Morbidity and Mortality Weekly Report www.cdc.gov/mmwr Recommendations and Reports December 10, 2010 / Vol. 59 / No. RR-11 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) department of health and human services Centers for Disease Control and Prevention MMWR CONTENTS The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Introduction .............................................................................. 1 Disease Control and Prevention (CDC), U.S. Department of Health Background .............................................................................. 2 and Human Services, Atlanta, GA 30333. 13-Valent Pneumococcal Conjugate Vaccine................................ 6 Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR 2010;59(No. RR-#):[inclusive page numbers]. 23-Valent Pneumococcal Polysaccharide Vaccine ....................... 11 Recommendations for Use of PCV13 and PPSV23 ...................... 12 Centers for Disease Control and Prevention Public Health Considerations .................................................... 14 Thomas R. Frieden, MD, MPH Director References .............................................................................. 15 Harold W. Jaffe, MD, MA Associate Director for Science James W. Stephens, PhD Office of the Associate Director for Science Stephen B. Thacker, MD, MSc Deputy Director for Surveillance, Epidemiology, and Laboratory Services Stephanie Zaza, MD, MPH Director, Epidemiology and Analysis Program Office Editorial and Production Staff Ronald L. Moolenaar, MD, MPH Editor, MMWR Series John S. Moran, MD, MPH Deputy Editor, MMWR Series Teresa F. Rutledge Managing Editor, MMWR Series David C. Johnson Lead Technical Writer-Editor Jeffrey D. Sokolow, MA Project Editor Martha F. Boyd Lead Visual Information Specialist Malbea A. LaPete Stephen R. Spriggs Terraye M. Starr Visual Information Specialists Quang M. Doan, MBA Phyllis H. King Information Technology Specialists Editorial Board William L. Roper, MD, MPH, Chapel Hill, NC, Chairman Virginia A. Caine, MD, Indianapolis, IN Jonathan E. Fielding, MD, MPH, MBA, Los Angeles, CA David W. Fleming, MD, Seattle, WA William E. Halperin, MD, DrPH, MPH, Newark, NJ King K. Holmes, MD, PhD, Seattle, WA Deborah Holtzman, PhD, Atlanta, GA John K. Iglehart, Bethesda, MD Dennis G. Maki, MD, Madison, WI Patricia Quinlisk, MD, MPH, Des Moines, IA Patrick L. Remington, MD, MPH, Madison, WI Barbara K. Rimer, DrPH, Chapel Hill, NC John V. Rullan, MD, MPH, San Juan, PR William Schaffner, MD, Nashville, TN Anne Schuchat, MD, Atlanta, GA Dixie E. Snider, MD, MPH, Atlanta, GA John W. Ward, MD, Atlanta, GA Vol. 59 / RR-11 Recommendations and Reports 1 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) Prepared by J. Pekka Nuorti, MD Cynthia G. Whitney, MD Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases SUMMARY On February 24, 2010, a 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused among infants and young children by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes also covered by the 7-valent pneumococcal conjugate vaccine for- mulation (PCV7 [Prevnar, Wyeth]). PCV13 contains the seven serotypes included in PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and six additional serotypes (serotypes 1, 3, 5, 6A, 7F, and 19A). PCV13 is approved for use among children aged 6 weeks–71 months and supersedes PCV7, which was licensed by FDA in 2000. This report summarizes recommendations approved by the Advisory Committee on Immunization Practices (ACIP) on February 24, 2010, for the use of PCV13 to prevent pneumococcal disease in infants and young children aged <6 years. Recommendations include 1) routine vaccination of all children aged 2–59 months, 2) vaccination of children aged 60–71 months with underlying medical conditions, and 3) vaccination of children who received ≥1 dose of PCV7 previously (CDC. Licensure of a 13-valent pneumococcal conjugate vaccine [PCV13] and recommendations for use among children—Advisory Committee on Immunization Practices [ACIP], 2010. MMWR 2010;59:258–61). Recommendations also are provided for targeted use of the 23-valent pneu- mococcal polysaccharide vaccine (PPSV23, formerly PPV23) in children aged 2–18 years with underlying medical conditions that increase their risk for contracting pneumococcal