Safety of PCV13 with Different Carrier Proteins (CRM197, TT, and TT/DT) - Jiangsu Province, China, 2022-2024.

INTRODUCTION

This study aimed to evaluate the safety of three kinds of 13-valent pneumococcal conjugate vaccines (PCV13) with different carrier proteins - cross-reactive material 197 (CRM197), tetanus toxoid (TT), and a novel tetanus toxoid/diphtheria toxoid (TT/DT) dual-carrier - by monitoring adverse events following immunization (AEFI) in Jiangsu Province, China.

METHODS

The Chinese National Adverse Events Following Immunization Information System and Jiangsu Province Vaccination Integrated Service Management Information System were used. Reporting rates (RR) per 100,000 doses were calculated and stratified. Chi-square tests with Bonferroni correction and disproportionality analyses were performed.

RESULTS

A total of 1,734,810 PCV13 doses were administered, with 5,195 AEFI reports (RR=299.46 per 100,000 doses). RR was highest for TT/DT-carrier (399.84 per 100,000 doses) versus CRM197-carrier (286.69 per 100,000 doses) and TT-carrier (286.01 per 100,000 doses). Common adverse reactions accounted for 98.23% (5,103/5,195) of all AEFIs, with fever, local redness, and induration being the most common. Disproportionality analysis revealed positive signals for general reactions.

CONCLUSION

All three PCV13 carrier protein types demonstrated acceptable safety profiles in Jiangsu Province from 2022 to 2024. Despite a higher RR for TT/DT-carrier PCV13 than for the other two PCV13 carrier protein types, most AEFIs were mild and common reactions.