Doubts voiced in US dismissed and branded ‘irresponsible’
Schoolgirls’ cervical jab scheme under fire
Published:
The promoters of a cervical cancer vaccination issued to thousands of girls across the country last night defended the programme after it was branded an “experiment” by a leading researcher.
The Scottish Government backed manufacturer GlaxoSmithKline in insisting the three-dose Cervarix vaccination had undergone “rigorous testing” before being administered. MSPs and health bosses at NHS Grampian also backed the medicine.
The comments came after one of the world's leading researchers, Dr Diane Harper, said there was still uncertainty over its side-effects.
In September the government launched a high-profile human papilloma virus (HPV) vaccination programme in schools to protect against two strains which cause 70% of cervical cancer.
The disease affects 300 women in Scotland each year and is responsible for 100 deaths. Around 10% of cases would be in the north-east, where more than 8,100 girls are being offered the jab.
Cervarix was approved by the European Medicines Agency in 2007. At £240, it is the dearest vaccine to be routinely offered by the NHS.
Dr Harper, director of the Gynaecologic Cancer Prevention Research Group at Dartmouth Medical School, New Hampshire, in the US, has now questioned its safety.
She helped Glaxo conduct safety trials but believes more should have been done before it was implemented.
She said: “We can't tell you it is 100% safe because we don't know that. In five years it will be pretty clear how safe it really is because 70% of adverse events occur within five years. That way we would have a good sense of comfort and you can reassure your population.”
She said there was “a lot of room for discussion” with regard to offering the vaccination on a voluntary basis.
Last night a spokesman for the manufacturers said the vaccine had only been issued after stringent testing. He said: “As with all medicines, to have been granted a licence Cervarix had to undergo rigorous testing with large numbers of people in numerous clinical studies. Over 70,000 doses of GSK's HPV vaccine have been administered in clinical studies, and girls and women who have received the vaccine have been monitored for more than six years. In clinical studies, Cervarix was found to be generally well tolerated.”
More than 300 cases of suspected negative reactions among girls receiving Cervarix have been reported to the Medicines and Healthcare Products Regulatory Agency.
A Scottish Government spokeswoman said: “We are satisfied that this vaccine is safe to use. The vaccine underwent a full evaluation of safety, quality and efficacy in order to be licensed in the UK and across the European Union.”
She said the vaccination would benefit 180,000 girls across the country in the first two years.
Dr Lesley Wilkie, director of public health at NHS Grampian, said feedback had been positive so far.
Worry
“There’s been a good response. In some schools we’re getting a 100% uptake,” she said.
“Generally, we’ve been getting good feedback from parents who view it as something that can prevent their daughter from something that’s not a nice disease.”
Tory health spokeswoman Mary Scanlon MSP said: “The first point is that this vaccination will undoubtedly save thousands of lives. Previous generations have worried about cervical, breast and other cancers so I think it’s worth welcoming this new vaccination.
“The second point is that this doctor had every opportunity to make her views known prior to the mass vaccination of girls in Scotland. By introducing uncertainties at this time, it’s an additional worry for parents and children that is unnecessary.”
However, Mrs Scanlon suggested vaccinating in schools may not be the best option.
“I’m very supportive of it but I think there are problems when it’s given in schools rather than in GP surgeries because GPs are aware of the family history and the child’s medical history. That information is not available at the time it’s implemented in schools,” she said.
North-east Labour MSP Richard Baker said: “There’s been agreement across all the parties that this is a sensible thing to do and it’s certainly not been rushed into.”
A Department of Health spokesman said it would be “irresponsible to raise inappropriate fears” over HPV vaccine safety without scientific evidence.
Readers' Comments