Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, CDC, Atlanta, GA 30333, USA.
MMWR Recomm Rep. 2010 May 7;59(RR-3):1-12.
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.
本报告介绍了 2009 年 6 月疾病预防控制中心免疫实施咨询委员会(ACIP)通过的关于使用麻疹、腮腺炎、风疹、水痘联合疫苗(MMRV,ProQuad,默克公司)的新建议。MMRV 疫苗于 2005 年 9 月在美国获得许可,可用于替代麻疹、腮腺炎、风疹疫苗(MMR,M-M-RII,默克公司)和水痘疫苗(VARIVAX,默克公司),以实施针对 12 个月至 12 岁儿童的两剂疫苗接种计划,预防麻疹、腮腺炎、风疹和水痘。在获得许可时,与分别注射等效成分疫苗(MMR 疫苗和水痘疫苗)相比,第一和第二剂均优先使用 MMRV 疫苗,这与 ACIP 关于联合疫苗使用的 2006 年一般建议一致(CDC. 一般免疫建议:免疫实施咨询委员会(ACIP)的建议。MMWR 2006;55;[RR-15 号])。自 2007 年 7 月以来,由于与疗效或安全性无关的制造限制,MMRV 疫苗的供应暂时无法获得。预计 MMRV 疫苗将于 2010 年 5 月在美国再次供应。2008 年 2 月,根据两项上市后研究的初步数据,在 12-23 个月大的儿童中,与接受第一剂 MMR 疫苗和水痘疫苗(在同一时间分开注射)的同年龄儿童相比,接种第一剂 MMRV 疫苗后 5-12 天发热性惊厥的风险增加,因此 ACIP 发布了关于 MMRV 疫苗使用的更新建议(CDC. 关于免疫实施咨询委员会(ACIP)使用组合 MMRV 疫苗的建议的更新。MMWR 2008;57:258-60)。这些更新的建议不优先推荐在第一和第二剂量上使用 MMRV 疫苗代替等效成分疫苗的单独注射。两项上市后研究的最终结果表明,在 12-23 个月大的儿童中,与接受第一剂 MMR 疫苗和水痘疫苗(在同一时间分开注射)的儿童相比,接种第一剂 MMRV 疫苗后 5-12 天发热性惊厥每 2300-2600 例儿童中增加 1 例。上市后研究的数据并未表明,与在同一时间接受 MMR 疫苗和水痘疫苗(在同一时间分开注射)的儿童相比,4-6 岁儿童在接种第二剂 MMRV 疫苗后发热性惊厥的风险增加。2009 年 6 月,在考虑了上市后数据和其他证据后,ACIP 就 MMRV 疫苗的第一和第二剂量的使用采纳了新的建议,并确定了癫痫发作的个人或家族史(即兄弟姐妹或父母)作为使用 MMRV 疫苗的注意事项。对于 12-47 个月大儿童的麻疹、腮腺炎、风疹和水痘疫苗的第一剂,可使用 MMR 疫苗和水痘疫苗或 MMRV 疫苗。考虑使用 MMRV 疫苗的提供者应与父母或看护人讨论两种疫苗接种方案的益处和风险。除非父母或看护人表示对 MMRV 疫苗的偏好,否则 CDC 建议在该年龄组中应使用 MMR 疫苗和水痘疫苗进行第一剂接种。对于任何年龄(15 个月至 12 岁)的麻疹、腮腺炎、风疹和水痘疫苗的第二剂,以及对于>或=48 个月大儿童的麻疹、腮腺炎、风疹和水痘疫苗的第一剂,一般优先使用 MMRV 疫苗而不是其等效成分疫苗(即 MMR 疫苗和水痘疫苗)。这一建议与 ACIP 关于联合疫苗使用的 2009 年临时一般建议一致(可在 http://www.cdc.gov/vaccines/recs/provisional/downloads/combo-vax-Aug2009-508.pdf 获得),该建议指出,一般优先使用联合疫苗而不是其等效成分疫苗。