Help fill the gaps in protection against pediatric invasive pneumococcal disease (IPD)1,2

VAXNEUVANCE provides robust immunogenicity, including coverage for key disease-causing serotypes 3, 22F, and 33F.1,3

Why choose VAXNEUVANCE?

Comparable immune response to PCV13 for 12 shared serotypes following a 4-dose series*

Superior immune response for shared serotype 3a and unique serotypes 22F and 33F following a 4-dose series; 22F and 33F are not covered in PCV132,*

Can be given with other routinely administered vaccines (including Pentacel, RECOMBIVAX HB®, RotaTeq®, M-M-R®II, VAQTA®, VARIVAX®, and Hiberix)

Brands mentioned are trademarks of their respective owners.

Can seamlessly switch from PCV13 at any point in the vaccination series2,b

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

aAt 30 days post dose 4, IgG GMC Ratio vs PCV13, 1.43 (95% CI: 1.30, 1.57).

bDose 1 of either PCV is given at 2 months, Dose 2 at 4 months, Dose 3 at 6 months, and Dose 4 at 12-15 months. See Dosage and Administration tab for additional information.

*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.

CI, confidence interval; GMC, geometric mean concentration (mcg/mL); GMT, geometric mean titer; IgG, Immunoglobulin G; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine

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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-ref2

Reference

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

  1. Prevnar 20. Prescribing Information. Pfizer; 2021.
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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
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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
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Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: risk factors. Last reviewed January 27, 2022. Accessed June 6, 2022. https://www.cdc.gov/pneumococcal/clinicians/risk-factors.html
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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
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Reference

  1. Centers for Disease Control and Prevention (CDC). Immunization Information Systems (IIS). CPT Codes Mapped to CVX Codes. Last reviewed September 2, 2022. Accessed September 7, 2022. https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cpt
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Reference

  1. American Medical Association (AMA). CPT Category I New Vaccine Codes (Including Incorporation of ACIP Abbreviations Listing) Long Descriptors. Updated October 10, 2022. Accessed October 19, 2022. https://www.ama-assn.org/system/files/vaccine-long-descriptors.pdf

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-00514 11/22