National Foundation for the Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Global Immunization Division, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Clin Infect Dis. 2021 Aug 16;73(4):e927-e933. doi: 10.1093/cid/ciab059.
In December 2017, the World Health Organization (WHO) prequalified the first typhoid conjugate vaccine (TCV; Typbar-TCV). While no safety concerns were identified in pre- and postlicensure studies, WHO's Global Advisory Committee on Vaccine Safety recommended robust safety evaluation with large-scale TCV introductions. During July-August 2018, the Navi Mumbai Municipal Corporation (NMMC) launched the world's first public sector TCV introduction. Per administrative reports, 113 420 children 9 months-14 years old received TCV.
We evaluated adverse events following immunization (AEFIs) using passive and active surveillance via (1) reports from the passive NMMC AEFI surveillance system, (2) telephone interviews with 5% of caregivers of vaccine recipients 48 hours and 7 days postvaccination, and (3) chart abstraction for adverse events of special interest (AESIs) among patients admitted to 5 hospitals using the Brighton Collaboration criteria followed by ascertainment of vaccination status.
We identified 222/113 420 (0.2%) vaccine recipients with AEFIs through the NMMC AEFI surveillance system: 211 (0.19%) experienced minor AEFIs, 2 (0.002%) severe, and 9 serious (0.008%). At 48 hours postvaccination, 1852/5605 (33%) caregivers reported ≥1 AEFI, including injection site pain (n = 1452, 26%), swelling (n = 419, 7.5%), and fever (n = 416, 7.4%). Of the 4728 interviews completed at 7 days postvaccination, the most reported AEFIs included fever (n = 200, 4%), pain (n = 52, 1%), and headache (n = 42, 1%). Among 525 hospitalized children diagnosed with an AESI, 60 were vaccinated; no AESIs were causally associated with TCV.
No unexpected safety signals were identified with TCV introduction. This provides further reassurance for the large-scale use of Typbar-TCV among children 9 months-14 years old.
2017 年 12 月，世界卫生组织（WHO）将首个伤寒结合疫苗（TCV；Typbar-TCV）纳入预认证。虽然在预认证和上市后研究中未发现安全性问题，但世卫组织全球疫苗安全咨询委员会建议在大规模引入 TCV 时进行严格的安全性评估。2018 年 7 月至 8 月，那格浦尔市政公司（NMMC）推出了世界上首个公共部门 TCV 引入计划。根据行政报告，有 113420 名 9 个月至 14 岁的儿童接种了 TCV。
我们通过（1）被动的那格浦尔市 AEFI 监测系统报告、（2）接种后 48 小时和 7 天对 5%的疫苗接种者进行电话访谈，以及（3）使用 Brighton 合作组织标准对 5 家医院收治的有特殊关注的不良事件（AESI）进行图表提取，然后确定疫苗接种状况，利用被动和主动监测来评估疫苗接种后不良反应（AEFI）。
我们通过那格浦尔市 AEFI 监测系统发现 222/113420（0.2%）例疫苗接种者发生 AEFI：211 例（0.19%）发生轻微 AEFI，2 例（0.002%）发生严重 AEFI，9 例（0.008%）发生严重 AEFI。接种后 48 小时，5605 名接种者中有 1852 名（33%）报告发生了≥1 种 AEFI，包括注射部位疼痛（n=1452，26%）、肿胀（n=419，7.5%）和发热（n=416，7.4%）。接种后 7 天完成的 4728 次访谈中，报告最多的 AEFI 包括发热（n=200，4%）、疼痛（n=52，1%）和头痛（n=42，1%）。在 525 名因 AESI 住院的儿童中，有 60 名接种了疫苗；没有 AESI 与 TCV 有因果关系。
TCV 引入后未发现任何意外的安全性信号。这为在 9 个月至 14 岁儿童中大规模使用 Typbar-TCV 提供了进一步的保证。
