The document provides details about Dr. Vijay K. Agrawal including his credentials and positions held. It also includes two disclosure statements indicating that Dr. Agrawal does not have any financial interests or arrangements that could be perceived as a conflict of interest. The rest of the document appears to be a slide presentation on pneumococcal disease.

1. 10/19/2020 VIJAY K AGRAWAL 1
Dr. VIJAY K. AGRAWAL
MBBS, MD, FCCP, FCCS, IDCCM
DIRECTOR, CRITICAL CARE MEDICINE & ACADEMIC PROGRAMS
SENIOR CONSULTANT, RESPIRATORY MEDICINE
HEAD , ITC/AHA BLS-ACLS COURSES & INFECTION CONTROL PROGRAM

2. 2
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3. 3
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4. 4
Overview
What is Pneumococcal Disease?01
Disease burden and Challenges02
Prevention Approach and Available Vaccines03
Evidences and Recommendations04

5. 5
WHY TO DISCUSS THIS TOPIC ???

6. 6
Global health-care concern
Preventable disease
The prevalence of antibiotic-resistant strains of S. pneumonia is increasing at an
alarming rate in India proving to be the primary obstacle in the effective treatment of
CAP.
Approximately 2.38 million deaths resulted from LRI in 2016.
S. pneumoniae emerged as the leading cause of LRI morbidity and mortality globally,
contributing to more deaths compared to all other etiologies combined
According to the World Health Organization (WHO), IPD (e. g., meningitis, pneumonia,
and sepsis) accounts for an estimated 600,000–800,000 cases of mortality among
adults every year.
Among American adults - >1.5 million adults are hospitalized annually due to the disease in the
country. Of the hospitalized patients, an estimated 100,000 die during hospitalization, and
approximately one out three patients die during subsequent years of hospitalization.
European region - among the adult population reported the incidence rate of CAP in the range of 1.6–11.6/1000
The WHO report revealed Asia to have the highest burden of pneumonia, with the
Indian subcontinent contributing the largest share of the disease burden.

7. 7
Basics

8. 8

9. 9

10. 10

11. 11
Clinical Presentations
Drijkoningen JJ, Rohde GG. Pneumococcal infection in adults: burden of disease. Clinical Microbiology and Infection. 2014 May;20:45-
51.
Pneumococcal
Disease
Non Invasive
(Mucosal)
URTI
LRTI
(Non-Pneumonia)
Pneumonia
Invasive
Bacteremia Meningitis
Other
Diseases
• Noninvasive forms of disease may become invasive
E.g., Pneumonia, when accompanied by bacteremia
URTI: upper respiratory tract infection
LRTI: lower respiratory tract infection

12. 12
Invasive Pneumococcal
Disease

13. 13

14. 14
Thomas K, Kesavan LM, Veeraraghavan B, Jasmine S, Jude J, Shubankar M, Kulkarni P, Steinhoff M, Network IS. Invasive
pneumococcal disease associated with high case fatality in India. Journal of clinical epidemiology. 2013 Jan 1;66(1):36-43.
J Clin Epidemiol.
2013;66(1):36-43.

15. 15
Case-fatality Rate in IPD Clinical Syndromes
Fatal Outcomes
Invasive Pneumococcal Disease (IPD)
36.9% 36.6%
20.8%
26.4%
0%
10%
20%
30%
40%
50%
Meningitis Sepsis Invasive
Pneumonia
Overall
Case-fatalityRate(%)
Clinical Presentation
Conclusion: Invasive Pneumococcal Disease (IPD) continues to be a problem
in India and is associated with high case fatality in spite of treatment in the
hospital setting. More than 80% of invasive STGs (Serotype/group) causing
disease in the elderly in India are included in the formulation of
polysaccharide pneumococcal vaccine

16. 16
ANSORP (2008–2009)
Asian Network for Surveillance of Resistant Pathogens (ANSORP)
• Surveillance network: 60 hospitals across 11 Asian countries
• 2184 S.pneumoniae isolates (Lower respiratory tract & Invasive)
Kim SH, Song JH, Chung DR, Thamlikitkul V, Yang Y, Wang H, Lu M, So TM, Hsueh PR, Yasin RM, Carlos CC. Changing trend of
antimicrobial resistance and serotypes in Streptococcus pneumoniae in Asian countries: an ANSORP study. Antimicrobial agents and
chemotherapy. 2012 Jan 9:AAC-05658.
Clinical Presentations of Serious Pneumococcal Disease
Pneumonia
80.0%
Meningitis
4.9%
Primary
Bacteremia
3.2%
Other,
11.9%
13.5% of Pneumonia
had Concomitant
Bacteremia

