Post-Marketing Surveillance Data of Adverse Events Following Immunization with Human Rabies Vaccine — China, 2021–2024

Lina Zhang¹; Keli Li^1#; Yan Li¹; Chunxiang Fan¹; Yuan Li¹; Minrui Ren¹; Lei Cao¹; Wenzhou Yu¹; Zundong Yin¹

1. National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases (NITFID), Center of National Immunization Program, Chinese Center for Disease Control and Prevention & Chinese Academy of Preventive Medicine, Beijing, China.

^# Corresponding author: Keli Li, likl@chinacdc.cn.

Human rabies vaccine has been widely used as a non-program vaccine in China for many years. This study analyzed adverse events following immunization (AEFI) associated with human rabies vaccine from 2021 to 2024. AEFI case reports and administered dose counts for human rabies vaccine during 2021–2024 were obtained from the Chinese National Immunization Information System of the China Information System for Disease Prevention and Control. AEFI characteristics and incidence rates were analyzed using descriptive epidemiological methods. During 2021–2024, a total of 34,684 AEFI cases were reported, yielding an overall incidence rate of 18.57 per 100,000 doses. Common vaccine reactions accounted for 96.29% of cases (17.88 per 100,000 doses), and rare vaccine reactions accounted for 2.62% (0.49 per 100,000 doses). Allergic rash was the most frequently reported rare vaccine reaction, with an incidence rate of 0.32 per 100,000 doses, followed by angioedema, Henoch-Schönlein purpura, anaphylactic shock, and febrile convulsion/convulsion, with incidence rates of 0.04, 0.02, 0.01, and 0.01 per 100,000 doses, respectively. Most AEFI cases associated with human rabies vaccine were common vaccine reactions. Allergic reactions, particularly allergic rash, constituted the predominant rare vaccine reactions. Although several cases of anaphylactic shock were reported, the incidence was extremely low. Timely identification and immediate management of post-vaccination allergic reactions are important measures for ensuring the safety of human rabies vaccine.

人用狂犬病疫苗疑似预防接种异常反应监测 — 中国，2021–2024年

张丽娜¹，李克莉^1,#，李燕¹，樊春祥¹，李媛¹，任敏睿¹，曹雷¹，余文周¹，尹遵栋¹

1. 传染病溯源预警与智能决策全国重点实验室，免疫规划中心，中国疾病预防控制中心（中国预防医学科学院），北京，中国。

^# 通信作者: 李克莉, likl@chinacdc.cn。

人用狂犬病疫苗作为一种非免疫规划疫苗在中国已广泛使用多年。本研究对2021年至2024年间的人用狂犬病疫苗接种后疑似预防接种异常反应（AEFI）进行了分析。本研究从中国疾病预防控制信息系统免疫规划子系统中获取了2021年至2024年人用狂犬病疫苗的AEFI报告个案及接种剂次数，采用描述性流行病学方法对AEFI的特征及发生率进行了分析。2021至2024年，共收到34，684例人用狂犬病疫苗AEFI报告，总体发生率为18.57/10万剂。96.29%（17.88/10万剂）为一般反应，2.62%（0.49/10万剂）为异常反应。过敏性皮疹是报告最多的异常反应，发生率为0.32/10万剂；其次是血管性水肿、过敏性紫癜、过敏性休克和热性惊厥/惊厥，其发生率分别为0.04/10万剂、0.02/10万剂、0.01/10万剂和 0.01/10万剂。人用狂犬病疫苗AEFI多为一般反应。异常反应主要是过敏反应，如过敏性皮疹。报告少数过敏性休克病例，但其发生率极低。及时识别并立即处理接种后的过敏反应是确保人用狂犬病疫苗安全性的重要措施。

For more information: https://weekly.chinacdc.cn/en/article/doi/10.46234/ccdcw2026.079

Combination Vaccines in Routine Childhood Immunization Programs — Worldwide, 2024

Fan Zheng^{1, 2, &}; Guzainuer Abudurusuli^1,&; Linlin Gong^{1, 2}; Jiayuan Xie^{1, 2}; Huaqing Wang^{1, 2, 3,#}

1. State Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen City, Fujian Province, China;

2. National Innovation Platform for Industry-Education Integration in Vaccine Research, Xiamen University, Xiamen City, Fujian Province, China;

3. National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases (NITFID), Center of National Immunization Program, Chinese Center for Disease Control and Prevention & Chinese Academy of Preventive Medicine, Beijing, China.

^& Joint first authors.

^# Corresponding author: Huaqing Wang, wanghq@chinacdc.cn.

