|Date:||26 September 2013|
|Subject:||Study finds no evidence that cervical cancer vaccine Cervarix causes chronic fatigue syndrome|
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The Medicines and Healthcare products Regulatory Agency (MHRA) today announced that it has found no evidence that Cervarix – the human papillomavirus (HPV) vaccine – may cause chronic fatigue syndrome.
Cervarix was given to over two million young women aged between 12 and 18 years as part of the Government’s HPV vaccination programme between September 2008 and September 2012. The MHRA’s scientists conducted their study after reports that some women were suffering from chronic fatigue syndrome following vaccination.
Scientists at the MHRA analysed patient record data from the Clinical Practice Research Datalink (CPRD) to compare the frequency of fatigue syndromes in young women before and after the start of the vaccination programme and the risk following vaccination compared to other time periods.
The study, published in the journal Vaccine, found no evidence of an increased risk of chronic fatigue syndrome in women after having the Cervarix vaccine. This conclusion supports earlier reporting trends from the MHRA’s Yellow Card surveillance system.
Dr Philip Bryan of the MHRA, who co-authored the study, said:
“We have one of the best HPV vaccination programmes in the world that protects women from cervical cancer.
“Our study found no evidence to implicate Cervarix vaccine in development of chronic fatigue syndrome, and we hope that our findings give further reassurance about the safety of the HPV vaccine.
“The MHRA is committed to protecting people’s health and our safety monitoring systems – the Yellow Card surveillance system and the Clinical Practice Research Datalink (CPRD) – are important tools in helping to monitor the safety of vaccines, medicines and medical devices.”
Robert Music, Chief Executive of Jo's Cervical Cancer Trust, said:
"Like all vaccines there are possible side effects to take into consideration and it’s important that those eligible and their guardians make themselves aware of these, but these research findings by the MHRA are very positive and we encourage all those who are eligible to take up the vaccine.
“Cervical cancer is a largely preventable disease thanks in part to the HPV vaccination which prevents 70% of cervical cancers. Indeed researchers have said that an 80% uptake year on year could see a two thirds reduction in cervical cancer incidence in women under 30 by 2025.”
Notes to Editor
- Please use link for published study in US journal Vaccine: Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK
- Cervarix, supplied by GlaxoSmithKline, was replaced by Gardasil, supplied by Sanofi Pasteur MSD, as the part of the HPV vaccination programme in September 2012 due to commercial reasons. See the Department of Health’s press release (Nov 2011) for details: HPV vaccine to change in September 2012
- The Clinical Practice Research Datalink (CPRD) is the new English NHS observational data and interventional research service, jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). CPRD services are designed to maximise the way anonymised NHS clinical data can be linked to enable many types of observational research and deliver research outputs that are beneficial to improving and safeguarding public health. CPRD website
- The Medicines and Healthcare Products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The Agency consists of three centres: the Clinical Practice Research Datalink (CPRD), the National Institute for Biological Standards and Control (NIBSC) and the MHRA.