17. 17
Microbial Causes of Community
Acquired Pneumonia (CAP):
Observations Based on Site of Care
ICU: Intensive care unit
Cilloniz C, Martin-Loeches I, Garcia-Vidal C, San Jose A, Torres A. Microbial etiology of pneumonia: Epidemiology,
diagnosis and resistance patterns. International journal of molecular sciences. 2016 Dec 16;17(12):2120.

18. 18
CAP in Indian Adults
Prevalence of S. Pneumoniae CAP
Study Details
Total
CAP Cases
(Adult)
Cases with
Confirmed
Etiology (N)
S. Pneumoniae
+ve CAP
(% of N)
2009; Lourdes hosp, Kerela1 145 110 32.41%
KIMS, Bengaluru2 100 38 26.3%
PD Hinduja hosp & BYL Nair
Hosp, Mumbai3
100 58 23%
AMCH, Bijapur4 50 26 16%
SKIMS, Srinagar5 100 29 3.4%
CMC, Ludhiana6 233 108 25.9%
IGMCH, Shimla7 70 53 35.8%
1. Menon RU et al. J Fam Med Primary Care 2013;2:244-9.
2. Mythri S et al. IOSR-JDMS.2013;12(2):16-9.
3. Dagaonkar et al. Am J Respir Crit Care Med. 2012;185:A6060
(poster).
4. Abdullah BB et al. ISRN Pulmonology, 2012.
5. Shah BA et al. Lung India. 2010;27(2): 54-7.
6. Oberoi et al. JK Science. 2006;8(2):79-82.
7. Bansal S et al. Indian J Chest Dis Allied Sci. 2004;46:17-22.
CAP: community acquired pneumonia

19. 19
Outcomes of Pneumococcal Pneumonia
CAPNETZ German Registry
Pletz MW, Von Baum H, Van Der Linden M, Rohde G, Schütte H, Suttorp N, Welte T. The burden of pneumococcal pneumonia–
experience of the German competence network CAPNETZ. Pneumologie. 2012 Aug;66(08):470-5.
Clinical Parameter Pneumococcal CAP Non-pneumococcal CAP p-value
Frequency of
Hospitalization
80% 66% <0.001
Pleural Effusion 19% 14% 0.001
Need for Oxygen
Insufflation
58% 44% <0.001
Mechanical Ventilation 5% 2.7% 0.001
Pneumococcal pneumonia: more severe clinical course demanding more medical
resources as compared to non-pneumococcal pneumonia
CAPNETZ- Medical competence network for community-acquired pneumonia (CAP)
CAP: community acquired pneumonia

20. 20
Pneumococcal Infections and
Associated Underlying Comorbidities
*Others: Including Chronic Renal Disease, Chronic Liver Disease, Cerebrovascular Disease.
Kim SH, Song JH, Chung DR, Thamlikitkul V, Yang Y, Wang H, Lu M, So TM, Hsueh PR, Yasin RM, Carlos CC. Changing trend of
antimicrobial resistance and serotypes in Streptococcus pneumoniae in Asian countries: an ANSORP study. Antimicrobial agents and
chemotherapy. 2012 Jan 9:AAC-05658.
20.4%
4.8%
6.6%
13.6%
Pulmonary Disease Chronic Renal disease Cardiovascular
Disease
Diabetes mellitus
0%
5%
10%
15%
20%
25%
Underlying Comorbidity
Patients(%)

21. 21

22. 22

23. 23

24. 24
Predisposing Risk Factors for Pneumococcal Disease in
adults
Pneumococcal
Disease
Decreased immune
function from
disease or drugs
Functional or
anatomic asplenia
Chronic heart, lung
(including asthma),
liver, or renal
disease
Cigarette smoking
Cerebrospinal fluid
leak or cochlear
implant
1. Pneumococcal Disease | Clinical | Risk Factors | CDC. 2017 [cited 7 January 2020]. Available from:
https://www.cdc.gov/pneumococcal/clinicians/risk-factors.html

