Safety evaluation of 13-valent pneumococcal polysaccharide conjugate vaccine (tetanus toxoid/diphtheria toxoid) in Tianjin
10.3969/j.issn.1006-2483.2026.02.004
- VernacularTitle:天津市13价肺炎球菌多糖结合疫苗（破伤风类毒素/白喉类毒素）安全性评价
- Author:
Guoping ZHANG
1
;
Shuo WANG
2
;
Yongcheng LI
1
;
Baihui GUO
1
;
Di ZHU
1
;
Xiaoyan LUO
1
Author Information
1. Tianjin Center for Disease Control and Prevention, Tianjin 300011, China
2. Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China
- Publication Type:Journal Article
- Keywords:
13-valent pneumococcal polysaccharide conjugate vaccine;
Safety;
Adverse events following immunization
- From:
Journal of Public Health and Preventive Medicine
2026;37(2):17-21
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of the 13-valent pneumococcal polysaccharide conjugate vaccine (tetanus toxoid/diphtheria toxoid) (PCV13-TT/DT) among age-eligible children in Tianjin through a combination of active and passive surveillance methods. Methods From July 15, 2023, to August 31, 2024, active surveillance for adverse events following immunization (AEFI) was conducted among recipients of PCV13-TT/DT at 18 selected vaccination clinics in Tianjin. Recipients were monitored through on-site observation or telephone follow-up within 30 minutes after vaccination and on days 1, 3, 7, and 28. Passive surveillance for AEFI was conducted among recipients of PCV13-TT/DT at other vaccination clinics across the city. The incidence of AEFI was analyzed using descriptive epidemiological methods. Results A total of 24 916 recipients of PCV13-TT/DT were observed, with 440 AEFI cases reported, resulting in an overall incidence rate of 176.59 per 10 000. The incidence rate of AEFI in active surveillance was 813.79 per 10 000, significantly higher than that in passive surveillance (20.49 per 10 000; P< 0.001). The incidence rates of general reactions, abnormal reactions, and coincidental cases in active surveillance were 744.44 per 10 000, 8.16 per 10 000, and 61.19 per 10 000, respectively, all of which were higher than those in passive surveillance (18.49 per 10 000, 0.50 per 10 000, and 1.50 per 10 000), with P values < 0.05. General reactions were mainly characterized by fever, local redness, and local induration. Abnormal reactions included angioedema and allergic rash. Coincidental cases were mainly infections. No severe adverse reactions occurred. Conclusion The large-scale vaccination of PCV13-TT/DT after its launch has good safety, and continuous strengthening of vaccine safety monitoring is needed.
