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Introducing HPV Vaccine

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Susan Wang- Challenges and Opportunıtıes for HPV Vaccine

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Introducing HPV Vaccine

  1. 1. Introducing HPV Vaccine Susan Wang, MD, MPH Department of Immunization, Vaccines & Biologicals World Health Organization, Geneva 18 May 2011Working Meeting on Comprehensive Cervical Cancer Prevention and Control in UNFPA EECARO and ASRO Countries, Antalya
  2. 2. Cervical Cancer Worldwide in 2008 Most frequent cancers for men and women  2nd most common cancer in women and 5th most common cancer overall  An estimated 529,000 new cases and 274,000 deaths in 2008 Available at http://globocan.iarc.fr/ ASR = age-standardized rate2| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  3. 3. Opportunities for Cervical Cancer Prevention and Control New vaccines – Offer a completely new strategy for prevention New assays and new algorithms for improved cervical cancer screening – May permit identification of precancerous and cancerous lesions with greater accuracy, less complexity, and fewer barriers to access New technology offers new possibilities for wide-spread access to effective prevention, i.e., ability to reduce inequity New advocates, new interest, new energy3| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  4. 4. Challenges for Cervical Cancer Prevention and Control Identifying best affordable programmatic practices for a given country – Vaccine delivery – Screening algorithms – National cervical cancer prevention and control strategies Establishing monitoring and evaluation Organization – Need coordination between partners who are not used to working together: immunization, sexual and reproductive health, cancer control, child and adolescent health, school health, health systems strengthening Human resources – Shortage of trained health workers for vaccinating, screening, treating Financial resources – High costs of new technologies – New costs for new delivery system4| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  5. 5. WHO Western Pacific RegionConsultation on Comprehensive Prevention and Control of Cervical Cancer, November 2009 Organized by WHO WPRO with countries 1) Non-communicable Disease 2) Reproductive Health/Making Pregnancy Safer 3) Immunization Objective: – To develop roadmaps and priority actions for developing and strengthening cervical cancer control programmes in WPR countries at different levels of socioeconomic and health systems development 5| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  6. 6. WHO Western Pacific RegionConsultation on Comprehensive Prevention and Control of Cervical Cancer, November 2009 Available at http://www.wpro.who.int/internet/resources.ashx/RPH/cervical+cancer+meeting.pdf 6| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  7. 7. HPV vaccines and prevention of cervical cancer
  8. 8. Progress in HPV vaccine implementation in 2009-2011  In April 2009, first WHO position paper on HPV vaccines was published  Both the quadrivalent and bivalent vaccines are licensed in >100 countries  In May and July 2009, HPV vaccines were WHO pre-qualified  In May and November 2009, WHO held consultations on HPV vaccine coverage and impact monitoring; consensus principles were published in 2010  By May 2011, 32 countries in the world had introduced HPV vaccine in their national immunization programmes (31 national, 1 partial)8| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  9. 9. WHO Position Paper on HPV Vaccine WHO recommends that HPV vaccination should be introduced into national immunization programmes where: – prevention of cervical cancer and other HPV-related diseases is a public health priority – vaccine introduction is programmatically feasible and financially sustainable – cost-effectiveness aspects have been duly considered. Recommendation is to prioritize high coverage in primary target population of girls 9-10 through 13 years HPV vaccine introduction should not divert resources from effective cervical cancer screening programmes HPV vaccination should be introduced as part of a coordinated strategy to prevent cervical cancer and other HPV-related disease9| UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  10. 10. HPV Vaccines Two vaccines currently available, widely licensed, and WHO prequalified: – Cervarix® (bivalent): Prevents precancerous lesions from HPV types 16 and 18 – Gardasil®/Silgard® (quadrivalent): Prevents precancerous lesions and anogenital warts from four HPV types 6, 11, 16 and 18 Neither vaccine will treat women with current HPV infection Both work best in individuals HPV-naïve to the vaccine types; both require 3 doses administered over 6 months Up to 30% of all cervical cancer cases caused by HPV types other than 16 and 18, so these vaccines do not eliminate need for future cervical cancer screening Recent studies suggest partial cross-protection by Cervarix® against HPV types 31, 33, and 45 and partial cross-protection by Gardasil®/Silgard® against HPV type 31.10 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  11. 11. Review of HPV Vaccine Safety The Global Advisory Committee on Vaccine Safety (GACVS) was established by WHO to review vaccine safety issues of potential global importance independently of WHO GACVS has reviewed HPV vaccine safety on three occasions: – June 2007 (WER 2008;28/29:255-6) – December 2008 (WER 2009;5:39) – June 2009 (WER 2009;32:328-9) • by March 2009, >60 million vaccine doses administered in 21 countries • Accumulating evidence was reassuring • No signals except for syncope were causally related to vaccination • Potential for syncope added to 1 vaccine label with recommendation to observe for 15 min post- vaccination http://www.who.int/vaccine_safety/topics/hpv/en/index.html Useful to have good risk communication strategy in place prior to HPV vaccine introduction to address spurious media reports11 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  12. 12. Cervical Cancer Incidence Worldwide in 2008 Age-standardized incidence rates per 100,000 Available at http://globocan.iarc.fr/12 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  13. 