PP-PNP-IND-0531 - Evidence Based Decision Choosing PCV

Evidence based decision in choosing
broad coverage pneumococcal

conjugate vaccine in practice
Speaker:
PP-PNP-IND-0531 | 01 February, 2021

Disclaimer:
“The Content in this presentation is only intended for healthcare professionals in India. The medical information in this presentation is provided
as an information resource only and is not to be used or relied on for any diagnostic or treatment purpose. “
“The views and opinions mentioned in the presentation is strictly that of the author and the individuals expressing the same and Pfizer may not
necessarily endorse the same. Pfizer (including its parent, subsidiary and affiliate entities) makes no representation or warranties of any kind,
expressed or implied; as to the content used in the presentation and/or the accuracy, completeness of its content.”
See summary of prescribing information on the last page These slides are for information or education purposes only and not for distribution or promotion.
CONFIDENTIAL – FOR INTERNAL USE ONLY
The Spectrum of the Pneumococcal Disease Burden in Children1,2
Meningitis Invasive
Bacteremia/Sepsis Pneumococcal
Bacteremic pneumonia Disease (IPD)
ity
e
r
ve
nc
Pneumonia X 100
Se
le
e va
Pr
Otitis media

Adapted from: CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. 2015; American Academy of Pediatrics.Pediatrics. 2000;106:367-376
1. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. In: Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C.
Public Health Foundation, 2015. 2. American Academy of Pediatrics.Pediatrics. 2000;106:367-376 2
These slides are for information or education purposes only and not for distribution or promotion.
Mortality from Pneumococcal Disease Is High Regardless
of Age
• Case fatality rates for Invasive Pneumococcal Disease are high, with
overall rates of approximately 20%1,2
• In children, mortality is highest in young infants2

– In developing countries mortality can reach as high as 50% for
meningitis2
– For those who survive, there is a significant risk of long-term
sequelae1,2
• As many as 58% of patients experience residual effects such as
hearing loss, mental retardation, motor abnormalities, and
seizures2

1. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. In: Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C.
Public Health Foundation, 2015. 2. World Health Organization. Wkly Epidemiol Rec. 2012;87(14):129-144. 3
No Topic
1 Available Pneumococcal Conjugate Vaccines (PCVs)
• Are they same, equal, similar, or different?
2 Broad Spectrum of the Pneumococcal Disease Burden
• Is a PCV that offers broad coverage desirable?
3 Is it important for a PCV to include
• Serotypes 3, 4, 18C, 6A and 19A?
4 Are evidence-based decisions important in choosing a PCV?
• Do both aspects of Immunogenicity (IgG and OPA) matter?
• Product switching – Can it be done with PCVs?
• Booster dose – What is its relevance?
5 Driving Evidence based differentiation
• Can PCV Impact data help us to choose the right PCV?
6 Establishing the value of PCV

• What factors serve as a guide to this decision?
IgG: Immunoglobulin G; OPA: Opsonophagocytic assay; PCV: pneumococcal conjugate vaccine
4
Pneumococcal Conjugate Vaccine Formulations1-4
1) PCV13, 2) Older-PCV10, 3) Newer PCV10
Vaccine Streptococcus pneumoniae serotypes
4 6B 9V 14 18C 19F 23F 1 5 7F 3 6A 19A
PCV13 3 2.2 μg 4.4 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg 2.2 μg
4 6B 9V 14 18C 19F 23F 1 5 7F

Older 1 3 μg 1 μg 1 μg 1 μg 3 μg 3 μg 1 μg 1 μg 1 μg 1 μg
PCV10
6B 9V 14 19F 23F 1 5 7F 6A 19A

Newer 2
PCV10 4 μg 2 μg 2 μg 2 μg 2 μg 2 μg 2 μg 2 μg 2 μg 2 μg
Protein Carrier Conjugation Chemistry

PCV13 3 CRM197 Reductive amination 4
TT (18C), and DT (19F) and
Older PCV10 Protein D (other serotypes) 1 Cyanylation with CDAP 4

Newer PCV10 2* CRM197 Cyanylation with CDAP 3
TT: Tetanus Toxoid; DT: Diphtheria Toxoid; CRM: cross reactive material; CDAP: 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry
1. Synflorix [summary of product characteristics]. GlaxoSmithKline Biologicals https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf last accessed 26th
January 2021.2. SII-PCV10, www.pneumosil.com/vaccine last accessed 26th January 2021 3. Prevenar13 Prescribing Information. Pfizer Limited. LPDPRV072019, version 17. 4.Turner AEB. et al. Synthetic and
Systems Biotechnology 2017: 2: 49-58
* - Serotypes are conjugated to non-toxic diphtheria CRM 197 protein by using 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP)
1. Available Pneumococcal Conjugate Vaccines 1,2,3
Are they same, equal, similar, or different?
Serotypes – PCV13 has 3 additional serotypes
 Older PCV10 – lacks 3, 6A and 19A
 Newer PCV10 – lacks 3, 4 and 18C
 Older as well as newer PCV10 – lack serotype 3
Composition
• Antigen concentration of each individual serotype used in PCV13 is
higher than that for newer PCV10
• Antigen concentration for majority of serotypes for PCV13 is more
than older PCV10*
Conjugation Technology
• Irrespective of the carrier protein used for conjugation, older as well as

newer PCV10 could use only 10 serotypes (vaccine 0.5mL), whereas
PCV13 could fit 13 serotypes in 0.5mL dose.
Available Pneumococcal Conjugate Vaccines are DIFFERENT
1. Synflorix [summary of product characteristics]. GlaxoSmithKline Biologicals
https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf last accessed 26th January 2021.2. SII-PCV10, * - except 4, 18C and 19F
www.pneumosil.com/vaccine last accessed 26th January 2021 3. Prevenar13 Prescribing Information. Pfizer Limited. LPDPRV072019,
These slides areversion 17.
for information or education purposes only and not for distribution or promotion.
No Topic

IgG – Immunoglobulin G
7
OPA – Opsonophagocytic assay
Broad Disease Coverage 1,2,3
India picture - S. pneumoniae as the leading cause of Meningitis4

Study
• Hospital based sentinel surveillance for bacterial meningitis was
conducted by Indian Council of Medical Research (ICMR)
Results
• The highest incidence of meningitis was due to S. pneumoniae
(82.9%), followed by Hib (14.4%) and N. meningitides (2.7%).
• Highest prevalence (55.3%) was observed among children 1 to
11months
Conclusion
• This study described the burden of bacterial meningitis among Indian

children <5 years and highlighted the predominance of S. pneumoniae
as an important etiological agent
1. Synflorix [summary of product characteristics]. GlaxoSmithKline Biologicals https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf last accessed 27 Jan 2021.2. SII-PCV10,
www.pneumosil.com/vaccine last accessed 27 Jan 2021 3. Prevenar13 Prescribing Information. Pfizer Limited. LPDPRV072019, version 17. 4. Jayaraman Y, Veeraraghavan B, Purushothaman GK, et.al. Burden of bacterial
meningitis in India: Preliminary data from a hospital based sentinel surveillance network. PloS one. 2018 May 16;13(5):e0197198.
India picture - S. pneumoniae and Pneumonia Deaths4

