use in the European Union by the European Medicines Agency there is no requirement for indemnity.

 

A Dáil question asked of the Minister of Health back in January 2017 which is very interesting.

Read his reply but we have highlighted 10 points of interest in his answer.

1. The Minister has been honest enough to admit that no medicine including vaccines is entirely without risk…..
2. The HPRA and the EMA in Europe continually monitor adverse events to vaccination…………that’s what is said…….
3.  The HSE provides information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether or not to give consent to vaccination.
4. The information booklets include information on the most common adverse events that can occur after each vaccination.
5. Seizures, muscle weakness, leg pain, joint pain and chronic fatigue are not mentioned as known side effects to Gardasil in the Patient Information Leaflet…..interesting ….
6. There are no known long term side effects to the vaccine Gardasil….so they say..
7. The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all adults as the average reading age in Ireland is 12 years of age……this is Dr Kevin Kellehers words not NALA as per reply to a letter to a public representative….
8.  He is aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. An illness that occurs around the time a vaccine is given and is already known to be common in adolescence does not imply the vaccine caused the problem. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses….so they say…..
9. It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter’s condition. It is important to reassure people that anyone who is suffering ill health is eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. The individual nature of the needs of some children may require access to specialist services. The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group…strange that it appears these girls first suffered symptoms around the time they received the hpv vaccine…….
10.  His Department has contacted the HSE who have confirmed that as the Gardasil vaccine has been approved for use in the European Union by the European Medicines Agency there is no requirement for indemnity…wow so is this saying that the manufacturer of the vaccine has not been indemnified by the state in the event of any related injuries or otherwise which may have been caused by the vaccine.

 

Minister for Health (Deputy Simon Harris):   I propose to take Questions Nos. 822, 921 and 953 together.

The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in a number of specialties including infectious diseases, paediatrics and public health. The committee’s recommendations are informed by public health advice and international best practice.

Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests. NIAC recommended that the human papillomavirus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

Gardasil is the HPV vaccine used in Ireland in the context of the HSE schools immunisation programme,. By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 620,000 doses of Gardasil have been administered and over 220,000 girls have been fully vaccinated against HPV since it was introduced in 2010.

No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level. In 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. 

The HSE provides information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether or not to give consent to vaccination. All vaccination information provided to parents is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics and Patient Information Leaflet. The information booklets include information on the most common adverse events that can occur after each vaccination. Seizures, muscle weakness, leg pain, joint pain and chronic fatigue are not mentioned as known side effects to Gardasil in the Patient Information Leaflet. There are no known long term side effects to the vaccine Gardasil. The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all adults as the average reading age in Ireland is 12 years of age. Parents are also given contact details for their local immunisation office and advised to speak to a member of the school immunisation team if they have any further questions.

Should parents require additional information about vaccines the immunisation leaflet refers to the HSE’s national immunisation website (www.immunisation.ie). The national immunisation website has been accredited by the World Health Organisation for credibility, content and good information practices. The website allows members of the public to contact the National Immunisation Office to ask a question if they require further information. These questions, when possible, are answered by the staff of the National Immunisation Office within one working day.

 I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. An illness that occurs around the time a vaccine is given and is already known to be common in adolescence does not imply the vaccine caused the problem. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses. It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter’s condition. It is important to reassure people that anyone who is suffering ill health is eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. The individual nature of the needs of some children may require access to specialist services. The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.

The benefits of HPV vaccines outweigh the known side effects. The safety of these vaccines, as with all medicines, will continue to be carefully monitored and will take into account any future new evidence of side effects that becomes available. I encourage the parents of all eligible girls to ensure that their daughters receive this important cancer preventing vaccine.

 My Department has contacted the HSE who have confirmed that as the Gardasil vaccine has been approved for use in the European Union by the European Medicines Agency there is no requirement for indemnity.

Finally my Department has carried out a search in the Minister’s Office and Constituency Office and found no record of the e-mail which Deputy Healy-Rae refers to. I would like to thank the Deputies Office for providing a copy of the correspondence to officials from my Department.