25. 25
Immunocompromizing Conditions
Conditions which
compromise the immune
system
Chronic Renal
Failure; Nephrotic
syndrome
HIV Infection
Leukemias;
Lymphomas; Multiple
Myeloma
Solid Cancers;
Generalized
Malignancy
Treatment with
Immunosuppressant
Medications
Immunodeficiencies
(Congenital / Acquired)
Transplantation:
Solid organ transplant /
Hematopoietic stem cell
transplantation
HIV: human immunodeficiency virus
1. Meidani M, Naeini AE, Rostami M, Sherkat R, Tayeri K. Immunocompromised patients: Review of the most common infections happened
in 446 hospitalized patients. J Res Med Sci. 2014;19(Suppl 1):S71–S73.
2. Duncan MD, Wilkes DS. Transplant-related immunosuppression: a review of immunosuppression and pulmonary infections. Proc Am

26. 26
Environmental, Occupational and Lifestyle Factors
• Cigarette smoking
• Alcohol abuse
• Mass gathering (e.g., Hajj pilgrimage) / Conditions
of overcrowding
• Passive exposure to smoke and pollution
• Conditions predisposing to pneumoconiosis
(e.g., mining, welding)
• Residence in long-term care facilities
• Nursing home residency; health-care professionals
Kyaw MH, Rose CE Jr, Fry AM, et al. J Infect Dis. 2005;192:377-386.

27. 27
IPD Risk in Co-morbidities
Disease Category Cases per 100,000 Relative Risk (95% CI)*
Healthy Adults 9 Reference
Diabetes Mellitus 51 3.4 (1.8–6.4)
Chronic Lung Disease 63 5.6 (3.2–9.9)
Chronic Heart Disease 94 6.4 (3.7–10.9)
Alcohol Abuse 100 11.4 (5.9–21.9)
Solid Cancers 300 22.9 (11.9–44.3)
HIV / AIDS 423 48.4 (24.8–94.6)
Hematologic Cancers 503 38.3 (15.9–92.2)
Adjusted RRs are from a multivariate model that included age (<50 years vs. >50 years), race (black or white), and the other
medical conditions evaluated. Adapted from: Kyaw MH, Rose CE Jr, Fry AM, et al. J Infect Dis. 2005;192:377-386.
HIV: human immunodeficiency virus
AIDS: acquired immunodeficiency syndrome
IPD: invasive pneumococcal disease
CI: confidence interval

28. 28
IPD Risk in Co-morbidities
* RR adjusted for age, race and associated medical conditions.
Adapted from Kyaw MH, Rose CE Jr, Fry AM, et al. J Infect Dis. 2005;192:377-386.
≥50 years old: 2.9-fold higher risk than <50 years old
Population Group
Relative Risk* (Fold Increase;
Compared with Healthy Adults)
Diabetes Mellitus; Chronic Heart /
Lung Disease
3–6 fold
Alcohol Abuse 11 fold
Cancers, HIV / AIDS, etc. 23–48 fold
IPD: invasive pneumococcal disease
HIV: human immunodeficiency virus
AIDS: acquired immunodeficiency syndrome

29. 29

30. 30

31. 31

32. 32

33. 33
Prevention of Pneumococcal Disease
World Health Organization. Wkly Epidemiol Rec. 2008;83:373-384.
“Given the high burden of pneumococcal
disease in children and adults, WHO considers
the prevention of pneumococcal disease to be
a high priority in both industrialized and
developing countries”

34. 34

35. 35
In India

36. 36
Partially purified pneumococcal capsular
polysaccharide

37. 37

38. 38

39. 39

40. 40
 uncertain effectiveness for prevention against non-bacteremic pneumococcal
Pneumonia
 Hypo-responsiveness upon repeated administration
 Decrease in clinical protection with age (>65 years) in the adult population.
 The PPSV23 is unable to provide long-lasting immunity to adult patients, with no
anamnestic effect occurring post revaccination.
 Immune response to the vaccine is also found to be specifically low in
immunocompromised adults and adults with various underlying comorbid
conditions.
 Little evidence in favor of the effectiveness of PPSV23 against pneumonia in
elderly patients or adults with chronic illness.
 The combined limitations of PPSV23 make the protection of the aging adult
population from IPD a challenge.
The key limitations associated with PPSV23 isolated use

