% IPD in adults 19–64 years caused byserotypes included in PNEUMOVAX 23IPD cases (%)100608040200~72%% IPD in adults ≥65 years caused byserotypes included in PNEUMOVAX 23IPD cases (%)100608040200~57%SerotypeEstimated contribution to IPD (%)a14%10%6%12%8%4%2%0%383435F417F7F10A7C3119F2015Bb6C11A23B16F819A33F15A12F35B9N23A22F31.01.11.31.41.51.71.91.92.03.23.33.3b3.43.43.73.84.24.24.44.54.74.94.94.911.212.3Serotype35B19A23A12F833F15A22F9N315Bb7F7C3411A2017F10A383135F19F423B6C16FTop 10 serotypes causing IPD in US adults aged ≥65 years, 2018IPD cases per 100,0004.02.03.01.00.0322F11A9N33F19A35B23A15A6C310A19A7F15B33F29V19F6B1423F411A20817F19N18C512F22F4447F4842464347A41A41F453435C3935A37384035F33E33D3625A28F32F273133B33C24F28A32A25F24B2933A18C19C18F2120A24A19B20B22A12A12B15C17F15F16F18B1315B17A16A18A10C11D11B11F10B11C10F9L11E6F7B6H7F6E7A6G6D7C2133F35B23A22F23F19F19A23B1415A12F9V10A9N11A9A846C6A36B5

Impact of Serotypes on Invasive Pneumococcal Disease

Polysaccharide Capsule:
Primary Virulence Factor1–5

Photos of capsules under microscope Outline of capsule Diagram of capsule
Icon of a hand
Tap here to
find out more

IgA=immunoglobulin A; Ply=pneumolysin.

Serotypes Responsible for Majority of
Pneumococcal Disease1–8

4447F4842464347A41A41F453435C3935A37384035F33E33D3625A28F32F273133B33C24F28A32A25F24B2933A18C19C18F2120A24A19B20B22A12A12B15C17F15F16F18B1315B17A16A18A10C11D11B11F10B11C10F9L11E6F7B6H7F6E7A6G6D7C2133F35B23A22F23F19F19A23B1415A12F9V10A9N11A9A846C6A36B5

There are approximately 100 known pneumococcal serotypes.2 However, most pneumococcal disease worldwide is caused
by certain serotypes (highlighted here).3–7

Study designs vary; data cannot be used to form conclusions about the global burden of disease.

Serotypes Responsible for
Burden of Pneumococcal Disease1–8

Serotypes

Serotypes table USA

United States3,a

Serotypes

Serotypes table Brazil

Brazil7,e

Serotypes

Serotypes table Europe

Europe4,b

Serotypes

Serotypes table Tunisia

Tunisia5,c

Serogroup/Serotype

Serotypes table China

China6,d

Study designs vary. Data are representative epidemiological data.

Serotypes Responsible for Burden of Invasive
Pneumococcal Disease, United States1–4

SerotypeEstimated contribution to IPD (%)a14%10%6%12%8%4%2%0%383435F417F7F10A7C3119F2015Bb6C11A23B16F819A33F15A12F35B9N23A22F31.01.11.31.41.51.71.91.92.03.23.33.3b3.43.43.73.84.24.24.44.54.74.94.94.911.212.3
Tap a serotype
to find out
more

IPD=invasive pneumococcal disease.

Indications and Usage

  • PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).
  • PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
  • PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Select Safety Information

  • Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.
  • Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.
  • Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

PNEUMOVAX®23

(Pneumococcal Vaccine Polyvalent)

310A19A7F15B33F29V19F6B1423F411A20817F19N18C512F22F
Please take a moment to review the Indications and Select Safety Information. After the associated audio on this slide has finished playing, you may advance to the next screen.

The Serotypes in PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)
Account for the Majority of Invasive Pneumococcal Disease Cases
in Adults, United States, 20181,a

% IPD in adults 19–64 years caused byserotypes included in PNEUMOVAX 23IPD cases (%)100608040200~72%
% IPD in adults ≥65 years caused byserotypes included in PNEUMOVAX 23IPD cases (%)100608040200~57%

The figure depicts CDC epidemiological data and does not reflect the vaccine efficacy.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease.

