The Polio eradication global targets and goals:
The Endgame Strategic Plan
Vaccinology 2013
1st International Symposium for Asia Pacific Experts
Bangkok, Thailand
November 11-14th, 2013
Dr J Prasad
MS.M.Ch. FIACS
Director General of Health Services
Ministry of Health and Family Welfare
Government of India
Topics
• Polio eradication status
• Rationale and benefits
• Challenges and risks
Wild Poliovirus1, Previous 12 Months*
Onset of most Number of Virus Type
recent case
districts
W1
W3
Ethiopia
19-Sep-13
1
6
Kenya
14-Jul-13
3
14
Niger
15-Nov-12
1
1
Nigeria
10-Sep-13
41
68
1
AFR Total
19-Sep-13
46
89
1
Afghanistan
15-Sep-13
13
17
Pakistan
26-Sep-13
19
54
Somalia
14-Sep-13
45
174
South Sudan
24-Aug-13
2
3
EMR Total
26-Sep-13
79
248
Total
26-Sep-13
125
337
1
Country
Wild virus type 1
Wild virus type 3
Endemic country
Country with WPV case in previous 6 months
Country with WPV case 6-12 months ago
Three endemic countries:
Nigeria, Afghanistan & Pakistan
*16 October 2012 - 15 October 2013
1Excludes
vaccine derived polioviruses and viruses detected from environmental surveillance.
Data in WHO HQ as of 15 October 2013
Total
WPV
6
14
1
69
90
17
54
174
3
248
338
Wild Poliovirus1, Previous 6 Months*
Onset of most Number of Virus Type
recent case
districts
W1
W3
Ethiopia
19-Sep-13
1
6
Kenya
14-Jul-13
3
14
Nigeria
10-Sep-13
17
28
AFR Total
19-Sep-13
21
48
Afghanistan
15-Sep-13
3
5
Pakistan
26-Sep-13
9
37
Somalia
14-Sep-13
45
174
South Sudan
24-Aug-13
2
3
EMR Total
26-Sep-13
59
219
Total
26-Sep-13
80
267
0
Country
Wild virus type 1
Endemic country
Country with WPV case in previous 6 months
*16 April – 15 October 2013
1Excludes
Reduction of cases in endemic countries
but importations in the horn of Africa &
other polio-free areas
vaccine derived polioviruses and viruses detected from environmental surveillance.
Data in WHO HQ as of 15 October 2013
Total
WPV
6
14
28
48
5
37
174
3
219
267
Polio, type 3 cases
1250
Nigeria & Pakistan
had type 3 in 2012
(no cases in 2013)
Cases
1000
750
500
250
0
2007
* At 5 March 2013
2008
2009
2010
2011
2012
Recent Vaccine virus outbreaks
>90% of cVDPV
polio cases are
due to type 2
All recent cVDPV outbreaks are due to Type 2 virus
250-500 VAPP cases/year
(40% due to Sabin type 2)
“Today, we reaffirm our agencies’ unflagging commitment to support governments and national
authorities to implement the GPEI’s Polio Eradication and Endgame Strategic Plan 2013-2018,
and to realize the health benefits polio eradication will bring worldwide.”
RATIONALE AND BENEFITS
Why is this endgame strategy needed?
• Address proactively Sabin type 2 burden of paralytic disease
(2012 marks the first year with more paralytic cases due to the vaccine).
• Regardless of fate of eradication initiative, since wild type 2
poliovirus was eradicated in 1999, we can lock in the type 2 gains
forever.
• Accelerate eradication and boost types 1 and 3 immunity with
bOPV & IPV.
• Dry run of all Sabin cessation (at a time when stakes are lower).
Objectives of Polio Endgame Strategic Plan
• Poliovirus detection and interruption
• Strengthening immunization and OPV withdrawal
• Containment and certification
• Legacy planning
Endgame
Major
Objectives
Virus detection &
interruption
Last wild polio case
2013
2014
2015
Wild virus
Interruption
RI strengthening & OPV
withdrawal
RI strengthening &
OPV2 pre-requisites
Containment &
certification
Finalize long-term
containment plans
Legacy Planning
Consultation &
strategic plan
Last OPV2 use
OPV
2016
Certification
2017
2018
Outbreak response(esp.
