Safety probe into cervical cancer jab
Families win action over side-effects
HEALTH regulators yesterday announced an investigation into the safety of the cervical cancer vaccine amid mounting concerns over severe side-effects.
Every girl at secondary school is offered the human papilloma virus jab against the disease.
Many experts say the programme is essential as it is the most common cancer among the under-35s.
But the European Medicines Agency will now carry out an official review which will focus on possible links to two rare conditions.
These are complex regional pain syndrome – a chronic pain condition affecting the limbs – and postural orthostatic tachycardia syndrome (PoTS), which causes abnormal heart rate.
Campaigners have been calling for an investigation for years as dozens of families warn that their daughters’ health had been severely affected by the jab.
Previously healthy teenagers have suffered fits, extreme tiredness or even been left wheelchair-bound. Official fig-
‘Problems are underdiagnosed’
ures show the HPV vaccination programme has drawn 8,228 reports of suspected side-effects since being launched in 2008, almost as much as all other routine jabs put together.
More than a quarter were classed as serious, which includes symptoms severe enough to require hospital treatment or even be life-threatening. Doctors stress, however, that this represents a tiny proportion of the 8million doses given in the same period.
Yesterday the EMA said it remains confident ‘ the benefits of HPV vaccines outweigh their risks’, adding that the jab would remain in use during its review.
The regulator added: ‘Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring but a causal link between them and the vaccines was not established.
‘Both conditions can occur in non-vaccinated individuals and it is important to further review if the number of cases reported with HPV vaccine is greater than would be expected.’
Caron Ryalls, secretary of the Association of HPV Vaccine Injured Daughters, said: ‘They had to take action so it is not surprising but it is welcome.
‘My concern is these problems are underdiagnosed so if officials are looking for confirmed diagnoses, a lot might be missed.
‘I hope the review will listen to the families and not just the pharmaceutical companies.’
Helen Drake, 51, has campaigned for an inquiry since her daughter started suffering severe exhaustion after two doses of the HPV jab five years ago aged 12. She was diagnosed with PoTS symptoms last year, aged 17,
Mrs Drake said the review is ‘ brilliant news’, adding: ‘ Any medical intervention must come with overwhelming proof that the benefits outweigh the risks’.
Cervical cancer, which killed reality TV star Jade Goody in 2009 aged only 27, affects 3,000 women in Britain each year.
The HPV jab has routinely been given to 12 and 13-year-old girls since 2008. It is thought the vaccinations could save almost half of the 1,000 lives lost each year to the disease.
The jab prevents infection by the sexually transmitted human papilloma virus, which is behind most cases of the cancer.
The review comes after two recent studies highlighted the potential risks of the HPV jab.
Dr Sarah Branch, of the UK Medicines and Healthcare products Regulatory Agency, said nearly 90 per cent of eligible teenagers had been vaccinated.
She added: ‘With this very high level of uptake, such reports are to be expected. But the vaccine isn’t necessarily the cause.’
GlaxoSmithKline, which makes one vaccine Cervarix, said its safety has been ‘ rigorously tested’ and the firm is ‘confident in the benefit-risk profile’.