• Around 43 million pneumonia cases (23% of the world’s total) occur
• Incidence is 0.37 episodes per child-year for clinical pneumonia
• Case fatality rate in severe pneumonia is 9.96%
Severe Pneumonia Pneumococcal Pneumonia

Episodes 3,600,000 560,000
Deaths 350,000 105,000

Adapted from: Farooqui H. et al. PloS one. 2015 Jun 18;10(6):e0129191.
1. Synflorix [summary of product characteristics]. GlaxoSmithKline Biologicals https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf last

accessed 27 Jan 2021.2. SII-PCV10, www.pneumosil.com/vaccine last accessed 27 Jan 2021 3. Prevenar13 Prescribing Information. Pfizer Limited. LPDPRV072019, version 17. 4.
Farooqui H, Jit M, Heymann DL, Zodpey S. Burden of severe pneumonia, pneumococcal pneumonia and pneumonia deaths in Indian states: modelling based estimates. PloS one. 2015
Jun 18;10(6):e0129191.
India picture - S. pneumoniae Otitis media – is protection desirable?

Otitis media – protection is important
• Most common pneumococcal infection in children 4
• Significant cause of childhood morbidity (hearing

impairment, impeded language & mental
development, and health care cost) 5
• Acute Otitis Media in Indian infants is often

associated with S. pneumoniae NP colonization 4
• Vaccine effective against Otitis Media is high in

Structure of the human ear
immunogenicity (mucosal penetration) 5
– Newer PCV10 does not have otitis media
indication in their label2
1 5 6A 6B 7F

9V 19A 19F 23F
14
Serotypes causing AOM 7-10

NP: Nasopharyngeal carriage; AOM: Acute otitis media
Adapted from: Encyclopædia Britannica. Structure of the human ear [Internet].
2020 [cited 27 Jan 2021]. Available from: References in footnotes
https://www.britannica.com/science/ear#/media/1/175622/530 These slides are for information or education purposes only and not for distribution or promotion.
1–15
Pneumococcal Serotypes & Disease Coverage

3 4 18C 6A 19A
Serotype 3 Serotype 4 Serotype 18C Serotype 6A Serotype 19 A

Necrotizing IPD3,4 IPD7 Resistance to antibiotics 5 IPD1,2,10
Pneumonia3,4 Outbreak Outbreak Serotype IPD1,2, 10 Pneumonia2,12,14
Empyema3,4 Serotype1 (Epidemic cycles)2 Pneumonia1,2,12,14 AOM1,2,15
AOM 1,2,13,15 Multi-drug resistance6
1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F
Serotype 1 Serotype 5 Serotype 6B Serotype 7F

IPD1,2, 10 IPD 1,2,10 IPD1,2,10 IPD1,2,10
AOM,1,13,15 Pneumonia 1,2,12,14 Pneumonia1,2,12,14
AOM 1,2,13,15
Pneumonia1,2,12,14
Pneumonia 1,2,12,14 AOM 1,2,13,15 AOM1,2,13,15
Outbreak Serotype
(Epidemic cycles)1,2 Outbreak Serotype1 Outbreak serotype1

Serotype 19 F
Serotype 9V and 14 Serotype 23 F
IPD1,2,10 IPD1,2,10
IPD1,2,10
Pneumonia1,2,12,14 Pneumonia1,2,12,14
Pneumonia1,2,12,14 AOM1,2,13,15
AOM1,2,13,15
AOM1,2,13,15
IPD: Invasive Pneumococcal Disease; AOM: Acute Otitis Media
References in foot notes These slides are for information or education purposes only and not for distribution or promotion.
Serotype Coverage Difference between different PCVs
from Recently Reported Studies from India1-3
100.0%
88% Older PCV10 (Newer) PCV10 PCV13

80%
76.8%
Serotype coverage percentage
80.0% 76%
72.7%
66.3% 68%
64% 64%
60.0%
40.0%
20.0%
0.0%
Nisarga R Mehendale S Vandana G
et.al (2015) et.al (HBSSBM, et.al (PID OPS,

2016) 2016)
Studies that documented data on the prevalence of pneumococcal serotype distribution
Adapted from:
Singh J Vaccine. 2017 Aug 16;35(35):4501-9 (Supplement 2); SII-PCV10, www.pneumosil.com/vaccine
Abbreviations in footnotes
1. Singh J Vaccine. 2017 Aug 16;35(35):4501-9 (Supplement 2); 2. SII-PCV10, www.pneumosil.com/vaccine last accessed 26 th January 2021. 3. Seruminstitute.com. 2021. Serum Institute Of India.
Press Release. Available at: <https://www.seruminstitute.com/news_pneumosil_281220.php> [Accessed 11 January 2021 4. Synflorix [summary of product characteristics]. GlaxoSmithKline
Biologicals https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf last accessed 26th January 2021.
2. Broad Spectrum of the Disease Burden
In India
• S. pneumoniae as the leading cause of Meningitis1
• S. pneumoniae responsible for Pneumonia Deaths2
• Protection against S. pneumoniae Otitis media is important3
Vaccine type Pneumococcal serotypes responsible for disease burden4:
• 1, 5, 6B, 7F, 9V, 14, 19F, and 23F
• 3, 4, 6A, 18C and 19A
Coverage difference (Indian studies) between available PCVs4

• PCV13 vs Newer PCV10 – 7.6% to 10.7%
• PCV13 vs Older PCV10 – 12% to 23.3%

Pneumococcal Conjugate Vaccine offering a broad serotype coverage is
desirable
1. Jayaraman Y, Veeraraghavan B, Purushothaman GK, et.al. Burden of bacterial meningitis in India: Preliminary data from a hospital based sentinel surveillance network. PloS one. 2018 May
16;13(5):e0197198. . 2. Farooqui H, Jit M, Heymann DL, Zodpey S. Burden of severe pneumonia, pneumococcal pneumonia and pneumonia deaths in Indian states: modelling based estimates. PloS one.
2015 Jun 18;10(6):e0129191. 3.Rupa V et al. Epidemiol. Infect. (2016), 144, 2191–2199. 4. . Singh J Vaccine. 2017 Aug 16;35(35):4501-9 (Supplement 2);
No Topic