Optimizing and streamlining immunization schedules through the use of combination vaccines can advance post-pandemic vaccination recovery and "The Big Catch-up" initiative. This study assessed the global landscape of combination vaccine use and its association with immunization coverage in 2024. Using 2024 World Health Organization/United Nations International Children's Emergency Fund (WHO/UNICEF) Joint Reporting Form (JRF) data and official national coverage estimates, we conducted a cross-sectional descriptive analysis of diphtheria-tetanus-pertussis (DTP)-containing and measles-containing combination vaccine use patterns; countries were stratified by WHO region and World Bank income classification. In 2024, eight types of combination vaccines were in use worldwide, divided into two categories: DTP-containing vaccines, including trivalent, quadrivalent, pentavalent, and hexavalent formulations; and measles-containing vaccines, including two bivalent types, trivalent, and quadrivalent formulations. Among DTP-containing vaccines, pentavalent formulations were the most widely used globally (151 of 194 Member States), while hexavalent vaccine use was concentrated in high-income countries. The trivalent formulation was the most commonly used measles-containing combination vaccine (119 countries), but 15 countries relied exclusively on monovalent measles vaccine. Significant regional and economic disparities were observed: low-income countries in Africa and the Americas experienced substantial coverage drop-off between the first and third DTP doses, suggesting service continuity bottlenecks despite high initial access. Although combination vaccines are widely used, their potential to bridge immunization equity gaps remains unrealized due to systemic barriers in low-resource settings. Strengthening primary healthcare and ensuring sustainable financing for advanced vaccine formulations are essential to achieving global immunization targets.

常规儿童免疫规划中的联合疫苗的应用 — 全球，2024年

郑凡^1,2,&; 古再努尔·阿布杜如苏力^1,&; 龚琳琳^1,2; 谢嘉缘^1,2; 王华庆^1,2,3,#

1.传染病疫苗研发全国重点实验室, 翔安创新实验室, 厦门大学公共卫生学院,厦门市, 福建省, 中国;

2.国家医学攻关产教融合创新平台（疫苗研发）, 厦门大学, 厦门市, 福建省, 中国;

3.免疫规划中心（国家传染病预测预警重点实验室）, 中国疾病预防控制中心（中国预防医学院）, 北京, 中国。

^& 共同第一作者。

^# 通信作者：王华庆, wanghq@chinacdc.cn。

通过使用联合疫苗来优化和简化免疫接种程序，有助于推动后疫情时代的疫苗接种恢复工作以及“大规模补种”行动。本研究评估了2024年全球联合疫苗的使用状况及其与免疫接种覆盖率之间的关联。我们利用2024年世界卫生组织/联合国儿童基金会（WHO/UNICEF）联合报告表（JRF）的数据以及各国官方覆盖率估计值，对含白喉-破伤风-百日咳（DTP）成分及含麻疹成分的联合疫苗接种模式进行了横断面描述性分析；各国按世界卫生组织区域及世界银行收入分类进行分层。2024年，全球共使用8种联合疫苗，分为两类：一类是含DTP成分的联合疫苗，包括三价、四价、五价和六价制剂；另一类是含麻疹成分的联合疫苗，包括两种二价、三价和四价制剂。在含DTP的疫苗中，五价疫苗是全球使用最广泛的联合疫苗（194个成员国中有151个使用）；六价疫苗的使用主要集中在高收入国家。三价疫苗是使用最广泛的含麻疹成分的联合疫苗（119个国家），但有15个国家仅使用单价麻疹疫苗。观察到显著的区域和经济水平差异：非洲和美洲地区的低收入国家在第一剂和第三剂DTP疫苗接种之间覆盖率大幅下降，这表明尽管初期接种率较高，但服务连续性存在瓶颈。尽管联合疫苗已被广泛使用，但由于资源匮乏地区存在系统性障碍，其在弥合免疫公平差距方面的潜力尚未得到充分发挥。加强初级卫生保健并确保为先进疫苗制剂提供可持续的资金支持，对于实现全球免疫目标至关重要。

For more information: https://weekly.chinacdc.cn/en/article/doi/10.46234/ccdcw2026.081

The Current Status of Simultaneous Vaccination of Children Aged 0-3 Years — China, 2022–2024

Xin Liu¹, Yuan Liang¹, Zhaonan Zhang¹, Sha Zhang¹, Jiakai Ye¹, Ruyue Hu², Lei Cao¹, Huixin Peng¹, Li Li¹, Yifan Song¹, Wenzhou Yu^1,#

1. National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases(NITFID), Center for National Immunization Program, Chinese Center for Disease Control and Prevention & Chinese Academy of Preventive Medicine, Beijing, China;

2. Sichuan Provincial Center for Disease Control and Prevention, Chengdu City, Sichuan Province, China.

^# Corresponding authors: Wenzhou Yu, yuwz@chinacdc.cn.

