National Immunisation Conference Dublin, 25 May 2018 HPV vaccine the global perspective Robb Butler Vaccine-preventable Diseases and Immunization WHO Regional Office for Europe
Presentation outline Burden of HPV related diseases WHO position on HPV vaccines HPV vaccines safety Introduction of HPV vaccine globally and in WHO European Region Early impact of HPV vaccines
Source: International Agency for Research on Cancer, Globocan 2012
Estimated cervical cancer incidence and mortality worldwide, 2012 Estimated age standardized rates per 100,000 Source: Globocan, 2012
Estimated cervical cancer incidence and mortality, WHO European Region, 2012 Source: Globocan, 2012
Human papillomavirus type distribution in invasive cervical cancer 2/4-valent vaccines direct protection 16 18 45 5.9 10.2 60.6 9-valent vaccines direct protection 2/4-valent vaccines crossprotection 33 31 3.8 3.7 52 2.8 58 2.3 0 20 40 60 80 % Serrano at al., 2015
WHO Position paper on HPV vaccine (WER May, 2017) (www.who.int/immunization/documents/positionpapers/en/) HPV vaccines should be included in national immunization programmes HPV vaccines should be introduced as part of a comprehensive strategy to prevent cervical cancer and other diseases caused by HPV Primary target group: girls aged 9 14 years, prior to becoming sexually active Secondary target group: females aged 15 years or males (if feasible, affordable, cost effective) Multiple age cohorts (9 18 years old) faster and greater population impact
To date GACVS has reviewed the following safety issues related to the HPV vaccine: Adverse events coinciding with pregnancy Aluminium adjuvant used in the 4vHPV vaccine Syncope and anaphylaxis Venous thromboembolism and stroke ; Autoimmune conditions (MS and Guillain Barre) and cerebral vasculitis Complex regional pain (CRPS) and / or other conditions of chronic pain syndrome. Postural orthostatic tachycardia syndrome (POTS)
WHO Global Advisory Committee on Vaccine Safety Statement, June 2017 Over 270 million doses of HPV vaccine distributed since 2006 Safety studies include million persons Wide range of outcomes was compared in vaccinated an unvaccinated subjects http://www.who.int/vaccine_safety/committee/topics/hpv/june_2017/en/
WHO Global Advisory Committee on Vaccine Safety Statement, June 2017 (Cont d) Risk of anaphylaxis was characterized as 1.7 cases per million doses Syncope was established as a common stress-related reaction to injection No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe However, attention continued to focus on spurious case reports and unsubstantiated allegations which have negative impact on coverage will result in real harm
Countries with HPV vaccine in the national immunization 0 1,200 2,400 4,800 Kil programme, May 2018 * Includes partial introduction Data source: WHO/IVB Database, Map production Immunization Vaccines and Biologicals (IVB), World Health Organization Introduced* to date (79 countries or 40.7%) Not Available, Not Introduced/No Plans (115 countries or 59.3%) The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO 2018. All rights reserved.
Introduction of HPV vaccine in WHO European Region, 2017 Russian Federation implement HPV vaccination in some regions Source: WHO/UNICEF JRF
Elements of successful introductions Transparent and inclusive decision making process Political commitment Effective communication tailored to the needs of target audiences Education and training of medical workers Setting up coverage targets and monitoring coverage rates Building resilience of immunization programmes, including capacity to timely and effectively respond to vaccine safety concerns, rumours, and anti-hpv lobbies / campaigns
The vaccines are very effective: in the real world Proportion of Australian born women diagnosed as having genital warts at first visit Against Genital Warts See also Bauer et al Am J Pub Health 2012 Leval et al JID 2012 Smith et al JID 2014 Baandrup et al STD 2013 Chow et al STI 2014 Howell-Jones et al JID 2013 Drolet et al Lancet Infect Dis, 2015 Females <21 years 92.6% decline post vaccination Females 21 30 yrs 72.6% decline post vaccination Ali et al BMJ 2013
Trends in rates of histologically-confirmed high-grade cervical abnormalities by age, Victoria, Australia, 2000-2014
Percentage of women positive for any HPV HPV prevalence pre and post vaccination, Scotland Kavanagh K, Pollock KG, Cuschieri K, Palmer T, Cameron RL, Bhatia R, Moore C, Cubie H, Cruickshank M, Robertson C. Lancet Infect Dis. 2017 Sep 28. pii: S1473 3099(17)30468 1
Percentage of 20-year old women diagnosed with CIN 2/CIN3+ by birth cohort year (1.0) (4.2) (35.6) (65.2) (69.3) (70.1) (86.5) (Vaccine uptake 3 doses) Slide: M. Cruickshank, Conference on HPV vaccine, MDA, 2018
Comprehensive approach to cervical cancer prevention and control INTEGRATION INTEGRATION