Susan Wang- Challenges and Opportunıtıes for HPV Vaccine

1. Introducing
HPV Vaccine
Susan Wang, MD, MPH
Department of Immunization,
Vaccines & Biologicals
World Health Organization, Geneva
18 May 2011
Working Meeting on Comprehensive Cervical
Cancer Prevention and Control in UNFPA
EECARO and ASRO Countries, Antalya

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 rate
2| UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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 energy
3| UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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 system
4| UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

5. WHO Western Pacific Region
Consultation 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. WHO Western Pacific Region
Consultation 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. HPV vaccines and prevention
of cervical cancer

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. 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 disease
9| UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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. 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 reports
11 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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. 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 map
Source: 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 of
provisional 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. Summary table on number of countries which have
introduced selected new and underutilized vaccines
Vaccine 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 To
Nov
2010
Hepatitis B 107 121 137 148 154 159 165 169 171 177 177
Hib 62 73 84 88 92 100 108 115 136 160 171
Pneumococcal 0 1 2 2 3 5 13 21 33 44 58
conjugate
Rotavirus 0 0 0 0 0 0 9 13 17 22 26
HPV 0 0 0 0 0 0 2 8 19 27 31
14 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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 country's comprehensive multiyear plan (cMYP) for the
national immunization programme
 Need to view vaccine as part of an integrated disease control
approach
15 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

16. WHO Vaccine Introduction Guidelines
16 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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 coverage
17 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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 impact
18 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

19. HPV Vaccine Coverage and Impact Monitoring Meeting : 16-17 Nov 2009
Consensus 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 useful
19 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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. 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. WHO-UNICEF Vaccine
Donation Policy

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. 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 used
24 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011

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.html
25 | UNFPA Meeting on Prevention of Cervical Cancer,
Antalya, 18 May 2011