To describe simultaneous vaccination among children aged 0–3 years in China during 2022–2024 and provide evidence to improve vaccination service efficiency and timely immunoprotection. Individual-level vaccination records from the National Immunization Program Information System(NIPIS) were analyzed for all vaccines administered to children aged 0–3 years nationwide from January 1,2022, to December 31, 2024, focusing on same-visit vaccination practices. A total of 748.30 million vaccine doses were administered. Among these, 46.27% were given as two-vaccine simultaneous combinations, 2.36% as three-vaccine combinations, and 0.003% as four or more vaccines. Two-vaccine combinations mainly involved only National Immunization Program (NIP) vaccines (74%–78%), whereas three- and four-vaccine combinations more often included both NIP and non-NIP vaccines. Common combinations included DTaP with inactivated poliovirus vaccine (IPV), and HepB with BCG, etc. Simultaneous vaccination of children aged 0-3 years in China is predominantly characterized by the co-administration of two vaccines, with three or more used less frequently. These findings provide evidence to guide optimization of immunization practices, research prioritization, and improvements in vaccination efficiency.

0至3岁婴幼儿疫苗同时接种现状 — 中国，2022–2024年

刘欣¹；梁媛¹；张肇南¹；张莎¹；叶家楷¹；胡入月²；曹雷¹；彭慧欣¹；李力¹；宋祎凡¹；余文周^1,#

1. 传染病溯源预警与智能决策全国重点实验室，免疫规划中心，中国疾病预防控制中心（中国预防医学科学院)，北京，中国；

2. 四川省疾病预防控制中心，成都市，四川省，中国。

^# 通信作者：余文周，yuwz@chinacdc.cn。

描述2022–2024年中国0–3岁儿童疫苗同时接种的现状，为提高预防接种服务效率、保障儿童及时获得免疫保护提供科学依据。本研究从国家免疫规划信息系统（NIPIS）中获取2022年1月1日至2024年12月31日期间全国0–3岁儿童疫苗接种的数据，对单次就诊（同日）同时接种情况进行现况描述和分析。2022–2024年，全国0–3岁儿童共接种疫苗7.48亿剂次；其中3.64亿剂次（46.27%）为两种不同疫苗的同时接种；1768万剂次（2.36%）为三种疫苗同时接种；2.46万剂次（0.003%）为四种及以上疫苗同时接种。按组合类型分析，两剂次同时接种中，74%–78%为免疫规划疫苗（NIP）之间的同时接种，15%–19%为免疫规划疫苗与非免疫规划疫苗的同时接种；三剂次同时接种中，49%–55%涉及免疫规划疫苗与非免疫规划疫苗同时接种；四剂次同时接种中，66%–77%涉及免疫规划疫苗与非免疫规划疫苗同时接种。常见的同时接种组合包括百白破疫苗与灭活脊髓灰质炎疫苗、乙肝疫苗和卡介苗等组合。本研究基于真实世界数据，系统描述了我国0–3岁儿童同时接种疫苗的剂次数量分布及组合模式。当前实践以两种疫苗同时接种为主，在特定条件下实施三种及以上疫苗的同时接种。本研究为进一步优化免疫服务模式、明确研究重点以及提升接种效率提供了数据基础。

For more information: https://weekly.chinacdc.cn/en/article/doi/10.46234/ccdcw2026.082

A Randomized, Double-Blind, Positive-Controlled Phase III Clinical Trial of an Anti-Rabies Monoclonal Antibody for Category III Rabies Exposure in Individuals Under 18 Years — China, 2021–2023

Jingyu Li^1,&; Yu Zhao^2,&; Yan Zheng¹; Xuexia Zhang²; Ya Jiang³; Jiangshu Guo⁴; Wenmei Bao⁵; Yinfeng Ma⁶; Yaoyuan Zhang²; Shuyuan Yin²; Yirui Ma²; Lijie Wang^2,#; Xiaoqiang Liu^1,7,#

1. Yunnan Provincial Center for Disease Control and Prevention, Kunming City, Yunnan Province, China;

2. State Key Laboratory of Antibody Research and Development, North China Pharmaceutical Company (NCPC) New Drug Research and Development Co. Ltd., Shijiazhuang City, Hebei Province, China;

3. Mile Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, China;

4. Gejiu Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, China;

5. Kaiyuan Center for Disease Control and Prevention, Honghe Hani and Yi Autonomous Prefecture, Yunnan Province, China;

6. Qiubei County Center for Disease Control and Prevention, Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan Province, China.