cVDPVs)
cVDPV)
Introduce
IPV
IPV
WithdrawalOPV2
OPV2
Complete containment
& certification globally
Initiate implementation of
legacy plan
12
Type 2 OPV-Related Problems are Becoming
Greater Than Type 2 OPV Benefits
• Type 2 WPV has been eradicated in 1999
• Type 2 OPV causes problems
– Lowers immunogenicity of types 1 and 3 OPV
– Causes circulating vaccine derived polio (cVDPV2) outbreaks
• These outbreaks paralyze children
• These outbreaks are expensive to fight
– Causes 40% of vaccine associated paralytic polio (VAPP)
Protection from Type 2 Polio is Still Needed
• Protection needed from emerging type-2 cVDPVs
• Thus, protection for type will be needed when type 2
sabin in tOPV evolves to become paralyzing and
circulating VDPVs
• Currently, protection for type-2 comes from either
tOPV or IPV
The Polio Endgame Strategy Proposed to Remove Type 2 OPV in
April 2016
• Trivalent OPV  Bivalent OPV (types 1 and 3)
• Change removes problems caused by type-2 Sabin virus in tOPV
– Eliminates the risk of new cVDPV2
– Eliminates VAPP caused by type-2 component of tOPV
• However, type 2 polio protection is still needed
– Even when there are no more cVDPV2 outbreaks, there will be a need for
protection from undetected cVDPV2 and its potential importations
• IPV alone will provide type 2 polio protection
– IPV introduction needs to be at least 6 months before switch to bOPV
– IPV is therefore essential in the Polio Endgame Strategy
Pre-requisites and Timelines for OPV2 Removal
•
GCC ‘conclusion’ of WPV2 eradication
•
Interruption of persistent cVDPV2s
•
Proven capacity to stop new cVDPV2s
•
Availability of affordable IPV options
•
Stockpile of mOPV2
•
Surveillance and Response capacity
•
Phase 2 containment of WPV2
SAGE Recommendation: At Least 1 Dose of IPV
in Routine Schedule
• SAGE recommendation made November 2012
– Included in Polio Endgame Strategy
– Endorsed by World Health Assembly in May 2013
• Purpose is to provide type 2 polio protection
– IPV contains inactivated polio type 2 vaccine
– Therefore, fills type 2 immunity gap resulting from tOPV  bOPV
switch
• Introduction of IPV must be done no later than October 2015
– Introduction of IPV can be done before October 2015
– Many countries already use IPV
WHO Member States
194
IPV only using
Countries
50
IPV only
Using Countries
50
Andorra
Australia
Austria
Bahamas
Belgium
Bosnia and
Herzegovina
Brunei
Darussalam
Bulgaria
Canada
Costa Rica
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Israel
Italy
Japan*
Latvia
Lithuania
Luxembourg
Malta
Mexico**
Monaco
Netherlands
New Zealand
Niue
Norway
Palau
Poland
Portugal
Republic of
Korea
Romania
San Marino
Slovakia
United Kingdom
of Great Britain
and Northern
Ireland
United States of
America
Uruguay**
Singapore
Slovenia
Spain
Sweden
Switzerland
Mostly OPV using Countries
125
Sequential
Schedules
19
Sequential
Schedules
19
Bahrain
Belarus
Brazil
Jordan
Kuwait
Lebanon
Malaysia
Marshall
Islands
Micronesia
Montenegro
Oman
Qatar
Russia
Saudi Arabia
Turkey
Ukraine
(Graduate)
United Arab
Emirates
South Africa
Syria
IPV in Policy
High Risk, Immunodeficient Populations
17
Stand-alone IPV
Licensed
8
Argentina
Columbia
Honduras
Indonesia*
Paraguay
Peru
Serbia
Trinidad and
Tobago
* IPV Demonstration
Project
Combo only
Licensed
4
El Salvador
Guyana
Jamaica
Panama
IPV Product Licensed
GAVI Eligible
29
No Products
Listed
5
Stand-alone
IPV Licensed
13
Combo only
Licensed
16
Belize
Barbados
Saint Kitts and
Nevis
Saint Lucia
Saint Vincent and
the Grenadines
Bangladesh
Benin
Burkina Faso
Cambodia
Cote d’Ivoire
Haiti
India
Kenya
Lao
Nigeria
Pakistan
Senegal
Vietnam
Cameroon
CAR
Chad
Ghana
Guinea
Madagascar
Mali
Mauritania
Myanmar
Nicaragua
Niger
Togo
Uganda
Tanzania
Uzbekistan
Yemen
IPV Product Licensed
Not GAVI Eligible
26
Stand-alone IPV
Licensed
16
Bolivia
Chile
China
Dominican
Republic
Ecuador
Egypt
Gabon
Georgia
Iran
Kazakhstan
Macedonia
Mauritius
Philippines
Venezuela
Sri Lanka
Thailand
Combo
only
Licensed
10
Albania
Armenia
Azerbaijan
Congo
Botswana
Guatemala
Morocco
Namibia
Moldova
Tunisia
No IPV License
GAVI Eligible
26
Polio
Priority
Countries
6
Afghanistan
DRC
Ethiopia
Somalia
South Sudan
Sudan
Other
20
Burundi
Comoros
Djibouti
Eritrea
Gambia
GuineaBissau
Kyrgyzstan
Lesotho
Liberia
Malawi
Mozambique
Papua New
Guinea
PR Korea
Rwanda
Sao Tome
Principe
Tajikistan
Sierra Leone
Solomon
Islands
Zambia
Zimbabwe
No IPV License
Not GAVI Eligible
22
GAVI
Graduates
6
Angola
Bhutan
Cuba
Kiribati
Mongolia
TimorLeste
Small Island
Nations
10
Antigua and
Barbuda
Cook Islands
Dominica
Grenada
Nauru
Samoa
Seychelles
Tonga
Tuvalu
Vanuatu
IPV License
Pending
5
Other
6
Cape Verde
Equatorial Guinea
Fiji
Libya
Swaziland
Turkmenistan
Stand-alone
3
Iraq
Maldives
Nepal
Combo
2
Algeria
