Authors' objectives: To provide the best available evidence to inform World Health Organisation's (WHO's) guidance on human papillomavirus (HPV) vaccine safety.

Authors' results and conclusions: A large body of high-level evidence is very consistent in finding no difference in the rate of serious adverse events between people who have received either Cervarix or Gardasil HPV vaccine and people who received a placebo or a control vaccine. Good quality cohort studies of specific autoimmune and other serious adverse events also found no relationship between exposure to HPV vaccination and development of these outcomes. The major concern with the body of evidence collated is the lack of standard definition of what constitutes a serious adverse event. Most trials did not define the serious adverse event they collected, how they would collect them or whether the collection of data was blinded to treatment allocation. Whilst most trials commented that their serious adverse events were not related to vaccination, there is no way to know if the criteria used were the same across studies. The pooled values contained in the report should be considered estimates as they may have been affected by the likely different outcome definitions used. The comparison between vaccine and placebo or control vaccine in each analysis is, however, still valid.

Project Status: Completed

Year Published: 2017

URL for published report: https://cdn.who.int/media/docs/default-source/medicines/pharmacovigilance/hpv_vaccination_safety_report_ahta_dec17.pdf?sfvrsn=6311cf3e_11&download=true

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Adelaide Health Technology Assessment

Contact Address: School of Public Health, Mail Drop 545, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8313 4617

Contact Name: ahta@adelaide.edu.au

Contact Email: ahta@adelaide.edu.au

Copyright: Adelaide Health Technology Assessment (AHTA)