14
Serotype 41,2,3
• Characterized by their likelihood to cause invasive pneumococcal disease 2,3
• Serotype 4 is an outbreak serotype 1
• Outbreak serotypes are infrequently isolated from the nasopharynx of young

healthy children 1,4
– Brief duration of colonization
– Survive better in the environment
• Outbreak serotypes 4
– Have been responsible for serious pneumococcal disease in closed
settings in the post-antibiotic era5
– Hence there is a need for early recognition and implementation of public
health measures in order to interrupt transmission5.
Outbreak serotypes 1,4,6

Examples: 1, 4, 5, 7F, and 18C
Others include: 6C, 8, 12F, 21, 22F and 23B etc.
1. Zivich PN, Grabenstein JD, Becker-Dreps SI, Weber DJ. Streptococcus pneumoniae outbreaks and implications for transmission and control: a systematic review. Pneumonia. 2018;10:11 2. Byington CL et al. Clin
Infect Dis 2005; 41(1): 21-29 3. Bender JM et al. Clin Infect Dis 2008; 46(9): 1346-1352 4. Weinberger DM, Warren JL, Dalby T, Shapiro ED, Valentiner-Branth P, Slotved HC, et al. Differences in the Impact of
Pneumococcal Serotype Replacement in Individuals With and Without Underlying Medical Conditions. Clin Infect Dis. 2019 Jun 18;69(1):100-6.5. Ihekweazu C et al. Outbreaks of serious pneumococcal disease in
closed settings in the post-antibiotic era: A systematic review. Journal of Infection (2010) 61, 21-27 6. Adebanjo TA, Pondo T, Yankey D, Hill HA, Gierke R, Apostol M, Barnes M, Petit S, Farley M, Harrison LH,
Holtzman C. Pneumococcal Conjugate Vaccine Breakthrough Infections: 2001–2016. Pediatrics. 2020 Mar 1;145(3).
Serotype 18 C 1,2,3
• Causes pneumococcal meningitis or bacteremic pneumonia

(Invasive Pneumococcal Disease)1
• Outbreak serotype responsible for Epidemic cycles 2,3

 Associated with higher case fatality 2,3
 Responsible for prolonged hospitalization rates 2,3

1. Imöhl M, Reinert RR, Ocklenburg C, van der Linden M. Association of serotypes of Streptococcus pneumoniae with age in invasive pneumococcal disease. Journal of clinical
microbiology. 2010 Apr 1;48(4):1291-6.; 2. Weingberger DM et al. Clin Infect Dis 2019; 69(1): 2. 3. Angelique G. S. C. Jansen, et al. Invasive Pneumococcal Disease among Adults:
Associations among Serotypes, Disease Characteristics, and Outcome. Clinical Infectious Diseases 2009; 49:e23–9
Serotype-Specific IgG Levels per Group Pre- and Post-Booster
PCV10, for
PCV13, 3+1
Children Vaccinated With PCV10 or PCV13 in the Netherlands
Serotype 6A Serotype 19A

*,†
40 37.45 18
Pre-booster Pre-booster *,†
Post-booster Post-booster 15.6
GMC mean concentration (μg/mL)
GMC mean concentration (μg/mL)

35 16
30 14
12
25
10
20
8
15
6
10 4
5 * † 2 0.86
* †
1.53 0.73 0.17 0.63

0.11
0 0
PCV10 PCV13 PCV10 PCV13
*P<0.05 compared with pre-booster counterparts *P<0.05 compared with pre-booster counterparts

†
PCV10 vs PCV13, P<0.001 †
PCV10 vs PCV13, P<0.001
Adapted from:
van Westen E, et al. Clin Infect Dis. 2015;61(3):342-349.
GMC=geometric mean concentration; IgG=immunoglobulin G.
1. van Westen E, Wijmenga-Monsuur AJ, van Dijken HH, et al. Differential B-cell memory around the 11-month booster in children vaccinated with a 10- or 13-valent pneumococcal 17
conjugate vaccine. Clin Infect Dis. 2015;61(3):342-349.
Serotype-Specific Memory B-cell Frequencies per Group Pre- and
Post-Booster for Children Vaccinated With PCV10 or PCV13 in
PCV10, PCV13, 3+1
the Netherlands
Serotype 6A Serotype 19A

50 30
Pre-booster *,† Pre-booster
45 Post-booster 43.56 Post-booster †
25 24.41
40
35
20
PBMCs
PBMCs
30 †
15.00
25 15
20 †
13.12 10
15
10 8.5
5 4.04 4.61
5 3.06
0 0
PCV10 PCV13 PCV10 PCV13
*P<0.05 compared with pre-booster counterparts †
PCV10 vs PCV13, P≤0.001

†
PCV10 vs PCV13, P=0.001
Adapted from: PBMCs=peripheral blood mononuclear cells.

van Westen E, et al. Clin Infect Dis. 2015;61(3):342-349.
1. van Westen E, Wijmenga-Monsuur AJ, van Dijken HH, et al. Differential B-cell memory around the 11-month booster in children vaccinated with a 10- or 13-valent pneumococcal 18
conjugate vaccine. Clin Infect Dis. 2015;61(3):342-349.
Serotype 3
PCV13 Provides Direct Protection Against Serotype 3 IPD in Young Children
Meta-analysis of Case Control Studies with Similar

Methodologies and High Quality
Study and Serotype 3
Year Setting Age in Months VE (95% CI) Cases
Study 4 (2014) England, Wales, N. Ireland 4 to ≤56 26 (-69, 68)* 55
Study 1 (2016) United States 2 to 59 79.5 (30.3, 94.8)† 43
Study 3 (2016) Germany ≤ 24 74 (2, 93)† 11

Study 2 (2017) Spain 7 to 59 25.9 (-65.3, 66.8)† 37
Overall (I2 = 15.7%, p=0.313) 63.5 (37.3, 89.7)

NOTE: Weights are from random effects analysis
-100 0 50 100
Not Effective Effective
Adapted from: Sings HL, et al. Clin Infect Dis. 2019: 68(12): 2135-43
Overall Serotype 3 IPD Vaccine Effectiveness of 63.5% (95%CI, 37.3, 89.7)

*VE for at least 2 doses before 12 months or 1 dose on or after 12 months. As a VE estimate was not available for at least 1 dose in this study, the
lower of the 2 VE estimates provided was used for the pooled analysis
IPD: Invasive Pneumococcal Disease; VE: Vaccine Effectiveness
Sings HL, et al. Clin Infect Dis. 2019: 68(12): 2135-43 These slides are for information or education purposes only and not for distribution or promotion.
3. Is it important for a PCV to include
Serotype 3
• PCV13 provides a direct protection in children1
Serotypes 4 and 18C

