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Invasive pneumococcal disease (IPD) remains a serious health threat for infants and can result in hospitalizations, serious complications, or even death.1-3 IPD rates peak at a critical stage in a child’s immune development, when maternal antibody protection wanes and the child has not yet received or is in the process of receiving their primary vaccination series.4 Pneumococcal vaccination is especially important during this vulnerable period to help protect against potentially severe consequences from IPD.2,4,5
Over the last 25 years, the widespread adoption of pneumococcal conjugate vaccines (PCVs) in children has led to a reduction in the spread of many different types of pneumococcal bacteria – referred to as serotypes.2 Although these vaccines have helped reduce the burden of disease, pneumococcal disease remains an issue, with specific serotypes presenting a greater threat to children’s health.6-10
Understanding the burden of IPD in children
According to the Centers for Disease Control and Prevention (CDC), the incidence of IPD is highest in the first year of life,3,* and the death rate due to IPD is higher in infants than in any other pediatric age group.11,† Infants' immune systems are still developing in the first year of life; therefore, protection during this time is critical.3,4,11
The CDC recommends routine pediatric pneumococcal vaccination as a four-dose series at months two, four, and six with a booster administered between 12-15 months.12 Despite the risks associated with invasive pneumococcal disease, some children do not receive all four doses.1-3,13 Many factors can contribute to incomplete childhood immunization coverage, including ethnicity, geographic location, and socioeconomic status.14 In fact, up to one in five babies within the Vaccines for Children Program have received only three of the four recommended PCV doses by two years of age, according to a CDC Morbidity and Mortality Weekly Report from 2021-2023.12,13 The immune response generated after the third dose of a pneumococcal conjugate vaccine is important when evaluating protection against IPD, especially for the children who don't receive their fourth dose.12,15,16
Additionally, certain serotypes, like Serotype 3, are responsible for more IPD cases and are associated with higher morbidity and mortality rates in children.7-10,a Despite being included in PCVs for over a decade, Serotype 3 continues to be a leading cause of IPD in children under five, as shown in a pooled analysis of national-level CDC data from 2018-2022.7,17 This particular serotype has resisted antibody-mediated clearance and continues to be associated with adverse effects.18
What should pediatricians consider when it comes to protecting children from IPD?
When it comes to protecting against IPD, it's important to consider factors in addition to the number of serotypes covered by a vaccine, such as early and robust protection against key serotypes that cause pediatric IPD in the first year of life.2,7,10,19
VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is a pediatric pneumococcal conjugate vaccine that can help deliver strong protection against key disease-causing serotypes during infancy, when the threat of IPD is the highest.2,3,7,10,19-21
Indications and Usage
VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
Select Safety Information
Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.
(Select Safety Information for VAXNEUVANCE continues below.)
VAXNEUVANCE delivers robust immune responses at seven months, following the third dose, for three key disease-causing serotypes: 3, 22F and 33F.7,10,19,b,c Clinical data showed that immune responses for VAXNEUVANCE were superior to PCV13 (pneumococcal 13-valent conjugate vaccine) for those three critical serotypes2,7,10,19,d and were comparable for the 12 shared serotypes between the vaccines.19
Further, VAXNEUVANCE showcased superior immune responses against Serotype 3 after the third dose with an immunoglobulin G (IgG) geometric mean concentrations (GMCs) response rate of 93.1% compared to PCV13, which demonstrated a 74% response rate.19,b
Although completing the full recommended immunization series remains the best way to help maximize protection,12,22 many children still receive fewer than the recommended four doses of a PCV.12,13 It is important to consider a vaccine that targets problematic serotypes and provides robust immune responses after three doses – of the four dose series – to help protect this vulnerable population from IPD.3,4,7,10,11,19
VAXNEUVANCE can help prevent pediatric IPD in the first year of life and beyond and is an important option for pediatricians to consider for their appropriate patients.7,19
###
Select Safety Information (continued)
The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).
The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).
Vaccination with VAXNEUVANCE may not protect all vaccine recipients.
Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.
