Sadoh Ayebo Evawere, Nwaneri Damian Uchechukwu, Ogboghodo Bamidele Charity, Sadoh Wilson Ehidiamen
Institute of Child Health, University of Benin, Benin City, Nigeria.
Department of Child Health, University of Benin, Benin City, Nigeria.
Pharmacoepidemiol Drug Saf. 2018 Jan;27(1):119-122. doi: 10.1002/pds.4243. Epub 2017 Jun 6.
Adverse events following immunization (AEFI) may follow the use of any vaccine. There is thus a need for documentation of the types and prevalence of AEFIs for each vaccine and early identification of new events or those occurring at rates higher than expected. When one vaccine replaces another, it is important to document the safety of the new vaccine as well as compare to that of the old. In this study, we aimed to document the AEFIs following the use of pentavalent vaccine recently introduced into the National Programme on Immunization and compare with those of diphtheria-tetanus-pertussis (DTwP) vaccine which it replaced.
This was a retrospective cohort study on infants with at least 2 immunization visits who commenced immunization between June 2011 and May 2013 at the Child Welfare Clinic of Institute of Child Health, University of Benin, Nigeria. At every visit for immunization, the caregiver is asked about any reaction that followed the previous immunization, and this is documented in immunization registers which data were reviewed for this study.
There were 2475 doses of DTwP and pentavalent vaccines administered to 946 children. Adverse events following immunizations were reported following 487 (19.7%) doses. The prevalence of AEFIs following pentavalent vaccine (22.1%) was significantly higher than that following DTwP (13.5%) P < .0001. Significantly more AEFIs followed the first dose of either vaccine compared to subsequent doses P < .0001. The commonest AEFI reported for either vaccine was fever.
Adverse events following immunization following pentavalent vaccine although higher than that following DTwP was within expected levels.
接种疫苗后可能出现不良事件(AEFI),任何疫苗的使用都可能引发此类情况。因此,需要记录每种疫苗的AEFI类型及发生率,并尽早识别新出现的事件或发生率高于预期的事件。当一种疫苗取代另一种疫苗时,记录新疫苗的安全性并与旧疫苗进行比较非常重要。在本研究中,我们旨在记录最近纳入国家免疫规划的五价疫苗接种后的AEFI,并与被其取代的白喉-破伤风-百日咳(DTwP)疫苗的AEFI进行比较。
这是一项回顾性队列研究,研究对象为2011年6月至2013年5月在尼日利亚贝宁大学儿童健康研究所儿童福利诊所开始接种疫苗且至少有2次接种记录的婴儿。每次接种疫苗时,都会询问看护人上次接种后有无任何反应,并记录在接种登记册中,本研究对这些数据进行了审查。
共向946名儿童接种了2475剂DTwP疫苗和五价疫苗。487剂(19.7%)接种后报告了接种疫苗后的不良事件。五价疫苗接种后AEFI的发生率(22.1%)显著高于DTwP疫苗接种后(13.5%),P <.0001。与后续剂量相比,两种疫苗的第一剂接种后出现的AEFI明显更多,P <.0001。两种疫苗报告的最常见AEFI是发热。
五价疫苗接种后的不良事件虽然高于DTwP疫苗接种后的不良事件,但仍在预期范围内。