13. Countries Using HPV in their National Immunization Schedule, 2011 (as of May 2011) The introduction status does not include countries that are reporting conducting demonstration projects Introduced (31 countries or 16%) The boundaries and names shown and the designations used on this mapSource: Countries Reported data through the Joint WHO and Partial introduction (1 country or 0.5%) do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country,UNICEF Reporting Form. Data as of May 2011.2011 data is territory, city or area or of its authorities, or concerning the delimitation ofprovisional its frontiers or boundaries. Dotted lines on maps represent approximate Not Introduced (161 countries or 83.5%) border lines for which there may not yet be full agreement.193 WHO Member States. Date of slide: 17 May 2011  WHO 2011. All rights reserved 13 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  14. 14. Summary table on number of countries which have introduced selected new and underutilized vaccinesVaccine 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 To Nov 2010Hepatitis B 107 121 137 148 154 159 165 169 171 177 177Hib 62 73 84 88 92 100 108 115 136 160 171Pneumococcal 0 1 2 2 3 5 13 21 33 44 58conjugateRotavirus 0 0 0 0 0 0 9 13 17 22 26HPV 0 0 0 0 0 0 2 8 19 27 3114 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  15. 15. Challenges with HPV vaccine introduction: common to any new vaccine introduction Need to fund costs of vaccine and delivery (i.e., transportation, cold chain, vaccine administration, injection equipment and disposal, safety monitoring, coverage monitoring, communication, human resources) Need to consider timeline and coordination with introduction of other new vaccines and other programme priorities Need to create a new vaccine introduction plan and incorporate plan into countrys comprehensive multiyear plan (cMYP) for the national immunization programme Need to view vaccine as part of an integrated disease control approach15 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  16. 16. WHO Vaccine Introduction Guidelines16 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  17. 17. Challenges with HPV vaccine introduction: unique to HPV vaccine introduction Target population is not one previously served routinely by immunization programs Challenges for vaccine delivery – High vaccine cost – New delivery platform needed so higher operational cost and more human resources required – Need 3 doses over the course of 6 months – Possible delivery options: health centre based, school-based, outreach in communities, campaign Delivery strategy should be: – Compatible with resources – Affordable – Cost-effective – Sustainable – Achieve highest possible coverage17 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  18. 18. Challenges with HPV vaccine introduction: unique to HPV vaccine introduction Possibility of integrating vaccine into package of adolescent health services New stakeholders and partners, not the traditional child health partners – Programmatic "home" or ownership not clear (immunization, cancer control, reproductive health, adolescent and/or school health); interdisciplinary coordination needed Challenges for monitoring safety, coverage, and impact18 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  19. 19. HPV Vaccine Coverage and Impact Monitoring Meeting : 16-17 Nov 2009Consensus on HPV Vaccine Coverage Monitoring For vaccine impact monitoring, HPV vaccine coverage monitoring by dose and age is necessary A useful indicator to compare vaccine coverage trends over time and across geographical areas will be the proportion of girls vaccinated with 3 doses of HPV vaccine by age 15 years For program improvement, HPV vaccine coverage by delivery strategy may be useful19 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  20. 20. Reporting of National HPV Vaccine Coverage for 2010 WHO-UNICEF Joint Reporting Form Age vaccine Number of 1st Number of 2nd Number of 3rd administered (years doses doses doses old, girls) <9 9 10 11 12 13 14 15+ Unknown age total 20 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  21. 21. Consensus on HPV vaccine coverage and impact monitoring - November 2009 meeting Initiating vaccine impact monitoring may be used as an opportunity to strengthen cervical cancer screening programs. HPV vaccine impact monitoring is complex and is not a precondition for HPV vaccine introduction – HPV prevalence monitoring in young women provides early indication of vaccine impact but requires considerable resource commitment for 5-10 years so only for limited sites – Establishing or improving reporting to cervical cancer registries is advisable for all countries to monitor impact of vaccine and cervical cancer screening programs Article on meeting highlights in 18 June 2010 Weekly Epidemiological Record, available at http://www.who.int/wer/2010/wer8525.pdf Complete meeting report available at http://whqlibdoc.who.int/hq/2010/WHO_IVB_10.05_eng.pdf 21 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  22. 22. WHO-UNICEF Vaccine Donation Policy
  23. 23. WHO-UNICEF Joint Statement on Vaccine Donations, 2010: 5 Minimum Requirements Suitable: Donated vaccines should be epidemiologically and programmatically appropriate for the recipient country. Sustainable: Prior to donation of a vaccine that is new to a recipient country, efforts should be undertaken to assure sustainable use of vaccine after donation (including negotiation of price). Informed: Responsible officials of the national immunization programme in the recipient country should be informed of all donations being considered, prepared, or actually under way, and vaccine shipped only on their confirmation. Supply: All donated vaccine should have at least 12 months shelf life remaining or shelf life sufficient to fulfill intended purpose of donation (for epidemic or emergency campaigns). Injectable vaccines should be provided with auto-disable syringes and safety boxes for safe disposal. Licensed: Vaccine subject to licensing or other control procedures in recipient country and licensed for the intended use by NRA of donor country.23 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  24. 24. WHO-UNICEF Joint Statement on Vaccine Donations, 2010 Country responsibility: All countries should have – A published process for registration of vaccines for use within the country – Surveillance of vaccine field performance (i.e., monitoring for adverse events following immunization or AEFIs) – Expertise to analyze documents on vaccine shipping and storage conditions in transit – Capacity to properly store vaccines until they are administered – Immunization plan to detail how vaccines will be used24 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011
  25. 25. WHO tools for cervical cancer prevention and control http://www.who.int/nuvi/hpv/resources/en/index.html http://www.who.int/reproductivehealth/topics/cancers/index.html25 | UNFPA Meeting on Prevention of Cervical Cancer, Antalya, 18 May 2011

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