* Based on pooled analysis of national-level CDC ABC surveillance data from 2018–2022, representing ~35 million people surveyed annually in 10 states across the US. IPD incidence rates were 10.3 in <1 year, 8.2 in 1 year, 4.0 in 2–4 years, 5.0 in 1–4 years, and 1.3 in 5–17 years (Regional variations may exist).3
† Based on national-level CDC ABC surveillance data from 2022, representing ~35 million people in 10 states across the US (Regional variations may exist).11
Key Study Details
GMC Ratios Postdose 3c
Primary endpoint: VAXNEUVANCE delivered comparable immune responses for 12 of the 13 shared serotypes found in PCV13. Shared Serotype 6A was just below the noninferiority criteria by a small margin, with the lower bound of the 2-sided 95% CI for the GMC ratio being 0.48 vs >0.5.19,23
Study Design
Study 8 was a pivotal, double-blind, active comparator-controlled study in which participants were randomized to receive VAXNEUVANCE (N=860) or PCV13 (N=860) in a 4-dose series. The first 3 doses were administered to infants at 2, 4, and 6 months of age and the fourth dose was administered to children at 12 through 15 months of age. Participants also received other licensed pediatric vaccines concomitantly. Immune responses were measured by IgG response rates, IgG GMCs, and OPA GMTs for all 15 serotypes contained in VAXNEUVANCE.19
aBased on a pooled analysis of national-level CDC data from 2018–2021, the top 6 IPD-causing serotypes in children under 5 years of age were 15C, 33F, 19F, 3, 23B, and 22F. Serotypes 15C and 23B are not included in any recommended pediatric PCV in the US.7,17,19,22,24
bPostdose 3 superiority was demonstrated based on measurements taken 30 days after the 6-month dose (at 7 months).19
cMeasurements were taken 30 days postdose specified.19
dSecondary endpoint: Postdose 3 IgG response rate percentage point difference vs PCV13 (95% CI): for Serotype 3, 19.1 (14.4, 24.0); for Serotype 22F, 8.1 (5.1, 11.5); for Serotype 33F, -5.1 (-9.5, -0.7).19,23
Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.19
References:
1Dalton M. Pneumoccal disease. National Foundation for Infectious Diseases. Published July 2024. https://www.nfid.org/infectious-disease/pneumococcal/
2Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Epidemiology and Prevention of Vaccine-Preventable Diseases. Published May 1, 2024. Accessed December 10, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html
3Data available on request from the Merck National Service Center via email at [email protected]. Please specify information package US-PVC-02072.
4Mohanty S, Done N, Liu Q, et al. Incidence of pneumococcal disease in children ≤48 months old in the United States: 1998–2019. Vaccine. Published online March 1, 2024. doi: 10.1016/j.vaccine.2024.03.013
5Clinical overview of pneumococcal disease. Centers for Disease Control and Prevention. February 6, 2024. Accessed May 22, 2024. https://www.cdc.gov/pneumococcal/hcp/clinical-overview/
6Wasserman MD, Perdrizet J, Grant L, et al. Clinical and economic burden of pneumococcal disease due to serotypes contained in current and investigational pneumococcal conjugate vaccines in children under five years of age. Infect Dis Ther. 2021;10(4):2701-2720. doi:10.1007/s40121-021-00544-1
7Centers for Disease Control and Prevention (CDC). Visualization – Based on 1998-2022 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance (ABCs). Updated July 22, 2024. Accessed August 30, 2024. https://data.cdc.gov/Public-Health-Surveillance/1998-2022-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/about_data
8Varghese J, Chochua S, Tran T, et al. Multistate population and whole genome sequence-based strain surveillance of invasive pneumococci recovered in the USA during 2017. Clin Microbiol Infect. 2020;26(4):512.e1-512.e10. doi:10.1016/j.cmi.2019.09.008
9Azarian T, Mitchell PK, Georgieva M, et al. Global emergence and population dynamics of divergent serotype 3 CC180 pneumococci. PLoS Pathog. 2018;14(11):e1007438. doi:10.1371/journal.ppat.1007438
10Hu T, Weiss T, Owusu-Edusei K, Petigara T. Health and economic burden associated with 15-valent pneumococcal conjugate vaccine serotypes in children in the United States. J Med Econ. 2020;23(12):1653-1660. doi:10.1080/13696998.2020.184021613
11Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2022. Centers for Disease Control and Prevention. Updated July 5, 2024. Accessed October 15, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2022.pdf
12Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. Addendum updated November 21, 2024. Accessed November 25, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
13Hill HA, et al. Decline in Vaccination Coverage by Age 24 Months and Vaccination Inequities Among Children Born in 2020 and 2021 — National Immunization Survey-Child, United States, 2021–2023. MMWR Morb Mortal Wkly Rep, pages 844–853.
