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SerotypesSerotypesSerotype CoverageSerotype SelectionCase CoverageEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

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Prevnar 20® is built on the efficacy already achieved by Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein])(PCV7)1,2
 Proven efficacy in a clinical trial of Prevnar (PCV7)

In babies fully vaccinated per CDC-recommended schedule. Vaccine efficacy of 93.9% (95% Cl, 79.6%-98.5%) was shown in the ITT population.2

Prevnar (PCV7) study in IPD

Randomized, controlled trial of 37,816 babies receiving Prevnar (PCV7) or a control vaccine at 2, 4, 6, and 12 to 15 months of age, followed from October 1995 to April 1999.2

Prevnar 20 and Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) were licensed based on immunogenicity end points. Prevnar 13 efficacy was inferred by showing noninferiority to Prevnar (PCV7). Prevnar 20 efficacy was inferred by showing noninferiority to Prevnar 13.1,2
Prevnar 20 is built on the effectiveness of Prevnar* vaccines1-3

The effectiveness of Prevnar 13 and Prevnar (PCV7) is relevant to Prevnar 20 due to manufacturing similarities and the 13 and 7 shared serotypes, respectively.1

 Incidence of IPD caused by serotypes covered by Prevnar 133

CDC surveillance data for children <5 years of age†

In children <5 years old, from 2000 to 2019, Prevnar* reduced the burden of IPD and prevented an estimated4
  • 16,000 meningitis cases
  • 172,000 bacteremia cases
 The only PCV indicated for otitis media in babies 1,2,5‡

Efficacy demonstrated in a clinical trial of Prevnar (PCV7)2

Understand the OM indication
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 Order today Loading References ABCs=Active Bacterial Core surveillance; CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease; ITT=intent to treat; OM=otitis media; PCV=pneumococcal conjugate vaccine; PCV7=7-valent pneumococcal conjugate vaccine; PCV13=13-valent pneumococcal conjugate vaccine. *Prevnar includes Prevnar, Prevnar 13, and Prevnar 20. In the US, Prevnar (PCV7) was available from 2000 to 2010, and Prevnar 13 was available from 2010 to 2024. Prevnar 20 has been available since 2023.1,2†Based on IPD incidence rates from 1998 through 2022 collected through ABCs, a laboratory- and population-based surveillance part of CDC’s Emerging Infections Program.3‡Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No OM efficacy data are available for serotypes 1, 3, 5, 6A, 7F, 8, 10A, 11A, 12F, 15B, 19A, 22F, or 33F.1,2 IPD can be caused by more than 90 identified Streptococcus pneumoniae serotypes. In 2000, Prevnar (PCV7) was licensed and indicated for active immunization of babies and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). From 1978 through 1994, these 7 serotypes were responsible for approximately 80% of IPD cases in children <6 years of age in the United States. In 2010, Prevnar 13 was approved 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.2,6,7
References:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information. Wyeth Pharmaceuticals LLC, 2023.Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information. Wyeth Pharmaceuticals LLC, 2019.Centers for Disease Control and Prevention. ABCs Bact Facts Interactive data dashboard. Streptococcus pneumoniae. May 22, 2024. Accessed April 1, 2025. https://www.cdc.gov/abcs/bact-facts/data-dashboard.html Wasserman M, Chapman R, Lapidot R, et al. Twenty-year public health impact of 7- and 13-valent pneumococcal conjugate vaccines in US children. Emerg Infect Dis. 2021;27(6):1627-1636. Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine) Prescribing Information. Merck Sharp & Dohme Corp, 2023.Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information. Wyeth Pharmaceuticals LLC, 2008.Butler JC, Breiman RF, Lipman HB, Hofmann J, Facklam RR. Serotype distribution of Streptococcus pneumoniae infections among preschool children in the United States, 1978-1994: implications for development of a conjugate vaccine. J Infect Dis. 1995;171(4):885-889.
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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
  • Prevnar 20® is a vaccine 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
IMPORTANT SAFETY INFORMATION
  • Do not administer Prevnar 20® to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® 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®
  • 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 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
  • 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 and redness, headache, and fever
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.INDICATIONSIndications
  • 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
  • Prevnar 20® is a vaccine 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