Protection against invasive pneumococcal disease (IPD) is important, including in the first year of life

4,16,17,18

IPD in the first year of life is more than 2x the rate compared to children ages 1 through 4.16

IPD incidence in children in the US in 201916,a

aThe CDC’s ABCs Report on Streptococcus pneumoniae for 2019 represented data from ~35 million persons across 10 states. There were 55 cases of IPD reported in infants less than 1 year of age, 42 cases in children 1 year of age, and 54 cases in children ages 2 to 4.16
bThe IPD rate of 5.8 per 100,000 people in the 1- to 4-year age group was calculated by combining the rate of 10.4 per 100,000 people for the 1-year age group with the rate of 4.3 per 100,000 people for the 2- to 4-year age group (assuming that the rate of IPD per 100,000 at 2, 3, and 4 was each 4.3) and then dividing it by 4.16

The CDC recommends that all infants complete the first 3 doses of the pneumococcal vaccination series by 6 months of age and get the fourth dose by 12-15 months of age.19

3 doses (primary series) given at19:

Fourth dose (booster dose) given at19:

Despite CDC’s recommendation as a four-dose series,

~9%

of insured patients

~22%

of uninsured patients

did not receive the 4th dose of the PCV series following the 3rd dose.20,f,g

cThe primary series consists of 3 doses routinely given at 2, 4, and 6 months of age. The minimum interval between doses given to infants is 4 weeks.19
dThe first dose can be administered as early as 6 weeks of age.19
eThe fourth dose should be administered at approximately 12-15 months of age and at least 2 months after the third dose.19
fNIS-Child, a random digit-dialed telephone survey of parents/guards of children born in 2018 and 2019, aged 19-35 months. The survey results were used by the CDC to estimate vaccination coverage with ACIP-recommended vaccines in the United States.20
gChildren’s health insurance status was reported by a parent or guardian. The insured population includes private insurance, Medicaid, and other insurance types.20

ABCs, Active bacterial core surveillance; ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; NIS-Child, National Immunization Survey – Child; PCV, pneumococcal conjugate vaccine.

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pediatric-ref4

Reference

  1. Gierke R, Wodi AP, Kobayashi M. Centers for Disease Control and Prevention (CDC). Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Last reviewed August 18, 2021. Accessed March 6, 2023.
    https://www.cdc.gov/
    vaccines/pubs/pinkbook/pneumo.html
pediatric-ref16

Reference

  1. Centers for Disease Control and Prevention (CDC). Active bacterial core surveillance (ABCs) report, emerging infections program network, Streptococcus pneumoniae, 2019. https://www.cdc.gov/abcs/
    downloads/SPN_

    Surveillance_Report_2019.pdf
pediatric-ref17

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-ref18

Reference

  1. Wodi P, Morelli V. Immunology and Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 1: Principles of vaccination. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed February 10, 2023. https://www.cdc.
    gov/vaccines/pubs/pinkbook/

    prinvac.html
pediatric-ref19

Reference

  1. Kobayashi M, Farrar JL, Gierke R, et al. Use of 15-valent pneumococcal conjugate vaccine among U.S. children: updated recommendations of the Advisory Committee on Immunization Practices – United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(37):1174-1181. doi:10.15585/mmwr.mm7137a3
pediatric-ref20

Reference

  1. Hill HA, Yankey D, Elam-Evans L, et al. Vaccination coverage by age 24 months among children born in 2018 and 2019 — national immunization survey-child, United States, 2019–2021. Morb Mortal Wkly Rep. 2023;72(2):33-38. doi:10.15585/mmwr.mm7202a3

Indication 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.

Indication 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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US-PVC-01250 05/23