Neha Reddy, Subeesh Viswam, Beulah Elsa, Gouri Nair, Maheswari Eswaran
Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bangalore, India.
Department of Pharmacology, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bangalore, India.
Perspect Clin Res. 2020 Jan-Mar;11(1):24-30. doi: 10.4103/picr.PICR_140_18. Epub 2019 Apr 26.
The United States Food and Drug Administration (FDA) has licensed three HPV (Human papilloma virus) vaccines. The centers for disease control and prevention (CDC) and advisory committee on immunization practices (ACIP) recommends routine HPV vaccination at age 11 or 12 years. This study aimed to summarize and characterize adverse events following HPV vaccination reported to VAERS database from July 2006 to May 2017.
A systematic data mining was performed in the VAERS database for reports associated with HPV vaccine. Clinically relevant Vaccine Event Combinations (VEC) were identified in the VAERS database following HPV vaccination. A VEC was considered for analysis only if a minimum of hundred reports were present in database for the given Adverse Event (AE). The data mining algorithm used in this study was reporting odds ratio. A value of ROR-1.96SE >1 was considered as positive signal.
VAERS received 49444 reports after receipt of HPV vaccine during the study period. Out of 49444, 2307 unique reactions were identified. A total of 177 death reports and 3526 non death serious reactions were reported to VAERS. ROR showed positive signals for abdominal pain, syncope, dizziness, convulsion, abortion spontaneous, alopecia, amenorrhea, anogenital warts, cervical dysplasia, anaemia, dyskinesia, migrane, blood pressure decreased, fall, head injury, loss of consciousness, pallor, presyncope, seizures.
The present analysis did not identify any new/unexpected safety concern and was consistent with the safety data from prelicensure trials. Further epidemiological studies are required to systematically validate the data provided by VAERS.
美国食品药品监督管理局（FDA）已批准三种人乳头瘤病毒（HPV）疫苗。疾病控制与预防中心（CDC）以及免疫实践咨询委员会（ACIP）建议在11或12岁时进行常规HPV疫苗接种。本研究旨在总结和描述2006年7月至2017年5月期间向疫苗不良事件报告系统（VAERS）数据库报告的HPV疫苗接种后的不良事件。
在VAERS数据库中对与HPV疫苗相关的报告进行系统的数据挖掘。在VAERS数据库中识别出HPV疫苗接种后临床上相关的疫苗事件组合（VEC）。仅当数据库中给定不良事件（AE）至少有100份报告时，才考虑对VEC进行分析。本研究中使用的数据挖掘算法是报告比值比。ROR-1.96SE>1的值被视为阳性信号。
在研究期间，VAERS收到了49444份HPV疫苗接种后的报告。在这49444份报告中，识别出2307种独特反应。VAERS共收到177份死亡报告和3526份非死亡严重反应报告。ROR显示腹痛、晕厥、头晕、惊厥、自然流产、脱发、闭经、肛门生殖器疣、宫颈发育异常、贫血、运动障碍、偏头痛、血压下降、跌倒、头部受伤、意识丧失、面色苍白、晕厥前状态、癫痫发作呈阳性信号。
本分析未发现任何新的/意外的安全问题，并且与上市前试验的安全数据一致。需要进一步的流行病学研究来系统地验证VAERS提供的数据。
