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'No evidence' of HPV vaccine link to chronic fatigue syndrome

Number of spontaneous reports of chronic fatigue post vaccination is consistent with background rates

Mark Gould

Friday, 27 September 2013

Government drug safety watchdogs say they have 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 Medicines and Healthcare products Regulatory Agency (MHRA) instigated a study after reports that some women were suffering from chronic fatigue syndrome following vaccination.

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.

MHRA scientists 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.

Near-real time "observed vs. expected" analyses were conducted comparing the number of reports of fatigue syndromes submitted via the Yellow Card scheme to the expected number, using background rates calculated from the Clinical Practice Research Datalink (CPRD) and estimates of vaccination coverage. Subsequently, an ecological analysis and a self-controlled case series (SCCS), both using CPRD, compared the incidence rate of fatigue syndromes in girls before and after the start of the vaccination campaign and the risk in the year post-vaccination compared to other periods.

The number of spontaneous reports of chronic fatigue following Cervarix vaccination was consistent with estimated background rates even assuming low reporting. Ecological analyses suggested that there had been no change in the incidence of fatigue syndromes in girls aged 12–20 years after the introduction of the vaccination, despite high uptake. The SCCS, including 187 girls, also showed no evidence of an increased risk of fatigue syndromes in the year post first vaccination (IRR: 1.07, 95% CI: 0.57–2.00, p = 0.84).

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.”

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