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Home20 Serotypes20 SerotypesSerotype coverageCase CoverageDisease BurdenEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

Clinical Trial
Results

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The only pneumococcal vaccine option you need for children1*ReferencesChildren who have received Prevnar 20® and who have certain underlying medical conditions do not require a dose of PPSV23.1The first dose may be given as early as 6 weeks of age.2The recommended dosing interval for the first, second, and third doses is 4 to 8 weeks.2The fourth dose should be administered at approximately 12 to 15 months of age and at least 2 months after the third dose.2On June 27, 2023, these recommendations were adopted by the CDC Director and are now official. They were published in the September 29, 2023 issue of MMWR.1Prevnar 20® is the only pneumococcal vaccine option needed for children with certain underlying medical conditions that increase the risk of pneumococcal disease1||¶

Children who have received a complete pneumococcal vaccine series that included Prevnar 20® don‘t need any additional doses.1

ReferencesChildren who have received Prevnar 20® and who have certain underlying medical conditions do not require a dose of PPSV23.1Risk conditions include cerebrospinal fluid leak, chronic heart disease, chronic kidney disease, chronic liver disease, chronic lung disease (including moderate persistent or severe persistent asthma), cochlear implant, diabetes mellitus, and immunocompromising conditions.1Risk conditions include1:
  • Cerebrospinal fluid leak
  • Chronic heart disease
  • Chronic kidney disease**
  • Chronic liver disease**
  • Chronic lung disease**
    (including moderate persistent or severe persistent asthma)
  • Cochlear implant
  • Diabetes mellitus
  • Immunocompromising conditions
    (on maintenance dialysis or with nephrotic syndrome; congenital or acquired asplenia or splenic dysfunction; congenital or acquired immunodeficiencies; diseases and conditions treated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, Hodgkin disease, and solid organ transplant; HIV infection; and sickle cell disease and other hemoglobinopathies)
For intramuscular injection only.

Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied pre-filled syringe. Optum® EHR Clinical Data (Q1 2020)ReferencesChildren who have received Prevnar 20® and who have certain underlying medical conditions do not require a dose of PPSV23.1The first dose may be given as early as 6 weeks of age.3The recommended dosing interval for the first, second, and third doses is 4 to 8 weeks.3The fourth dose should be administered at approximately 12 to 15 months of age and at least 2 months after the third dose.3Based on an Optum Q1 2020 post hoc analysis of 2019 calendar year electronic healthcare records (EHR) of babies aged 24 months who received the Prevnar 13® third dose in 2019, derived from healthcare provider organizations covering 105 million adult and pediatric patients in the US.2Babies who receive their first dose at ≥7 months of age are not indicated for the fourth dose.3As observed in clinical practice with Prevnar 13®.2 CDC=Centers for Disease Control and Prevention; MMWR=Morbidity and Mortality Weekly Report; PCV=pneumococcal conjugate vaccine; PCV13=pneumococcal 13-valent conjugate vaccine; PCV15=pneumococcal 15-valent conjugate vaccine; PPSV23=23-valent pneumococcal polysaccharide vaccine.Prevnar 20® is the only pneumococcal vaccine option you need for children with certain underlying medical conditions that increase the risk of pneumococcal disease1**††ReferencesReferencesExpanded underlying medical conditions identified during the Advisory Committee on Immunization Practices meeting on June 22, 2023.1Rate Ratios of Invasive Pneumococcal Disease Among Children with Certain Underlying Medical Conditions Versus No Underlying Medical Conditions (95% Confidence Interval)3††​​​​​​​
Scroll left to view table
Underlying medical
condition (UMC)3		 Age <5 yrs rate ratio for IPD in children
with UMC compared with healthy children3		 Age 5-17 yrs rate ratio for IPD in children with UMC compared with healthy children3
Asthma‡‡ 1.6× higher risk 2.1× higher risk
Chronic heart disease 2.4× 9.9x
Chronic liver disease§§ 18.5× Data not available
Chronic lung disease 2.5x 3.6x
Diabetes§§ Data not available 5.4×
Chronic renal failure 3.8x 69.7x
Congenital immunodeficiency 13.2× 27.9×
Diseases of white blood cells 16.6× 116.3×
Immunosuppressive drugs/conditions 25.6× 43.6x
Scroll left to view table
ReferencesAdditional underlying medical conditions identified during the Advisory Committee on Immunization Practices meeting on June 22, 2023.1Asthma is only indicated for moderate persistent or severe persistent asthma.Limited numbers of IPD events prevented reporting robust estimates of disease rates.3Complete all 4 doses on time for optimal immune response3