14Feemster K, Weaver J, Buchwald U, Banniettis N, Cox KS, McIntosh ED, Spoulou V. Pneumococcal Vaccine Breakthrough and Failure in Infants and Children: A Narrative Review. Vaccines (Basel). 2023 Nov 24;11(12):1750. doi:10.3390/vaccines11121750. PMID: 38140155; PMCID: PMC10747311.
15Recommendations to assure the quality, safety and efficacy of pneumoccoccal conjugate vaccines. Annex 3. TRS no 977. World Health Organization. October 19, 2013. Accessed October 31, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
16Guidelines on clinical evaluation of vaccines: regulatory expectations. Annex 9. TRA No 924.World Health Organization. Last reviewed October 21, 2020. Accessed October 31, 2024. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
17Prevnar 13. Prescribing Information. Pfizer; 2019.
18Luck JN, Tettelin H, Orihuela CJ. Sugar-Coated Killer: Serotype 3 Pneumococcal Disease. Front Cell Infect Microbiol. 2020;10:613287. Published 2020 Dec 23. doi:10.3389/fcimb.2020.613287
19VAXNEUVANCE. Prescribing Information. Merck & Co., Inc., 2024.
20Moraes-Pinto MI, Suano-Souza F, Aranda CS. Immune system: development and acquisition of immunological competence. J Pediatr (Rio J). 2021;97(S1):S59-S66. doi:10.1016/j.jped.2020.10.006
21Wodi AP, Morelli V. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 1: Principles of vaccination. Centers for Disease Control and Prevention. Last reviewed March 2024. Accessed May 9, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-1-principles-of-vaccination.html
22Pneumococcal vaccination. Centers for Disease Control and Prevention. Last reviewed September 12, 2024. Accessed September 30, 2024. https://www.cdc.gov/pneumococcal/vaccines/index.html
23Lupinacci R, Rupp R, Wittawatmongkol O, et al. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023;41(5):1142-1152. doi:10.1016/j.vaccine.2022.12.054
24Prevnar 20. Prescribing Information. Pfizer; 2023.
Copyright © 2025 Frontline Medical Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the Publisher. Frontline Medical Communications Inc. will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein. The opinions expressed in this publication do not necessarily reflect the views of the Publisher. All other trademarks are property of their respective owners.
Neither the editors of Pediatric News nor the Editorial Advisory Board nor the reporting staff contributed to this content.
US-PVC-01998 03/25
Invasive pneumococcal disease (IPD) remains a serious health threat for infants and can result in hospitalizations, serious complications, or even death.1-3 IPD rates peak at a critical stage in a child’s immune development, when maternal antibody protection wanes and the child has not yet received or is in the process of receiving their primary vaccination series.4 Pneumococcal vaccination is especially important during this vulnerable period to help protect against potentially severe consequences from IPD.2,4,5
Over the last 25 years, the widespread adoption of pneumococcal conjugate vaccines (PCVs) in children has led to a reduction in the spread of many different types of pneumococcal bacteria – referred to as serotypes.2 Although these vaccines have helped reduce the burden of disease, pneumococcal disease remains an issue, with specific serotypes presenting a greater threat to children’s health.6-10
Understanding the burden of IPD in children
According to the Centers for Disease Control and Prevention (CDC), the incidence of IPD is highest in the first year of life,3,* and the death rate due to IPD is higher in infants than in any other pediatric age group.11,† Infants' immune systems are still developing in the first year of life; therefore, protection during this time is critical.3,4,11
The CDC recommends routine pediatric pneumococcal vaccination as a four-dose series at months two, four, and six with a booster administered between 12-15 months.12 Despite the risks associated with invasive pneumococcal disease, some children do not receive all four doses.1-3,13 Many factors can contribute to incomplete childhood immunization coverage, including ethnicity, geographic location, and socioeconomic status.14 In fact, up to one in five babies within the Vaccines for Children Program have received only three of the four recommended PCV doses by two years of age, according to a CDC Morbidity and Mortality Weekly Report from 2021-2023.12,13 The immune response generated after the third dose of a pneumococcal conjugate vaccine is important when evaluating protection against IPD, especially for the children who don't receive their fourth dose.12,15,16
Additionally, certain serotypes, like Serotype 3, are responsible for more IPD cases and are associated with higher morbidity and mortality rates in children.7-10,a Despite being included in PCVs for over a decade, Serotype 3 continues to be a leading cause of IPD in children under five, as shown in a pooled analysis of national-level CDC data from 2018-2022.7,17 This particular serotype has resisted antibody-mediated clearance and continues to be associated with adverse effects.18
What should pediatricians consider when it comes to protecting children from IPD?