41. 41

42. 42
EVIDENCE

43. 43

44. 44
Landmark clinical trials on PCV13 in Older Adults:
(2015)
(2018)
Bonten MJ, Huijts SM, Bolkenbaas M,
et. al Polysaccharide conjugate
vaccine against pneumococcal
pneumonia in adults. New England
Journal of Medicine. 2015 Mar
19;372(12):1114-25.
McLaughlin JM, Jiang Q, Isturiz RE, Sings HL, Swerdlow DL, Gessner BD, Carrico RM, Peyrani P, Wiemken TL,
Mattingly WA, Ramirez JA, Jodar L. Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Against
Hospitalization for Community-Acquired Pneumonia in Older US Adults: A Test-Negative Design. Clin Infect
Dis. 2018 Oct 30;67(10):1498-1506.
CAPiTA study
Louisville
study

45. 45
Community-Acquired Pneumonia Immunization Trial
in Adults (CAPiTA)
A phase 4, randomized, placebo-controlled
clinical trial of 13-valent pneumococcal
conjugate vaccine efficacy in prevention of
vaccine-serotype pneumococcal community-
acquired pneumonia and invasive
pneumococcal disease
Bonten MJ, Huijts SM, Bolkenbaas M, et. al Polysaccharide conjugate vaccine against pneumococcal
pneumonia in adults. New England Journal of Medicine. 2015 Mar 19;372(12):1114-25.
CAPiTA study
The 5-year, randomized controlled, CAP
Immunization Trial in Adults was a landmark study
that highlighted the importance of PCV13 vaccine in
adult immunization. The trial, conducted among >
80,000 adults (aged > 65 years)

46. 46
Study Objectives
Primary and Secondary Efficacy Objectives
Demonstrate the Efficacy of PCV 13 in the Prevention
of a First Episode of
• Vaccine-serotype (VT) Pneumococcal CAP
– Invasive or non-invasive
• VT Non-Bacteremic / Non-Invasive (NB / NI) Pneumococcal CAP
• VT Invasive Pneumococcal Disease (IPD) with or without
pneumonia
1○
2○
2○
Bonten MJ, Huijts SM, Bolkenbaas M, et. al Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. New England
Journal of Medicine. 2015 Mar 19;372(12):1114-25.

47. 47
CAPiTA Efficacy Results:
Primary and Secondary Objectives1
Statistically Significant Reductions in First Episode of
VT Pneumococcal CAP With PCV 13
0
10
20
30
40
50
60
70
80
80
100
VaccineEfficacy(%)
Primary end point:
Prevention of a first
episode of VT
pneumococcal CAP
46%
P<0.001
45%
P=0.007
75%
P<0.001
Secondary end point:
Prevention of a first episode
of VT nonbacteremic /
noninvasive
pneumococcal CAP
Secondary end point:
Prevention of a first
episode of VT IPD
Overall, adverse event profile was consistent with that of prior studies in adults
Reduction in Pneumococcal Disease with PCV 13
CAP=community-acquired pneumonia; CAPiTA=Community-Acquired Pneumonia Immunization Trial in Adults; IPD=invasive
pneumococcal disease; VT=vaccine type.
Bonten MJ, Huijts SM, Bolkenbaas M, et. al Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. New
England Journal of Medicine. 2015 Mar 19;372(12):1114-25.

48. 48
The CAPiTA trial had several limitations
• it is uncertain whether PCV13 is more efficacious than the 23-valent pneumococcal
polysaccharide vaccine (PPSV23) or whether giving PCV13 in addition to PPSV23 adds
value for older adults.
• It did not have a comparative group that received PPV23, so it did not address the
question of whether PCV13 provides better protection for adults than PPSV23 against
the 13 serotypes contained within it.
• The trial specifically excluded subjects who were regarded as immunocompromised.
• Importantly, among subjects who developed an immunocompromising condition or who
were placed on some immunosuppressive therapy during the period of the study,
PCV13 exhibited no protective effect (22 cases of pneumococcal disease in vaccine
recipients versus 24 cases in placebo recipients).
• Because this trial began before PCV13 was used routinely in infants in the Netherlands,
it does not answer the question of whether PCV13 is efficacious in countries that
routinely administer conjugate vaccines to infants