Prevnar§ has helped protect pediatric patients for over 20 years from IPD.4,5 

In a study of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), babies who receive late doses are UP TO
6× LESS LIKELY to complete the series than those who receive doses on time.6||,||¶¶##

Optum® EHR Clinical Data (Q1 2020)||,||

The Optum® 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 105 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® 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® 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.6

ReferencesBased on an Optum Q1 2020 post hoc analysis of 2019 calendar year electronic healthcare records (EHR) of babies aged 24 months who received the Prevnar 13® third dose in 2019, derived from healthcare provider organizations covering 105 million adult and pediatric patients in the US.6Babies who receive their first dose at ≥7 months of age are not indicated for the fourth dose.6As observed in clinical practice with Prevnar 13®. A dose was considered late if received after 119 days of age for dose 1, after 179 days of age for dose 2, and after 239 of age for dose 3.6Complete all 4 doses on time for optimal immune response2Prevnar 20® achieved a 1.5- to 6.5-fold increase in antibody levels after Dose 4 in babies in the pivotal study2*** Prevnar 20® antibody levels attained with Dose 3 and Dose 42

In babies in the pivotal study

ReferencesPneumococcal antipolysaccharide IgG GMCs were calculated from blood samples taken from 831-833 infants and 753-755 toddlers who received a 4-dose series of Prevnar 20®.2CDC=Centers for Disease Control and Prevention; GMC=geometric mean concentration; IgG=immoglobulin G; MMWR=Morbidity and Mortality Weekly Report; PCV=pneumococcal conjugate vaccine; PCV13=13-valent pneumococcal conjugate vaccine; PCV15=15-valent pneumococcal conjugate vaccine; PCV20=20-valent pneumococcal conjugate vaccine; PPSV23=23-valent pneumococcal polysaccharide vaccine.
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LoadingReferences:Farrar JL, Gierke R, Andrejko KL, et al. Use of 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(39):1072.Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023Pelton SI, Weycker D, Farkouh RA, Strutton DR, Shea KM, Edelsberg J. Risk of pneumococcal disease in children with chronic medical conditions in the era of pneumococcal conjugate vaccine. Clin Infect Dis. 2014;59(5):615-623. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.Centers for Disease Control and Prevention. Pneumococcal Disease: Surveillance and Reporting. Published September 21, 2023. Accessed January 23, 2024. https://www.cdc.gov/pneumococcal/surveillance.htmlData on file. Optum Data 2022. Pfizer, Inc.
Manufactured by Wyeth Pharmaceuticals Inc.
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© 2024 Pfizer Inc.
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INDICATIONS 
  • Prevnar 20® is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older
  • Both Prevnar 20® and Prevnar 13® are vaccines indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in individuals 6 weeks through 17 years of age
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine.
Important Safety Information
  • Do not administer Prevnar 20® or Prevnar 13® to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or Prevnar 13® or to diphtheria toxoid
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups, and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to Prevnar 13®
  • 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
  • For Prevnar 20®, in individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever
  • For Prevnar 20®, in individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever
  • For Prevnar 13®, in individuals 6 weeks through 17 years of age, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
  • For Prevnar 13®, in individuals 6 weeks through 17 years of age, the most common side effects were irritability, decreased appetite, decreased or increased sleep, fever, and injection site tenderness, redness, or swelling
  • In individuals 6 years through 17 years of age, Prevnar 13® is administered as a single dose
Patients should always ask their healthcare providers 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 http://www.vaers.hhs.gov or call 1-800-822-7967.

Please click for Prevnar 20® full Prescribing Information.

Please click for Prevnar 13® full Prescribing Information.Indications
  • Prevnar 20® is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older
  • Both Prevnar 20® and Prevnar 13® are vaccines indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in individuals 6 weeks through 17 years of age
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine.