Indonesian Technical Advisory Group on Immunization

(Komite Penasehat Ahli Imunisasi Nasional)

Manfaat & Pentingnya Pemberian Imunisasi PCV

Prof Dr dr Sri Rezeki Hadinegoro Sp.A(K)
1
Ketua ITAGI

Webinar, 24 September 2022

Slide Sri Rezeki 9/24/22
2 Topik bahasan
 Kebijakan global
 Rekomendasi ITAGI
 Vaksin dan Imunisasi PCV pada Anak
 Manfaaf imunisasi PCV pada anak, dampak
langsung dan tidak langsung
 Rangkuman

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3
Kebijakan Global

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Kebijakan Global
WHO position paper 2007 (WER – WHO 2007)

 Dasar kebijakan, pertimbangan tingginya beban penyakit pada

anak serta keamanan dan efikasi vaksin pneumokokus PCV

 WHO menyarankan vaksin PCV diprioritaskan untuk masuk

dalam program imunisasi nasional terutama,
angka kematian anak di bawah usia lima tahun >50 per 1000
kelahiran hidup
kematian lebih dari 50,000 anak per tahun.
 Tantangan Global
pada Kesehatan Anak
Penyebab meninggal
karena pneumonia,
diare, campak
45% dengan
malnutrisi dan
6.3 juta balita stunting 1 dari 3 anak balita
(52%) meninggal akan mengalami
tiap tahun gangguan tumbuh
disebabkan oleh kembang
PD3I
2.9 juta (44%)
BBLR, asfiksia &
diantaranya bayi infeksi
baru lahir
6
WHO position paper 2019

WHO merekomendasikan Jadwal PCV untuk NIP

vaksin PCV dalam NIP 2+1 atau 3+0 Pemilihan PCV
Dilakukan bersama strategi Imunogenisitas lebih tergantung dari
pencegahan pneumonia: ASI baik jadwal 2+1 ketersediaan vaksin,
eksklusif, nutrisi seimbang, harga, prevalensi
menghindari polusi dalam Interval 4-8 minggu, serotipe lokal, dan
ruang termasuk asap booster pada umur 9-18 resistensi antimikrobial
rokok bulan

Slide Sri Rezeki 9/24/22

Reference: World Health Organization Meeting report , 29 February 2019
7 WHO Recommendation
8
Measuring Impact of PCV Introduction
Cost of medical care

Antibiotic treatment
Societal
burden

Healthcare
burden Meningitis/Bacteremia /
Bacteriemic Pneumonia
Burden
of
disease

Loss of work/ Pneumonia Otitis media Loss of work/

productivity productivity
(carer) (patient)

Primary care
Hospitalization resources

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Spread of infection from
carriers (children) to older adults
9 Rekomendasi ITAGI

Slide Sri Rezeki 9/24/22

Kesehatan Anak di Indonesia
 Anak Indonesia tidak dapat berulang tahun kelima1
• Tahun 1990 : 395.000 anak
• Tahun 2015 : 147.000 anak
 Jumlah kematian anak th 2014 : 5,9 juta anak/tahun1
 Kematian balita2
• Tahun 1960 : 222 anak/1000 kelahiran hidup
• Tahun 2021 : 23/1000 kelahiran hidup atau 110.042 anak
 Keberhasilan
• Pemberian ASI, imunisasi, pelayanan neonatal, ketersediaan air bersih, nutrisi seimbang

Sumber: 1. Data UNICEF, 2015. 2. https://data.unicef.org/country/idn/2021

Rekomendasi ITAGI 30 Januari 2017
mengenai Imunisasi Pneumokokus

Dasar Rekomendasi
 Surat Direktur SKK Ditjen PP-PL Kemkes RI tanggal 8 Desember
2015 perihal permohonan kajian penggunaan vaksin
pneumokokus dalam program imunisasi nasional.
 Pertemuan tanggal 27 April 2016 mengenai persiapan
demonstration project pneumokokus di Pulau Lombok
 Surat dari Direktur SKK kepada Ketua ITAGI mengenai
demonstration project preparedness vaksin pneumokok di
pulau Lombok no TU.02.05/D.3/II.4/1131/2016
Rekomendasi ITAGI
Dikeluarkan di Jakarta pada tanggal 30 Januari 2017