Select Safety Information for PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent)

  • Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.
  • Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.
Photo of product
Product shown not actual size.
Please take a moment to review the Select Safety Information. After the associated audio on this slide has finished playing, you may advance to the next screen.

Of the Top 10 Most Common Serotypes Causing IPD in
Adults Aged ≥65 Years, 6 are Included in PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent)1,a

Top 10 serotypes causing IPD in US adults aged ≥65 years, 2018IPD cases per 100,0004.02.03.01.00.0322F11A9N33F19A35B23A15A6C
Tap graph to view serotypes
included in PNEUMOVAX 23

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

IPD=invasive pneumococcal disease.

Of the Top 10 Most Common Serotypes Causing IPD in
Adults Aged ≥65 Years, 6 are Included in PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent)1,a

Top 10 serotypes causing IPD in US adults aged ≥65 years, 2018IPD cases per 100,0004.02.03.01.00.0322F11A9N33F19A35B23A15A6C
6 serotypes
included in
PNEUMOVAX 23

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

IPD=invasive pneumococcal disease.

Select Safety Information for PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent)

  • Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.
  • PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
Photo of woman getting vaccine
Not actual patients or
health care professionals.
Please take a moment to review the Select Safety Information. After the associated audio on this slide has finished playing, you may advance to the next screen.

Summary1-6

  • Although there are ~100 known pneumococcal serotypes, a smaller number of serotypes are responsible for the majority of invasive pneumococcal disease.1,2
  • Serotypes differ in their prevalence and tendency to cause invasive disease (eg, by patient age group, geographic area, site of infection).2,3
  • Serotypes 3 and 22F are among the most common serotypes causing invasive pneumococcal disease in the overall US population.4
    • Of the top 10 most common serotypes causing IPD in adults ≥65 years, 6 (3, 22F, 11A, 9N, 33F, and 19A) are included in PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent).5
  • Among US adults, approximately 72% of IPD cases in those aged 19–64 and approximately 57% of IPD cases in those aged ≥65 are caused by serotypes included in PNEUMOVAX 23.6
  • PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
IPD=invasive pneumococcal disease.

Select Safety Information for PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent)

  • The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.
  • For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.
  • Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
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Not actual patients or
health care professionals.
Please take a moment to review the Select Safety Information. After the associated audio on this slide has finished playing, you may advance to the next screen.

Survey

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Thank you for your response

Before administering
PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent),
please read the accompanying Prescribing Information.
The Patient Information also is available.

Merck logo

Copyright © 2021 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved. US-PNX-01289 07/21

Welcome to: Impact of Serotypes on Invasive Pneumococcal Disease. In this session, we will take a closer look at the most common serotypes causing invasive pneumococcal disease, or IPD, focusing on adults.

  • Streptococcus pneumoniae (or pneumococcus) are lancet shaped gram-positive bacteria, typically observed in pairs.1
  • S. pneumoniae have multiple virulence factors that contribute to pathogenesis.2
  • The polysaccharide capsule is the primary virulence factor.2–5
  • While each serotype has pathogenic potential, individual serotypes markedly differ in their tendency to cause invasive disease.3,4
  • Please click the icon to learn more about the polysaccharide capsule.

S. pneumoniae=Streptococcus pneumoniae.

References

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease. Last Reviewed February, 2021. Accessed March 16, 2021. cdc.gov/vaccines/pubs/pinkbook/pneumo.html
  2. Brooks L, Mias GI. Streptococcus pneumoniae’s virulence and host immunity: Aging, diagnostics, and prevention. Front Immunol. 2018;9:1366. doi: 10.3389/fimmu.2018.01366
  3. Geno KA, Gilbert GL, Song JY, et al. Pneumococcal capsules and their types: Past, present, and future. Clin Microbiol Rev. 2015;28(3):871-899. doi: 10.1128/CMR.00024-15
  4. Weiser J, Ferreira DM, Paton JC. Streptococcus pneumoniae: Transmission, colonization and invasion. Nat Rev Microbiol. 2018;16(6):355-367. doi: 10.1038/s41579-018-0001-8
  5. Henriques-Normark B, Tuonamen EI. The pneumococcus: Epidemiology, microbiology, and pathogenesis. Cold Spring Harb Perspect Med. 2013;3(7):a010215. doi: 10.1101/cshperspect.a010215