^& Joint first authors.

^# Corresponding authors: Xiaoqiang Liu, liuxqms@163.com; Lijie Wang, wanglijie@ncpc.com.

Rabies is a severe zoonotic infectious disease that remains almost uniformly fatal once clinical symptoms onset occurs. Currently, all anti-rabies monoclonal antibodies available on the domestic market are indicated for individuals aged 18 years and above. According to World Health Organization (WHO) statistics, individuals under the age of 15 account for 40% of rabies cases. The data were derived from a Phase III Clinical Trial conducted in Yunnan Province from 2021 to 2023, involving a total of 240 individuals under the age of 18 who had been exposed to rabies Category III. The safety results showed that the incidences of adverse events in the ormutivimab and HRIG groups were 53.78% and 59.17%, respectively, with related adverse event rates of 40.34% and 48.33%, respectively. The efficacy results demonstrated the following: 1. For individuals with serum rabies virus neutralizing antibody activity <0.5 IU/mL prior to drug administration (mFAS1), (1) On day 3 post-administration, the antibody seroconversion rate in the omeltivimab group was similar to that in the HRIG group. By day 7, the ormutivimab group showed significantly higher antibody seroconversion rates than the HRIG group (P=0.0312). By days 14 and 42 post-administration, both groups achieved 100% seroconversion rates. (2) On day 3 post-administration, the GMC levels in the omeltivimab group were significantly lower than those in the HRIG group (P=0.0087). By day 7, GMC levels in both groups were comparable with no significant difference (P=0.2540). By days 14 and 42, omeltivimab group antibody GMC levels were significantly higher than those in the HRIG group (P<0.0001). 2. Survival rates remained 100% up to 1 year in both groups after completing the full vaccination regimen. These findings provide evidence supporting the use of anti-rabies monoclonal antibodies in individuals under 18 years of age with Category III Rabies Exposure.

一项针对18岁以下III级狂犬病暴露的抗狂犬病病毒单克隆抗体（奥木替韦）的随机、双盲、阳性对照的III期临床试验 — 中国，2021–2023年

李婧瑜^1,&，赵玉^2,&，郑艳¹，张雪霞²，蒋娅³，郭江书⁴，保文梅⁵，马银烽⁶，张耀元²，尹淑园²，马艺芮²，王利杰^2,#，刘晓强^1,7,#

1. 云南省疾病预防控制中心，昆明市，云南省，中国；

2. 抗体研发国家重点实验室，华北制药集团新药研究开发有限责任公司，石家庄市，河北省，中国；

3. 弥勒市疾病预防控制中心，弥勒市，红河哈尼族彝族自治州，云南省，中国；

4. 开远市疾病预防控制中心，开远市，红河哈尼族彝族自治州，云南省，中国；

5. 个旧市疾病预防控制中心，个旧市，红河哈尼族彝族自治州，云南省，中国；

6. 丘北县疾病预防控制中心，丘北县，文山壮族苗族自治州，云南省，中国；

7. 昆明医科大学公共卫生学院，昆明市，云南省，中国。

^& 共同第一作者。

^# 通信作者：刘晓强, liuxqms@163.com; 王利杰, wanglijie@ncpc.com。

狂犬病是一种严重的人畜共患病，一旦出现临床症状，几乎均会导致死亡。目前国内上市的抗狂犬病单克隆抗体均用于18岁及以上人群。根据世界卫生组织（WHO）统计数据，15岁以下人群占狂犬病病例的40%。本研究旨在评价抗狂犬病病毒单克隆抗体在18岁以下III类狂犬病暴露人群中的免疫原性与安全性。数据来源于2021年-2023年在云南省开展的III期临床试验，共纳入240名18岁以下的III级狂犬病暴露者。安全性结果显示：奥木替韦组和HRIG组不良事件发生率分别为53.78%和 59.17%，有关的不良事件发生率分别为40.34%和 48.33%。有效性结果显示：1.对于注射药物前血清狂犬病毒中和抗体活性＜0.5IU/mL人群（mFAS1），（1）用药后第3天奥木替韦组抗体阳转率与HRIG组相近，用药后第7天奥木替韦组抗体阳转率显著高于HRIG组（P=0.0312）。用药后第14天 和 42 天奥木替韦组和HRIG组阳转率都达到了100%。（2）用药后第3天，奥木替韦组GMC水平显著低于 HRIG 组（P=0.0087）。第7天时，两组GMC水平相接近，无显著差异（P=0.2540），第14天和42天奥木替韦组抗体GMC显著高于HRIG组（P<0.0001）。2.观察至全程疫苗接种后1年，奥木替韦组和HRIG组受试者的生存率均为100%。本研究结果为18岁以下III级暴露人群使用抗狂犬病单克隆抗体提供了证据支持。