 Streptococcus pneumoniae (Pneumococcus) merupakan

penyebab kematian utama pada anak khususnya di bawah
lima tahun, selain Haemophillus influenzae type b (Hib).
Pemberian imunisasi pneumokokus (PCV) akan meningkatkan
kelangsungan hidup anak.
 Pada tahap awal prioritas dipilih daerah risiko tinggi dan
memilki data dasar pneumonia sebagai daerah untuk
demonstration program (Lombok Barat dan Timur)
 Vaksin pneumokokus diberikan secara bersamaan dengan
vaksin DPT-HB-Hib (Pentavalen) dan OPV
13 Rekomendasi ITAGI
Jadwal dan cara pemberian vaksin PCV
• Jadwal vaksin PCV dalam
program nasional
– Jadwal 2+1 (imunisasi dasar 2x dan
ulangan 1x)
– PCV-1 bersamaan dengan Pentabio-1*
(usia 2 bulan ),
– PCV-2 bersamaan dengan Pentabio-2
(usia 3 bulan)
– PCV-3 diberikan pada usia 12 bulan
* Pentabio berisi DPwT+HB+Hib
Slide Sri Rezeki
 Cara pemberian
o Vaksin PCV diberikan secara bersamaan
dengan vaksin lainnya seperti DPT-HB-
Hib, OPV (multiple injection, suntikan
ganda)
 Pemantauan keamanan vaksin
(KIPI)
o Pemantauan KIPI dilakukan secara
berkala, bekerjasama dengan
KOMNAS/KOMDA PP KIPI setempat
9/24/22
14 Vaksin PCV dan Imunisasi PCV pada Anak

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Perbedaan mekanisme kerja antara PPSP dan PCV
PPSV=Pneumococcal polysaccharide vaccine; PCV=Pneumococcal conjugate vaccine
 16

Vaksin Pneumokokus Konjugasi

(Pneumococcal Conjugate Vaccine =
PCV)
Vaksin Serotipe yang ada dalam vaksin

PCV7 4 6B 9V 14 18C 19F 23F

PCV10 4 6B 9V 14 18C 19F 23F 1 7F 5

PCV13 4 6B 9V 14 18C 19F 23F 1 7F 5 6A 3 19A

• Vaksin PCV13 mencakup 46%-60% serotipe yang ada di Indonesia

17 PCV13 telah digunakan pada lebih dari
130 negara sebagai Imunisasi Nasional1,2

PCV13 Only* = 127

PCV13 / PCV10† Shared = 5
(PCV13 covers >50% of total BC)

PCV13 / PCV10† Shared = 1

(PCV13 covers <50% of total BC)

PCV10 Only = 31
Adapted from Gavi Alliance Annual Progress Report 2017; Data on file.
Pfizer Inc, New York, NY. 2020.

*Canadian province of Quebec and Italian region of Piemonte have initiated PCV vaccination programs with PCV10.
†Both PCVs are available/reimbursed in the NIP or the NIP consists of different PCVs by region.
BC=birth cohort.
NIP=national immunization program.
1. Gavi Alliance Annual Progress Report 2017. http://www.gavialliance.org/results/gavi-progress-reports/. Accessed April, 2021.
2. Data on file. Pfizer Inc, New York, NY. 2020. As of Nov 2020
18 Program Imunisasi Nasional PCV13 mempergunakan
tiga Jadwal yang Berbeda1,2*

PCV13 PCV13 + PCV10†

3+1
3+0
2+1

Adapted from Johns Hopkins Bloomberg School of Public Health

– IVAC 2016; Data on file. Pfizer Inc, New York, NY. 2020. As of Nov 2020
PCV13 is included in more than 130 NIPs, with exclusivity in 127 countries worldwide1,2
*PCV13 is used in either a 3+1, 3+0, or 2+1 schedule, depending on a specific country’s NIP guidelines.
†Both PCVs are available/reimbursed in the NIP or the NIP consists of different PCVs by region/county; shared NIPs use either a 3+1 or 2+1 schedule.

NIP=national immunization program.

