Invasive pneumococcal disease (IPD) still remains a serious threat to children under 5 in the US1,4,5

Below, you can find information on diseases and other concerns you should be aware of.

Despite a decline in IPD cases after the introduction of pneumococcal conjugate vaccines (PCVs), IPD is still a concern today.4,6

IPD is caused by the bacteria Streptococcus pneumoniae
and can lead to serious illnesses, including4,7,8:

PNEUMOCOCCAL MENINGITIS

About 1 in 12 children
with pneumococcal meningitis die
of the infection, while survivors may have lifelong disabilities, such as hearing loss or other neurological complications.9

PNEUMOCOCCAL BACTEREMIA

The most common type of IPD
in children under 2 years of age,a and
about 1 in 30 affected children will die.4,9

aWithout a known site of infection.4

S. pneumoniae is the leading cause of bacterial meningitis among children younger than age 5 in the US.4

Help protect your youngest patients against critical IPD-causing
serotypes3,10

There are ~100 known pneumococcal serotypes. A smaller number are responsible for most cases of IPD.7,11

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.1,3,12,13

Three of the top five serotypes causing childhood cases of IPD are14,b:

Three of the Top Five Serotypes Causing Childhood Cases of IPD Are: 3 (~10% of Cases), 33F (~9% of Cases), 22F (~8% of Cases). (14,b)

bAs of 2018-2019, the top 5 IPD-causing serotypes in children aged 5 and under are 3, 33F, 22F, 23B, and 15C. Serotypes 15C and 23B are not included in any PCV in the US.2,14,15,16

In 2018-2019, serotype 3
was the #1 cause of IPD in children under 5 in the US.14

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pediatric-ref1

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. 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 May 5, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html
pediatric-ref6

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-ref7

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: Streptococcus pneumoniae. Last reviewed January 27, 2022. Accessed May 12, 2022. https://www.cdc.gov/pneumococcal/clinicians/streptococcus-­pneumoniae.html
pediatric-ref7

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: Streptococcus pneumoniae. Last reviewed January 27, 2022. Accessed May 12, 2022. https://www.cdc.gov/pneumococcal/clinicians/streptococcus-­pneumoniae.html
pediatric-ref8

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: Types of infection. Last Reviewed September 1, 2020. Accessed August 8, 2022. https://www.cdc.gov/pneumococcal/about/infection-types.html
pediatric-ref9

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: Symptoms and complications of pneumococcal disease. Last reviewed May 18, 2022. Accessed May 31, 2022. https://www.cdc.gov/pneumococcal/about/symptoms-complications.html
pediatric-ref10

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-ref11

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-ref12

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-ref13

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-ref14

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-ref15

Reference

  1. Prevnar 20. Prescribing Information. Pfizer; 2021.
pediatric-ref16

Reference

  1. Pneumococcal vaccination. Centers for Disease Control and Prevention. Last reviewed January 24, 2022. Accessed October 25, 2022. https://www.cdc.gov/vaccines/vpd/pneumo/index.html
pediatric-ref5

Reference

  1. Centers for Disease Control and Prevention (CDC). Active bacterial core surveillance (ABCs) report, emerging infections program network, Streptococcus pneumoniae, 2019. Accessed May 5, 2022. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2019.pdf
pediatric-ref2

Reference

  1. Prevnar 13. Prescribing Information. Pfizer; 2019.

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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