When it comes to protecting against IPD, it's important to consider factors in addition to the number of serotypes covered by a vaccine, such as early and robust protection against key serotypes that cause pediatric IPD in the first year of life.2,7,10,19
VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is a pediatric pneumococcal conjugate vaccine that can help deliver strong protection against key disease-causing serotypes during infancy, when the threat of IPD is the highest.2,3,7,10,19-21
Indications and Usage
VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
Select Safety Information
Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.
(Select Safety Information for VAXNEUVANCE continues below.)
VAXNEUVANCE delivers robust immune responses at seven months, following the third dose, for three key disease-causing serotypes: 3, 22F and 33F.7,10,19,b,c Clinical data showed that immune responses for VAXNEUVANCE were superior to PCV13 (pneumococcal 13-valent conjugate vaccine) for those three critical serotypes2,7,10,19,d and were comparable for the 12 shared serotypes between the vaccines.19
Further, VAXNEUVANCE showcased superior immune responses against Serotype 3 after the third dose with an immunoglobulin G (IgG) geometric mean concentrations (GMCs) response rate of 93.1% compared to PCV13, which demonstrated a 74% response rate.19,b
Although completing the full recommended immunization series remains the best way to help maximize protection,12,22 many children still receive fewer than the recommended four doses of a PCV.12,13 It is important to consider a vaccine that targets problematic serotypes and provides robust immune responses after three doses – of the four dose series – to help protect this vulnerable population from IPD.3,4,7,10,11,19
VAXNEUVANCE can help prevent pediatric IPD in the first year of life and beyond and is an important option for pediatricians to consider for their appropriate patients.7,19
###
Select Safety Information (continued)
The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).
The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).
Vaccination with VAXNEUVANCE may not protect all vaccine recipients.
Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.
* Based on pooled analysis of national-level CDC ABC surveillance data from 2018–2022, representing ~35 million people surveyed annually in 10 states across the US. IPD incidence rates were 10.3 in <1 year, 8.2 in 1 year, 4.0 in 2–4 years, 5.0 in 1–4 years, and 1.3 in 5–17 years (Regional variations may exist).3
† Based on national-level CDC ABC surveillance data from 2022, representing ~35 million people in 10 states across the US (Regional variations may exist).11
Key Study Details
GMC Ratios Postdose 3c
Primary endpoint: VAXNEUVANCE delivered comparable immune responses for 12 of the 13 shared serotypes found in PCV13. Shared Serotype 6A was just below the noninferiority criteria by a small margin, with the lower bound of the 2-sided 95% CI for the GMC ratio being 0.48 vs >0.5.19,23
Study Design
Study 8 was a pivotal, double-blind, active comparator-controlled study in which participants were randomized to receive VAXNEUVANCE (N=860) or PCV13 (N=860) in a 4-dose series. The first 3 doses were administered to infants at 2, 4, and 6 months of age and the fourth dose was administered to children at 12 through 15 months of age. Participants also received other licensed pediatric vaccines concomitantly. Immune responses were measured by IgG response rates, IgG GMCs, and OPA GMTs for all 15 serotypes contained in VAXNEUVANCE.19
aBased on a pooled analysis of national-level CDC data from 2018–2021, the top 6 IPD-causing serotypes in children under 5 years of age were 15C, 33F, 19F, 3, 23B, and 22F. Serotypes 15C and 23B are not included in any recommended pediatric PCV in the US.7,17,19,22,24
bPostdose 3 superiority was demonstrated based on measurements taken 30 days after the 6-month dose (at 7 months).19
cMeasurements were taken 30 days postdose specified.19
dSecondary endpoint: Postdose 3 IgG response rate percentage point difference vs PCV13 (95% CI): for Serotype 3, 19.1 (14.4, 24.0); for Serotype 22F, 8.1 (5.1, 11.5); for Serotype 33F, -5.1 (-9.5, -0.7).19,23
Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.19
References:
1Dalton M. Pneumoccal disease. National Foundation for Infectious Diseases. Published July 2024. https://www.nfid.org/infectious-disease/pneumococcal/
2Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Epidemiology and Prevention of Vaccine-Preventable Diseases. Published May 1, 2024. Accessed December 10, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html
3Data available on request from the Merck National Service Center via email at [email protected]. Please specify information package US-PVC-02072.
