MHRA: Cervarix ‘in clear’
pharmafile | October 1, 2013 | News story | Sales and Marketing | GSK, Gardasil, MHRA, ceravix
Cervarix, a key drug in the UK government’s human papillomavirus (HPV) vaccination programme, has been cleared of any involvement in causing chronic fatigue syndrome.
Following an investigation, the Medicines and Healthcare products Regulatory Agency (MHRA) says it has found ‘no evidence’ that GlaxoSmithKline’s drug had this effect – a conclusion that the regulator’s ‘yellow card’ surveillance system had already pointed towards.
The Department of Health replaced Cervarix in the HPV vaccination programme with Sanofi and MSD’s Gardasil in September last year because it is cheaper.
But GSK’s brand was given to more than two million females aged from 12 to 18 years between September 2008 and September 2012, and there were reports that some women were suffering from chronic fatigue syndrome following vaccination.
The MHRA’s scientists looked at patient records from the Clinical Practice Research Datalink in a bid to crunch the data and their report was published in the journal Vaccine.
The investigation compared the frequency of fatigue syndromes before and after the start of the vaccination programme and the risk following vaccination compared to other times.
“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,” said the MHRA’s Dr Philip Bryan, who co-authored the study.
“We have one of the best HPV vaccination programmes in the world that protects women from cervical cancer,” he concluded.
Around 70% of cervical cancers are caused by HPV, which is sexually transmitted, and both Cervarix and Gardasil focus on stopping this virus and in turn, lowering the risk of cervical cancer.
But Gardasil gives a wider range of protection, preventing infection from four HPV strains as well as anogenital warts, whereas Cervarix only protects against two types of HPV strains and not against any form of genital warts.
The charity Jo’s Cervical Cancer Trust called the MHRA findings on Cervarix ‘very positive’ and urged people to become vaccinated.
Researchers have suggested that an 80% uptake year-on-year could see a two-thirds reduction in cervical cancer incidence in women under 30 by 2025.
Adam Hill
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