Help protect your youngest patients against critical IPD-causing serotypes19

VAXNEUVANCE elicited superior immune responses vs PCV13 for shared Serotype 3 and unique Serotypes 22F and 33F through the first year of life and beyond*

In 2010, PCV13 introduced routine pediatric coverage against Serotype 3.4,21 According to a pooled analysis from 2018-2021, Serotypes 3, 22F, and 33F were three of the top six IPD-causing serotypes in children under 5 years.19,a,b

Additionally, Serotypes 3, 22F, and 33F can cause significant IPD-related morbidity in children and are associated with varying degrees of antimicrobial resistance.20,23,24

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

*Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.

In a pooled analysis from 2018-2021, ~1 in 4 cases of IPD in children under 5 years of age were caused by the following serotypes19,a,b:

Image Showing the Percentage of IPD Cases in Children Under 5 Years of Age Caused by Serotypes 3 (~8%), 22F (~7%), and 33F (~9%).

aFrom 2018-2021, the top 6 IPD-causing serotypes in children under 5 years were 15C, 33F, 19F, 3, 23B, and 22F.
Serotypes 15C and 23B are not included in any pediatric PCV in the US.19,21,25,26

bThe CDC noted that historic decreases of IPD burden in 2020 were likely due to the associated mitigation measures implemented during the COVID-19 pandemic, as documented by the Active Bacterial Core (ABC) surveillance data.15

VAXNEUVANCE provided superior immune responses for shared Serotype 3 vs PCV13 postdose 3 and 4*

Superior IgG response rate for shared Serotype 3 vs PCV13

Postdose 3 (primary series)

IgG response rate percentage point difference (VAXNEUVANCE-PCV13), 19.1 (95% CI: 14.4, 24.0).

Superior IgG GMC Ratios for shared Serotype 3 vs PCV13

Postdose 3 (primary series)

lgG GMC Ratio vs PCV13, 1.70
(95% CI: 1.54, 1.86).

Superior IgG GMC Ratios for shared Serotype 3 vs PCV13

Postdose 4 (booster dose)

lgG GMC Ratio (VAXNEUVANCE/PCV13),
1.43 (95% CI: 1.30, 1.57).

*Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.

Study Design

Study 8 was a pivotal, double-blind, active comparator-controlled study in which participants were randomized to receive VAXNEUVANCE (N=860) or PCV13 (N=860) in a 4-dose series. The first 3 doses were administered to infants at 2, 4, and 6 months of age and the fourth dose was administered to children at 12 through 15 months of age. Participants also received other licensed pediatric vaccines concomitantly. Immune responses were measured by IgG response rates, IgG GMCs, and OPA GMTs for all 15 serotypes contained in VAXNEUVANCE.

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AAP, American Academy of Pediatrics; AAFP, American Academy of Family Physicians; CDC, Centers for Disease Control and Prevention; CI, confidence interval; GMC, geometric mean concentration (mcg/mL); GMT, geometric mean titer; IgG, Immunoglobulin G; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV, pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine.

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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-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-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-ref10

Reference

  1. Immunizations. American Academy of Pediatrics (AAP). Last updated July 10, 2023. Accessed January 2, 2024. https://www.aap.org/en/patient-care/immunizations/
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-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
pediatric-ref21

Reference

  1. Prevnar 13. Prescribing Information. Pfizer, Inc.; 2019.
pediatric-ref22

Reference

  1. Lupinacci R, Rupp R, Wittawatmongkol O, et al. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023;41(5):1142-1152. doi:10.1016/j.vaccine.2022.12.054
pediatric-ref23

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-ref24

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-ref25

Reference

  1. Prevnar 20. Prescribing Information. Pfizer, Inc.; 2023.
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Reference

  1. Pneumococcal vaccination. Centers for Disease Control and Prevention. Last reviewed September 21, 2023. Accessed October 5, 2023. https://www.cdc.gov/vaccines/vpd/pneumo/index.html
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Reference

  1. American Academy of Family Physicians (AAFP). Immunization schedules. 2024. Accessed November 29, 2023. https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/immunization-schedules.html
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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
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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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