For more information: https://weekly.chinacdc.cn/en/article/doi/10.46234/ccdcw2026.083

Epidemiological Investigation of a Tuberculosis Cluster Outbreak at a University — Changsha City, Hunan Province, China, September 2023–November 2025

Cifu Xie¹; Pengliang Yin¹; Linxin Song¹; Zi Xiong^1,#; Liqiong Bai^2,#

1 Department of Tuberculosis Prevention and Control, Changsha Center for Disease Control and Prevention, Changsha City, Hunan Province, China;

2 Department of Director's Office, Hunan Chest Hospital, Changsha City, Hunan Province, China.

^# Corresponding author: Zi Xiong, changshajfk@163com; LiqiongBai, liqiong99@126.com.

Between September 2023 to November 2025, a cluster outbreak of active tuberculosis (TB) was identified at a university in Changsha City, Hunan Province, China. Contacts were screened, and patients with positive etiological results underwent sputum culture and drug susceptibility testing. Environmental samples (from air conditioners and air) were collected after terminal disinfection for polymerase chain reaction testing. A quantitative analysis of the infection risk was performed using linear regression models. Preventive intervention treatment effectiveness was evaluate dusing the log-rank test and Cox proportional hazard sregression model. Of 671 contacts [110: latent tuberculosis infection (LTBI); 25: new active TB0], all 26 cases, including the index case, were students. Whole-genome sequencing of five culture-positive cases howed high homology with ≤3 single nucleotide polymorphisms for four of them. For each additional hour of contact with the index patient, the prevalence of LTBI among contacts increased by 0.48%, and the TB incidence among individuals with LTBI increasedby 0.20%. Developing active TB among individual swith LTBI who received Mycobacterium vaccae immunotherapy was 0.10 times that of the control group, the cumulative incidence within 2 years remained as high as 10.67%. Terminal disinfection of the epidemic sites was incomplete, and M. tuberculosis was detected in the air conditioner filters and air samples from the index case classroom and dormitory. Contributing factors were failure to detect the index case during the new student entrance health examination, incomplete terminal disinfection of epidemic sites, and lack of follow-up monitoring of individuals with LTBI who received preventive immunotherapy.

某大学一起结核病聚集性疫情的流行病学调查 — 长沙市，湖南省，中国，2023年9月–2025年11月

谢赐福¹，尹鹏亮¹，宋丽新¹，熊姿^1#，白丽琼^2#

1. 结核病防治科，长沙市疾病预防控制中心，长沙市，湖南省，中国；

2. 院长办公室，湖南省胸科医院，长沙市，湖南省，中国。

^# 通信作者：熊姿，changshajfk@163com；白丽琼，liqiong99@126.com。

2023年9月至2025年11月，中国湖南省长沙市某大学发生一起活动性结核病聚集性疫情。对接触者进行筛查，对病原学检测阳性者的痰标本进行培养和药物敏感性试验。终末消毒后采集环境样本（空调及空气）进行聚合酶链式反应检测。采用线性回归模型对感染风险进行量化分析，使用对数秩检验和Cox比例风险回归模型评价预防性干预治疗的效果。671名接触者中发现结核潜伏感染者110例、新发活动性结核病例25例，连同指示病例共26例，均为学生。5例培养阳性菌株的全基因组测序显示，其中4例具有高度同源性（单核苷酸多态性差异≤3个）。与指示病例的接触时间每增加1小时，接触者的结核潜伏感染率增加0.48%，结核潜伏感染者中的结核发病率增加0.20%。接受母牛分枝杆菌免疫治疗的结核潜伏感染者发展为活动性结核的风险是对照组的0.10倍，但其2年内累积发病率仍高达10.67%。疫源地终末消毒不彻底，在指示病例所在教室和宿舍的空调滤网及空气样本中均检测到结核分枝杆菌。导致此次疫情发生的因素包括：新生入学体检未能发现指示病例、疫源地终末消毒不彻底，以及接受预防性免疫治疗的潜伏性结核感染者缺乏后续监测。

For more information: https://weekly.chinacdc.cn/en/article/doi/10.46234/ccdcw2026.084