49. 49
In Adults 65+ Hospitalized With CAP, PCV-3 Effectiveness in a Real-World Setting
Nested case-control study using a test–negative design (TND), conducted within a
large population based CAP surveillance study in the United States (in Louisville,
Kentucky)
Nearly 88% of patients had 1 comorbid medical condition:
~ 53% with chronic obstructive pulmonary disease
~ 35% with coronary artery disease
~ 32% with congestive heart failure
~ 32% with diabetes
46% of the total population of patients was considered immunocompromised
McLaughlin JM, Jiang Q, Isturiz RE, Sings HL, Swerdlow DL, Gessner BD, Carrico RM, Peyrani P, Wiemken TL, Mattingly WA, Ramirez JA, Jodar L.
Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Against Hospitalization for Community-Acquired Pneumonia in Older US Adults: A Test-
Negative Design. Clin Infect Dis. 2018 Oct 30;67(10):1498-1506.
Louisville
study

50. 50
PCV-13 reduced the risk for hospitalized VT–CAP by 73% in adults 65+,
complementing the vaccine efficacy observed in CAPiTA
McLaughlin JM, Jiang Q, Isturiz RE, Sings HL, Swerdlow DL, Gessner BD, Carrico RM, Peyrani P, Wiemken TL, Mattingly WA, Ramirez JA, Jodar L.
Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Against Hospitalization for Community-Acquired Pneumonia in Older US Adults: A
Test-Negative Design. Clin Infect Dis. 2018 Oct 30;67(10):1498-1506.
Louisville
study
VT- CAP – Vaccine type Community Acquired Pneumonia; CI- Confidence Intervals

51. 51
Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, et al. Sequential
administration of 13-valent pneumococcal conjugate vaccine and 23-valent
pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults
60-64 years of age. Vaccine 2014;32:2364-74.
A study conducted among treatment-naive adults revealed that an initial single dose of
PCV13 amplifies the anti-pneumococcal response to subsequent administration of
PPSV23 for many common vaccine serotypes.
This occurs due to a recalled and augmented immune response by the conjugated
PCV13 vaccine when followed upon by sequential administration of PPSV23.
On the contrary, an initial administration of PPSV23 before PCV13 results in a
diminished response to subsequent administration of PCV13 for all the serotypes.
The study helped in providing a reasonable rationale for the recommendation on first
administering PCV13 followed by PPSV23.

52. Pneumococcal Vaccine
Recommendations

53. 53
Global PCV Recommendations
in Older Adults
International recommendations
1. NICE guidelines (2010)
2. KDIGO clinical practice guidelines (2012)
3. ACIP (2015 and 2019 update)
4. Spanish consensus scientific society (2014)
5. ADA guidelines (2017)
6. GOLD guidelines (2019)
KIDGO: Kidney Disease: Improving Global Outcomes
ACIP: Advisory Committee on Immunization Practices
GOLD: The Global Initiative for Chronic Obstructive Lung Disease

54. 54
NICE Guidelines for vaccination of COPD
patients (NICE, UK 2010)
Pneumococcal vaccination and an annual influenza
vaccination to be offered to all patients with COPD

55. 55
Abboud O, Adler S, Bertram K, Garabed E, Norbert L, Wheeler D. Clinical Practice Guideline for the Evaluation and
Management of Chronic Kidney Disease. Journal of the International Society of Nephrology.
KDIGO. 2012:5-119.
https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf [Last accessed on January 07, 2020]
KIDGO: Kidney Disease:
Improving Global
Outcomes

56. 56
KDIGO – For CKD (2012)
Abboud O, Adler S, Bertram K, Garabed E, Norbert L, Wheeler D. Clinical Practice Guideline for the Evaluation and Management of
Chronic Kidney Disease. Journal of the International Society of Nephrology. KDIGO. 2012:5-119. https://kdigo.org/wp-
content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf [Last accessed on January 07, 2020]
KIDGO: Kidney Disease: Improving Global Outcomes
CKD: chronic kidney disease
AKI: Acute kidney injury
GFR: glomerular filtration rate

57. 57
Intervals between PCV13 and PPSV23 Vaccines: Recommendations
of the Advisory Committee on Immunization Practices (ACIP) 2015
Pneumococcal Vaccine-naïve Persons Aged ≥65 Years
PCV13 at Age ≥65 years PPSV23
≥1 Year
PCV13 at Age
≥65 years
PPSV23
≥1 Year
PPSV23 already received at
Age ≥65 years
≥1 Year
≥5 Years
Persons Who Previously Received PPSV23 before Age 65 Years Who Are Now Aged ≥65 Years
Persons Who Previously Received PPSV23 at Age ≥65 Years
PPSV23 already received
at Age ≥65 years
PCV13
≥1 Year
Kobayashi M, Bennett NM et. al. Intervals between PCV13 and PPSV23 vaccines: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2015 Sep 4;64(34):944-7.