disease or experiencing complications of pneumococcal disease if infected. The ACIP recommendation for routine vaccination with PCV13 and the immunization schedules for children aged ≤59 months who have not received any previous PCV7 or PCV13 doses are the same as those published previously for PCV7 (CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2000;49[No. RR-9]; CDC. Updated recommendation from the Advisory Committee on Immunization Practices [ACIP] for use of 7-valent pneumococcal conjugate vaccine [PCV7] in children aged 24–59 months who are not completely vac- cinated. MMWR 2008;57:343–4), with PCV13 replacing PCV7 for all doses. For routine immunization of infants, PCV13 is recommended as a 4-dose series at ages 2, 4, 6, and 12–15 months. Infants and children who have received ≥1 dose of PCV7 should complete the immunization series with PCV13. A single supplemental dose of PCV13 is recommended for all children aged 14–59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through age 71 months. Children aged 2–18 years with underlying medical conditions also should receive PPSV23 after completing all recommended doses of PCV13. Introduction Streptococcus pneumoniae (pneumococcus) remains a lead- ing cause of serious illness, including bacteremia, meningitis, This report originated in the Division of Bacterial Diseases, Rana and pneumonia among children and adults worldwide. It is Hajjeh, MD, Director, and the National Center for Immunization also a major cause of sinusitis and acute otitis media (AOM). and Respiratory Diseases, Anne Schuchat, MD, Director. Corresponding preparer: Cynthia G. Whitney, MD, National Center In February 2000, a 7-valent pneumococcal polysaccharide- for Immunization and Respiratory Diseases, CDC, 1600 Clifton Rd, protein conjugate vaccine (PCV7; Prevnar, Wyeth) was licensed NE, MS C-23, Atlanta GA 30333. Telephone: 404-639-4927; Fax: by the Food and Drug Administration (FDA) for use among 404-639-3970; E-mail: [email protected]. infants and young children in the United States (1). In pre- 2 MMWR December 10, 2010 licensure randomized clinical trials, PCV7 was demonstrated Background to be safe and highly efficacious against invasive pneumococ- cal disease (IPD), moderately efficacious against pneumonia, and somewhat effective in reducing otitis media episodes and Clinical Efficacy of Pneumococcal related office visits (2–4). On the basis of the results of these Conjugate Vaccines clinical trials, in 2000, ACIP recommended routine use of The efficacy of pneumococcal conjugate vaccines (PCVs) PCV7 for all children aged 2–23 months and for children aged was evaluated in randomized, controlled trials among children 24–59 months who are at increased risk for pneumococcal aged <2 years. A prelicensure clinical efficacy trial of PCV7 con- disease (e.g., children with anatomic or functional asplenia, ducted among 37,868 healthy children at a health maintenance sickle cell disease (SCD), HIV infection or other immunocom- organization in northern California indicated that PCV7 was promising condition, or chronic illness including chronic heart 97.4% (95% confidence interval [CI] = 82.7%–99.9%) effica- or lung disease, cerebrospinal fluid leaks, and diabetes mellitus) cious against IPD caused by vaccine serotypes (the primary end- (1). In 2007, ACIP revised its recommendation for routine point) among fully vaccinated infants (2). A recently updated use to include all children aged 2–59 months (5). National systematic review by the Cochrane Collaboration included Immunization Survey data indicate that in 2009, PCV7 cov- results from five randomized, controlled trials to evaluate PCVs erage among children aged 19–35 months was 92.6% for ≥3 (including PCV7 and experimental 9-valent and 11-valent vac- doses and 80.4% for ≥4 doses (6). cine formulations) against IPD and/or pneumonia. The trials The safety, efficacy, and effectiveness in practice of PCV7 conducted in various settings in both industrialized countries and other pneumococcal conjugate vaccines has been estab- (U.S. general population [2] and Native American children lished in multiple settings in both industrialized and develop- [13]) and developing countries (South Africa [14], the Gambia ing countries (7). In 2007, the World Health Organization