01. Foundational / Icons / 32x32px/Menu @1x Open Menu 01. Foundational / Icons / 32x32px/Close @1x Close Menu

Protection matters including in the first year of life when pediatric IPD incidence is highest1-4

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 analysis3,a

IPD incidence in children in the US from a 2018-2021 pooled analysis3,a

Chart Showing the Incidence of Invasive Pneumococcal Disease (IPD) in Children in the US, From a 2018–2021 Pooled Analysis. The Rates of IPD During This Time per 100,000 People Were 10.2 at <1 Year, 8.4 at 1 Year, and 3.3 at 2 to 4 Years of Age. Combined Incidence of the 1 Year of Age and 2–4 Years of Age Groups Was 4.5 per 100,000 People. The Incidence of IPD in Children in the First Year of Life Was >2x That of Children 1–4 Years of Age (3,a)Chart Showing the Incidence of Invasive Pneumococcal Disease (IPD) in Children in the US, From a 2018–2021 Pooled Analysis. The Rates of IPD During This Time per 100,000 People Were 10.2 at <1 Year, 8.4 at 1 Year, and 3.3 at 2 to 4 Years of Age. Combined Incidence of the 1 Year of Age and 2–4 Years of Age Groups Was 4.5 per 100,000 People. The Incidence of IPD in Children in the First Year of Life Was >2x That of Children 1–4 Years of Age (3,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.3,5

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 PCVs1,3,6

Key effects of common IPD types

Pneumococcal Meningitis

  • About 1 in 12 children die of the infection7
  • Survivors may have lifelong disabilities, such as hearing loss or other neurological complications7

Pneumococcal Bacteremia

  • The most common type of IPD in children under 2 years of age1,7,b
  • About 1 in 30 affected children will die7

bWithout a known site of infection.1

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.8

Despite this recommendation, about 1 in 6 toddlers receive 3 or fewer of the 4 doses of PCV by 2 years of age.8,9,c

Learn about IPD vaccine coverage 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 2020.9

ABC, Active Bacterial Core; ACIP, Advisory Committee on Immunization Practices; CDC, Centers 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.8,10,11

Explore immunogenicity

Explore immunogenicity

Assess immune response vs PCV13

Assess immune response vs PCV13

Learn about specific populations

Learn about specific populations

Review CDC, AAP, and AAFP recommendations

Review CDC, AAP, and AAFP recommendations

References

  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 May 1, 2024. Accessed August 1, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html
  2. 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
  3. 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.
  4. 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
  5. CDC. 2020 Data and Impacts of COVID-19. Last reviewed May 22, 2024. Accessed June 26, 2024. cdc.gov/abcs/reports/2020-data.html?CDC_AAref_Val=https://www.cdc.gov/abcs/reports-findings/data-2020.html
  6. 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
  7. Centers for Disease Control and Prevention. Symptoms and complications of pneumococcal disease. Last reviewed February 6, 2024. Accessed July 9, 2024. https://www.cdc.gov/pneumococcal/signs-symptoms/?CDC_AAref_Val=https://www.cdc.gov/pneumococcal/about/symptoms-complications.html
  8. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States 2024. Updated June 27, 2024. Accessed August 23, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
  9. 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
  10. 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
  11. Guidelines on clinical evaluation of vaccines, regulatory expectations. WHO Technical Report Series 1004, Annex 9, 2017. World Health Organization. Accessed May 28, 2024. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
ExternalSitePopup

By clicking on this link, you will be leaving Merck Vaccines.

Cancel
Proceed
Cancel
Proceed

Indications and Usage

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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® (Pneumococcal 15-valent Conjugate Vaccine) 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

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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® (Pneumococcal 15-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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® (Pneumococcal 15-valent Conjugate Vaccine) 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® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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.