1. Johns Hopkins Bloomberg School of Public Health – IVAC: International Vaccine Access Center (View-Hub) data. www.view-hub.org. Accessed April,
2021. 2. Data on file. Pfizer Inc, New York, NY. 2020.
19
Penambahan vaksin PCV pada Jadwal Imunisasi

12 month
+PCV-3

+PCV-2

+PCV-1

9/24/22

Slide Sri Rezeki

20
Jadwal Imunisasi Nasional
Umur Imunisasi
<24 jam Hepatitis B-O
1 bulan BCG, OPV1
2 bulan DPT-HB-Hib 1, OPV 2 + PCV 1
3 bulan DPT-HB-Hib 2, OPV 3 + PCV 2
4 bulan DPT-HB-Hib 3, OPV 4 & IPV
Suntikan ganda
9 bulan MR 1, JE
12 bulan PCV 3
18 bulan MR 2, DPT-HB-Hib 4
SD kl 1 DT, MR
SD kl 2 Td
SD kl 5 Td, HPV1
SD kl 6 HPV2
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21 Suntikan Ganda (multiple injection)

 Definisi: pemberian dua atau lebih antigen (yang berada Bagaimana mengurangi rasa sakit?
dalam kemasan vaksin yang berbeda) diberikan dalam  Posisi anak yang diinginkan: duduk sendiri atau
dipangku
waktu yang bersamaan
 Cara penyuntikan
 Cara pemberian o Usap (dengan halus) lalu tekan daerah dekat
tempat penyuntikan
o Dapat diberikan pada tempat yang berbeda
o Lakukan suntikan dengan cepat
o Jika diberikan pada tempat yang sama harus diberi jarak sekitar  Tips
2,5 cm
o Vaksin yang tidak menimbulkan rasa sakit
disuntikkan terlebih dulu
o Suntikan intramuskular lakukan secara cepat
tanpa aspirasi (aspirasi menyebabkan rasa sakit)

9/24/22

Slide Sri Rezeki

23
Manfaat Imunisasi PCV pada Anak,
dampak langsung dan tidak langsung

Slide Sri Rezeki 9/24/22

 Vaksin PCV mencegah karier nasofarings pneumokokus, berarti
mencegah penularan

Streptococcus pneumoniae Bayi lain

Saudara

Ibu/ayah

Nenek/kakek
IPD=invasive pneumococcal disease; PCV=pneumococcal polysaccharide vaccine.
Davis SM, et al. Vaccine. 2013;32:133-145.
 25
Real-World Impact of PCV13 Against Vaccine-Type IPD in Children*
NORWAY4‡
ENGLAND AND
WALES2 100%
(<2 years)
89% DENMARK7‡
(<2 years)
84%
USA1† (<2 years)
93% FRANCE3‡
(<5 years) 84%
(<2 years)

ISRAEL6†
70%
(<5 years)

GAMBIA8‡ SOUTH AFRICA5‡ AUSTRALIA9§

82% 57% 70%
(<2 years) (<2 years) (<2 years)
PCV13 NIP10

*Time since PCV implementation, population demographics, and vaccine uptake varied among countries shown.
†Due to serotypes 1, 3, 5, 7F, and 19A in PCV13.
‡Due to 6 additional serotypes in PCV13.
§ Due to serotypes 1,3 , 6A, 7F and 19A

Slide Sri Rezeki

IPD=invasive pneumococcal disease; NIP=national immunization program. 9/24/22
1. Moore MR, et al. Lancet Infect Dis. 2015;15(3):301-309. 2. Ladhani SN et al. Lancet Infect Dis. 2018;18(4):441-451. Lepoutre A, et al. Vaccine. 2015;33(2):359-366. 4. Steens A, et al. Vaccine.
2013;31(52):6232-6238. 5. von Gottberg A, et al. N Engl J Med. 2014;371(20):1889-1899. 6. Ben-Shimol S, et al. Vaccine. 2014;32(27):3452-3459. 7. Harboe ZB, et al. Clin Infect Dis.
2014;59(8):1066-1073. 8. Mackenzie GA, et al. Lancet Infect Dis. 2016;16(6):703-711. 9. Jayasinghe S, et al. Clin Infect Dis. 2017;64(2):175-183. 10. NIP PCV13- Data on File.
 26 Real-World Impact of PCV13 Against All-Cause Pneumonia in Children

