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Dosing

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Dosing

Recommended dosing schedule

For optimal immune response, complete all 4 doses of Prevnar 13® on time, based on ACIP and AAP recommendations1-3

** This is an optional area where footnotes can live.

In infants and young children, Prevnar 13® is administered as a 4-dose series at 2, 4, 6, and 12 to 15 months of age1*†‡

  • In children 6 years through 17 years of age, Prevnar 13® is administered as a single dose1   
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) does not provide 100% protection against all vaccine serotypes or protect against nonvaccine serotypes1​​​​​​​

    *The first dose may be given as early as 6 weeks of age.1

    †The recommended dosing interval for the first, second, and third doses is 4 to 8 weeks.1

    ‡The fourth dose should be administered at approximately 12 to 15 months of age and at least 2 months after the third dose.1

​​​​​​​AAP=American Academy of Pediatrics; ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention.

For children 7 months through 5 years of age who have not received Prevnar® (PCV7)§ or Prevnar 13®, one of the following three catch-up schedules should be used based on the child’s age when administered the first dose.1

  • ​​​​​​​Children 7 through 11 months of age should receive 2 doses administered at least 4 weeks apart and a third dose after the 1-year birthday, separated from the second dose by at least 2 months
  • Children 12 through 23 months of age should receive 2 doses at least 2 months apart
  • Children 24 months through 5 years of age (prior to the sixth birthday) should receive a single dose
The immune responses induced by a catch-up schedule may result in lower antibody concentrations for some serotypes compared with antibody concentrations following 4 doses of Prevnar 13® given at 2, 4, 6, and 12 to 15 months of age.1


For children and adolescents 6 years through 17 years of age who have not previously received Prevnar 13®, Prevnar 13® should be administered as a single dose.1

§Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).

Additional dosing information

Late dosing

Late doses of Prevnar 13® remain an obstacle to CDC-recommended protection4||

Patients who receive their third dose between 7 and 11 months are almost twice as likely to miss their fourth dose or receive it late compared to those who receive it on time4||¶

    ||Based on an Optum Q4 2018 post hoc analysis of 2018 calendar year electronic healthcare records (EHR) of children aged 19-35 months who received the Prevnar 13® third dose in 2018, derived from healthcare provider organizations covering 97 million adult and pediatric patients in the US.

   ¶According to the CDC, the fourth dose is not indicated if third dose is received ≥12 months after birth.5

​​​​​​​Nearly 50% of third doses are administered late4

** This is an optional area where footnotes can live.

Over 25% of fourth doses are administered late4​​​​​​​

** This is an optional area where footnotes can live.

  • 19% of children had not received the fourth dose of Prevnar 13® by age 18 months4

Consider how a reminder-recall program may help improve childhood vaccination rates in your practice

Optum’s longitudinal clinical repository from Humedica is derived from healthcare provider organizations in the US that include more than 700 hospitals and 7000 clinics treating more than 97 million patients receiving care. The data are certified as de-identified by an independent statistical expert following HIPAA statistical de-identification rules, and managed according to Optum's customer data use agreements. Clinical claims and other medical administrative data are obtained from both inpatient and ambulatory electronic health records (EHR), practice management systems, and numerous other internal systems, and are processed, normalized, and standardized across the continuum of care from both acute inpatient stays and outpatient visits. Optum's data elements include demographics; medications prescribed and administered; immunizations; allergies; lab results (including microbiology); vital signs and other observable measurements; clinical and inpatient stay administrative data; and coded diagnoses and procedures. In addition, Optum uses natural language processing (NLP) computing technology to extract critical facts from physician notes into usable datasets. The NLP data provide detailed information regarding signs and symptoms, family history, disease-related scores (eg, RAPID3 for rheumatoid arthritis or CHADS2 for stroke risk), genetic testing, medication changes, and physician rationale behind prescribing decisions that might never be recorded in the EHR.1

Optum EHR Clinical Data (Q4 2018)||

Missed well visits

AAP-recommended well visit attendance declines with age4||

Missed well visits are a primary cause of undervaccination among children6#

Fewer patients return to the office for their 15-month well visit4

** This is an optional area where footnotes can live.

Scheduling the fourth dose at 12 months allows for unforeseen delays, and therefore may help with timely completion of the full series4††

    The fourth dose should be administered at approximately 12 to 15 months of age and at least 2 months after the third dose.1

  **The decrease of 12 percentage points from 64% at month 12 to 52% at month 15 represents an 18% decrease in well visit attendance.

    #Based on a national Blue Cross Blue Shield analysis of 843,610 commercially insured children born between 2010 and 2013 receiving medical services between birth and December 31, 2016. Children are counted as fully immunized upon receiving the needed vaccine(s) by age 27 months, allowing 9 months of buffer time for parents/guardians running behind schedule to take their children to their physician to receive their vaccines. A series of 7 CDC-recommended vaccines was chosen as a summary measure.6​​​​​​​

 ††In children 6 years through 17 years of age, Prevnar 13® should be administered as a single dose.1

Fewer patients without commercial insurance attend well visits4||

** This is an optional area where footnotes can live.

    The fourth dose should be administered at approximately 12 to 15 months of age and at least 2 months after the third dose.

 ‡‡Comprises patients who are uninsured or receiving coverage from Medicare, Medicaid, or other undefined payers.1

References:
  1. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
  2. Centers for Disease Control and Prevention. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.
  3. American Academy of Pediatrics, Committee on Infectious Diseases. Policy statement—recommendations for the prevention of Streptococcus pneumoniae infections in infants and children: use of 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23). Pediatrics. 2010;126(1):186-190.
  4. Data on file. Pfizer Inc., New York, NY.
  5. Centers for Disease Control and Prevention. Catch-up guidance for healthy children 4 months through 4 years of age: pneumococcal conjugate vaccine: PCV. https://cdc.gov/vaccines/schedules/downloads/child/job-aids/pneumococcal.pdf. Updated January 2019. Accessed September 5, 2019.
  6. Blue Cross Blue Shield Association. Early childhood vaccination trends in America.
    https://www.bcbs.com/sites/default/files/file-attachments/health-of-america-report/HoA.Childhood.Vaccines.Report_1.pdf.
    ​​​​​​​Published January 18, 2018. Accessed November 7, 2019.

Dosing

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PREVNAR 13® is a registered trademark of Wyeth LLC.
Manufactured by Wyeth Pharmaceuticals Inc.
© 2021 Pfizer Inc.
  • Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine is a contraindication
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response
  • 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 risks
  • In infants and toddlers, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most commonly reported solicited adverse reactions were injection site tenderness, redness, or swelling, irritability, decreased appetite, decreased or increased sleep, and fever
  • In children 6 years through 17 years of age, Prevnar 13® is administered as a single dose

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). ​​Visit www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for Prevnar 13®.

  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
  • In children 6 weeks through 17 years for invasive disease caused by the 13 serotypes, and for children 6 weeks through 5 years of age for otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)​​​​​​​

Limitations of Use and Effectiveness

  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

IndicationS

  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F​​​​​​​​​​​​​​
  • In children 6 weeks through 17 years for invasive disease caused by the 13 serotypes, and for children 6 weeks through 5 years of age for otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)
    ​​​​​​​

Limitations of Use and Effectiveness

  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

Please see full Prescribing Information.

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