Suriname
* Sabin IPV
** Still uses
OPV in
National
Campaigns
Evidence: 'prevent polio if exposed to a VDPV2 or WPV2‘
VAPP number
In 1992,
single-dose
IPV at 3 mos
before OPV
• Hungary: no VAPP reported after
2006,
introduction of 1 IPVIn
dose
IPV-only in
sequential schedule schedule
in 1992
• US: no VAPP reported in infants
who received at least 1 IPV dose in
IPV/OPV schedule
Year
Evidence: 'improve response to mOPV2 in an outbreak‘
IPV priming effect, Cuba, 2010
P2
P1
P3
100%
• Cuba: single IPV dose in naive 4-mo old infants
seroconverts 47%-63% against type 2
Percent seroconversion
80%
60%
•
40%
20%
Not immune
2nd dose
94%-98% of infants who didn't seroconvert
after single
Priming
IPV dose responded with priming response
PV 2
1st dose
(Resik et al. NEJM:2013)
0%
ID
IM
ID
IM
ID
IM
Evidence: 'reduce transmission of a re-introduced type 2‘
40
20
30
• Moradabad, India: single IPV dose
to months
6-11
infants and older children with history of
multiple OPV doses dramatically boosts
5-6 years
intestinal mucosal immunity
10
10-11 years
• Effect is larger than with a bOPV dose
0
P1 excretion after day 28 challenge (%)
Impact of IPV vs. bOPV booster, Moradabad, India, 2012
Day 31
Day 35
Day 42
Evidence: 'boost immunity to wild poliovirus 1 & 3‘
Impact of IPV vs. OPV booster after OPV3 in seronegative
individuals at 9 months of age, Côte d'Ivoire (Lancet, 1993)
100
100
90
81
80
• In previously67OPV-immunized children,
an IPV booster dose has greater impact
OPVin
Booster
than an OPV booster
closing immunity
IPV Booster
gap to all 3 serotypes
Percent
70
60
50
40
27
30
20
14
10
5
0
Type 1
Type 2
Type 3
Benefits of “at least 1 IPV dose prior to OPV2 cessation”
•
Prevent polio if exposed to a VDPV2 or WPV2
•
Improve response to mOPV2 in an outbreak
•
Reduce transmission of a reintroduced type 2
•
Boost immunity to WPV types 1 & 3
•
Boost mucosal immunity in OPV primed children
•
Reduce incidence of VAPP in OPV using countries
Supply of IPV and bOPV; parental preference
CHALLENGES AND RISKS
Critically Important Challenges (1)
• Licensing bOPV products in time to have a sufficient
and reliable stocks and supply of bOPV
• Securing timely supply of IPV to have a sufficient
supply of IPV
• Determining the best feasible transition plan
Critically Important Challenges (2)
• Assuring sufficient funding for the transition to IPV
and for long-term use of IPV
• Educating all stakeholders about the polio vaccine
changes
–
–
–
–
EPI professionals
Immunization providers
Pediatricians
Parents
Important Risks to Avoid: Decline in Coverage of
Polio Vaccines During Transition to IPV
• During and after polio endgame, it is critically important to
attain and sustain high population immunity against polio
• OPV will be needed in a combined OPV/IPV schedule
– Routine immunization and polio SIAs
• Maintaining parental confidence in OPV during transition is
important
• Parents who want only IPV for their child may refuse OPV
– Can lead to decline in population immunity unless IPV is available
Experience in U.S. and Japan
• United States
– Transition schedule was 1997 through 2000: IPV, IPV, OPV
– Following introduction of routine IPV, many parents preferred all IPV
– IPV demand was filled because supplies of IPV were not limited
• Japan
–
–
–
–
–
Switch from all-OPV to all-IPV was September 2011 with IPV standalone
Prior to switch, parents were informed that IPV will become routine
Many parents declined OPV, preferring to wait for IPV
Coverage declined to 76% prior to availability of IPV in Japan
IPV then successfully introduced
Strategies to Minimize Risk of Loss of Parental
Confidence in OPV
• Develop communication strategic plan to fully inform
parents and providers of transition
• Use early doses of IPV to evaluation operational issues
– Parental concerns and preferences
– Logistics of vaccine use
– Emerging safety signal for new vaccines, especially Sabin IPV
• Develop secure access to sufficient IPV supply with back-up
availability to meet additional demand for IPV
Additional Thoughts
• When to schedule the dose of IPV
– SAGE provided some guidance on this consideration
• Considerations of policy options include:
– Costs of vaccines and injections
– Benefits of cases of VAPP avoided
– Risks and risk mitigation strategies
• Long-term considerations could include transition to IPVcontaining combination vaccines
Conclusions
• Countries and Region has a huge, direct benefit from the
polio endgame strategic plan
• Switch to bOPV depends on achieving global prerequisites
• Introduction of IPV in one country does not depend on
any achievements outside of that country
• Maintaining high poliovirus vaccination coverage is
essential before, during, and after the transition to IPV
THANK YOU !