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Home20 Serotypes20 SerotypesSerotype coverageCase CoverageDisease BurdenEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

Clinical Trial
Results

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Built on established efficacy and effectivenessBuilt on established efficacy and effectiveness
Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is built on the efficacy already achieved by Prevnar® (PCV7) (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein])1,2
Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is built on the efficacy already achieved by Prevnar® (PCV7) (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein])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 endpoints. 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 the next generation of Prevnar,* providing a new level of pediatric protection against IPD.1

Prevnar 20® is the next generation of Prevnar,* providing a new level of pediatric protection against IPD.1

Prevnar 20® is the next generation of Prevnar,* providing a new level of pediatric protection against IPD.1

Prevnar includes Prevnar® (PCV7) and Prevnar 13®. In the US, Prevnar® (PCV7) was available from 2000 to 2010, and Prevnar 13® has been available since 2010.2Prevnar 20® is built on the effectiveness of Prevnar† vaccines1-3Prevnar includes Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). In the US, Prevnar® (PCV7) was available from 2000 to 2010, and Prevnar 13® has been available since 2010.2

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 13®3

CDC surveillance data for children <5 years of age‡

In babies, from 2000-2019, Prevnar† reduced the burden of IPD and has prevented4:
  • >16,000 meningitis cases
  • >172,000 bacteremia cases
CDC surveillance data are observational data only, based on incidence rates from 1998 through 2019 collected through the NNDSS and the ABCs system run by the CDC.3

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.2,5

ABCs=Active Bacterial Core surveillance; CDC=Centers for Disease Control and Prevention; CI=confidence interval; IPD=invasive pneumococcal disease; ITT=intent-to-treat; NNDSS=National Notifiable Diseases Surveillance System.

See how Prevnar 20® provides broad serotype coverage
against 20 serotypes

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. Pneumococcal disease surveillance reporting and trends. Reviewed September 1, 2020. Accessed March 11, 2022. https:// www.cdc.gov/pneumococcal/surveillance.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.Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals Inc., 2009.
Manufactured by Wyeth Pharmaceuticals LLC.
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Efficacy Robust immune response with Prevnar 20® after 4 doses1 See Trial Results Loading Order Prevnar 20®

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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.