USA1*
27% FRANCE4
(<2 years) 32%
(<2 years)

NICARAGUA2*
33%
(<1 year) ISRAEL5
38%
(<5 years)
ARGENTINA3*
PCV13 NIP6 51%
(<5 years)

*Reductions in hospitalizations.
NIP=national immunization program. Slide Sri Rezeki 9/24/22
1. Griffin MR, et al. MMWR Morb Mortal Wkly Rep. 2014;63(44):995-998. 2. Becker-Dreps S, et al. Pediatr Infect Dis J. 2014;33(6):637-642. 3. López EL, et al.
J Pediatric Infect Dis Soc. 2018;7(1):30-35.. 4. Angoulvant F, et al. Clin Infect Dis. 2014;58(7):918-924. 5. Greenberg D, et al. Vaccine. 2015;33(36):4623-4629. 6. NIP PCV13- Data on File.
 Taiwan: Number of IPD Isolates by Serotype in Relation to PCVs Used in
27 Children <5 Years of Age
IPD Isolates Based on PCV Serotypes, 2008–2017
Vaccine Introduction/
Low Vaccination Coverage

PCV7 PCV10 PCV13 PCV13 PCV7

(2006) Catch-up NIP 1, 5, 7F
250 2-5y 1-5y 2+1 3
Number of isolates

6A
200 19A
19A PPV23-specific
150
Others
100

50 PCV7 serotypes

0
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Year Adapted from Lu CY, et al. Clin Infect Dis. 2019;69(9):1581–1587.

• Based on the unique epidemiology in Taiwan, where the highest incidence of IPD occurred in children 2–4 years of age, a single-dose PCV13
program for children 2–5 years of age was introduced in 2013, and extended to children 1–5 years of age in 2014, followed by a universal 2+1
program starting in 2015
• The incidence of IPD due to serotype 19A in children 0–5 years of age declined significantly, by 32.6%–44.3%, yearly from 2012 to 2017 (P<0.0001)
Slide Sri Rezeki 9/24/22

IPD=invasive pneumococcal disease; NIP=national immunization program. PCV7 as mentioned above is presently not registered in Singapore.
 Argentina, PCV13; 2+1
Hospitalisasi pneumonia pneumokokus
pada Balita di Argentina
Perawatan RS karena
Perawatan RS Pneumonia Pneumokokus* Pneumonia Pneumokokus + Empiema†
~72% ~64%
20 reduction 20 reduction
11.8
(per 10,000 admissions) (95% CI 8.4–15.9) 10.9
Hospitalization rates
(95% CI 7.2–14.5)
15 15

10 10 3.9
3.3
(95% CI 1.6–5.9) (95% CI 1.6–6.2)
5 5

0 0
Pre-PCV13 Post-PCV13 Pre-PCV13 Post-PCV13
The pre-PCV13 period was 2009–2011; the post-PCV13 period was 2012–2013.

Perawatan RS pneumonia pneumokokus menurun ~72% setelah program

imunisasi PCV13. Perawatan RS karena pneumonia pneumokokus + Empiema
menurun ~64% pada periode yang sama
*P-CAP was pneumococcal CAP confirmed by positive blood culture.
†P-PD was pneumococcal pulmonary disease defined as P-CAP plus pneumococcal empyema.

IPD refers to PE, P-CAP, meningitis, bacteremia, peritonitis, arthritis, cellulitis and other.
CAP=community-acquired pneumonia; CI=confidence interval; PE=pneumococcal empyema; P-CAP= pneumococcal community-acquired pneumonia; P-PD=pneumococcal pulmonary
28
disease (P-CAP+PE).. López EL, et al. J Pediatric Infect Dis Soc. 2017; doi: 10.1093/jpids/piw089.
 Argentina, PCV13, 2+1

Impact of PCV13 Vaccination on Pneumococcal

Pneumonia in Children ≤15 Years of Age
Discharge rates and percent reduction for pneumococcal pneumonia by age, 2007–2014
64.3%
(44.9%–76.9%)
77.6%
(59.6%–87.6%) 42.3%
(per 10,000 hospital discharges)

