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SERTIFIKASI GLOBAL dan POLIO ENDGAME

ISMOEDIJANTO
POKJA AHLI SUVEILANS POLIO

Kilas balik (1)


WHA th 1988 : memutuskan /merekomendasikan GPEI
(Global Polio Eradication Initiative) dg target th 2000.
Dilakukan imunisasi serentak dg OPV dalam NID, di
Indonesia th 1995,1996,1997. negara yg tertinggal
menularkan ke negara yg sdh bebas.
Diragukan bisa eradikasi ok adanya VAPP dan VDPV, terakhir
adanya klb WPV di Suriah (dari Pakistan) dan WPV1
Palestina di limbah lingkungan .
Namun WHO tetap dg rencana semula dan per region akan
dibantu RCC untuk mempercepat bebas polio. Polio liar P2
dan P3 sdh hilang , upaya pada eradikasi P1 .

Kilas balik (2)


Imunisasi adalah alat untuk mengendalikan penyakit menular
dan bekerja dengan jalan:
Membuat bayi menjadi kebal (serokonversi)
Mempertahankan kekebalan dengan suntikan booster terus menerus
Membuat cakupan imunisasi tinggi sehingga terbentuk herd immunity
Herd immunity menahan dan menolak transmisi atau penularan
Herd immunity akan menyurut dan memicu timbul KLB
Cakupan imunisasi harus tetap tinggi, sehingga tidak ada immunization
gap dan akumulasi penduduk yang tidak kebal
Gap terjadi bila terbentuk sela populasi yg sensitif (cohort yang tidak
diimunisasi) dan tidak ada jendela waktu tanpa kekebalan ( dewasa
yang tidak diimunisasi tetapi tidak sakit ok waktu bayi herd immunity
tinggi) . Contoh Jawa Timur difteri pada dewasa.

Kilas balik (3)


Surveilans adalah alat untuk mengetahui adanya KLB:

Bertindak sebagai sensor adanya bahaya penyakit untuk masyarakat


Mengamati kejadian secara pasif dengan mencermati laporan
Peka terhadap laporan yang aneh, diluar kelaziman
Eradication march:

Endemisitas tinggi: tiap hari ada kasus dimana saja


Kasus menurun, KLB terjadi akibat akumulasi penduduk yang tidak kebal
KLB menjadi sering dengan kasus yang besar
KLB main jarang dengan jumal kasus yang menurun
Kasus menghilang dari tempat praktek, poliklinik, kasus terabaikan
Active surveillance

Active : mencari di RS dengan HRR atau pencarian mingguan atau


community dengan melibatkan lembaga sosial, dengan reporting sites
yang sangat banyak.

Kemajuan yang besar menuju eradikasi global


(AFRO serta EMRO) bebas polio
Penurunan > 99.9% semua kasus
Tinggal 3 negara endemic polio
poliovirus type 2 terakhir tahun 1999
Polio virus type 3 tidak dilaporkan sejak 2014
Tinggal 2 WHO Regions yang belum sertifikasi bebas
Polio virus type 1 sudah mencapai titik rendah

Eradikasi Virus Polio liar, 1988-2012


400

Polio300
cases (thousands)

200

2012
100

Kasus Polio tipe


2 di dunia

Kasus Polio
terakhir di India

0
1985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012

South East Asia Regional Office


(SEARO)
road to polio free region certification
1.
2.
3.
4.
5.
6.
7.
8.
9.

Bangladesh
Bhutan
DPR korea
India
indonesia
Myanmar
Nepal
Thailand
Timor Leste

Recent
Developments

Rukshar Khatoon
West Bengal, India
January 2011

Setelah berupaya sejak tahun 1995, 19 tahun kemudian


27 maret 2014 SEARO bebas kasus polio

WHY

HARUS MELAKUKAN PIN


MENGGANTI Topv dengan Bopv
MENGGUNAKAN IPV

namun kita mempunyai tugas .