Polysaccharide Capsule Virulence Factor2–4

  • Allows adherence and colonization of the nasopharynx
  • Inhibits bacterial mucus entrapment
  • Inhibits phagocytosis by innate immune cells
  • Prevents recognition by host receptors and complement system
  • Escapes neutrophil extracellular traps

  • There are approximately 100 known capsular types of Streptococcus pneumoniae, which are classified into serotypes.2
  • Most S. pneumoniae serotypes have the potential to cause invasive pneumococcal disease.1,2
    • Only a small number of serotypes are responsible for the majority of pneumococcal infections.2
  • For example, the serotypes shown in indigo cause most pneumococcal disease cases worldwide.3–7

S. pneumoniae=Streptococcus pneumoniae.

References

  1. Geno KA, Gilbert GL, Song JY, et al. Pneumococcal capsules and their types: Past, present, and future. Clin Microbiol Rev. 2015;28(3):871-899. doi: 10.1128/CMR.00024-15.
  2. Centers for Disease Control and Prevention (CDC). Pneumococcal disease. Last Reviewed February, 2021. Accessed March 16, 2021. cdc.gov/vaccines/pubs/pinkbook/pneumo.html
  3. Beall B, Chochua S, Gertz RE, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the US during 2015–2016. Front Microbiol. 2018;9:1-19. doi.org/10.3389/fmicb.2018.02670
  4. European Centers for Disease Control. Invasive pneumococcal disease: Annual epidemiological report for 2018. September 2020. Accessed March 25, 2021. ecdc.europa.eu/en/publications-data/invasive-pneumococcal-disease-annual-epidemiological-report-2018
  5. Ktari S, Jmal I, Mroua M, et al. Serotype distribution and antibiotic susceptibility of Streptococcus pneumoniae strains in the south of Tunisia: A five-year study (2012–2016) of pediatric and adult populations. Int J Infect Dis. 2017;65:110-115. doi: 10.1016/j.ijid.2017.10.015
  6. Chen K, Zhang X, Shan W. Hum Vaccin Immunother. 2018;14(6):1453-1463. doi: 10.1080/21645515.2018.1435224
  7. Brandileone M-CC, Almeida SCG, Minamisava Streptococcus pneumoniae’s virulence and host immunity: Aging, diagnostics, and prevention. Front Immunol. 2018;9:1366. doi:10.3389/fimmu.2018.01366

  • Serotypes differ in their prevalence and tendency to cause invasive disease (eg, by patient age group, geographic area, and site of infection).2,8
  • Serotypes contributing to the disease burden vary by geographic region based on many factors.3–7

References

  1. Geno KA, Gilbert GL, Song JY, et al. Pneumococcal capsules and their types: Past, present, and future. Clin Microbiol Rev. 2015;28(3):871-899. doi: 10.1128/CMR.00024-15.
  2. Centers for Disease Control and Prevention (CDC). Pneumococcal disease. Last Reviewed February, 2021. Accessed March 16, 2021. cdc.gov/vaccines/pubs/pinkbook/pneumo.html
  3. Beall B, Chochua S, Gertz RE, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the US during 2015–2016. Front Microbiol. 2018;9:1-19. doi.org/10.3389/fmicb.2018.02670
  4. European Centers for Disease Control. Invasive pneumococcal disease: Annual epidemiological report for 2018. September 2020. Accessed March 25, 2021. ecdc.europa.eu/en/publications-data/invasive-pneumococcal-disease-annual-epidemiological-report-2018
  5. Ktari S, Jmal I, Mroua M, et al. Serotype distribution and antibiotic susceptibility of Streptococcus pneumoniae strains in the south of Tunisia: A five-year study (2012–2016) of pediatric and adult populations. Int J Infect Dis. 2017;65:110-115. doi: 10.1016/j.ijid.2017.10.015
  6. Chen K, Zhang X, Shan W. Hum Vaccin Immunother. 2018;14(6):1453-1463. doi: 10.1080/21645515.2018.1435224
  7. Brandileone M-CC, Almeida SCG, Minamisava R, et al. Vaccine. 2018;36(19):2559-2566. doi: 10.1016/j.vaccine.2018.04.010
  8. Brooks L, Mias GI. Streptococcus pneumoniae’s virulence and host immunity: Aging, diagnostics, and prevention. Front Immunol. 2018;9:1366. doi:10.3389/fimmu.2018.01366