• Widespread usage of PCV7/PCV13 and older PCV10 for all these years has
controlled the disease burden due to these serotypes and hence their removal
from the vaccine can result in outbreaks2,3 (resurgence of infections)
Serotypes 6A and 19A

• Experience with PCVs have now shown that direct protection against serotypes
6A and 19A is desirable and is definitely superior to any cross protection offered
by the unrelated serotypes even of the same group in a PCV formulation as
mentioned in the IAP recommended Immunization schedule4
It is important as well as essential for a PCV to include serotypes 3, 4, 18C, 6A

and 19A for a broader coverage
1. Sings HL, et al. Clin Infect Dis. 2019: 68(12): 2135-43 2. Weinberger DM, Warren JL, Dalby T, Shapiro ED, Valentiner-Branth P, Slotved HC, et al. Differences in the Impact of
Pneumococcal Serotype Replacement in Individuals With and Without Underlying Medical Conditions. Clin Infect Dis. 2019 Jun 18;69(1):100-6. 3. Angelique G. S. C. Jansen, et al. Invasive
Pneumococcal Disease among Adults: Associations among Serotypes, Disease Characteristics, and Outcome. Clinical Infectious Diseases 2009; 49:e23–9 4. Vashishtha VM. Key
statements of IAPCOI and IAP Immunization Timetable for year 2012. Pediatric Infectious Disease. 2012 Jul 1;4(3):112-24.
No Topic

21
Do both aspects of Immunogenicity (IgG & OPA) matter? 1-4
• Memory B cells are
associated with protection
Serotype-specific IgG (ELISA) against nasopharyngeal
measured post-vaccination carriage acquisition
reflects intensity of the immune
system stimulations, and thus • Important predictors for
may be used as surrogate for overall impact of PCV on
memory B-cell stimulation all pneumococcus related
disease
Opsonophagocytic activity (OPA)

titer is a surrogate of functional • Direct protection
humoral protection

IgG – Immunoglobulin G - measures quantity (amount) of antibody i.e. Geometric Mean Concentration (GMC)
OPA – Opsonophagocytic assay measures quality of the antibody i.e. Geometric Mean Titer (GMT)
1. Papadatou I et al. The Role of Serotype-Specific Immunological Memory in Pneumococcal Vaccination: Current Knowledge and Future Prospects. Vaccines (Basel) 2019 Mar; 7(1): 13.
2. Pennington et al, Am J Respir Crit Care Med, 2016: 194:1523–31
3. Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody
concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011;18(12):2161-2167. doi:10.1128/CVI.05313-11
4. Song JY, Moseley MA, Burton RL, Nahm MH. Pneumococcal vaccine and opsonic pneumococcal antibody. Journal of Infection and Chemotherapy. 2013 Jun 1;19(3):412-25.
Pneumococcal Serotype-specific IgG GMCs Four Weeks After the
Third Primary Dose of newer PCV 10 or PCV131
IgG ELISA
% ≥0.35 µg/mL (95% CI)
Newer PCV10 PCV13 % diff (95% CI)
1 99 (94.6, 100.0) 100 (96.4, 100.0) −1.0 (−5.5, 2.8)
5 100 (96.4, 100.0) 97 (91.5, 99.4) 3 (−1.2, 8.4)
6A 79 (69.7, 86.5) 91 (83.6, 95.8) −12.0 (−21.9, −2.0)
6B 89 (81.2, 94.4) 96.9 (91.1, 99.4) −7.9 (−15.8, −0.5)
7F 97 (91.5, 99.4) 100 (96.4, 100.0) −3.0 (−8.4, 1.2)
9V 94 (87.4, 97.8) 97 (91.5, 99.4) −3.0 (−9.8, 3.3)
14 98 (93.0, 99.8) 97 (91.4, 99.4) 1 (−4.4, 6.7)
19A 92 (84.8, 96.5) 97.9 (92.7, 99.8) −5.9 (−13.1, 0.6)
19F 99 (94.6, 100.0) 99 (94.6, 100.0) 0 (−4.5, 4.6)
23F 91 (83.6, 95.8) 97 (91.5, 99.4) −6.0 (−13.5, 0.9)
PCV: Pneumococcal conjugate vaccine; IgG: Immunoglobulin G; GMC: Geometric mean concentration; ELISA: enzyme-linked immunosorbent assay

Adapted from: Clarke, E. et al. Vaccine 2020; 38(2): 399-410
Compared to PCV13, serotypes 6A, 6B, 19A, and 23F in newer PCV10 missed the
threshold cut off (% responders IgG ≥0.35 μg/mL), i.e. their IgG responses were
lower
1. Clarke, E. et al. Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine candidate in adults, toddlers, and infants in The Gambia—
Results of a phase 1/2 randomized, double-blinded, controlled trial Vaccine 2020; 38(2): 399-410 These slides are for information or education purposes only and not for distribution or promotion.
Pneumococcal OPA GMTs Four Weeks After the Third Primary Dose of Either newer PCV10
or PCV131
OPA GMT
Newer PCV10 PCV13 Newer PCV10 vs PCV13
GMT GMT GMT Ratio p value

(95% CI) (95% CI) (95% CI)
1 50.7 29.4 1.72 0.353
(24.9, 109.9) (13.9, 80.4) (0.52, 5.16)
5 113.9 104.8 1.09 0.836
(65.9, 176.6) (57.2, 200.4) (0.48, 2.34)
6A 1243.9 3068.2 0.41 0.007
(880.7, 1942.6) (2052.7, 5700.0) (0.23, 0.88)
6B 1530.4 2267.4 0.67 0.38
(821.7, 2516.2) (950.0, 3873.7) (0.32, 2.00)
7F 876.6 3763.2 0.23 <0.001
(570.7, 1291.6) (2562.5, 5702.5) (0.13, 0.42)
9V 197.2 752.8 0.26 <0.001
(80.5, 379.5) (492.7, 1084.4) (0.10, 0.57)
14 1243.4 1108 1.12 0.822
(652.1, 2035.0) (410.7, 2306.8) (0.45, 3.48)
19A 151.3 765.7 0.2 <0.001
(51.7, 252.6) (568.6, 928.5) (0.07, 0.34)