The NCCPE of all countries should advocate with the national
government on the following;
To prepare annual updates of their national
documentation for polio eradication and submit to the
NCCPE for review.
Continue doing risk assessment, risk registry and risk
mitigation activities.
Conduct simulation exercise of the national plan for polio
outbreak preparedness and response.
Maintain a buffer stock of OPV so that the minimum
qualities of vaccines are available at country level in an
emergency response at earliest.

usulan untuk Indonesia maret 2014 (1)


Indonesia
There were clear evidences of two main gaps:
1) reduced routine immunization coverage
2) gaps in AFP surveillance.
The commission is concerned about the declining trend of the
programme performance in a populous country. Though there
is no wild poliovirus has been reported after the outbreak was
stopped in 2006, but the accumulation of susceptible
population due to low immunization coverage keeping the
country at a high risk of polio importation and outbreak.
The RCCPE supports the statement by the NCCPE that the
there is no evidence of wild poliovirus circulation in the country
during the past three years.

usulan untuk Indonesia Maret 2014 (2)


The RCCPE recommends that
The NCCPE should advocate with the national government
for their attention and take urgent action to improve
programme quality and population immunity everywhere
in the country through strengthening routine
immunization, supplementary immunization and high
quality AFP surveillance.
The NCCPE should advocate with national government to
facilitate cross border collaboration with neighboring countries
as a risk mitigation activity.

Setelah sertifikasi

Cakupan polio yg rendah


Gap imunisasi yg tetap tinggi
Peningkatan cakupan imunisasi rutin gagal
Kinerja surveilans yg cenderung turun
Selesai nya demonstrasi suntikan IPV Jogya

Solusi sebelum ke IPV..

PIN

Non-polio AFP Rate*


SEAR, 20112015
13.49

13.94 12.50

12.38
7.84

6.12

and above

SEAR Minimum Target

* Number of discarded AFP cases per 100,000 children under 15 years of age

16

Data as of 10 Aug 2015

Percent Adequate Stool Specimen Collection*


SEAR, 2011-2015

Percent

Minimum Target

*Percentage with 2 specimens 24 hours apart and within 14 days of paralysis onset.

17

Data as of 10 Aug 2015

immunization gap Indonesia


Data as of 09 Sep 2013

N=44

N=170

N=78

N=43

N=170

N=100

N=194

N=103

N=303

N=277

N=281

N=258

N=17434

N=33691

N=35175

N=33081

N=30908

N=535

N=862

N=909

N=847

N=881

N=98

N=164

N=137

N=931

N=491

N=987

N=762

N=800

Percent of Non-Polio AFP Cases Under Immunized for OPV


(6 Months to 5 Yrs), SEAR, 2009-2013

19
Data as of 10 Aug 2015

N=103

N=97

N=236

N=291

N=303

N=277

N=11491

N=28749

N=30571

N=33691

N=35175

N=472

N=838

N=794

N=862

N=909

N=80

N=76

N=100

N=170

N=253

N=158

N=145

N=164

N=898

N=964

N=44

N=987

N=931

N=35

Percent of Non-Polio AFP Cases Under Immunized for OPV


(6 Months to 5 Yrs), SEAR, 2011-2015

Risk analysis for SEAR countries for transmission following WPV


importation into polio-free areas, 2012

Low Risk
Medium Risk
High Risk

Sub-national risk analysis for SEAR countries for transmission


following WPV importation into polio-free areas, 2012

Low Risk
Medium Risk
High Risk

Data as of 31 Dec 2012

SEARO and WPRO: Sub-national Polio Risk


Assessment: 2012

Low
risk
Medium risk
High risk

Cross-border
meeting China,
Myanmar, Laos,
Thailand, Viet Nam
planned 2013
(WPRO, SEARO)

Surveillance Indicators by Province


Indonesia, 2015
Non-polio AFP Rate*
Non-Polio AFP Rate
<1
1 1.99
>2
No Non-Polio AFP Case

Percent Adequate Stool Specimen Collection **

Total AFP Cases = 618


Non-Polio AFP Rate = 1.33
Adequate Stool specimen = 94%
Provinces reporting AFP cases= 30 (85%)

Adequate Stool
Specimen Collection
< 60%
60% 79%
> 80%
No AFP Case

* Number of discarded AFP cases per 100,000 children under 15 years of age (annualized by week 32, 2015)
** Percentage with 2 specimens 24 hours apart and within 14 days of paralysis onset.
Note: Some AFP cases may still be pending final classification.

Data as of 10 Aug 2015

23

Surveillance Indicators by Province


Indonesia, 2014
Non-polio AFP Rate*
Non-Polio AFP Rate
<1
1 1.99
>2
No Non-Polio AFP Case

Percent Adequate Stool Specimen Collection **

Total AFP Cases = 1765


Non-Polio AFP Rate = 2.43
Adequate Stool specimen = 89%
Provinces reporting AFP cases= 34 (100%)

Adequate Stool
Specimen Collection
< 60%
60% 79%
> 80%
No AFP Case

* Number of discarded AFP cases per 100,000 children under 15 years of age
** Percentage with 2 specimens 24 hours apart and within 14 days of paralysis onset.
Note: Some AFP cases may still be pending final classification.

