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. 2022 Sep 16;71(37):1174-1181.
doi: 10.15585/mmwr.mm7137a3.

Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022

Miwako Kobayashi, Jennifer L Farrar, Ryan Gierke, Andrew J Leidner, Doug Campos-Outcalt, Rebecca L Morgan, Sarah S Long, Katherine A Poehling, Adam L Cohen; ACIP Pneumococcal Vaccines Work Group; CDC Contributors
Collaborators, Affiliations

Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022

Miwako Kobayashi et al. MMWR Morb Mortal Wkly Rep. .

Abstract

The 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer, Inc]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Merck Sharp & Dohme LLC]) have been recommended for U.S. children, and the recommendations vary by age group and risk group (1,2). In 2021, 15-valent pneumococcal conjugate vaccine (PCV15 [Vaxneuvance, Merck Sharp & Dohme LLC]) was licensed for use in adults aged ≥18 years (3). On June 17, 2022, the Food and Drug Administration (FDA) approved an expanded usage for PCV15 to include persons aged 6 weeks-17 years, based on studies that compared antibody responses to PCV15 with those to PCV13 (4). PCV15 contains serotypes 22F and 33F (in addition to the PCV13 serotypes) conjugated to CRM197 (genetically detoxified diphtheria toxin). On June 22, 2022, CDC's Advisory Committee on Immunization Practices (ACIP) recommended use of PCV15 as an option for pneumococcal conjugate vaccination of persons aged <19 years according to currently recommended PCV13 dosing and schedules (1,2). ACIP employed the Evidence to Recommendation (EtR) Framework,* using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE)† approach to guide its deliberations regarding use of these vaccines. Risk-based recommendations on use of PPSV23 for persons aged 2-18 years with certain underlying medical conditions§ that increase the risk for pneumococcal disease have not changed.

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Conflict of interest statement

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Katherine A. Poehling reports institutional support from Safe Sleep for All Newborns, Love Out Loud Early Childhood Fellow, Intimate Partner Violence Collaborative Project, Because You Matter: Conversations You Want about COVID-19, text messaging follow-up for patients who missed well-child visits, and Reimagining Health and Wellness by Mothers for Our Babies, Families, and Communities. No other potential conflicts of interest were disclosed.

References

    1. Nuorti JP, Whitney CG; CDC. Prevention of pneumococcal disease among infants and children—use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2010;59(RR-11):1–18. - PubMed
    1. CDC. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6–18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2013;62:521–4. - PMC - PubMed
    1. Food and Drug Administration. Approval letter: Vaxneuvance. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/media/150820/download
    1. Food and Drug Administration. Approval letter: Vaxneuvance. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/media/159338/download
    1. Farrar J, Nsofor C, Childs L, Kobayashi M, Pilishvili T. Systematic review of 13-valent pneumococcal conjugate vaccine effectiveness against pneumonia among children. 12th International Symposium on Pneumococci and Pneumococcal Diseases meeting presentation; Toronto, Canada; June 21, 2022.