58. 58
ACIP: Adult Immunization Schedule (2019)
Recommended Adult Immunization Schedule. Cdc.gov. 2019 [cited 07 JAN 2020]. Available from:
https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
Recommended immunization schedule for adults aged 19 years
or older by age group, United States, 2019
*in India PCV-13 is recommended in adults >50 yrs of age
*
*

59. 59
ACIP: Adult Immunization Schedule (2019)
Recommended immunization schedule for adults aged 19 years or older by medical condition and other indications
Recommended Adult Immunization Schedule. Cdc.gov. 2019 [cited 07 JAN 2020]. Available from:
https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf

60. 60
Updated Recommendations of the
Advisory Committee on Immunization Practices
• ACIP recommends PCV13 based on shared clinical
decision-making for adults aged ≥65 years who do not have
an immunocompromising condition, CSF leak, or cochlear
implant and who have not previously received PCV13.
• If a decision to administer PCV13 is made, it should be
administered before PPSV23.
• The recommended intervals between pneumococcal
vaccines remain unchanged for adults.
• All adults aged ≥65 years should receive a dose of PPSV23
New Pneumococcal Vaccine Recommendations for Adults Aged ≥65 Years
Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-
Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the
Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2019;68:1069–1075.

61. 61
Updated Recommendations of the
Advisory Committee on Immunization Practices
ACIP recommends to consider regularly offering PCV13 to their
patients aged ≥65 years who have not previously received PCV13
• Persons residing in nursing homes or other long-term care
facilities
• Persons residing in settings with low pediatric PCV13 uptake
• Persons traveling to settings with no pediatric PCV13 program
• Patients aged ≥65 with chronic heart, lung, or liver disease,
diabetes, or alcoholism, and those who smoke cigarettes or who
have more than one chronic medical condition
What are the current recommendations of ACIP on PCV13?
Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-Valent Pneumococcal Conjugate Vaccine and
23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the
Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2019;68:1069–1075.

62. 62
Spain Consensus Scientific Societies (2014)
The 16 signatories of this Consensus Scientific Societies consider
that adults with underlying conditions listed in the key points 8 and
9 should be vaccinated against pneumococcus and preferably
receive at least 1 dose of PCV13 to be administered long before
VNP23 in those cases where it revaccination is indicated.
Spanish Society Rev Esp Quimioter 2014;26(3):232-252

63. 63
Immunocompetent or Immunocompromised Patients Considered with Other Underlying
Diseases or Risk Factors (Not Previously Vaccinated)
Subjects With
Immunosuppression or
Considered
Immunocompromised
PCV13 → PPV23
(Minimum interval 8 weeks)
• Hodgkin’s disease, leukemia, lymphoma
• Multiple myeloma
• Chronic kidney disease stage 4–5
• Chronic kidney disease stage 3 with increased risk (nephritic syndrome, diabetes mellitus
or immunosuppressive therapy)
• Solid organ or hematopoietic stem cell transplantation
• Chemotherapy or immunosuppressant treatment
• Infection HIV
• Inflammatory rheumatic disease autoimmune
• Inflammatory bowel disease (including Crohn’s disease and ulcerative colitis)
Immunocompetent Subject to
Other Diseases of Base or Risk
Factors
PCV13
• Chronic respiratory disease (including COPD, asthma and diffuse interstitial lung
disease)
• Chronic liver disease (including cirrhosis)
• Chronic cardiovascular disease (including coronary heart disease, congestive heart failure
and stroke)
• Diabetes mellitus treated with insulin or ADO
• Smoking
• Alcohol abuse
Rojas AG, Peréz-Trallero E, Gregorio PG, de la Cámara R, Morató ML, Rodríguez A, Barberán J, Domínguez V, Rufo10 ML, Sanz11
IJ, Portolés12 JM. Consensus on pneumococcal vaccination in adults with underlying pathologies◊,∆. Rev Esp Quimioter.
2013;26(3):232-52.
Spain Consensus Scientific Societies (2014)

