HPV vaccine does not cause syndromes, EU agency rules

European Medicines Agency says there is no reason to change the way the drug is used

Minister for Health Leo Varadkar. Mr Varadkar has said the HPV vaccine protected against two high-risk types that caused 73 per cent of all cervical cancers. Photograph: Alan Betson/The Irish Times

Minister for Health Leo Varadkar. Mr Varadkar has said the HPV vaccine protected against two high-risk types that caused 73 per cent of all cervical cancers. Photograph: Alan Betson/The Irish Times

 

The HPV vaccine given to teenage girls to protect against cervical cancer does not cause two syndromes linked to severe pain, fainting and migraines, Europe’s drug regulator has ruled.

There is, therefore, no reason to change the way the vaccine is used or to amend current product information, according to the European Medicines Agency.

The vaccine used in Ireland, known commercially as Gardasil, is opposed here by a parents’ support group Reaction and Effects of Gardasil Resulting in Extreme Trauma (Regret), whose members claim their teenage girls became ill after getting the vaccine.

One of its members is currently seeking a High Court order for the withdrawal of the licence given for Gardasil HPV, which is offered to the parents of 11- to 16-year-old girls as a possible cervical cancer preventative.

A risk-assessment committee of the agency made the finding following a detailed scientific review of the evidence about complex regional pain syndrome and postural orthostatic tachycardia syndrome in young women given the vaccine.

The review found no evidence that the overall rates of the two syndromes in vaccinated girls were different from expected rates, even taking into account possible under-reporting.

The committee’s decision has to be ratified by another committee, but its finding is unlikely to change.

Adverse reactions

In Ireland, the Health Products Regulatory Authority says it has received 921 reports of suspected adverse reactions to the vaccine and most are consistent with the expected pattern of effects, such as gastrointestinal symptoms, malaise, headache, dizziness and soreness or a rash at the injection site.

These are short-lived, it says.

In the Dáil this week, before the European Medicines Agency published the results of its review, Minister for Health Leo Varadkar said the vaccine protected against two high-risk types of HPV that caused 73 per cent of all cervical cancers and could save an estimated 60 lives annually in Ireland.

The safety profile of the vaccine had been continuously monitored since it was first authorised nationally, he said: “Healthcare professionals should therefore continue using them in accordance with the current product information.”