19F 744.9 499 1.49 0.201
(580.7, 974.1) (223.8, 752.9) (0.96, 3.77)
23F 627.3 921.4 0.68 0.356
Adapted from: Clarke, E. et al. Vaccine 2020; 38(2): 399-410
(294.4, 1040.3) (508.1, 1498.6) (0.29, 1.47)
Compared to PCV13, serotypes 7F, 9V and 19A missed the twofold criterion (GMC ratio)
PCV: Pneumococcal conjugate vaccine; OPA: opsonophagocytic assays; GMT: Geometric mean titer
4a. Do both aspects of Immunogenicity (IgG & OPA) matter?
Both IgG and OPA are important parameters of judging an immune

response and how a vaccine will work
• IgG – Newer PCV10 immune responses to serotype 6A, 6B, 19A,

and 23F missed the WHO-established immunogenicity threshold (%
responders IgG ≥0.35 μg/mL) vs PCV13
• OPA GMT - Serotypes 7F, 9V and 19A, missed the GMC ratio
twofold criterion
Based on immunogenicity results available, newer PCV10 may be

at considered as “comparable” to PCV13 for 4 serotypes (1, 5, 14
and 23F) based on IgG and OPA titers

4b. Product Switching – Can it be done with PCVs?
• WHO SAGE recommends that product switching for individual children is

only acceptable if it is not possible to complete the primary series or
booster with the original product1.
• PCV interchangability dossier released by John Hopkins University

makes it clear that the available interchangeability data, especially for
newer PCV10 are limited 2

WHO: world health organization; SAGE: Strategic Advisory Group of Experts on Immunization
1. Pneumococcal conjugate vaccines. Weekly Epidemiological Records 2017; 92: 729-748
2. Evidence Dossier. Pneumococcal Conjugate Vaccine (PCV) Interchangeability. John Hopkins Bloomberg School of Public Health. November 2019: 1-16.
4c. Booster Dose – What is its relevance?
• Booster dose is a supplementary injection of a vaccine given to

maintain the immunization provided by an earlier dose1.
• A booster dose reactivates immune memory (memory B cells) and
results in a rapid increase of IgG antibody titer by a rapid proliferation
of memory B cells and their evolution into abundant antibody
secreting plasma cells. 2
• Booster is recommended across children population be it for
vaccines like Hib, IPV, DTwP/DTaP and PCVs (PCV13 and older
PCV10)2
• Newer PCV10 does not have booster dose recommendation in its

label3
Hib: Haemophilus influenzae type b; IPV: Inactivated poliovirus vaccine; DTwP: diphtheria, tetanus, and whole-cell pertussis; DTaP: diphtheria, tetanus, and acellular pertussis; PCV: Pneumococcal conjugate vaccine
1. Definition of booster dose | Dictionary.com. www.dictionary.com. 2021 [cited 28 January 2021]. Available from: https://www.dictionary.com/browse/booster--dose
2. Balasubramanian S et al. IAP Guidebook on Immunization 2018-19 By Advisory Committee on Vaccines and Immunization Practices (ACVIP) pp20
3. Pneumosil package insert These slides are for information or education purposes only and not for distribution or promotion.
No Topic

28
PCV Impact over twenty years of use
• From its introduction in 2000, PCV7 and PCV13 demonstrated efficacy and effectiveness in multiple
countries around the world1
• PCV7 and PCV13 utilized a single-protein carrier (CRM 197) with >20 years of use in other pediatric
vaccines, the same protein carrier currently used in PCV 13 2,3
IPD Pneumonia AOM Herd Effect

• USA: 100% decrease in • USA: 39% reduction in all- • Greece: 48% reduction in • USA: 92% reduction of
vaccine-type IPD (<5 years)4 cause community-acquired pneumococcal AOM visits vaccine-type IPD (≥65
• UK: 98% decrease in pneumonia hospitalizations (<14 years)13 years)4
vaccine-type IPD (<2 years)5 (<2 years)10 • Greece: 38% reduction in • Norway: 48% reduction of
• Norway: 95% decrease in • USA: 65% reduction in overall AOM episodes (<14 vaccine-type IPD (>5
vaccine-type IPD (<5 years)6 pneumococcal pneumonia years)13 years)6
hospitalizations (<2 years)10 • USA: 43% reduction in • UK: 81% reduction of
• Ireland: 91% decrease in
vaccine-type IPD (<2 years)7 • UK: 22% reduction in ambulatory visits for AOM vaccine-type IPD (≥65
empyema-related (<2 years)14 years)5
• Belgium: 97% decrease
hospitalization (<15 years)11 • Italy: 36% reduction in
in vaccine-type IPD (<5
years)8 • Italy: 71% reduction in vaccine-type AOM
• Netherlands: 90% pneumococcal pneumonia hospitalizations (<2 years)12

decrease in vaccine-type hospitalizations (<2 years)12
IPD (<2 years)9
•AOM=acute otitis media. IPD – Invasive Pneumococcal Disease PCV: Pneumococcal conjugate vaccine
1. Data on file. Pfizer Inc, New York, NY. 2. Centers for Disease Control. MMWR Morb Mortal Wkly Rep. 1991;40(RR01):1-7. 3. Prevenar [summary of product characteristics]. Kent, United Kingdom: Pfizer Limited;
2011. 4. Pilishvili T, et al. J Infect Dis. 2010;201(1):32-41. 5. Miller E, et al. Lancet Infect Dis. 2011;11(10):760-768. 6. Vesterheim DF, et al. Vaccine. 2010;28(10):2214-2221. 7. HPSC Annual Report. 1.8
Streptococcus pneumoniae (invasive). 2010:28-30. 8. Pedisurv Annual Reports. Surveillance des maladies infectieuses chez les enfants en Belgique. 2009. www.wiv-isp.be/pedisurv. Accessed 22 SEP, 2020. 9.
Rodenburg G, et al. Emerg Infect Dis. 2010;16(5):816-823. 10. Grijalva C, et al. Lancet. 2007;369(9568):1179-1186. 11. Koshy E, et al. Thorax. 2010;65(9):770-774. 12. Durando P, et al. Vaccine. 2009;27(25-
26):3459-3462. 13. Stamboulidis K, et al. Ped Infect Dis J. 2011;30(7):551-555. 14. Zhou F, et al. Pediatrics. 2008;121(2):253260. 29
PCV13 Has Shown Substantial Impact on Invasive Pneumococcal Disease in
Infants after Introduction in National Programs
NORWAY4‡
100%
(<2 years)
DENMARK7‡
ENGLAND 84%
AND WALES2 (<2 years)
89%
ISRAEL6†
(<2 years)
70%
(<5 years)
US1 ‡
AUSTRALIA9 $
93%
(<5 years) 70%
(<2 years)
GAMBIA8 ‡
82% FRANCE3‡ South Africa5‡

