青少年（15 - 18岁）接种Covaxin后的不良事件——印度北部某地区的一项药物警戒研究。
Adverse events following Covaxin administration among adolescents (15-18 years) - A pharmacovigilance study in a district in Northern India.
作者信息
Deb Tirthankar, Kaur Manmeet, Misra Saurav, Verma Neelam, Sindhu Nitika, Kairi Jayant
机构信息
Department of Pharmacology, Kalpana Chawla Government Medical College, Karnal, Haryana, India.
Deputy Civil Surgeon with Immunization, Karnal, Haryana, India.
出版信息
J Family Med Prim Care. 2024 Mar;13(3):838-840. doi: 10.4103/jfmpc.jfmpc_892_23. Epub 2024 Apr 4.
INTRODUCTION
The study was undertaken to observe the adverse event following immunization (AEFI) to the Covaxin vaccine in young adolescents in the age group of 15-18 years in a district in Northern India. The study was conducted to assess the safety profile of the COVAXIN vaccine.
METHODOLOGY
This was a prospective observational study conducted at rural and urban health centers of a district in Northern India. We included the beneficiaries of the COVAXIN between the age of 15 and 18 years. The administration of the COVAXIN occurred in our district from January 2022. Periodic visits were conducted to the urban and rural health centers of the city to record any suspected adverse drug reaction following immunization in the defined population. The study was conducted for a period of 1 year (January 2022 to December 2022).
RESULTS
A total of 72,771 adolescents (15-18 years) received the first dose of Covaxin and 49,046 received the second dose. No adverse drug event following immunization was reported during the study.
CONCLUSION
Thus, it can be concluded that Covaxin was found to be safe in adolescents (15-18 years).
引言
本研究旨在观察印度北部某地区15至18岁青少年接种Covaxin疫苗后的免疫接种不良反应（AEFI）。本研究旨在评估Covaxin疫苗的安全性。
方法
这是一项在印度北部某地区的农村和城市卫生中心进行的前瞻性观察研究。我们纳入了15至18岁接种Covaxin疫苗的受益者。Covaxin疫苗于2022年1月在我们地区开始接种。我们定期走访该城市的城乡卫生中心，记录特定人群接种疫苗后出现的任何疑似药物不良反应。本研究为期1年（2022年1月至2022年12月）。
结果
共有72,771名青少年（15至18岁）接种了第一剂Covaxin疫苗，49,046名青少年接种了第二剂。研究期间未报告接种疫苗后出现药物不良事件。
结论
因此，可以得出结论，Covaxin疫苗在青少年（15至18岁）中被发现是安全的。
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