24
Data as of 10 Aug 2015

polio end game:


mengapa bOPV dan IPV ?

cVDPV Cases1, Previous 6 Months2

Capaian dan kendala secara umum


Telah ada 4 region yg bebas polio: PAHO, EURO dan WPRO,
SEARO, yang belum bebas polio: EMRO, AFRO
RCC dibentuk untuk mendorong region memberantas polio di
semua negara anggotanya dan mencegah penularan.
Adanya klb importasi inter dan antar region
Review dan validasi dokumen negara
Review dan validasi internasional ke negara masing2
Mendorong imunisasi dan s afp masing2 negara
KLB polio setelah sertifikasi bebas polio tetap terjadi, namun
negara endemis kurang (tinggal 3) dan kasus sangat menurun,
GPEI optimis bisa tercapai th 2018.
SEARO : bukti adanya komitmen pimpinan pusat dan lokal serta
peran serta masyarakat tinggi, bisa untuk peny lain

UPDATE ON POLIO
P2 sdh tidak ada sejak 1999
P3 sdh tidak dilaporkan sejak 2014
P1 sudah sangat rendah
cVDPV P2 menjadi polio liar baru
Sabin bisa jadi liar kembali

Vaccine-associated paralytic poliomyelitis* : lumpuh ok OPV

+Birth cohort in countries using OPV


*Overall risk

arti dari KLB cVDPV, 2000-2012: polio liar sdh hampir punah,
muncul cVDPV dan VAPP sebagai polio liar baru

Type 1 (79 cases)

Type 2 (478 cases)


Type 3 (9 cases)

Tipe 2 komponent dari tOPV harus dihentikan karena


menyebabkan > 90% dari circulating vaccine derived poliovirus
(cVDPV)
pada beberapa tahun terakhir ini

*as of 31 December 2014)

Revised goal for ERAPO:


to complete the eradication and
containment of all wild, vaccinerelated and Sabin
polioviruses.

Penemuan baru yang merubah


endgame

type 2 cVDPV is the main 'post-eradication'


problem.

Vaksin bivalent baru (bOPV) terbukti lebih


efisien dari vaksin tOPV untuk kekebalan wP1
& wP3 (P2 sdh tidak ada)

merupakan opsi pilihan untuk mengganti


tOPV.

33
New 'IPV' options allow all countries
to

Kasus Polio virus tipe 1, 2014


306

Tidak ada kasus polio liar


yang terlaporkan di Afrika
atau Timur Tengah sejak
11 Agustus, 2014
Endemic countries
Infected countries

359
Israel = Env. positive isolates ( 2014, N=14 , last 30 Mar 2014)
Gaza = Env. positve isolates (2014, N=1, Jan )

350

Kasus Polio liar tipe 1,


2012-15*

300

2012

250

2013

2014

303

2015

Tidak ada kasus polio


liar yang terlaporkan
di Nigeria sejak 24 Juli
2014

200
Cases
150

93

100
50
0

37

14

55

53

28

103

Afghanistan
6
6
6
6
6
6
6
4

*Data per 18 August 2015 :

Nigeria

Pakistan
12
0

Update terkini ttg cVDPVs : polio 2


Circulating Vaccine-Derived
Poliovirus Oubreaks
(cVDPVs) 2000-2010
Type 1 (79 cases)
Type 2 (450

cases)

Type 3 (9 cases)

Since 2009, 97% of


cVDPV cases are due
to type 2
(& 40% of VAPP)
36

Highlights of New Wild Poliovirus and cVDPV Cases


2014
Wild poliovirus
4 new officially reported WPV1 cases
2 cases and 2 new district* in Pakistan
1 case in Cameroon, a new country
1 case in Equatorial Guinea , a new country

Data in WHO HQ as of
18 March 2014

cVDPV
1 case in Nigeria

2013
Wild poliovirus - No new WPV case
cVDPV - No new cVDPV case
*New district, governorate and country refer to areas that was previously without WPV in
2014.
1
Case was previously reported by advance notification on 28 January but does not yet appear
in EMRO official data (awaiting sequencing.)

