Su John R, Leroy Zanie, Lewis Paige W, Haber Penina, Marin Mona, Leung Jessica, Woo Emily Jane, Shimabukuro Tom T
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases,
School Health Branch, Division of Population Health, National Center for Chronic Disease Prevention and Health Promotion, and.
Pediatrics. 2017 Mar;139(3). doi: 10.1542/peds.2016-2536. Epub 2017 Feb 7.
In 2006, routine 2-dose varicella vaccination for children was recommended to improve control of varicella. We assessed the safety of second-dose varicella vaccination.
We identified second-dose single-antigen varicella vaccine reports in the Vaccine Adverse Event Reporting System during 2006 to 2014 among children aged 4 to 18 years. We analyzed reports by age group (4-6 and 7-18 years), sex, serious or nonserious status, most common adverse events (AEs), and whether other vaccines were administered concomitantly with varicella vaccine. We reviewed serious reports of selected AEs and conducted empirical Bayesian data mining to detect disproportional reporting of AEs.
We identified 14 641 Vaccine Adverse Event Reporting System reports after second-dose varicella vaccination, with 494 (3%) classified as serious. Among nonserious reports, injection site reactions were most common (48% of children aged 4-6 years, 38% of children aged 7-18 years). The most common AEs among serious reports were pyrexia (31%) for children aged 4 to 6 years and headache (28%) and vomiting (27%) for children aged 7 to 18 years. Serious reports of selected AEs included anaphylaxis (83), meningitis (5), encephalitis (16), cellulitis (52), varicella (6), herpes zoster (6), and deaths (7). One immunosuppressed adolescent was reported with vaccine-strain herpes zoster. Only previously known AEs were reported more frequently after second-dose varicella vaccination compared with other vaccines.
We identified no new or unexpected safety concerns for second-dose varicella vaccination. Robust safety monitoring remains an important component of the national varicella vaccination program.
2006年，建议对儿童进行常规两剂水痘疫苗接种以加强水痘控制。我们评估了第二剂水痘疫苗接种的安全性。
我们在疫苗不良事件报告系统中识别出2006年至2014年期间4至18岁儿童接种第二剂单抗原水痘疫苗的报告。我们按年龄组（4至6岁和7至18岁）、性别、严重或非严重状态、最常见的不良事件以及水痘疫苗接种时是否同时接种其他疫苗对报告进行分析。我们审查了选定不良事件的严重报告，并进行经验贝叶斯数据挖掘以检测不良事件的不成比例报告。
我们识别出14641份第二剂水痘疫苗接种后的疫苗不良事件报告系统报告，其中494份（3%）被归类为严重报告。在非严重报告中，注射部位反应最为常见（4至6岁儿童中有48%，7至18岁儿童中有38%）。严重报告中最常见的不良事件，4至6岁儿童为发热（31%），7至18岁儿童为头痛（28%）和呕吐（27%）。选定不良事件的严重报告包括过敏反应（83例）、脑膜炎（5例）、脑炎（16例）、蜂窝织炎（52例）、水痘（6例）、带状疱疹（6例）和死亡（7例）。报告了1名免疫抑制青少年发生疫苗株带状疱疹。与其他疫苗相比，第二剂水痘疫苗接种后仅报告了先前已知的不良事件更频繁。
我们未发现第二剂水痘疫苗接种有新的或意外的安全问题。强有力的安全监测仍然是国家水痘疫苗接种计划的重要组成部分。
