Gardasil, the vaccine manufactured by Sanofi-Pasteur, is offered to girls from the age of 12 to protect them against developing certain strains of cervical cancer.
Speculation about potential adverse reaction to the vaccine has grown internationally, and this week, the European Medicines Agency launched a review of the cervical cancer vaccine’s safety, while asserting that the review should not raise questions about whether the vaccine’s benefits in preventing cervical cancer outweigh their risks.
The agency also said there should be no change to national HPV vaccination recommendations.
Fianna Fáil has called for a review of suspected cases of serious side effects from the HPV vaccine, after Senator Darragh O’Brien raised concerns about reported cases of severe side effects from the vaccine.
“I have spoken to a number of parents whose daughters became seriously ill after receiving the vaccine. These were happy, active girls who now struggle to get out of bed due to severe dizziness, seizures, lethargy, headaches and joint pain. While the parents suspect that the illness may be linked to the vaccine, they want concrete answers about any possible links,” he said.
Diane Harper, who helped develop Gardasil for Merck has said that there is no data to substantiate that the benefits outweigh the risks.
“The truth is that we know very little about the side effects of the HPV vaccine,” said Dr Harper.
However, establishing a causal link between a vaccine and its possible side-effects can be difficult, according to consultant oncologist John Crown.
“The risk may be zero. We have no evidence that there is any risk. There is no proven evidence at this stage that there is any serious side effect that is clearly caused by this vaccine,” he said.
Cervical cancer can be lethal. It kills 80 to 100 women each year in Ireland.
However, fatalities have fallen in countries where female populations are routinely screened for pre-cancerous cell changes in the cervix. As cervical cancer develops slowly, health policy that involves regular screening, and treatment where necessary, has a high success rate.
The HPV vaccine was first authorised in the EU in 2006, and was introduced to the national immunisation programme in 2010.
“While no medicine (including vaccines) are entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level,” Health Minister Leo Varadkar wrote in response to a letter sent by Mr O’Brien which raised concerns about the vaccine.
Despite no proven link between the vaccine and the symptoms people are reporting, parents in Spain are suing for damages that they believe were caused by the vaccine, and a judge in France has awarded damages to a young girl, saying that her MS was partially caused by the Gardasil vaccine.
Abbey was a healthy, happy 13-year-old when she received her first dose of Gardasil, along with the Tdap vaccine in school on September 2014.
“She had an adverse reaction straight away. For over an hour, she was left lying on a mat on the floor while the rest of the girls were being vaccinated,” said her father Martin Colohan.
During this time she had seizure-like jerking, rolling eyes, blurred vision, headache, and nausea.
Abbey’s parents were called one hour and 20 minutes later. “When I arrived at the school and asked why an ambulance wasn’t called, I was told I was overreacting and this would wear off,” said Mr Colohan.
The next day, Abbey’s parents found her their home in Co Meath, having turned a red-blue colour, she was jerking uncontrollably and was unable to speak, with chest pain and swollen joints. Lorraine, Abbey’s mum, called the GP, but by the time Abbey was seen her symptoms had stopped.
She had a seizure the following day at school. She was transported to Drogheda hospital where she was kept for six days. As she was being discharged, Abbey had another bad seizure.
“It was like watching a horror movie where someone is possessed,” said Mrs Colohan. “Abbey was sitting on the bed, very flushed, when her mouth clamped shut, her eyes rolled back in her head and her body started jerking severely.
“It looked like something was strangling her. You could only see the whites of her eyes and her whole body was in spasm.”
The medical team ran tests but could not find anything “organically wrong”. The tests all indicated that Abbey was a perfectly healthy girl.
“A doctor told me that we would just have to get used to it. The seizures started immediately after the vaccine. If there had been a gap, of even a few days I don’t know if I’d have even connected it,” said Mrs Colohan.
Abbey missed 89 full days of first year, and has missed many additional half days. Her parents are fighting to get home tuition for her so that she has some chance of catching up with her year.
Abbey is now 14, she still gets blurred vision, dizziness, ‘spaced-out moments’, weak arms and legs, fatigue, jerking movements, and constant headaches.
“The headaches can become very severe anytime and really knock her for six, with pains in her face, and her eyes. Sometimes she has so many complaints that I can understand how the doctors are sceptical when everything shows up clear on various tests and scans.” said Mrs Colohan.“Abbey’s been through a lot. But she’s a tough, happy-go-lucky child, otherwise I doubt she’d have made it through all this.”
The symptoms started with a headache on May 10, 2011 — the day that she received her third shot of the Gardasil cervical cancer vaccine.
Roisin Heelan from Boherbue, Co Cork, was in second year, she was an A student, a competitive boxer, a GAA enthusiast, popular, sociable, and happy.
Constant, chronic headaches quickly became a fact of life. Sometimes they became so acute that she could not get out of bed, and they often lasted for 10 days consecutively.
That summer she experienced her second severe symptom of acute leg pain. Una Heelan found her daughter lying on the floor one afternoon screaming with pains in her legs.
Roisin, now 18, said headaches and back pain are her most constant and difficult symptoms, but the full list of symptoms that she has experienced since May 2011 takes up an entire A4 page.
Roisin started falling asleep in school, her school work deteriorated, and she had memory loss.
“Her neurological system and immune system were hugely affected,” said her mum Una.
“She couldn’t concentrate and she was always sick, picking up every bug. She had rarely ever been sick before. She had been a really healthy girl.
“Someone had to stay with her all the time because she’d get black outs, and she became so weak that she could fall anytime.”
Roisin also experienced breathing problems, a fast heartbeat, chest pain, panic attacks, constant chronic pain, epileptic-type seizures, dizziness and vomiting.
She’s now in pain and fatigued every day, sometimes she does not have the strength to write or open a bottle.
Her symptoms were so constant that she missed a year and a half of school, and she could not sit her Leaving Cert.
With tenacity and some home tuition she managed to complete the State exams this year, but she had to drop from six honours subjects and one pass, to four pass and three honours.
She was a candidate for over 500 points.
“My friends are still shocked, they couldn’t believe it because they got the vaccine too, but now other girls in my area are reporting similar symptoms to mine,” said Roisin, who did not receive any other vaccines in secondary school.
“Since May 2011 it’s been a downhill spiral.
“There are days that are very hard for her. We don’t know if down the line the pain or fatigue will go away completely,” said Una.
Roisin has applied for social work and dental nursing on her CAO, although she had planned to study psychology.
“We don’t know if she’ll be well enough to take a college place in September.
“Four years is a long time to be in pain, and Roisin doesn’t have the social life her friends do,” said Una.
“It’s hard going out, being in pain the whole time, I have to bring pain killing medication with me.
“Sometimes I have to go to south doc and get injections in my back because no medicine works,” said Roisin.