64. 64
GOLD Guidelines 2019
• Pneumococcal vaccinations PCV13 and PPSV23 are
recommended for all patients ≥65 years of age
• PPSV23 is also recommended for younger COPD
patients with significant comorbid conditions
including chronic heart or lung disease
• PCV13 has been shown to exhibit at least the same
or greater immunogenicity than the PPSV23 up to 2
years after vaccination in COPD patients.
• In a large RCT, PCV13 demonstrated significant
efficacy for the prevention of vaccine-type
community acquired pneumonia (45.6%) and vaccine
type invasive pneumococcal disease (75%) among
adults ≥65 years of age, and efficacy persisted for at
least 4 years
Global
strategy for
Diagnosis,
Management,
and
prevention of
Chronic
Obstructive
Pulmonary
Disease:
2020
REPORT
Global strategy for Diagnosis, Management, and prevention of Chronic Obstructive Pulmonary Disease: 2020 REPORT. Goldcopd.org.
2019 [cited 26 December 2019]. Available from: https://goldcopd.org/wp-content/uploads/2019/12/GOLD-2020-FINAL-ver1.2-
03Dec19_WMV.pdf

65. 65
Indian PCV Recommendations
in Chronic Lung Diseases
Indian recommendations
1. GSI: Indian vaccine advocacy guidelines (2012)
2. API guidelines (2014)
3. RSSDI (2017)
4. IMA (2018)
API: Association of Physicians of India
GSI: Geriatric society of India
RSSDI: Research Society for the Study of Diabetes in India
IMA: Indian Medical association

66. 66

67. 67

68. 68
Indian Recommendations
Pneumococcal Vaccine Recommendations in Older Adults
– Research Society for Study of Diabetes in India (RSSDI)
Bajaj S. RSSDI clinical practice recommendations for the management of type 2 diabetes mellitus 2017. International journal of
diabetes in developing countries. 2018 Mar 1;38(1):1-15.
Research Society for the
Study of Diabetes in
India (2018)
PCV13 is available for vaccination of older adults and
must be considered an important step for vaccinating
older diabetes patients with age of >50 years. PPSV23 may
be offered to immune-compromised patients with diabetes
for additional coverage after PCV13.
Repeated vaccination with PPSV23 must be avoided to
prevent hypo-responsiveness. Secondary immune
response after PCV13 immunization is higher, whereas
response is lower after immunization with PPSV23 vaccine
Source Recommendations

69. 69
2018
Adults
• PCV13 is recommended
for adults above 50
years, as a single dose
• PPSV23 – is
recommended ONLY FOR
HIGH RISK population
(pediatric > 2years and
adults)
Indian Medical Association, Life course Immunization guidebook Dec 2018
release at National Annual Conference of IMA (NATCON) held in Bangalore,
India in 2018

70. 70
Immunocompromised individuals (all ages)
Recipients of Hematopoietic Stem Cell
Transplant (HSCT)
 Administer pneumococcal (PCV13 followed by 23PPV)
 Three doses 3-6 months after transplant
Recipients of Solid Organ Transplantation  Administer PCV in both children and adults
Vaccination for Cancer Patients  PCV 1 dose at not less than 3 months after chemotherapy
HIV Infection
 PCV13 recommended
o Infants aged under 12 months when diagnosed
 PCV13 starting from 6 weeks at age-appropriate schedule
o Children aged 12 months to <5 years when diagnosed
 PCV13 age-appropriate catch-up schedule
o Adults aged 18 years and older when diagnosed with HIV
 1 dose of PCV13
 Immunization for Travel and Mass
Gatherings
 Vaccine recommendations for Hajj pilgrims
 Vaccination recommended for pneumococcal disease
 PCV13 recommended for >65 years
Other conditions
 Cystic fibrosis or other chronic lung
diseases
 Diabetes
 Sickle cell disease
 Cochlear implants or intracranial shunts,
and infants with Down’s syndrome
 PCV13 replaces PCV10 on the schedule for these children
 PCV13 replaces PCV10 on the schedule for these children
 PCV and PPV are recommended. If children have
commenced immunization with PCV10, they can complete it with
PCV13, followed by PPSV at the appropriate age
 PCV13 replaces PCV10 on the schedule for these infants
Indian Medical Association, Life course Immunization guidebook Dec 2018
release at National Annual Conference of IMA (NATCON) held in Bangalore, India in 2018

71. Summary &
conclusion

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Recommendation of pneumococcal vaccination
 All adults ≥65 years old and adults <65 years old who are at risk
for pneumococcal infection or severe complications from
pneumococcal infection
 For adults ages 19 to 64 years with certain chronic conditions (eg,
chronic heart, lung, or liver disease, diabetes mellitus, smoking,
alcohol use disorder), give a single dose of PPSV23
 For adults with higher risk conditions (ie, immunocompromise,
asplenia, cerebrospinal fluid leak, cochlear implant, or history of
invasive pneumococcal disease), give both PCV13 and PPSV23
 For adults ≥65 years, give PPSV23. generally do not give PCV13
unless they have another indication for PCV13 (eg, asplenia,
immunocompromise) because the incidence of pneumococcal
disease caused by PCV13 serotypes is very low.

