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Merck has expanded the scope of its voluntary partial recall to an additional ten lots of VAXNEUVANCE. Click here for more.

Immunogenicity matters through the first year of life and beyond to help protect against pediatric IPD—consider VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine)1-5

Why VAXNEUVANCE?

Administered as a 4-dose series at 2, 4, 6, and 12 through 15 months of age

Elicited robust immune responses to all 15 serotypes in the vaccine postdose 3 and postdose 4

More reasons to choose VAXNEUVANCE for your pediatric patients

Protection matters including in the first year of life, when pediatric IPD incidence is highest4,6-8

Explore IPD burden

The immune response generated postdose 3 is an important measure when evaluating protection against IPD during the first year of life2,5,9

See immune response

Comparable immune response to PCV13 for 12 shared serotypes and superior immune responses vs PCV13 for shared Serotype 3 and unique Serotypes 22F and 33Fa

View immunogenicity

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

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aStudy 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.

VAXNEUVANCE is CDC, AAP, and AAFP recommended as an option for all of your appropriate pediatric patients9-12

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

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References

  1. Weekly epidemiological record. World Health Organization. 2019;85–104. Accessed January 26, 2024. https://www.who.int/publications/i/item/10665-310968
  2. Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. World Health Organization. October 19, 2013. Accessed February 13, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
  3. Gruber MF, Marshall VB. Chapter 80: Regulation and testing of vaccines in the US. In: Orenstein WA, Offit PA, Edwards KM, Plotkin SA, eds. Plotkin’s Vaccines. 8th ed. Elsevier; 2022;1640-1659.e2.
  4. 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 May 1, 2024. Accessed August 1, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html
  5. Guidelines on clinical evaluation of vaccines: regulatory expectations. WHO Technical Report Series 1004, Annex 9, 2017. World Health Organization. Accessed May 28, 2024. https://www.who.int/publications/m/item/WHO-TRS-1004-web-annex-9
  6. 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
  7. 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-01698.
  8. Wodi AP, Morelli V. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 1: Principles of vaccination. Centers for Disease Control and Prevention. Last reviewed August 18, 2021. Accessed January 10, 2024. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf
  9. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States 2024. Updated June 27, 2024. Accessed August 23, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
  10. Immunizations. American Academy of Pediatrics. Last updated June 24, 2024. Accessed July 4, 2024. https://www.aap.org/en/patient-care/immunizations
  11. Immunization schedules. American Academy of Family Physicians. 2024. Accessed May 8, 2024. https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/immunization-schedules.html
  12. Farrar J, Gierke R, Andrejko K, et al. ACIP updates: recommendations for use of 20-valent pneumococcal conjugate vaccine in children ― United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:1072. doi: 10.15585/mmwr.mm7239a5
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Indications and Usage

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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® (Pneumococcal 15-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae

VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or

Do not administer VAXNEUVANCE® (Pneumococcal 15-valent Conjugate Vaccine) 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.