Post-marketing safety surveillance for both CRM197 and TT carrier proteins PCV13 in Jiangsu, China

Ran Hu; Yuanbao Liu; Lei Zhang; Guodong Kang; Borong Xu; Mingma Li; Jing Yu; Yuanyuan Zhu; Hongxiong Guo; Zhiguo Wang

doi:10.3389/fpubh.2023.1272562

Post-marketing safety surveillance for both CRM197 and TT carrier proteins PCV13 in Jiangsu, China

Front Public Health. 2023 Oct 16:11:1272562. doi: 10.3389/fpubh.2023.1272562. eCollection 2023.

Authors

Ran Hu¹, Yuanbao Liu¹, Lei Zhang¹, Guodong Kang¹, Borong Xu¹, Mingma Li², Jing Yu¹, Yuanyuan Zhu¹, Hongxiong Guo¹, Zhiguo Wang¹

Affiliations

¹ Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
² Department of Epidemiology and Health Statistics, Southeast University School of Public Health, Nanjing, China.

Abstract

Background: This study is to evaluate the safety of two kinds of PCV13 carriers by monitoring the occurrence of adverse event following immunization (AEFI) after the launch of two kinds of PCV13 carriers in Jiangsu Province, China.

Methods: The AEFI Information System (CNAEFIS) of mainland China was used to monitor the incidence and classification of adverse reactions of the CRM197-carrier protein PCV13 and TT-carrier protein PCV13 vaccines.

Results: There was no statistical difference between the cumulative reported incidence of AEFI between the two vaccines from 2020 to 2022 (χ² = 1.991, p < 0.158). 96.62% of the AEFIs were classified as common reactions; rare reactions and coincidental events only accounted for 2.99 and 0.39% of all the AEFI cases, respectively. Redness (2.6 cm-5 cm) is the commonest symptom at the injection site for both vaccines. More than 97% of AEFIs occurred between 30 min and 3 days after administration for both types of PCV13.

Conclusion: Both vaccines perform well in terms of safety. We did not identify any new/unexpected safety concern from the NAEFISS during a 4 years timespan.

Keywords: adverse reaction; carrier protein; pneumococcal polysaccharide conjugate vaccine; post-marketing surveillance; safety; vaccine.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Bacterial Proteins
Carrier Proteins
Immunization*
Vaccination*

Substances

CRM197 (non-toxic variant of diphtheria toxin)
Bacterial Proteins
Carrier Proteins

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This project was supported partly by the project funded by the Scientific Research Project of the Jiangsu Provincial Health Commission (M2021030) &Yangtze River Delta Immunization Program Leading Talent Research Project (CSJP001).