The Medicines and Healthcare products Regulatory Agency (MHRA) has found no evidence that Cervarix – an HPV vaccine which protects against cervical cancer- causes chronic fatigue syndrome, also known as ME.
The MHRA’s scientists conducted their study after reports that some women were suffering from chronic fatigue syndrome following vaccination.
Cervarix vaccine was given to over 2 million young women aged between 12 and 18 years as part of the Government’s human papillomavirus (HPV) vaccination programme. The jabs began in September 2008 and ended in September 2012 when the vaccine was replaced by Gardasil, which protects against both cervical cancer and genital warts.
Both vaccines are licensed in the UK. The NHS currently uses Gardasil to vaccinate girls aged 12 – 13 years old.
Scientists at the MHRA analysed patient records 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 jab. This supports earlier reporting trends from the MHRA’s own Yellow Card surveillance system which collects information from doctors, other healthcare professionals and patients regarding suspected adverse reactions.
Dr Philip Bryan of the MHRA, who co-authored the study, says in a press release: “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.”
Robert Music, Chief Executive of Jo’s Cervical Cancer Trust, says in a prepared statement: “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.”
The MHRA says the safety and efficacy of both Cervarix and Gardasil vaccines has been extensively studied in clinical trials before licensing. The most common side-effects are injection-site reactions, fever, headache, fatigue, muscle pain, nausea, vomiting and diarrhoea.
It says Cervarix and Gardasil have now been used in tens of millions of people and their safety is well established. However, as with all vaccines and medicines used in the UK the MHRA will continue to monitor their safety.
