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Clinical Trial
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In a phase 3 pivotal study, Prevnar 20® demonstrated a safety profile consistent with Prevnar 13® (Pneumococcal 13-valent
Conjugate Vaccine [Diphtheria CRM197 Protein]

Percentage of participants with solicited adverse reactions within 7 days after vaccination1*†

Scroll left to view table
 Dose 1Dose 2Dose 3Dose 4
Prevnar 20 (n=993)
Prevnar 13 (n=974)Prevnar 20 (n=940)Prevnar 13 (n=924)Prevnar 20 (n=914)Prevnar 13 (n=901)Prevnar 20
(n=826)		Prevnar 13
(n=815)
Pain at injection site49.145.344.041.738.639.035.735.8
Swelling16.418.815.517.317.117.614.917.3
Redness25.524.623.226.425.427.223.526.6
Fever10.37.517.316.312.613.714.514.0
Decreased appetite24.423.926.423.520.622.424.825.2
Irritability70.971.771.668.864.463.061.061.1
Drowsiness67.266.054.755.644.144.139.539.5
Over 2.5 billion doses of Prevnar vaccines have been given globally since 2000 through October 2024.2ReferencesPCV7=7-valent pneumococcal conjugate vaccine.n=number of participants with any e-diary data reported after the specified dose. This value is the denominator for the percentage calculations.*Study conducted in the United States, including Puerto Rico.1†Local reactions, systemic reactions, and use of antipyretic/pain medication were collected in the e-diary from day 1 through day 7 after each dose. If a severe reaction was identified by the investigator as a Grade 4 reaction at a follow-up assessment, it was also reported as an adverse event.‡Any local reaction: any redness >0.0 cm, any swelling >0.0 cm, or any pain at the injection site after the specified dose.1§Any systemic reaction: any fever ≥38.0 °C, any decreased appetite, any drowsiness, or any irritability after the specified dose.1Prevnar includes Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), 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 Prevnar 20 is recommended as a 4-dose series1,3

Complete all 4 doses to optimize the Prevnar 20 immune response.1,3

See the dosing schedules
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Percentage of participants with solicited adverse reactions within 7 days after vaccination1*†
Scroll left to view table
 Dose 1Dose 2Dose 3Dose 4
Prevnar20®
(N=993)		Prevnar13®
(N=974)		Prevnar20®
(N=940)		Prevnar13®
(N=924)		Prevnar20®
(N=914)		Prevnar13®
(N=901)		Prevnar20®
(N=826)		Prevnar13®
(N=815)
Any local reactions‡
Pain at injection site49.145.344.041.738.639.035.735.8
Swelling16.418.815.517.317.117.614.917.3
Redness25.524.623.226.425.427.223.526.6
Any systemic reactions§
Fever10.37.517.316.312.613.714.514.0
Decreased appetite24.423.926.423.520.622.424.825.2
Irritability70.971.771.668.864.463.061.061.1
Drowsiness67.266.054.755.644.144.139.539.5
Clinical Trial Results Learn about Prevnar 20 dosing schedules
See the recommendations
ReferencesPCV7=7-valent pneumococcal conjugate vaccine.n=number of participants with any e-diary data reported after the specified dose. This value is the denominator for the percentage calculations.*Study conducted in the United States, including Puerto Rico.1†Local reactions, systemic reactions, and use of antipyretic/pain medication were collected in the e-diary from day 1 through day 7 after each dose. If a severe reaction was identified by the investigator as a Grade 4 reaction at a follow-up assessment, it was also reported as an adverse event.‡Any local reaction: any redness >0.0 cm, any swelling >0.0 cm, or any pain at the injection site after the specified dose.1§Any systemic reaction: any fever ≥38.0 °C, any decreased appetite, any drowsiness, or any irritability after the specified dose.1Prevnar includes Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), 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 2023.1,2References:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information. Wyeth Pharmaceuticals LLC, 2023.Chapman R, Sutton K, Dillon-Murphy D, et al. Ten year public health impact of 13-valent pneumococcal conjugate vaccination in infants: a modelling analysis. Vaccine. 2020;38(45):7138-7145.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.
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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