4Mohanty S, Done N, Liu Q, et al. Incidence of pneumococcal disease in children ≤48 months old in the United States: 1998–2019. Vaccine. Published online March 1, 2024. doi: 10.1016/j.vaccine.2024.03.013
5Clinical overview of pneumococcal disease. Centers for Disease Control and Prevention. February 6, 2024. Accessed May 22, 2024. https://www.cdc.gov/pneumococcal/hcp/clinical-overview/
6Wasserman MD, Perdrizet J, Grant L, et al. Clinical and economic burden of pneumococcal disease due to serotypes contained in current and investigational pneumococcal conjugate vaccines in children under five years of age. Infect Dis Ther. 2021;10(4):2701-2720. doi:10.1007/s40121-021-00544-1
7Centers for Disease Control and Prevention (CDC). Visualization – Based on 1998-2022 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance (ABCs). Updated July 22, 2024. Accessed August 30, 2024. https://data.cdc.gov/Public-Health-Surveillance/1998-2022-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/about_data
8Varghese J, Chochua S, Tran T, et al. Multistate population and whole genome sequence-based strain surveillance of invasive pneumococci recovered in the USA during 2017. Clin Microbiol Infect. 2020;26(4):512.e1-512.e10. doi:10.1016/j.cmi.2019.09.008
9Azarian T, Mitchell PK, Georgieva M, et al. Global emergence and population dynamics of divergent serotype 3 CC180 pneumococci. PLoS Pathog. 2018;14(11):e1007438. doi:10.1371/journal.ppat.1007438
10Hu T, Weiss T, Owusu-Edusei K, Petigara T. Health and economic burden associated with 15-valent pneumococcal conjugate vaccine serotypes in children in the United States. J Med Econ. 2020;23(12):1653-1660. doi:10.1080/13696998.2020.184021613
11Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2022. Centers for Disease Control and Prevention. Updated July 5, 2024. Accessed October 15, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2022.pdf
12Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. Addendum updated November 21, 2024. Accessed November 25, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
13Hill HA, et al. Decline in Vaccination Coverage by Age 24 Months and Vaccination Inequities Among Children Born in 2020 and 2021 — National Immunization Survey-Child, United States, 2021–2023. MMWR Morb Mortal Wkly Rep, pages 844–853.
14Feemster K, Weaver J, Buchwald U, Banniettis N, Cox KS, McIntosh ED, Spoulou V. Pneumococcal Vaccine Breakthrough and Failure in Infants and Children: A Narrative Review. Vaccines (Basel). 2023 Nov 24;11(12):1750. doi:10.3390/vaccines11121750. PMID: 38140155; PMCID: PMC10747311.
15Recommendations to assure the quality, safety and efficacy of pneumoccoccal conjugate vaccines. Annex 3. TRS no 977. World Health Organization. October 19, 2013. Accessed October 31, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
16Guidelines on clinical evaluation of vaccines: regulatory expectations. Annex 9. TRA No 924.World Health Organization. Last reviewed October 21, 2020. Accessed October 31, 2024. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
17Prevnar 13. Prescribing Information. Pfizer; 2019.