The boundaries and names shown and the designations used in the maps in this document 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 2014. All rights reserved

What next
Menggunakan IPV untuk mengganti OPV
Untuk mencegah cVDPV dan VAPP

IPV dalam bentuk vaksin kombinasi


Dalam bentuk pentavalent atau hexavelent

Selama transisi:

Mengganti tOPV dengan bOPV, mencegah cVDPV2


Memberikan minimal satu dosis IPV, primming P2
Meningkatkan imunisasi rutin sampai cakupan >90%
Mempertahankan surveilans AFP agar KLB terdeteksi

Bagaimana selanjutnya ? Apa yang berubah ?


poliovirus liar type 2 terakhir di temukan di India th 1999
Lebih dari 10 tahun tanpa poliovirus liar type 2
Namun , ~40% dari vaccine-associated paralytic poliomyelitis
(VAPP) global berasal dari Sabin type 2 (100-200 cases
annually),
95% dari kasus cVDPV ok type 2

Kasus poliovirus liar type 3 paling rendah selama ini


SAGE Working Group merekomendasikan endgame strategy
baru (Sabin 2 cessation) and new polio vaccines.

Tipe Virus Polio

Schematic description of
technical rationale for
use of at least one dose
of IPV as part of the
Endgame Strategy

tOPV: 3 rings of protection


against types 1, 2, and 3

Type 1
Type 2
Type 3
tOPV-bOPV
switch

bOPV

bOPV
+
IPV

IPV adds protection


against type 2 & boosts
immunity to 1 & 3
(enhancing bOPV effect)

2 rings of protection
against types 1 and
3

mOPV2

bOPV + mOPV2
Protection against
type 2 provided by
supplementary use
of mOPV2 in the
setting of an
outbreak

Potential Type 2
outbreak
requiring
mOPV2

bOPV + IPV

mOPV2

bOPV + IPV + mOPV2


bOPV & mOPV2 effect is
enhanced in an IPV
population thus
facilitating outbreak
control

Bivalent OPV Efficacy & Use


Seroconversion after 2 x bOPV
vs. tOPV, India, 2008-2009

bivalent OPV use


as of Sept 2011

Introduced
Dec 09-Aug 11
Planned by
end-2011

Type 1

Type 3
42

Mengapa b OPV dan IPV


tOPV menimbulkan antibodi secara lambat dan sequential, ok
ada interferensi intestinal antar polio Sabin P1,P2,P3 contoh di
India : tOPV 3x kekebalan sekitar 60%
mOPV dan bOPV terbukti cepat
meningkatkan antibodi
Menekan transmisi, menghilangkan outbreak secara cepat
mOPV memunculkan WPV 3 sehingga terpaksa menggunakan bOPV
(P1 dan P3)
India cepat hilang kasusnya sekalipun cakupannya belum 90%, namun
memunculkan cVDPV terutama yg P2
Sabin harus dihentikan meskipun jasa nya sangat besar

Karena cVDPV muncul sebagai polio liar baru WHA


merekomendasikan menghentikan OPV,
43

Perubahan epidemiologik 2013


VDPV= OPV yg de attenuated dalam usus manusia
Semula eradikasi ditujukan WPV, namun kini termasuk cVDPV
dan bahkan oral polio vaccine OPV Sabine
VAPP dan cVDPV setara dengan WPV secara epidemiologik
Terjadi KLB di daerah cakupan rendah dan miskin, baik WPV
maupun VDPV
Environmental surveillance : mencari cVDPV tapi ketemu
WPV di Israel
Endgame jadi synchronized WPV dan OPV

Perubahan strategi
Semula WPV baru VDPV, kini semua sekaligus
mOPV dan bOPV lebih cepat mengatasi KLB dibanding tOPV
Ok WPV2 sdh lenyap th 1999, OPV2 harus dihentikan agar

tidak berubah menjadi cVDPV2


Shift dari tOPV ke bOPV (polio1 dan 3) untuk imunisasi rutin
Primming polio2 dg IPV.
Memperkuat imunisasi rutin dan SAFP harus mampu

mendeteksi peredaran polio

Potential benefits of 'at least 1 IPV dose prior to OPV2 cessation'


a)

prevent polio if exposed to a VDPV2 or


WPV2

b)

improve response to mOPV2 in an


outbreak

c)

reduce transmission of a reintroduced type


2

d)

boost immunity to WPV1 & 3

Some Implications for IPV: must be used

OPV should be replace by IPV

Transsisi selama end game

IPV dapat dipercepat penggunaannya (i.e. tOPV-bOPV switch


could be prior to 2015).

