Rotavirus Vaccine for the Prevention of Rotavirus Gastroenteritis Among Children
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March 19, 1999 / Vol. 48 / No. RR-2 Recommendations and Reports Rotavirus Vaccine for the Prevention of Rotavirus Gastroenteritis Among Children Recommendations of the Advisory Committee on Immunization Practices (ACIP) Continuing Education Examination Education Continuing Inside: U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Atlanta, Georgia 30333 The MMWR series of publications is published by the Epidemiology Program Office, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA 30333. SUGGESTED CITATION Centers for Disease Control and Prevention. Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48(No. RR-2):[inclu- sive page numbers]. Centers for Disease Control and Prevention....................Jeffrey P. Koplan, M.D., M.P.H. Director The material in this report was prepared for publication by National Center for Infectious Diseases.................................. James M. Hughes, M.D. Director Division of Viral and Rickettsial Diseases ................. Brian W. J. Mahy, Ph.D., Sc.D. Director National Immunization Program ...........................................Walter A. Orenstein, M.D. Director Epidemiology and Surveillance Division ...........................John R. Livengood, M.D. Director The production of this report as an MMWR serial publication was coordinated in Epidemiology Program Office.................................... Stephen B. Thacker, M.D., M.Sc. Director Office of Scientific and Health Communications ......................John W. Ward, M.D. Director Editor, MMWR Series Recommendations and Reports................................... Suzanne M. Hewitt, M.P.A. Managing Editor Valerie R. Johnson Project Editor Morie M. Higgins Visual Information Specialist Vol. 48 / No. RR-2 MMWR i Contents Clinical and Epidemiologic Features of Rotavirus Disease.............................................. 2 Laboratory Testing for Rotavirus ................................................................................. 3 Morphology, Antigen Composition, and Immune Response................................... 3 Rotavirus Vaccine................................................................................................................. 4 Background ..................................................................................................................... 4 Immunogenicity ............................................................................................................. 5 Efficacy ............................................................................................................................ 6 Transmission of Attenuated Rotavirus Vaccine Strains............................................ 7 Vaccine Distribution, Handling, and Storage ............................................................. 8 Cost-Effectiveness of a Universal Childhood Immunization Program to Prevent Rotavirus .................................................................................. 8 Recommendations for the Use of Rotavirus Vaccine....................................................... 9 Routine Administration ................................................................................................. 9 Contraindications ........................................................................................................... 9 Precautions and Special Situations ........................................................................... 10 Adverse Events After Rotavirus Vaccination................................................................... 12 Future Needs In Rotavirus Surveillance, Research, Education, and Implementation.................................................................................................. 15 Surveillance .................................................................................................................. 15 Research ........................................................................................................................ 16 Education of Health-Care Providers and Parents .................................................... 16 Implementation ............................................................................................................ 16 References .......................................................................................................................... 16 Summary Table. Recommendations and Quality of Evidence...................................... 