18Luck JN, Tettelin H, Orihuela CJ. Sugar-Coated Killer: Serotype 3 Pneumococcal Disease. Front Cell Infect Microbiol. 2020;10:613287. Published 2020 Dec 23. doi:10.3389/fcimb.2020.613287
19VAXNEUVANCE. Prescribing Information. Merck & Co., Inc., 2024.
20Moraes-Pinto MI, Suano-Souza F, Aranda CS. Immune system: development and acquisition of immunological competence. J Pediatr (Rio J). 2021;97(S1):S59-S66. doi:10.1016/j.jped.2020.10.006
21Wodi AP, Morelli V. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 1: Principles of vaccination. Centers for Disease Control and Prevention. Last reviewed March 2024. Accessed May 9, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-1-principles-of-vaccination.html
22Pneumococcal vaccination. Centers for Disease Control and Prevention. Last reviewed September 12, 2024. Accessed September 30, 2024. https://www.cdc.gov/pneumococcal/vaccines/index.html
23Lupinacci R, Rupp R, Wittawatmongkol O, et al. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023;41(5):1142-1152. doi:10.1016/j.vaccine.2022.12.054
24Prevnar 20. Prescribing Information. Pfizer; 2023.
Copyright © 2025 Frontline Medical Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the Publisher. Frontline Medical Communications Inc. will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein. The opinions expressed in this publication do not necessarily reflect the views of the Publisher. All other trademarks are property of their respective owners.
Neither the editors of Pediatric News nor the Editorial Advisory Board nor the reporting staff contributed to this content.
US-PVC-01998 03/25
Invasive pneumococcal disease (IPD) remains a serious health threat for infants and can result in hospitalizations, serious complications, or even death.1-3 IPD rates peak at a critical stage in a child’s immune development, when maternal antibody protection wanes and the child has not yet received or is in the process of receiving their primary vaccination series.4 Pneumococcal vaccination is especially important during this vulnerable period to help protect against potentially severe consequences from IPD.2,4,5
Over the last 25 years, the widespread adoption of pneumococcal conjugate vaccines (PCVs) in children has led to a reduction in the spread of many different types of pneumococcal bacteria – referred to as serotypes.2 Although these vaccines have helped reduce the burden of disease, pneumococcal disease remains an issue, with specific serotypes presenting a greater threat to children’s health.6-10
Understanding the burden of IPD in children
According to the Centers for Disease Control and Prevention (CDC), the incidence of IPD is highest in the first year of life,3,* and the death rate due to IPD is higher in infants than in any other pediatric age group.11,† Infants' immune systems are still developing in the first year of life; therefore, protection during this time is critical.3,4,11
The CDC recommends routine pediatric pneumococcal vaccination as a four-dose series at months two, four, and six with a booster administered between 12-15 months.12 Despite the risks associated with invasive pneumococcal disease, some children do not receive all four doses.1-3,13 Many factors can contribute to incomplete childhood immunization coverage, including ethnicity, geographic location, and socioeconomic status.14 In fact, up to one in five babies within the Vaccines for Children Program have received only three of the four recommended PCV doses by two years of age, according to a CDC Morbidity and Mortality Weekly Report from 2021-2023.12,13 The immune response generated after the third dose of a pneumococcal conjugate vaccine is important when evaluating protection against IPD, especially for the children who don't receive their fourth dose.12,15,16
Additionally, certain serotypes, like Serotype 3, are responsible for more IPD cases and are associated with higher morbidity and mortality rates in children.7-10,a Despite being included in PCVs for over a decade, Serotype 3 continues to be a leading cause of IPD in children under five, as shown in a pooled analysis of national-level CDC data from 2018-2022.7,17 This particular serotype has resisted antibody-mediated clearance and continues to be associated with adverse effects.18
What should pediatricians consider when it comes to protecting children from IPD?
When it comes to protecting against IPD, it's important to consider factors in addition to the number of serotypes covered by a vaccine, such as early and robust protection against key serotypes that cause pediatric IPD in the first year of life.2,7,10,19
VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) is a pediatric pneumococcal conjugate vaccine that can help deliver strong protection against key disease-causing serotypes during infancy, when the threat of IPD is the highest.2,3,7,10,19-21
Indications and Usage
VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
Select Safety Information
Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.
