Invasive pneumococcal disease (IPD) is still a concern today

4,5

Despite a decline in IPD cases after the introduction of pneumococcal conjugate vaccines (PCVs), IPD is still a concern today.4,5

Help protect your youngest patients against critical
IPD-causing serotypes2,6

There are ~100 known pneumococcal serotypes. A smaller number are responsible for most cases of IPD.7,8 Serotypes 3, 22F, and 33F can cause significant IPD-related morbidity in children. All three serotypes are also associated with varying degrees of antimicrobial resistance.1,2,9,10

Three of the top five serotypes causing childhood cases of IPD are11,a:

Three of the Top Five Serotypes Causing Childhood Cases of IPD Are: 3 (~10% of Cases), 33F (~9% of Cases), 22F (~8% of Cases). Based on 2018-2019 data. (11,a)

aAs of 2018-2019, the top 5 IPD-causing serotypes in children under 5 years were 3, 33F, 22F, 23B, and 15C. Serotypes 15C and 23B are not included in any PCV in the US.3,11,12,13

In 2018-2019, serotype 3 was the #1 cause of IPD in children under 5 in the US.11,a

VAXNEUVANCE provides robust immunogenicity including coverage for key disease-causing serotypes 3, 22F, and 33F, and in various pediatric patient populations.1,2

Robust immunogenicity in various pediatric patient populations

VAXNEUVANCE was approved for use in infants and children based on data from seven randomized, double-blind clinical studies designed to evaluate immunogenicity, safety, and tolerability.

Phase 3 clinical trials for VAXNEUVANCE included…

Children born prematurely
who have ~5X greater
risk for IPD vs infants born at full term.14

Children living with HIV or sickle cell disease who have ~50X greater risk for IPD vs healthy children.15

Study Designs

In a descriptive analysis within studies 8, 9, and 10, the safety and immunogenicity of VAXNEUVANCE were evaluated in enrolled preterm infants (<37 weeks gestation at birth). Participants were randomized to receive VAXNEUVANCE (N=142) or PCV13 (N=144) as a 4-dose series administered at 2, 4, 6, and 12 through 15 months of age. Participants in these studies may have received either US-licensed or non-US licensed concomitant vaccines according to the local recommended schedule.

Study 13 was a double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE in children 5 to 17 years of age with sickle cell disease. Participants were randomized 2:1 to receive a single dose of VAXNEUVANCE (N=70) or PCV13 (N=34).

Study 14 was a double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE in HIV-infected children 6 to 17 years of age, with CD4+ T-cell count ≥200 cells per microliter and plasma HIV RNA value <50,000 copies/mL. Participants were randomized to receive a single dose of VAXNEUVANCE (N=203) or PCV13 (N=204), followed by PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) two months later.

HIV, human immunodeficiency virus; PCV, pneumococcal conjugate vaccine; RNA, ribonucleic acid.

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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
pediatric-ref3

Reference

  1. Prevnar 13. Prescribing Information. Pfizer; 2019.
pediatric-ref2

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. Poster presented at: International Symposium of Pneumococci and Pneumococcal Disease; June 21-24, 2020; Toronto, Canada.
pediatric-ref5

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-ref6

Reference

  1. Pilishvili T. Advisory Committee on Immunization Practices. Impact of PCV13 on invasive pneumococcal disease (IPD) burden and the serotype distribution in the U.S. National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention; 2018. https://stacks.cdc.gov/view/cdc/61449
pediatric-ref7

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: Streptococcus pneumoniae. Last reviewed January 27, 2022. Accessed March 9, 2023. https://www.cdc.gov/pneumococcal/clinicians/streptococcus-­pneumoniae.html
pediatric-ref8

Reference

  1. Gierke R. Current epidemiology of pneumococcal disease and pneumococcal vaccine coverage among children, United States. Slide deck presented at: Advisory Committee on Immunization Practices (ACIP) meeting. February 24, 2022; Atlanta, Georgia.
pediatric-ref9

Reference

  1. Varghese 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
pediatric-ref10

Reference

  1. Azarian 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
pediatric-ref11

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-00623.
pediatric-ref12

Reference

  1. Prevnar 20. Prescribing Information. Pfizer; 2023.
pediatric-ref13

Reference

  1. Pneumococcal vaccination. Centers for Disease Control and Prevention. Last reviewed February 9, 2023. Accessed February 17, 2023. https://www.cdc.gov/vaccines/vpd/
    pneumo/index.html
pediatric-ref14

Reference

  1. Weycker D, Farkouh RA, Strutton DR, Edelsberg J, Shea KM, Pelton SI. Rates and costs of invasive pneumococcal disease and pneumonia in persons with underlying medical conditions. BMC Health Serv Res. 2016;16:182. doi:10.1186/s12913-016-1432-4
pediatric-ref15

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: risk factors. Last reviewed January 27, 2022. Accessed February 1, 2023. https://www.cdc.gov/pneumococcal/clinicians/risk-factors.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-ref2

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. Poster presented at: International Symposium of Pneumococci and Pneumococcal Disease; June 21-24, 2020; Toronto, Canada.
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-ref2

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. Poster presented at: International Symposium of Pneumococci and Pneumococcal Disease; June 21-24, 2020; Toronto, Canada.

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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