Protection matters when pediatric IPD incidence is highest4,6,7,8

IPD incidence in children in the US during the first year of life was >2x that of children 1-4 years of age, per a 2018-2021 pooled analysis7,a

IPD incidence in children in the US from a 2018-2021 pooled analysis7,a

aThe CDC’s ABC surveillance areas for Streptococcus pneumoniae included 10 states from 2018-2021, representing more than 34 million persons per year. During that period, there were 161 cases of IPD reported in infants less than 1 year of age, 134 cases in children 1 year of age, and 164 cases in children ages 2 to 4. Data for 2020 may have been impacted by associated mitigation measures implemented during the COVID-19 pandemic.7,15

VAXNEUVANCE is administered as a 4-dose series at 2, 4, 6, and 12 through 15 months of age.

IPD is still a concern despite decline in cases after introduction of PCVs4,7,16

Key effects of common IPD types

Pneumococcal Meningitis

  • About 1 in 12 children die of the infection
  • Survivors may have lifelong disabilities, such as hearing loss or other neurological complications17

Pneumococcal Bacteremia

  • The most common type of IPD in children under 2 years of age17,b
  • About 1 in 30 affected children will die17
  • bWithout a known site of infection.4

Recommended PCV dosing

PCVs are recommended as a 4-dose series. Children wait 6-9 months after the third dose until they are able to receive the fourth dose.9

Despite this recommendation, about 1 in 6 toddlers receive 3 or fewer of the 4 doses of PCV by 2 years of age.9,18,c

Learn about IPD vaccine disparities among children

cNIS-Child, a random digit-dialed telephone survey of parents/guardians of children aged 19–35 months that the CDC used to estimate the vaccination coverage with ACIP-recommended vaccines in the US among children born in 2019 and 2020.18

ABC, Active Bacterial Core; ACIP, Advisory Committee on Immunization Practices; CDC, Center for Disease Control and Prevention; IPD, invasive pneumococcal disease; NIS-Child, National Immunization Survey – Child; PCV, pneumococcal conjugate vaccine.

The immune response generated postdose 3 is an important measure when evaluating protection against IPD during the first year of life.2,5,9

Explore
immunogenicity

Immunogenicity

Assess immune response vs PCV13

Immune Response

Learn about specific
populations

Specific Populations

Review CDC, AAP, and
AAFP recommendations

Recommendations

pediatric-ref2

Reference

  1. Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. World Health Organization. October 19, 2013. Accessed January 26, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
pediatric-ref4

Reference

  1. Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed April 10, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html
pediatric-ref5

Reference

  1. Guidelines on clinical evaluation of vaccines: regulatory expectations. WHO Technical Report Series 1004, Annex 9, 2017. World Health Organization. Accessed July 18, 2023. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
pediatric-ref6

Reference

  1. Moraes-Pinto M, Suano-Souza F, Aranda C. Immune system: development and acquisition of immunological competence. J Pediatr (Rio J). 2021; S59-S66. doi:10.1016/j.jped.2020.10.006
pediatric-ref7

Reference

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-PVC-01698.
pediatric-ref8

Reference

  1. Wodi 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 August 18, 2021. Accessed January 10, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf
pediatric-ref9

Reference

  1. Centers for Disease Control and Prevention (CDC). Child and adolescent immunization schedule. Last updated November 16, 2023. Accessed November 16, 2023. https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
pediatric-ref12

Reference

  1. Farrar JL, Gierke R, Andrejko KL, et al. ACIP updates: recommendations for use of 20-valent pneumococcal conjugate vaccine in children–United States, 2023. Supplement. MMWR Morb Mortal Wkly Rep. 2023;72(39):1072. Accessed October 2, 2023. https://stacks.cdc.gov/view/cdc/133252
pediatric-ref15

Reference

  1. Centers for Disease Control and Prevention. ABCs 2020 Data and Impacts of COVID-19. Last reviewed September 22, 2023. Accessed September 25, 2023. https://www.cdc.gov/abcs/reports-findings/data-2020.html
pediatric-ref16

Reference

  1. Kaplan SL, Barson WJ, Ling P, et al. Invasive pneumococcal disease in children’s hospitals: 2014–2017. Pediatrics. 2019;144(3). doi: 10.1542/peds.2019-0567
pediatric-ref17

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: Symptoms and complications of pneumococcal disease. Last reviewed May 18, 2022. Accessed December 4, 2023. https://www.cdc.gov/pneumococcal/about/symptoms-complications.html
pediatric-ref18

Reference

  1. Hill HA, Yankey D, Elam-Evans LD, Chen M, Singleton JA. Vaccination Coverage by Age 24 Months Among Children Born in 2019 and 2020 — National Immunization Survey-Child, United States, 2020–2022. MMWR Morb Mortal Wkly Rep. 2023;72:1190–1196. DOI: http://dx.doi.org/10.15585/mmwr.mm7244a3
pediatric-ref19

Reference

  1. Centers for Disease Control and Prevention (CDC). Visualization – Based on 2016-2021 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance (ABCs). Updated May 17, 2024. Accessed May 23, 2024. https://data.cdc.gov/d/qvzb-qs6p/visualization
pediatric-ref20

Reference

  1. Hu 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:10.1080/13696998.2020.1840216
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Indications and Usage for VAXNEUVANCE

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 for VAXNEUVANCE

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.

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%).

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications and Usage for VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine)

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.

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae

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 for VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine)

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.

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%).

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or

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.

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