Footnotes

aBased on analysis of CDC Active Bacterial Core surveillance data (2015–2016) reporting most common serotypes identified in recovered invasive disease isolates (N=5,284) from persons of all ages (represents ~90% of IPD cases).

bBased on European Surveillance System (2018) reporting 10 most common serotypes contributing to 16,371 cases of IPD in persons of all ages.

cBased on analysis of invasive and noninvasive serotypes (n=278) collected between 2012 and 2016 in Tunisia in persons of all ages.

dBased on a systematic literature review and meta-analysis including 85 articles (2000–2016) reporting noninvasive and invasive S. pneumoniae isolates (N=1,963) in Mainland China in adults aged 18 years and older.

eBased on a national laboratory-based surveillance study, in which distribution of serotypes was investigated in all age groups (2014–2015; n=1,630 invasive isolates). Most common serotypes represent those contributing to pneumococcal meningitis and nonmeningitis invasive disease.

CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease;
S. pneumoniae=Streptococcus pneumoniae.

  • In a US analysis of pneumococcal serotypes causing IPD, representative of ~90% of cases in 2015–2016, certain serotypes were identified as the cause of most IPD in persons of all ages.1
  • Please click on serotypes 3 and 22F to learn more about each serotype.

IPD=invasive pneumococcal disease.

  • Compared with other serotypes, the polysaccharide capsule of serotype 3 is thicker and denser.2
    • This feature may make it less susceptible to antibody-mediated defense mechanisms.2,3
  • This characteristic of the polysaccharide capsule contributes to the high virulence of serotype 3 and allows the bacteria to escape host immune system defenses.2

  • The characteristic of serotype 22F may also lend to its continued burden.4
  • The polysaccharide capsule determines the pneumococcal surface charge.4
  • Most pneumococcal clinical isolates have a negative charge, including 22F, which are associated with increased colonization and better biofilm formation, decreased mucosal clearance, and interference with phagocytosis.4
  • Of note, serotype 19A is another example of a capsule-negative strain with similar characteristics.4

References

  1. Beall B, Chochua S, Gertz RE, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the US during 2015–2016. Front Microbiol. 2018;9:1-19. doi.org/10.3389/fmicb.2018.02670
  2. Sugimoto N, Yamagishi Y, Hirai J, et al. Invasive pneumococcal disease caused by mucoid serotype 3 Streptococcus pneumoniae: a case report and literature review. BMC Res Notes. 2017;10:21. doi.org/10.1186/s13104-016-2353-3
  3. Poolman J, Kriz P, Feron C, et al. Pneumococcal serotype 3 otitis media, limited effect of polysaccharide conjugate immunisation and strain characteristics. Vaccine. 2009;27(24):3213-3222. doi: 10.1016/j.vaccine.2009.03.017
  4. Sempere J, de Miguel S, Gonzalez-Camacho F, et al. Clinical relevance and molecular pathogenesis of the emerging serotypes 22F and 33F of Streptococcus pneumoniae in Spain. Front Microbiol. 2020;11:309. doi: 10.3389/fmicb.2020.00309

Footnotes

aBased on analysis of CDC Active Bacterial Core surveillance data (2015–2016) reporting most common serotypes identified in recovered invasive disease isolates (N=5,284) from persons of all ages (represents ~90% of IPD cases).

bReported as 15BC.

CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease.

SEROTYPE 3

Thick capsule protecting bacteria from phagocytosis and enabling escape from immune system defenses2,3

SEROTYPE 22F

Negative polysaccharide capsule surface charge that may increase colonization, biofilm formation, decrease mucosal clearance, and help repel phagocytosis4
(of note, serotype 19A is also characterized as a capsule-negative strain)

  • The CDC routinely collects data on invasive bacterial pathogens including S. pneumoniae.1,2
  • CDC Active Bacterial Core surveillance data from 2018 showed the serotypes included in PNEUMOVAX 23 covered most cases of IPD in US adults1:
    • ~72% in adults aged 19–64 years
    • ~57% in adults aged ≥65 years
  • PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease;
S. pneumoniae=Streptococcus pneumoniae.

