Use of combination measles, mumps, rubella, and varicella vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report presents new recommendations adopted in June 2009 by CDC's Advisory Committee on Immunization Practices (ACIP) regarding use of the combination measles, mumps, rubella, and varicella vaccine (MMRV, ProQuad, Merck & Co., Inc.). MMRV vaccine was licensed in the United States in September 2005 and may be used instead of measles, mumps, rubella vaccine (MMR, M-M-RII, Merck & Co., Inc.) and varicella vaccine (VARIVAX, Merck & Co., Inc.) to implement the recommended 2-dose vaccine schedule for prevention of measles, mumps, rubella, and varicella among children aged 12 months-12 years. At the time of its licensure, use of MMRV vaccine was preferred for both the first and second doses over separate injections of equivalent component vaccines (MMR vaccine and varicella vaccine), which was consistent with ACIP's 2006 general recommendations on use of combination vaccines (CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55;[No. RR-15]). Since July 2007, supplies of MMRV vaccine have been temporarily unavailable as a result of manufacturing constraints unrelated to efficacy or safety. MMRV vaccine is expected to be available again in the United States in May 2010. In February 2008, on the basis of preliminary data from two studies conducted postlicensure that suggested an increased risk for febrile seizures 5-12 days after vaccination among children aged 12-23 months who had received the first dose of MMRV vaccine compared with children the same age who had received the first dose of MMR vaccine and varicella vaccine administered as separate injections at the same visit, ACIP issued updated recommendations regarding MMRV vaccine use (CDC. Update: recommendations from the Advisory Committee on Immunization Practices [ACIP] regarding administration of combination MMRV vaccine. MMWR 2008;57:258-60). These updated recommendations expressed no preference for use of MMRV vaccine over separate injections of equivalent component vaccines for both the first and second doses. The final results of the two postlicensure studies indicated that among children aged 12--23 months, one additional febrile seizure occurred 5-12 days after vaccination per 2,300-2,600 children who had received the first dose of MMRV vaccine compared with children who had received the first dose of MMR vaccine and varicella vaccine administered as separate injections at the same visit. Data from postlicensure studies do not suggest that children aged 4--6 years who received the second dose of MMRV vaccine had an increased risk for febrile seizures after vaccination compared with children the same age who received MMR vaccine and varicella vaccine administered as separate injections at the same visit. In June 2009, after consideration of the postlicensure data and other evidence, ACIP adopted new recommendations regarding use of MMRV vaccine for the first and second doses and identified a personal or family (i.e., sibling or parent) history of seizure as a precaution for use of MMRV vaccine. For the first dose of measles, mumps, rubella, and varicella vaccines at age 12--47 months, either MMR vaccine and varicella vaccine or MMRV vaccine may be used. Providers who are considering administering MMRV vaccine should discuss the benefits and risks of both vaccination options with the parents or caregivers. Unless the parent or caregiver expresses a preference for MMRV vaccine, CDC recommends that MMR vaccine and varicella vaccine should be administered for the first dose in this age group. For the second dose of measles, mumps, rubella, and varicella vaccines at any age (15 months-12 years) and for the first dose at age >or=48 months, use of MMRV vaccine generally is preferred over separate injections of its equivalent component vaccines (i.e., MMR vaccine and varicella vaccine). This recommendation is consistent with ACIP's 2009 provisional general recommendations regarding use of combination vaccines (available at http://www.cdc.gov/vaccines/recs/provisional/downloads/combo-vax-Aug2009-508.pdf), which state that use of a combination vaccine generally is preferred over its equivalent component vaccines.

Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices.

The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in immunization and related fields, selected by the Secretary of the U.S. Department of Health and Human Services, to provide advice and guidance on control of vaccine-preventable diseases. In its role as a federal advisory committee, the ACIP develops written recommendations, subject to approval of the Director of the Centers for Disease Control and Prevention, for administration of U.S. Food and Drug Administration-licensed vaccines to children, adolescents, and adults in the U.S. civilian population. On the basis of careful review of available scientific data, including disease morbidity and mortality in the general U.S. population and in specific risk groups, vaccine safety and efficacy, cost-effectiveness, and related factors, the ACIP recommends vaccines and age for vaccine administration, number of doses and dosing interval, and precautions and contraindications. The ACIP works closely with several liaison organizations, including the American College of Physicians, to develop immunization recommendations that are harmonized among key professional medical organizations in the United States. This report includes a description of the member composition of the ACIP, the degree to which Committee members are screened for conflicts of interest, the workgroups that gather information before full Committee consideration, and the process and types of evidence used to formulate recommendations.

National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect: defining the national agenda for fetal alcohol syndrome and other prenatal alcohol-related effects.

Prenatal alcohol exposure can lead to serious birth defects and developmental disabilities. A need exists to develop effective strategies for both children with fetal alcohol syndrome (FAS) or other prenatal alcohol-related effects and for women at high risk for having an alcohol-exposed pregnancy. Since the syndrome was identified approximately 30 years ago, advancements have been made in FAS diagnostics, surveillance, prevention, and intervention, but a substantial amount of work remains. Collaborations among partners in federal state, and local agencies, academia, clinical professions, school systems, and families are critical to developing and implementing successful efforts related to FAS and fetal alcohol effect (FAE). In 1999, Congress directed the Secretary of the U.S. Department of Health and Human Services to convene the National Task Force on FAS and FAE (the Task Force). CDC's National Center on Birth Defects and Developmental Disabilities, Fetal Alcohol Syndrome Prevention Team, coordinates the Task Force and manages its operation. Since the Task Force was chartered in 2000, Task Force members, with input from multiple partners, have convened to deliberate and determine the Task Force mission, goals, and priority concerns to be addressed. This report describes the structure, function, mission, and goals of the Task Force and provides their first recommendations. An explanation of how the Task Force recommendations were generated and the Task Forces next steps are also reported.