(<2 years)
84% 57%
(<2 years) (<2 years) PCV13 NIP 10
PCV: Pneumococcal Conjugate Vaccine; IPD: Invasive Pneumococcal Disease; NIP: national immunization program
† Due to serotypes 1, 3, 5, 7F, and 19A in PCV13; ‡ Due to 6 additional serotypes in PCV13; $ 70% reduction was observed in children aged < 2 years in 2014 compared to 2008-2011
1. Moore MR, et al. Lancet Infect Dis. 2015;15(3):301-309; 2. Waight PA, et al. Lancet Infect Dis. 2015;15(5):535-543; 3. 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
PCV13 Has Shown Substantial Impact on All Cause
Pneumonia after Introduction in National Programs
US1*
27%
(<2 years)
FRANCE4
32%
(<2 years)
ISRAEL5†
NICARAGUA2 59%
33% (<5 years)
URUGUAY3†
(<1 year)

39%
(≤2 years)
PCV13 NIP 6
Reductions in hospitalizations; † Bacteremic pneumonia;
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. Hortal M, et al. Vaccine. 2012;30(33):4934-4938;
4. Angoulvant F, et al. Clin Infect Dis. 2014;58(7):918-924; 5. Ben-Shimol S, et al. Pediatr Infect Dis J. 2015;34(4):409-416; 6. NIP PCV13 – Data on file
PCV – Pneumococcal Conjugate Vaccine. NIP: National immunization program

PCV13 Has Shown Substantial Impact on Acute Otitis
Media after Introduction in National Programs
UK2*
51%
(<10 years)
US1*
40.5%
(<2 years)
ISRAEL3†‡
85%
(<2 years)

PCV13 NIP 4
All-cause OM; † Pneumococcal OM caused by additional PCV13 serotypes 1, 3, 5, 7F, and 19A; ‡ Includes complex OM cases; OM = Otitis Media;
1. Marom TM, et al. JAMA Pediatr. 2014;168(1):68-75; 2. Lau WCY, et al. Vaccine. 2015;33(39):5072-5079; 3. Ben-Shimol S, et al. Clin Infect Dis. 2014;59(12):1724-1732; 4. NIP PCV13 –
Data on file
PCV – Pneumococcal Conjugate Vaccine. NIP: National immunization program

PCV13 Has Shown Substantial Reduction in Nasopharyngeal
Colonization after Introduction in National Programs
US1,2 France3,4 Israel5 Italy6
PCV13 vs. PCV7 PCV13 vs. PCV7

Post-PCV13 introduction
Significantly lower Significant decline
Reduction observed
in children with AOM for additional serotypes
in children <5 years1
<2 years3 in children 7–24 months5
Post-PCV13 introduction Post-PCV13 introduction

PCV13 vs. PCV7
Significant decrease Smaller proportion
Prevalence was lower

in children 6–59 of isolates in children
in children 3–59 months6
months old2 3–40 months4
1. Loughlin AM, et al. Pediatr Infect Dis J. 2014;33(5):504-510; 2. Desai AP, et al. Pediatr Infect Dis J. 2015;34(11):1168-1174; 3. Cohen R, et al. Pediatr Infect Dis J. 2012;31(3):297-301; 4.
Dunais B, et al. Pediatr Infect Dis J. 2015;34(3):286-288; 5. Dagan R, et al. Clin Infect Dis. 2013;57(7):952-962; 6. Zuccotti G, et al. Vaccine. 2014;32(5):527-534.
PCV – Pneumococcal Conjugate Vaccine.
PCV13 Has Shown Substantial Decrease in Antibiotic
Resistant IPD in Children <5 Years
Annual Rates of Antibiotic Resistant IPD, 2005–2013 *†‡§
10
PCV13
IPD Cases per 100,000
8
Antibiotic % Change
6 2009 vs. 2013
63% Macrolides
4
Cephalosporin
81%
s
2
81% Tetracyclines
0 83% Penicillins
2005 2006 2007 2008 2009 2010 2011 2012 2013
Year
Macrolides Cephalosporins Tetracyclines Penicillins

Adapted from: Tomczyk S, et al. Clin Infect Dis. 2016;62(9):1119-1125
Following the introduction of PCV13 in 2010, the incidence of antibiotic resistance was substantially reduced
for macrolides, cephalosporins, tetracyclines, and penicillins in children <5 years of age in USA
* All isolates were susceptible to fluoroquinolones or glycopeptides; † Pre-PCV13 era (2005–2009); post-PCV13 era (2010–2013); ‡ A total of 1130 non-susceptible IPD isolates were
obtained from the blood, cerebrospinal fluid, or pleural fluid between 2005 and 2013 from children <5 years of age. 1; § CLSI breakpoints were used to define non-susceptibility.
CLSI = Clinical and Laboratory Standards Institute;
PCV: Pneumococcal Conjugate Vaccine.
Tomczyk S, et al. Clin Infect Dis. 2016;62(9):1119-1125 These slides are for information or education purposes only and not for distribution or promotion.
PCV13 Has Shown Substantial Herd Effect in Adults ≥65
Years
50
PCV13
40 PCV7
(2000–2007 to 2011–2013)
100,000 Population
No. of Cases per
30
10% reduction in 6
v additional PCV13
20
serotypes
10 88% reduction in
PCV7 serotypes
0
00
01
02
03
04
05
06
07
08
09
10
11
12
13
20
20
20
20
20
20
20
20
20
20
20
20
20
20
Year
PCV7 Serotypes PCV13 Additional Serotypes Non-PCV7 / PCV13 Serotypes

Adapted from: Harboe ZB, et al. Clin Infect Dis. 2014;59:1066-1073; Statens Serum Institute (2015)
25% reduction in overall IPD cases was observed post-PCV13 introduction

(2011–2013) compared to the pre-PCV period (2000–2007) in Denmark
IPD = Invasive Pneumococcal Disease; PCV7 = 7-valent Pneumococcal Conjugate Vaccine; PCV13 = 13-valent Pneumococcal Conjugate Vaccine;
1. Harboe ZB, et al. Clin Infect Dis. 2014;59:1066-1073;
2. Statens Serum Institute. Invasive pneumococcal disease and PCV coverage 2013. https://en.ssi.dk/news/epi-news/2013/no-19---2013 Accessed Jan 26, 2021
5. Driving Evidence based differentiation
PCV13 has shown substantial impact on

• Invasive Pneumococcal Disease
• All cause pneumonia
• Otitis media
• Nasopharyngeal colonization
• Antibiotic resistance
• Herd effect in adults >65 years

Robust impact data does lead us to choose the right PCV
References in footnotes These slides are for information or education purposes only and not for distribution or promotion.
No Topic

37
PCV13 Is Included in Over 130 NIPs, With Exclusivity in
127 Countries Worldwide1,2
PCV13 Only* = 127
PCV13 / Older PCV10† Shared = 5

