Frequently asked questions for pediatric patients


What are the 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.

What is the 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.

What is the recommended dosing for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)?

VAXNEUVANCE is a suspension for injection (0.5 mL dose), supplied as a single-dose prefilled syringe. It is given as an intramuscular injection only.

Administer VAXNEUVANCE as a 4-dose series at 2, 4, 6 and 12 through 15 months of age (and at least 2 months after the third dose). The first dose may be given as early as 6 weeks of age.

How is VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) administered?

To administer VAXNEUVANCE, hold the prefilled syringe horizontally and shake vigorously immediately prior to use to obtain an opalescent suspension. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed.

Can VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) be administered concurrently with other pediatric vaccines in children?

Yes, VAXNEUVANCE can be given with other pediatric vaccines (including Pentacel, RECOMBIVAX HB®, RotaTeq®, M-M-R®II, VAQTA®, VARIVAX®, and Hiberix).

Brands mentioned are trademarks of their respective owners.

Is VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) interchangeable with PCV13?

Yes, VAXNEUVANCE is interchangeable with PCV13. Pediatric patients who started on PCV13 can be switched to VAXNEUVANCE at any point in the series.3

What is the catch-up dosing schedule for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in pediatric patients?

Infants 7 months through 11 months of age should be administered 3 doses of VAXNEUVANCE. The first 2 doses are given at least 4 weeks apart and the 3rd dose is given after the one-year birthday, separated from the second dose by at least 2 months.

Toddlers 12 months through 23 months of age should be administered 2 doses of VAXNEUVANCE. These 2 doses should be given at least 2 months apart.

Children and adolescents 2 years through 17 years of age who have received an incomplete series of another pneumococcal conjugate vaccine should be administered a single dose of VAXNEUVANCE. At least 2 months should elapse between receipt of the last dose of another pneumococcal conjugate vaccine and administration of VAXNEUVANCE.

What are the CDC guidelines for use of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in pediatric patients?

The CDC recommends the use of VAXNEUVANCE as an option for routine vaccination in infants and children, as well as vaccination in children with certain medical conditions.19

What pneumococcal serotypes are contained in VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)?

VAXNEUVANCE is a sterile suspension of purified capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F.

When was VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) first approved for use by the FDA?

VAXNEUVANCE was initially approved by the FDA in July 2021. VAXNEUVANCE received approval for pediatrics in June 2022.

What are the contraindications for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for pediatric patients?

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

What are the warnings and precautions for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for pediatric patients?

Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of VAXNEUVANCE.

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. A decision about when to administer VAXNEUVANCE to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

What are the most common adverse reactions for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for pediatric patients?

The most commonly reported solicited adverse reactions in children vaccinated with a 4-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 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 and adolescents 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%).

What are the storage requirements for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)?

Store refrigerated at 2°C to 8°C (36°F to 46°F).

Do not freeze. Protect from light.

What is the CPT Code for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine)?

The CPT Code for VAXNEUVANCE is 90671.27

The information provided here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes. This information is subject to change. Merck cautions that payer coding requirements vary and can frequently change, so it’s important to regularly check with each payer as to payer-specific requirements.

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck makes no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs. Diagnosis codes should be selected only by a health care professional.

CPT, Current Procedural Terminology.

CPT is a registered trademark of the American Medical Association.

How can I order VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for my practice?

VAXNEUVANCE can be ordered via ordering.merckvaccines.com, by calling into the Merck Vaccines Customer Care line 877.VAX.MERCK (877.829.6372), or through your preferred wholesaler/distributor. For a list of Merck authorized distributors please go to Authorized distributors – Merck.com.

Is VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) available for children through the Vaccines For Children (VFC) Program?

Yes, VAXNEUVANCE is available through the VFC Program.25

How do I report a suspected adverse event?

To report a suspected adverse reaction, contact Merck at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

How do I report a suspected product quality complaint?

To report a suspected product quality complaint, contact Merck at 1-877-888-4231.


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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-ref3

Reference

  1. Prevnar 13. Prescribing Information. Pfizer; 2019.
pediatric-ref19

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
pediatric-ref20

Reference

  1. Hill HA, Yankey D, Elam-Evans L, et al. Vaccination coverage by age 24 months among children born in 2018 and 2019 — national immunization survey-child, United States, 2019–2021. Morb Mortal Wkly Rep. 2023;72(2):33-38. doi:10.15585/mmwr.mm7202a3
pediatric-ref25

Reference

  1. Centers for Disease Control and Prevention (CDC). VFC. CDC Vaccine Price List. Updated June 2, 2023. Accessed June 2, 2023. https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html
pediatric-ref27

Reference

  1. Centers for Disease Control and Prevention (CDC). Immunization Information Systems (IIS). CPT Codes Mapped to CVX Codes. Last updated May 17, 2023. Accessed May 19, 2023. https://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cpt

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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