MORE THAN 60 adverse reactions to the cervical cancer vaccine used in the State’s national immunisation programme have been reported so far to the Irish Medicines Board (IMB).
To date about 45,000 doses of the HPV vaccine have been given to school girls as part of the national immunisation programme which began in May and almost all of the adverse reactions have been reported among 12-14 year old girls, the age group being targeted in the programme.
Interestingly a small number of adverse reactions have also been reported in older women – women in their 20s and 40s – who are choosing to get the vaccine themselves. It is only licensed for those up to the age of 26 years.
Dr Joan Gilvarry, director of human medicines with the IMB, said the majority of the 64 adverse reactions reported were expected ones such as injection site reactions, headache, dizziness, fatigue, fainting, panic attacks and allergic-type reactions.
She said there had also been two report of seizures, one in a patient with a history of epilepsy. These were not among the possible reactions listed on the product information leaflet but in both cases the children recovered, as did all others who suffered adverse reactions.
“We are not at all concerned by what we’ve seen. It’s exactly as expected on worldwide data. The balance of risks and benefits for the vaccine remains positive.”
She does not regard the number of adverse reactions which have been reported in connection with the use of the Gardasil vaccine as high given the numbers vaccinated so far and the fact that healthcare professionals were asked to report all adverse reactions they came across.
Asked about the adverse reactions in older women, Dr Gilvarry said: “Well it’s only licensed up to the age of 26 but some people choose to get the vaccine and their doctors are happy to give it to them”.
This is described as “off label” use, which had also been seen in other countries too.
“That is every doctor’s prerogative . . . if they think it’s in the best interests of their patients to do that they are quite entitled to do that,” she said.
The HPV vaccine, most effective when given before girls become sexually active, guards against 70 per cent of cervical cancer strains and is given in three doses.
About 250 women in the State get cervical cancer each year, and 80 women die from it.
The HPV vaccination programme, in conjunction with smear testing, is expected to reduce that death toll in the coming years.