(PCV13 covers >50% of total BC)
PCV13 / Older PCV10† Shared = 1

(PCV13 covers <50% of total BC)
Older PCV10 Only = 31

BC: Birth cohort. As of Nov 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.
1. Gavi Alliance Annual Progress Report 2017. http://www.gavialliance.org/results/gavi-progress-reports/. Accessed Dec 18, 2020.
2. Data on file. Pfizer Inc, New York, NY. 2020.
Safety profile of PCV 13 has been evaluated in several
clinical trials1
13 controlled clinical trials
Approximately 15,000 doses given to 4,729 healthy infants, from

6 weeks through 16 months of age
In a catch-up study, 354 children (7 months to 5 years) who received
at least one dose of PCV13 were also assessed for safety
PCV13 was co-administered with routine pediatric vaccines.
PCV13 was generally well tolerated in clinical trials in infants

and children. The adverse event profile generally similar to that
of PCV7 after any vaccine dose2

Concomitant administration of PCV 13 demonstrated with: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated polio myelitis, hepatitis B,
meningococcal serogroup C, measles, mumps, rubella, and varicella.
PCV13: Pneumococcal conjugate vaccine
1. Prevenar 13 Local Product Document LPDPRV072019, version 17

2. Sean T. Duggan. Pneumococcal Polysaccharide Conjugate Vaccine (13-Valent Adsorbed) [Prevenar
These13], Drugs
slides 2010;
are for 70 (15):or1973-1986
information education purposes only and not for distribution or promotion.
The Value of PCV
6 weeks to 5 ≥ 50 years
years 6 to 17
years
13 valent Pneumococcal Conjugate Vaccine (PCV 13)

The First and Only PCV to Help Protect children, adolescents and adults over 50 years,
at Increased Risk for Pneumococcal Disease 1-3

1. Prevenar 13 Local Product Document LPDPRV072019, version 17
2. Pneumococcal conjugate vaccine 10-valent product monograph; August 31, 2018 https://ca.gsk.com/media/591956/synflorix.pdf [Last accessed on 27 Jan 2021]
3. Pneumosil package insert
PCV: Pneumococcal conjugate vaccine

SUMMARY: Relying on Evidence based decisions in
choosing broad coverage PCV in practice
1. PCV should be able to cover the broad pneumococcal disease
spectrum including invasive pneumococcal disease, pneumonia and
otitis media*
2. Should have a broad disease coverage
3. PCV should be able to demonstrate an impact that extends beyond

pneumococcal disease prevention
• Not only demonstrate impact in invasive pneumococcal disease,
pneumonia, otitis media*
• But also show effect in reducing nasopharyngeal carriage, curbing
antibiotic resistance and demonstrating herd effect
4. Of the available PCVs, it is PCV13 that is included in 130 National

Immunization Programs, with exclusivity in 127 countries worldwide
5. PCV13 is the first and only PCV to Help Protect children (6 weeks to 5
years), 6-17 years and adults over 50 years
* - caused by serotypes included in the vaccine
PCV – Pneumococcal Conjugate Vaccine These slides are for information or education purposes only and not for distribution or promotion.
Thank you !
Don’t hesitate, vaccinate! 1

1. Don’t hesitate, vaccinate! . Who.int. 2016 [cited 24 January 2021]. Available from: 42
https://www.who.int/china/news/detail/26-04-2016-don-t-hesitate-vaccinate- These slides are for information or education purposes only and not for distribution or promotion.
PREVENAR 13® (Pneumococcal Polysaccharide Conjugate Vaccine [Adsorbed] I.P., 13-Valent)
Summary of prescribing Information (1/2)
Adapted from LPDPRV072019, version 17
Composition: Pneumococcal 13-valent Conjugate Vaccine is a sterile solution of saccharides of the capsular antigens of Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated by reductive amination to non-toxic diphtheria CRM 197 protein.
Each 0.5 mL dose is formulated to contain 2.2 μg of each saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 4.4 μg of
saccharide for serotype 6B, conjugated to CRM197 carrier protein, 0.02% polysorbate 80 and 0.125 mg of aluminum as aluminum phosphate adjuvant.
Indications:
 For active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F
and 23F (including sepsis, meningitis, bacteremia, pneumonia and acute otitis media) in infants and children from 6 weeks to 5 years of age.
 For active immunization for the prevention of Pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B,
7F, 9V, 14, 18C, 19A, 19F and 23F in children of 6 years to 17 years of age.
 For active immunization for the prevention of Pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B,
7F, 9V, 14, 18C, 19A, 19F and 23F in adults of 50 years and older age group.
Contraindications: Hypersensitivity to any component of the vaccine, or to diphtheria toxoid
Adverse reactions:
 Infants and children aged 6 weeks to 5 years: Decreased appetite, irritability, drowsiness/increased sleep; restless sleep/decreased sleep, Fever;
any injection-site erythema, induration/swelling or pain/tenderness; injection-site erythema or duration/swelling; diarrhea; vomiting.
 Children and adolescents 6 to 17 years of age: Decreased appetite, Irritability; any vaccination-site erythema; induration/swelling or
pain/tenderness; somnolence; poor quality sleep; vaccination-site tenderness
 Adults aged 50 years and older: Decreased appetite, Headaches, Diarrhea, Rash, generalized new/aggravated joint pain; generalized
new/aggravated muscle pain, Chills; fatigue; vaccination-site erythema, vaccination site induration/swelling; vaccination-site pain/tenderness;
limitation of arm movement, vomiting, Fever.
Warnings and Precautions: Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine and will not protect
against other microorganisms that cause invasive disease, pneumonia, or otitis media. This vaccine is not intended to be used for treatment of active
infection. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic
event following the administration of the vaccine. The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be

considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation), and particularly for those with
a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Reference: Prevenar13 Prescribing Information. Pfizer Limited LPDPRV072019, version 17 full prescribing information available on request
Registered Proprietor – Wyeth LLC, USA. Licensed User – Pfizer Limited, India.
For the use only of registered medical practitioners or a hospital or a laboratory.

Pfizer Limited, The Capital – A Wing, 1802, 18 th Floor, Plot No. C-70, G
Block, Bandra-Kurla Complex, Bandra (East), Mumbai 400 051, India These slides are for information or education purposes only and not for distribution or promotion.
Summary of prescribing Information (2/2)
Dosage: (For intramuscular use only)

For infants, the immunization series of Prevenar 13 consists of 3 doses of 0.5ml each at 6 weeks, 10 weeks and 14 weeks of age, followed by a
fourth dose of 0.5 ml at 12-15 months of age. The customary age for the first dose is 2 months of age, but it can be given as young as 6 weeks of
age. The recommended dosing interval is 4 to 8 weeks. The fourth dose should be administered at least 2 months after the third dose.
For children 6 years to 17 years of age, 1 dose of 0.5 mL Prevenar 13
For adults 50 years of age and older, Prevenar13 is to be administered as a single dose, including for those previously vaccinated with a
pneumococcal polysaccharide vaccine.