23 Insert: Continuing Education Activity .......................................................................... CE-1 Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services. Copies can be purchased from Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325. Telephone: (202) 512-1800. ii MMWR March 19, 1999 Advisory Committee on Immunization Practices Membership List, October 1998 CHAIRMAN EXECUTIVE SECRETARY John F. Modlin, M.D. Dixie E. Snider, Jr., M.D., M.P.H. Professor of Pediatrics and Medicine Associate Director for Science Dartmouth Medical School Centers for Disease Control Lebanon, New Hampshire and Prevention Atlanta, Georgia MEMBERS Richard D. Clover, M.D. Charles M. Helms, M.D., Ph.D. University of Louisville University of Iowa Hospital and Clinics School of Medicine Iowa City, Iowa Louisville, Kentucky David R. Johnson, M.D., M.P.H. David W. Fleming, M.D. Michigan Department of Oregon Health Division Community Health Portland, Oregon Lansing, Michigan Mary P. Glode, M.D. Chinh T. Le, M.D. The Children’s Hospital Kaiser Permanente Medical Center Denver, Colorado Santa Rosa, California Marie R. Griffin, M.D., M.P.H. Paul A. Offit, M.D. Vanderbilt University The Children’s Hospital of Philadelphia Medical Center Philadelphia, Pennsylvania Nashville, Tennessee Jessie L. Sherrod, M.D. Fernando A. Guerra, M.D. King Drew Medical Center San Antonio Metropolitan Los Angeles, California Health District Bonnie M. Word, M.D. San Antonio, Texas Monmouth Junction, New Jersey EX OFFICIO MEMBERS Robert F. Breiman, M.D. T. Randolph Graydon Centers for Disease Control Center for Medicaid and and Prevention State Operations Atlanta, Georgia Baltimore, Maryland Geoffrey S. Evans, M.D. M. Carolyn Hardegree, M.D. Health Resources and Food and Drug Administration Services Administration Rockville, Maryland Rockville, Maryland Vol. 48 / No. RR-2 MMWR iii Advisory Committee on Immunization Practices Membership List, October 1998 — Continued Regina Rabinovich, M.D. David H. Trump, M.D., M.P.H. National Institutes of Health Office of the Assistant Secretary Bethesda, Maryland of Defense (Health Affairs) Falls Church, Virginia Kristin Lee Nichol, M.D., M.P.H. VA Medical Center Minneapolis, Minnesota LIAISON REPRESENTATIVES American Academy of Family Physicians Biotechnology Industry Organization Richard Zimmerman, M.D. Yvonne E. McHugh, Ph.D. Pittsburgh, Pennsylvania Emeryville, California American Academy of Pediatrics Canadian National Advisory Larry Pickering, M.D. Committee on Immunization Norfolk, Virginia Victor Marchessault, M.D. Neal A. Halsey, M.D. Cumberland, Ontario Baltimore, Maryland Hospital Infection Control Practices American Association of Health Plans Advisory Committee Gregory P. Gilmet, M.D. Jane D. Siegel, M.D. South Field, Michigan Dallas, Texas American College of Obstetricians Infectious Diseases Society of America and Gynecologists Samuel L. Katz, M.D. Stanley A. Gall, M.D. Durham, North Carolina Louisville, Kentucky National Immunization Council and American College of Physicians Child Health Program, Mexico Pierce Gardner, M.D. Jose Ignacio Santos, M.D. Stony Brook, New York Mexico City, Mexico American Hospital Association National Medical Association William Schaffner, M.D. Walter Faggett, M.D. Nashville, Tennessee Atlanta, Georgia American Medical Association National Vaccine Advisory Committee H. David Wilson, M.D. Georges Peter, M.D. Grand Forks, North Dakota Providence, Rhode Island Association of Teachers of Pharmaceutical Research and Preventive Medicine Manufacturers of America W. Paul McKinney, M.D. Gordon R. Douglas, Jr., M.D. Louisville, Kentucky Whitehouse Station, New Jersey iv MMWR March 19, 1999 Members of the Rotavirus Working Group Advisory Committee on Immunization Practices (ACIP) John F. Modlin, M.D., Chairman Chinh T. Le, M.D. David W. Fleming, M.D. ACIP Members Roger I. Glass, M.D., Ph.D. Joseph S. Bresee, M.D. Division of Viral and Rickettsial Diseases National Center for Infectious Diseases, CDC Margaret Rennels, M.D. Department of Pediatrics University of Maryland Richard Zimmerman, M.D. American Academy of Family Physicians Neal A. Halsey, M.D. American Academy of Pediatrics Peter R. Paradiso, Ph.D. Lederle-Praxis Biologicals Division Wyeth-Lederle Vaccines and Pediatrics Florian Schodel, M.D. Office for Clinical Vaccine Research Merck Research Labs Vol. 48 / No. RR-2 MMWR v The following CDC staff members prepared this report: Joseph S. Bresee, M.D. Roger I. Glass, M.D., Ph.D. Division of Viral and Rickettsial Diseases National Center for Infectious Diseases Charles R. Vitek, M.D., M.P.H. Epidemiology and Surveillance Division National Immunization Program vi MMWR March 19, 1999 Vol. 48 / No. RR-2 MMWR 1 Rotavirus Vaccine for the Prevention of Rotavirus Gastroenteritis