Post-Marketing Surveillance of Adverse Events Following Rotavirus Vaccination - China, 2013-2023.

Introduction: Two live attenuated rotavirus vaccines (RVs) were licensed in China. Passive surveillance for adverse events following immunization (AEFI) provides valuable evidence for potential safety signal detection of RV in China. Methods: We obtained data on RV doses administered and RV AEFI reports from the Chinese National Immunization Information System (CNIIS) during January 2013 to December 2023. We conducted a descriptive analysis of RV AEFI characteristics and estimated incidences of RV AEFI. Results: During the study period, 77.36 million doses of RV were administered, and 20,556 RV AEFI reports were made, yielding an overall incidence of 26.57 AEFI per 100,000 doses administered; incidences were 26.42 for RV1 and 26.85 for RV5. Among all RV AEFI, 20,334 (98.92%) were non-serious. Vaccine product-related reactions accounted for 95.68% of AEFI reports, including 18,192 (88.50%) common and 1,476 (7.18%) rare vaccine reactions. Among common vaccine reactions, case reports per 100,000 doses administered were 16.85 (13,031 reports) for fever, 5.84 (4,520 reports) for gastrointestinal disorders, and 1.28 (988 reports) for rash. Among rare vaccine reactions, case reports per 100,000 doses were 1.43 (1,104 reports) for allergic rash, 0.07 (56 reports) for thrombocytopenic purpura, 0.03 (26 reports) for febrile convulsion, and 0.01 (5 reports) for intussusception. Conclusions: Most RV AEFIs were mild and non-serious, and the incidence of rare vaccine reactions was very low. RVs have reasonable safety surveillance profiles and AEFI evaluation should be continued.