Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK

摘要: Abstract Introduction Over 70% of cervical cancers are related to human papillomavirus types 16 and 18. In 2008, the vaccine Cervarix, protecting against these two strains, was introduced into routine UK immunisation programme for girls aged 12–13 years, with a catch-up in up 18 years. As part risk management planning this new campaign, Medicines Healthcare products Regulatory Agency (MHRA) anticipated range conditions, including chronic fatigue syndrome, which might be reported as adverse events temporal association vaccine. Methods Near-real time ‘observed vs. expected’ analyses were conducted comparing number reports syndromes submitted via MHRA's Yellow Card passive surveillance scheme expected number, using background rates calculated from Clinical Practice Research Datalink (CPRD) estimates vaccination coverage. Subsequently, an ecological analysis self-controlled case series (SCCS), both CPRD, compared incidence rate before after start campaign year post-vaccination other periods. Results The spontaneous following Cervarix consistent estimated even assuming low reporting. Ecological suggested that there had been no change 12–20 years introduction despite high uptake (IRR: 0.94, 95% CI: 0.78–1.14). SCCS, 187 girls, also showed evidence increased post first 1.07, 0.57–2.00, p = 0.84). Discussion successful implementation enhanced pharmacovigilance plan provided immediate reassuring between syndromes. This has now further demonstrated more comprehensive epidemiological studies.