(Select Safety Information for VAXNEUVANCE continues below.)
VAXNEUVANCE delivers robust immune responses at seven months, following the third dose, for three key disease-causing serotypes: 3, 22F and 33F.7,10,19,b,c Clinical data showed that immune responses for VAXNEUVANCE were superior to PCV13 (pneumococcal 13-valent conjugate vaccine) for those three critical serotypes2,7,10,19,d and were comparable for the 12 shared serotypes between the vaccines.19
Further, VAXNEUVANCE showcased superior immune responses against Serotype 3 after the third dose with an immunoglobulin G (IgG) geometric mean concentrations (GMCs) response rate of 93.1% compared to PCV13, which demonstrated a 74% response rate.19,b
Although completing the full recommended immunization series remains the best way to help maximize protection,12,22 many children still receive fewer than the recommended four doses of a PCV.12,13 It is important to consider a vaccine that targets problematic serotypes and provides robust immune responses after three doses – of the four dose series – to help protect this vulnerable population from IPD.3,4,7,10,11,19
VAXNEUVANCE can help prevent pediatric IPD in the first year of life and beyond and is an important option for pediatricians to consider for their appropriate patients.7,19
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Select Safety Information (continued)
The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).
The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).
Vaccination with VAXNEUVANCE may not protect all vaccine recipients.
Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.
* Based on pooled analysis of national-level CDC ABC surveillance data from 2018–2022, representing ~35 million people surveyed annually in 10 states across the US. IPD incidence rates were 10.3 in <1 year, 8.2 in 1 year, 4.0 in 2–4 years, 5.0 in 1–4 years, and 1.3 in 5–17 years (Regional variations may exist).3
† Based on national-level CDC ABC surveillance data from 2022, representing ~35 million people in 10 states across the US (Regional variations may exist).11
Key Study Details
GMC Ratios Postdose 3c
Primary endpoint: VAXNEUVANCE delivered comparable immune responses for 12 of the 13 shared serotypes found in PCV13. Shared Serotype 6A was just below the noninferiority criteria by a small margin, with the lower bound of the 2-sided 95% CI for the GMC ratio being 0.48 vs >0.5.19,23
Study Design
Study 8 was a pivotal, double-blind, active comparator-controlled study in which participants were randomized to receive VAXNEUVANCE (N=860) or PCV13 (N=860) in a 4-dose series. The first 3 doses were administered to infants at 2, 4, and 6 months of age and the fourth dose was administered to children at 12 through 15 months of age. Participants also received other licensed pediatric vaccines concomitantly. Immune responses were measured by IgG response rates, IgG GMCs, and OPA GMTs for all 15 serotypes contained in VAXNEUVANCE.19
aBased on a pooled analysis of national-level CDC data from 2018–2021, the top 6 IPD-causing serotypes in children under 5 years of age were 15C, 33F, 19F, 3, 23B, and 22F. Serotypes 15C and 23B are not included in any recommended pediatric PCV in the US.7,17,19,22,24
bPostdose 3 superiority was demonstrated based on measurements taken 30 days after the 6-month dose (at 7 months).19
cMeasurements were taken 30 days postdose specified.19
dSecondary endpoint: Postdose 3 IgG response rate percentage point difference vs PCV13 (95% CI): for Serotype 3, 19.1 (14.4, 24.0); for Serotype 22F, 8.1 (5.1, 11.5); for Serotype 33F, -5.1 (-9.5, -0.7).19,23
Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.19
References:
1Dalton M. Pneumoccal disease. National Foundation for Infectious Diseases. Published July 2024. https://www.nfid.org/infectious-disease/pneumococcal/
2Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Epidemiology and Prevention of Vaccine-Preventable Diseases. Published May 1, 2024. Accessed December 10, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html
3Data available on request from the Merck National Service Center via email at [email protected]. Please specify information package US-PVC-02072.
