Scroll for Important Safety Information and Indications
IMPORTANT SAFETY INFORMATION
- Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine is a contraindication
- Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response
- 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 infants and toddlers, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
- In children 6 weeks through 17 years, the most commonly reported solicited adverse reactions were injection site tenderness, redness, or swelling, irritability, decreased appetite, decreased or increased sleep, and fever
- In children 6 years through 17 years of age, Prevnar 13® is administered as a single dose
INDICATIONS
- Prevnar 13® is a vaccine indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
- In children 6 weeks through 17 years for invasive disease caused by the 13 serotypes, and for children 6 weeks through 5 years of age for otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)
Limitations of Use and Effectiveness
- Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine
Patients should always ask their doctors 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 www.vaers.hhs.gov or call 1-800-822-7967.
Please see full Prescribing Information for Prevnar 13®.
Reference:
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Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2017.
References:
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Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2017.
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Centers for Disease Control and Prevention. Pneumococcal disease: surveillance and reporting. https://www.cdc.gov/pneumococcal/surveillance.html. Updated
August 1, 2018. Accessed January 4, 2019. -
Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2009.
References:
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Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2017.
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Centers for Disease Control and Prevention. Licensure of a 13-valent conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.
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American Academy of Pediatrics, Committee on Infectious Diseases. Policy statement—recommendations for the prevention of Streptococcus pneumoniae infections in infants and children: use of 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23). Pediatrics. 2010;126(1):186-190.
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Yeh SH, Gurtman A, Hurley DC, et al; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126(3):e493-e505.
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Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Hamborsky J, Stanton A, Wolfe C, eds. 12th ed. Washington, DC: Public Health Foundation; 2012.
References:
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Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2017.
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Hill HA, Elam-Evans LD, Yankey D, et al. Vaccination coverage among children aged 19-35 months—United States, 2017. MMWR Morb Mortal Wkly Rep. 2017;66(43):1171-1177.
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Centers for Disease Control and Prevention. ChildVaxView website. https://www.cdc.gov/vaccines/imz-managers/coverage/childvaxview/data-reports/pcv/trend/index.html. Accessed November 10, 2018.
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Office of Disease Prevention and Health Promotion. HealthyPeople.gov website. https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives. Updated November 17, 2017. Accessed November 17, 2017.
References:
-
Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2017.
-
Centers for Disease Control and Prevention. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.
-
American Academy of Pediatrics, Committee on Infectious Diseases. Policy Statement—recommendations for the prevention of Streptococcus pneumoniae infections in infants and children: use of 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23). Pediatrics. 2010;126(1):186-190.
-
Centers for Disease Control and Prevention. ChildVaxView website. https://www.cdc.gov/vaccines/imz-managers/coverage/childvaxview/data-reports/pcv/trend/index.html. Accessed January 23, 2018.
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Hill HA, Elam-Evans LD, Yankey D, et al. Vaccination coverage among children aged 19-35 months—United States, 2016. MMWR Morb Mortal Wkly Rep. 2017;66(43):1171-1177.
-
Office of Disease Prevention and Health Promotion. HealthyPeople.gov website. https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives. Updated November 17, 2017. Accessed November 17, 2017.
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