Pharmaceutical Form, Dosage and Method of Administration: 0.5 mL/dose intramuscularly. Prevenar 13 is available as a pre-filled syringe.
The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in older children and adults. The
vaccine should not be injected in the gluteal area.

Interactions:
Infants and children aged 6 weeks to 5 years: Prevenar 13 can be given with any of the following vaccine antigens, either as monovalent or
combination vaccines: diphtheria, tetanus, acellular or whole-cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B,
meningococcal serogroup C, measles, mumps, rubella and varicella. Prevenar 13 can also be given concomitantly between 12-23 months with the
tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with
Prevenar 13
Adults aged 50 years and older: Prevenar 13 can be administered concomitantly with trivalent inactivated influenza vaccine (TIV). The immune
responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.

Overdose: Overdose with Prevenar 13 is unlikely due to its presentation as a pre-filled syringe and as a single dose vial. However, there have
been reports of overdose with Prevenar 13 defined as subsequent doses administered closer than recommended to the previous dose. In general,
adverse events reported with overdose are consistent with those that have been reported with doses given in the recommended schedules of
Prevenar 13.


Storage: Store refrigerated at 2°C to 8°C. Do not freeze. Discard if the vaccine has been frozen. Store in original package.
Reference: Prevenar13 Prescribing Information. Pfizer Limited. LPDPRV072019, version 17 full prescribing information available on request

Balancing Risk Information
Prevenar 13 does not provide 100% protection against vaccine serotypes or protect against non-vaccine serotypes. The approval of
Prevenar 13 was based upon functional antibody responses in adults 50 years and older. Measures of immune responses to Prevenar 13
reflect the study population and do not necessarily predict protection in an individual. The antibody threshold that correlates with protection
against pneumococcal disease / invasive pneumococcal disease in adults has not been determined for any serotype Memory B cell
production has not been studied with Prevenar 13 in adults. The frequency of pneumococcal serotypes and serogroups can vary from
country to country, which could influence the effectiveness of vaccination in any given country. Since serotypes other than those contained in
the vaccine may contribute to the burden of pneumococcal disease/invasive pneumococcal disease, protection against all pneumococcal
disease/invasive pneumococcal disease should not be expected. When compared with a non-conjugated pneumococcal polysaccharide
vaccine (PPSV) in pivotal clinical trials, Prevenar 13 demonstrated a non-inferior functional antibody response (primary end point) for all
shared serotypes, and the immune response to 6A achieved predetermined study thresholds for superiority. Prevenar 13 is approved for use
in children from 6 weeks to 5 years of age; children 6 years to 17 years of age; and adults of 50 years of age and above.

Reference: Prevenar13 Prescribing Information. Pfizer Limited. LPDPRV072019, version 17
full prescribing information available on request


PP-PNP-IND-0531 - Evidence Based Decision Choosing PCV

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Evidence based decision in choosing

broad coverage pneumococcal

PP-PNP-IND-0531 | 01 February, 2021

PP-PNP-IND-0531 | 01 February, 2021

• In children, mortality is highest in young infants2

PP-PNP-IND-0531 | 01 February, 2021

PP-PNP-IND-0531 | 01 February, 2021

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

6B 9V 14 19F 23F 1 5 7F 6A 19A

Protein Carrier Conjugation Chemistry

PP-PNP-IND-0531 | 01 February, 2021

PP-PNP-IND-0531 | 01 February, 2021

PP-PNP-IND-0531 | 01 February, 2021

India picture - S. pneumoniae as the leading cause of Meningitis4

PP-PNP-IND-0531 | 01 February, 2021

India picture - S. pneumoniae and Pneumonia Deaths4

• Incidence is 0.37 episodes per child-year for clinical pneumonia

• Case fatality rate in severe pneumonia is 9.96%

Severe Pneumonia Pneumococcal Pneumonia

PP-PNP-IND-0531 | 01 February, 2021

1. Synflorix [summary of product characteristics]. GlaxoSmithKline Biologicals https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf last

India picture - S. pneumoniae Otitis media – is protection desirable?

• Significant cause of childhood morbidity (hearing

• Acute Otitis Media in Indian infants is often

• Vaccine effective against Otitis Media is high in

PP-PNP-IND-0531 | 01 February, 2021

Serotypes causing AOM 7-10

Pneumococcal Serotypes & Disease Coverage

Serotype 3 Serotype 4 Serotype 18C Serotype 6A Serotype 19 A

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

Serotype 1 Serotype 5 Serotype 6B Serotype 7F

PP-PNP-IND-0531 | 01 February, 2021

88% Older PCV10 (Newer) PCV10 PCV13

PP-PNP-IND-0531 | 01 February, 2021

Coverage difference (Indian studies) between available PCVs4

PP-PNP-IND-0531 | 01 February, 2021

PP-PNP-IND-0531 | 01 February, 2021

• Outbreak serotypes are infrequently isolated from the nasopharynx of young

PP-PNP-IND-0531 | 01 February, 2021

• Causes pneumococcal meningitis or bacteremic pneumonia

• Outbreak serotype responsible for Epidemic cycles 2,3

PP-PNP-IND-0531 | 01 February, 2021

Serotype 6A Serotype 19A

GMC mean concentration (μg/mL)

1.53 0.73 0.17 0.63

PP-PNP-IND-0531 | 01 February, 2021

GMC=geometric mean concentration; IgG=immunoglobulin G.

Serotype 6A Serotype 19A

PP-PNP-IND-0531 | 01 February, 2021

Adapted from: PBMCs=peripheral blood mononuclear cells.

Meta-analysis of Case Control Studies with Similar

Study 4 (2014) England, Wales, N. Ireland 4 to ≤56 26 (-69, 68)* 55

Study 1 (2016) United States 2 to 59 79.5 (30.3, 94.8)† 43

Study 3 (2016) Germany ≤ 24 74 (2, 93)† 11

Overall (I2 = 15.7%, p=0.313) 63.5 (37.3, 89.7)

Overall Serotype 3 IPD Vaccine Effectiveness of 63.5% (95%CI, 37.3, 89.7)

PP-PNP-IND-0531 | 01 February, 2021

IPD: Invasive Pneumococcal Disease; VE: Vaccine Effectiveness

Serotypes 4 and 18C

Serotypes 6A and 19A

It is important as well as essential for a PCV to include serotypes 3, 4, 18C, 6A

PP-PNP-IND-0531 | 01 February, 2021