4Mohanty S, Done N, Liu Q, et al. Incidence of pneumococcal disease in children ≤48 months old in the United States: 1998–2019. Vaccine. Published online March 1, 2024. doi: 10.1016/j.vaccine.2024.03.013
5Clinical overview of pneumococcal disease. Centers for Disease Control and Prevention. February 6, 2024. Accessed May 22, 2024. https://www.cdc.gov/pneumococcal/hcp/clinical-overview/
6Wasserman MD, Perdrizet J, Grant L, et al. Clinical and economic burden of pneumococcal disease due to serotypes contained in current and investigational pneumococcal conjugate vaccines in children under five years of age. Infect Dis Ther. 2021;10(4):2701-2720. doi:10.1007/s40121-021-00544-1
7Centers for Disease Control and Prevention (CDC). Visualization – Based on 1998-2022 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance (ABCs). Updated July 22, 2024. Accessed August 30, 2024. https://data.cdc.gov/Public-Health-Surveillance/1998-2022-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/about_data
8Varghese J, Chochua S, Tran T, et al. Multistate population and whole genome sequence-based strain surveillance of invasive pneumococci recovered in the USA during 2017. Clin Microbiol Infect. 2020;26(4):512.e1-512.e10. doi:10.1016/j.cmi.2019.09.008
9Azarian T, Mitchell PK, Georgieva M, et al. Global emergence and population dynamics of divergent serotype 3 CC180 pneumococci. PLoS Pathog. 2018;14(11):e1007438. doi:10.1371/journal.ppat.1007438
10Hu T, Weiss T, Owusu-Edusei K, Petigara T. Health and economic burden associated with 15-valent pneumococcal conjugate vaccine serotypes in children in the United States. J Med Econ. 2020;23(12):1653-1660. doi:10.1080/13696998.2020.184021613
11Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2022. Centers for Disease Control and Prevention. Updated July 5, 2024. Accessed October 15, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2022.pdf
12Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. Addendum updated November 21, 2024. Accessed November 25, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
13Hill HA, et al. Decline in Vaccination Coverage by Age 24 Months and Vaccination Inequities Among Children Born in 2020 and 2021 — National Immunization Survey-Child, United States, 2021–2023. MMWR Morb Mortal Wkly Rep, pages 844–853.
14Feemster K, Weaver J, Buchwald U, Banniettis N, Cox KS, McIntosh ED, Spoulou V. Pneumococcal Vaccine Breakthrough and Failure in Infants and Children: A Narrative Review. Vaccines (Basel). 2023 Nov 24;11(12):1750. doi:10.3390/vaccines11121750. PMID: 38140155; PMCID: PMC10747311.
15Recommendations to assure the quality, safety and efficacy of pneumoccoccal conjugate vaccines. Annex 3. TRS no 977. World Health Organization. October 19, 2013. Accessed October 31, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
16Guidelines on clinical evaluation of vaccines: regulatory expectations. Annex 9. TRA No 924.World Health Organization. Last reviewed October 21, 2020. Accessed October 31, 2024. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
17Prevnar 13. Prescribing Information. Pfizer; 2019.
18Luck JN, Tettelin H, Orihuela CJ. Sugar-Coated Killer: Serotype 3 Pneumococcal Disease. Front Cell Infect Microbiol. 2020;10:613287. Published 2020 Dec 23. doi:10.3389/fcimb.2020.613287
19VAXNEUVANCE. Prescribing Information. Merck & Co., Inc., 2024.
20Moraes-Pinto MI, Suano-Souza F, Aranda CS. Immune system: development and acquisition of immunological competence. J Pediatr (Rio J). 2021;97(S1):S59-S66. doi:10.1016/j.jped.2020.10.006
21Wodi AP, Morelli V. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 1: Principles of vaccination. Centers for Disease Control and Prevention. Last reviewed March 2024. Accessed May 9, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-1-principles-of-vaccination.html
22Pneumococcal vaccination. Centers for Disease Control and Prevention. Last reviewed September 12, 2024. Accessed September 30, 2024. https://www.cdc.gov/pneumococcal/vaccines/index.html
23Lupinacci R, Rupp R, Wittawatmongkol O, et al. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023;41(5):1142-1152. doi:10.1016/j.vaccine.2022.12.054
24Prevnar 20. Prescribing Information. Pfizer; 2023.
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