References

  1. Centers for Disease Control and Prevention (CDC). Active Bacterial Core surveillance report, Emerging Infections Program Network, Streptococcus pneumoniae, trends by serotype group, 1998–2018. Last Reviewed July 17, 2018. Accessed November 24, 2020. wwwn.cdc.gov/BactFacts/index.html
  2. CDC. Active Bacterial Core surveillance. Last Reviewed July 27, 2018. Accessed April 14, 2021. cdc.gov/abcs/overview/background.html

Footnote

aData derived from the CDC’s Active Bacterial Core surveillance data, a laboratory and population-based surveillance system that monitors invasive bacterial pneumococcal infections in persons living in 10 areas in the United States. Surveillance areas represent >34 million persons.

  • Data from the CDC also provide greater insight on specific serotypes contributing to IPD in adults aged ≥65 years.1
  • Please click on the graph to view serotypes included in PNEUMOVAX 23.

CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease.

Reference

  1. Pilishvili T, Gierke R, Farley M, et al. Epidemiology of invasive pneumococcal disease (IPD) following 18 years of pneumococcal conjugate vaccine (PCV) use in the United States. International Symposium on Pneumococci and Pneumococcal Diseases, June 21-24 2020, Toronto, Canada. Poster Presentation.

Footnote

aData derived from the CDC’s Active Bacterial Core surveillance data, 1998-2018. Incidence rates (cases/100,000) were calculated using US Census Bureau population denominators.

  • In 2018, of the 10 most common serotypes causing IPD in adults aged ≥65 years, 6 were included in PNEUMOVAX 23.1

IPD=invasive pneumococcal disease.

Reference

  1. Pilishvili T, Gierke R, Farley M, et al. Epidemiology of invasive pneumococcal disease (IPD) following 18 years of pneumococcal conjugate vaccine (PCV) use in the United States. International Symposium on Pneumococci and Pneumococcal Diseases, June 21-24 2020, Toronto, Canada. Poster Presentation.

Footnote

aData derived from the CDC’s Active Bacterial Core surveillance data, 1998-2018. Incidence rates (cases/100,000) were calculated using US Census Bureau population denominators.

References

  1. Geno KA, Gilbert GL, Song JY, et al. Pneumococcal capsules and their types: Past, present, and future. Clin Microbiol Rev. 2015;28(3):871-899. doi: 10.1128/CMR.00024-15
  2. Centers for Disease Control and Prevention (CDC). Pneumococcal disease. Last Reviewed February 22, 2021. Accessed February 25, 2021. cdc.gov/vaccines/pubs/pinkbook/pneumo.html
  3. Brooks L, Mias GI. Streptococcus pneumoniae’s virulence and host immunity: Aging, diagnostics, and prevention. Front Immunol. 2018;9:1366. doi:10.3389/fimmu.2018.01366
  4. Beall B, Chochua S, Gertz RE, et al. A population-based descriptive atlas of invasive pneumococcal strains recovered within the US during 2015–2016. Front Microbiol. 2018;9:1-19. doi.org/10.3389/fmicb.2018.02670
  5. Pilishvili T, Gierke R, Farley M, et al. Epidemiology of invasive pneumococcal disease (IPD) following 18 years of pneumococcal conjugate vaccine (PCV) use in the United States. International Symposium on Pneumococci and Pneumococcal Diseases, June 21-24 2020, Toronto, Canada. Poster Presentation.
  6. CDC. Active Bacterial Core surveillance report. Emerging Infections Program Network, Streptococcus pneumoniae, trends by serotype group, 1998–2018. Last Reviewed July 17, 2018. Accessed February 18, 2021. cdc.gov/BactFacts/index.html

PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

Indications and Usage

  • PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).
  • PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
  • PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Select Safety Information

  • Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.
  • Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.
  • Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
  • Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.
  • Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.
  • Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.
  • PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
  • The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.
  • For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.
  • Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.