IPV sendirian dapat digunakan menuju end game dengan


IPV dalam hexavalent sebagai kunci 'post-eradication'.

Bilamana strategy berhasil, penggunaan IPV jangka


panjang dapat diperluas dan diperlama sampai tidak ada
virus polio apapun beredar.
47

A new 'Endgame' strategy: parallel


instead of sequential risk management
Last wild polio case
Years

trivalent OPV cessation


4

Sequential risk
management

Wild virus
eradication

Certification &
containment

Parallel risk
management

Wild virus
eradication

Certification &
containment

VDPV2 elimination &


validation

OPV2 cessation
& IPV introduction

10

12

VDPV elimination &


validation

Post-OPV
surveillance

Post-OPV
surveillance

bivalent OPV 1&3


(bOPV) cessation
48

Potential polio policies for


each phase
Eradication

Now

Global certification

2014-15

2018-19

Stop all OPV


Hexavalent introduction

tOPV bOPV
IPV introduction

IPV for
acceleration

bOPV in routine
immunization +
1 dose IPV

Hexavalent IPV for


routine immunization

Objective 2 of The Plan addresses the Endgame through three distinct


stages

2019-2020
2016

Withdraw
Switch

Before end
2015

of bOPV & routine OPV


use

tOPV to bOPV

Introduce
at least one dose of IPV
into routine immunization

Ongoing STRENGTHENING of routine immunization services


3/15/16

50

Penggunaan IPV: Rekomendasi SAGE

IPV tidak menggantikan dosis OPV

Kubu optimis eradikasi akan dicapai


Sejak tahun 1999 tidak ada WPV2
Kemungkinan menghilangkan baik WPV3 maupun WPV1
dengan bOPV atau mOPV terbuka
Menghilangkan VAPP dan cVDPV dengan IPV
Polio hanya hidup di usus manusia
Penelitian Yogya : setelah 6 bulan penggunaan IPV , tidak
beredar lagi polio Sabin (vaksin) di limbah
Pengamatan selama 4 tahun tidak di jumpai adanya Sabin
dari luar propinsi pada limbah sentral Yogya
Transmisi dan imunitas tergantung pada tiap negara

Kubu pesimis : mengingatkan ada kendala eradikasi


Imunitas intestinal bisa menurun, sehingga dapat dihuni virus
polio lagi
Setelah sertifikasi tercapai akan terjadi penurunan kegiatan
imunisasi dan surveialans
Cakupan imunisasi suntikan rendah di beberapa negara
Maintenance program ? KLB difteri, campak, pertussis
Perlu waktu lama sebelum imunisasi polio dan surveilans AFP
bisa dihentikan

Highlights of New Wild Poliovirus and VDPV Positive Results

From AFP surveillance


Wild poliovirus
No new WPV case

VDPV
2 new cVDPV1 cases
2 cases in Ukraine, a new1 country
1

New country refers to an area without cVDPV1 in 2015

The boundaries and names shown and the designations used in the maps in this document 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 2015. All rights reserved

Data in WHO HQ as of 01 Sept 2015

Wild Poliovirus & cVDPV Cases1, Previous 12 Months2

Wild poliovirus type 1


cVDPV type 1
cVDPV type 2
Endemic country
Excludes viruses detected from environmental surveillance.
Onset of paralysis 02 September 2014 01 September 2015

1
2

Data in WHO HQ as of 01 Sept 2015

Wild Poliovirus Cases1, Previous 6 Months2

Wild poliovirus type 1


Endemic country
Excludes viruses detected from environmental surveillance.
Onset of paralysis 02 March 01 September 2015

1
2

Data in WHO HQ as of 01 Sept 2015

cVDPV Cases1, Previous 6 Months2

cVDPV type 1
cVDPV type 2
Endemic country
Excludes viruses detected from environmental surveillance.
Onset of paralysis 02 March 01 September 2015

1
2

Data in WHO HQ as of 01 Sept 2015

J.John and co-workers demonstrated in India that IPV


induced higher and consistent immune response vs. OPV
in several field intervention studies
Intervention study in Tamil Nadu (1987-1992) by ICMR
2.5 million received IPV: incidence dropped from 14 to 0.3/100,000
person-years with VC of 84%
2.5 million received OPV: incidence dropped from 9 to 0.4/100,000
person-years with VC of 95%
Intervention study in Mumbai slums (1988-1991) by R.Patel
Successive introduction of IPV in 3 blocks of 100,000 population over a
3-year period from 1988 to 1990
Incidence dropped to 0/100,000 person-years in the year following
introduction in each block
John TJ, Samuel R, Balraj V, John R. Lancet 1998;352:58-61
John TJ. Proc Indian Natl Sci Acad 2003;B69:393-422
John TJ. Indian J Med Res 2004;119:1-17