(18.2%–59.4%)
70.5%
50 (40.4%–82.8%)
66.2%
(43.6%–79.8%)
40 56.3%
Discharge rates

71.8% (35.0%–70.6%)
(53.1%–83.0%)
Pre-vaccination period (2007–2011)*
30 51.7%
(30.0%–66.7%)
Intervention period (2012)

20 Post-vaccination period (2013–2014)*

10

0
0–11 months 12–23 months 24–59 months 5–15 years
Age group

• There was an overall 68.8% decrease in discharge rates related to pneumococcal

pneumonia between the pre- and post-vaccination periods, with the largest decrease
(77.6%) seen in children 12 to 23 months of age

*Data shown correspond to annual averages. 29

Gentile A, et al. PLoS One. 2018;13(7):e0199989.
 PCV13 Effectiveness - IPD 2+1
MADRID, SPAIN
IPD INCIDENCE RATE PER AGE GROUP BEFORE AND AFTER PCV13
50

45

40
43% reduction of IPD in children <2 years; mainly
43% attributable to the reduction in disease caused by serotypes 1,
35
5, 7F and 19A
IPD incidence rate

30

25

20

15 34%

10

0
< 2y 2y to < 5y 5y to < 15y <15y
Age group
May 2007 to April 2010 (Pre-PCV13) May 2010 to April 2011 (Post-PCV13)
30
Picazo J, Ruiz-Contreras J, Casado-Flores J et al. First impact data of 13-valent pneumococcal conjúgate vaccine (PCV13) on invasive
pneumococcal disease in children in Madrid, 2010-2011 (Heracles Study). Presented at the 8th International Symposium on
Pneumococci and Pneumococcal Diseases, March 11-15, 2012, Iguaçu Falls, Brazil.
 United Kingdom, PCV7, PCV13; 2+1

IPD-Related Mortality in Children <5 Years of Age

Post-PCV Introduction
Incidence of IPD-associated deaths in England and Wales,
PCV7 September 2006–August 2014*
1.4
Incidence/100,000 children
PCV7 PCV13 Other Not Known
1.2
PCV13
1
0.8
0.6
0.4
0.2
0
2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13 2013/14

A 69% decline in IPD-related mortality in children younger than 5 years of age

was observed over the 8-year period following PCV introduction

*PCV7=serotypes included in the 7-valent pneumococcal conjugate vaccine. PCV13=serotypes included in the 13-valent pneumococcal conjugate
vaccine but not in PCV7. Other=non-PCV13 serotypes. Not known=non-serotyped isolates.
Oligbu G, et al. Clin Infect Dis. 2017 Jun 12. doi: 10.1093/cid/cix310. [Epub ahead of print].
31 31
32
Manfaat Imunisasi PCV
Manfaat langsung (direct effect)
 Mencegah IPD pada anak
 Mencegah pneumonia pada anak
Manfaat tidak langsung (indirect effect)
 Menurunkan kejadian pneumonia pada
anak & dewasa serumah

 Mencegah otitis media akut  Mengurangi waktu dewasa (orang tua)

tidak masuk bekerja
 Mengurangi karier nasofarings
 Sangat cost effective
 Mengurangi perawatan di rumah sakit
 Mengurangi resistensi antibiotik

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33
Rangkuman
 Pemberian imunisasi PCV pada anak bermanfaat baik secara langsung
(direct effect) maupun tidak langsung (tidak langsung)
 Rekomendasi ITAGI
– Jadwal PCV 2 + 1 (umur 2 dan 3 bulan + 1 booster umur 12 bulan)
– Imunisasi PCV1 dan PCV2 diberikan bersama-sama Pentavalen
(DPT/HB-Hib)
 Pemberian suntikan ganda (multiple injection) aman dan efek
 Mulai tahun 2022 imunisasi PCV dimasukkan dalam Program Imunisasi
Nasional
 Perlu dilakukan survailans aktif terhadap kasus pneumonia pada balita
untuk mengetahui impact dari imunisasi PCV

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34 Semangat daerah untuk
Imunisasi PCV

Slide Sri Rezeki

9/24/22