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Recommendation of pneumococcal vaccination
 When both PCV13 and PPSV23 are indicated, they should be given
at separate time points to help ensure that protective antibodies to
each vaccine develop. When possible, PCV13 should be given
before PPSV23
 For adults who have not received any pneumococcal vaccine
previously, PCV13 should be given before PPSV23. If the primary
indication for vaccination is age ≥65 years, PPSV23 should be
given ≥1 year after PCV13. For adults between ages 19 and 64
years who require both vaccines, PPSV23 can be given ≥8 weeks
after PCV13.
 For adults who have already received PPSV23, PCV13 should be
given ≥1 year following PPSV23.
 Revaccination with PPSV23 is recommended for selected patients
because immunity to polysaccharide vaccines wanes over time.

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PREVENAR 13® (Pneumococcal Polysaccharide Conjugate Vaccine
[Adsorbed] I.P., 13-Valent)
Balancing Risk Information [Adapted from LPDPRV062019, version 15]
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. The most commonly reported solicited local and systemic adverse reactions (≥20%) in clinical
trials with Prevenar 13 were redness, swelling, tenderness, hardness, and pain at the injection site,
limitation of arm movement, decreased appetite, headache, diarrhea, chills, fatigue, rash, and worsening
of or new joint or muscle pain. Hypersensitivity (eg, anaphylaxis) to any component of Prevenar 13 or any
diphtheria toxoid-containing vaccine is a contraindication to the use of Prevenar 13. Antimicrobial
resistance rates vary by region and from country to country. 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.
Full Prescribing Information Available on request.
Pfizer Limited, The Capital – A Wing, 1802, 18th Floor, Plot No. C-70, G Block, Bandra-Kurla Complex, Bandra (East), Mumbai 400 051, India.
For the use only of registered medical practitioners or a hospital or a laboratory.
Registered Proprietor – Wyeth LLC, USA. Licensed User – Pfizer Limited, India.

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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 CRM197 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.
Summary of Prescribing Information for
Prevenar13 [Adapted from LPDPRV062019, version 15 (1/2)]
Full Prescribing Information Available on request.
Pfizer Limited, The Capital – A Wing, 1802, 18th Floor, Plot No. C-70, G Block, Bandra-Kurla Complex, Bandra (East), Mumbai 400 051, India.
For the use only of registered medical practitioners or a hospital or a laboratory.
Registered Proprietor – Wyeth LLC, USA. Licensed User – Pfizer Limited, India.

76. 76
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.
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.
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.
Storage: Store refrigerated at 2°C to 8°C. Do not freeze. Discard if the vaccine has been frozen. Store in original package.
Summary of Prescribing Information for
Prevenar13 [Adapted from LPDPRV062019, version 15 (2/2)]
Full Prescribing Information Available on request.
Pfizer Limited, The Capital – A Wing, 1802, 18th Floor, Plot No. C-70, G Block, Bandra-Kurla Complex, Bandra (East), Mumbai 400 051, India.
For the use only of registered medical practitioners or a hospital or a laboratory.
Registered Proprietor – Wyeth LLC, USA. Licensed User – Pfizer Limited, India.

77. 77
Take home message
PCV13 is immunogenic regardless of prior pneumococcal
vaccination status
1
PCV13 may be administered concomitantly with influenza vaccine
(TIV or QIV)
2
Regardless of prior pneumococcal vaccination status, if the use
of PPV is considered appropriate, PCV13 should be given first
3
Safety of PCV13 has been demonstrated regardless of prior
pneumococcal vaccination status
4
PCV: Pneumococcal conjugate vaccine
TIV: Trivalent Influenza Vaccine
QIV: Quadrivalent influenza vaccine
PPSV: Pneumococcal polysaccharide vaccine