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Prevnar 20® is the only pneumococcal conjugate vaccine indicated and available for otitis media in babies1-3*

Prevnar (PCV7) OM study design2
Double-blind vaccine efficacy trial in which 1662 babies were randomized 1:1 to receive either Prevnar (PCV7) or a control vaccine, Recombivax HB® (Hepatitis B Vaccine [Recombinant]), at 2, 4, 6, and 12 to 15 months of age.2

OM results in more than 10 million pediatric office visits annually, making it one of the most frequent reasons for office visits.4
Prevnar 20 was studied in a phase 3 pivotal trial1,5References:
Explore the study design
Loading Efficacy Robust immune response with Prevnar 20® after 4 doses1 See trial results Loading References ITT=intent to treat; OM=otitis media; PCV7=7-valent pneumococcal conjugate vaccine. *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.1,2Recombivax HB is a registered trademark of Merck & Co Inc. 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.Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine) Prescribing Information. Merck Sharp & Dohme Corp, 2023.Gierke R, Wodi AP, Kobayashi M. Pneumococcal disease. In: Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. Centers for Disease Control and Prevention. 14th ed. Public Health Foundation; 2021:255-274. Watson W. 20-valent pneumococcal conjugate vaccine (PCV20) phase 3 in pediatrics. Presented at: Advisory Committee on Immunization Practices; February 22-24, 2023; Atlanta, GA. Accessed April 12, 2025. https://www.cdc.gov/acip/downloads/slides-2023-02-22-24/Pneumococcal-04-Watson-508.pdf
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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