59

IPV introduction program in the Yogyakarta province of


Indonesia: High impact on vaccination coverage, PV
circulation and seroprevalence
Switch from an OPV-only to an IPV-only schedule (condensed
3+1) in Sept 2007 in a population of 3,571,865 with an annual
birth cohort of 52,723
No drop in vaccination coverage rates during 4 consecutive
years of follow up (remained > 95%)
Environmental sampling (inlet sewage)
Maintenance of absence of WPV circulation
Very rapid decrease of isolated PV with only 5 samples with Sabin like
and no VDPVs (but 24 out of the 55 months period of F/U were missed)

Seroprevalence and dose 3-to-dose 4 seroconversion survey


done on 188 infants revealed 100% SP post-dose 3 and increase
in GMT from dose 3 to dose 4
IPV Introduction Project in Yogyakarta, Stakeholder meeting; 25 26 April 2012

60

IPV-followed-by-OPV regimen have


been the most documented
13 trials done with several types of IPV-containing vaccines in 7 countries since
1986
USA (5), China (3), UK, Brazil, Mexico, Taiwan & Guatemala

1 or 2 IPV followed by 1 or 2 OPV administered as 2+1, 3+1 or 3+0 regimen


No OPV given at birth in all cases
Several types of study design
Non-randomized descriptive-only licensing or launch studies or RCTs between
sequential schedules and IPV-only and / or OPV-only schedules
Some trials have investigated prevalence, intensity, duration and genetics of PV
excretion after OPV vaccination / challenge

Several types of IPV-containing vaccines


IPV stand-alone
wP-based combinations
aP-based combinations
61

IPV-followed-by-OPV regimen is the most


relevant from a Public Health perspective
Address the VAPP issue
Combine the full benefit of both vaccines in terms of breath of immune
responses (mucosal and humoral)
The incorporation of at least one dose of IPV at the start of the immunization
schedule increase post-primary series Ab levels compared to OPV-only
schedules
I-I-O primary series during the first year of life schedule is the best
performer in terms of absolute post-primary series antibody levels (versus
OPV-only)
Two doses of IPV during the first year of life schedule is able to reduce
prevalence, intensity and duration of PV excretion following an early OPV
vaccination / challenge compared to 1st time OPV-recipients
Hypothesis that prior IPV might result in faster excretion of revertant virus
after PV infection (by OPV) is not confirmed
62

IPV-containing vaccines have demonstrated


excellent and consistent immunogenicity profile
whatever conditions of use
Extensive database with various IPV-containing products (15) used in many
countries
More than 300 pre- and post-licensure clinical trials or intervention studies done in
more than 50 countries since 1977
Product performances documented
In primary immunization in infant / toddlers

IPV-only regimen (2+1; 3+0; 3+1)


IPV-followed-by-OPV sequential regimen
IPV-only regimen supplemented by OPV NIDs or by OPV SIAs
Mixed / Combined IPV / OPV regimen
OPV-followed-by-IPV sequential regimen
All these regimen completed or not with OPV at birth

As a polio vaccine in adolescents and adults with unknown vaccination histories with a 2dose regimen
As a polio immunity booster in pre-school children, adolescents, adults and elderly
In special populations: HIV+, bone-marrow transplanted, pre-terms
63

IPV-containing products do induce


seroconversion and seroprotective levels in
almost all subjects after two doses
Immunological priming documented after 1st dose
High immunogenicity after 2nd dose
In 30 trials involving >4500 subjects, seroprotection
against poliovirus
89-100% against type 1
92-100% against type 2
70-100% against type 3

Immunogenicity expectedly reinforced after 3rd dose


In 48 trials involving >6000 subjects, 95-100%
seroprotection rates against all 3 types

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Inclusion of IPV
Protection against possible cVDPV type 2 only through IPV
under new plan
The most medically- and epidemiologically-sounded
regimen is the IPV-followed-by-OPV sequential schedule
made of I I O O given as a 3+1
Switching to aP-IPV combos is by essence adopting an
IPV-only regimen
The clinical performance of the WHO-proposed regimen is
not yet fully documented
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