Surveillance on the adverse events following immunization with the pentavalent vaccine in Zhejiang, China

Abstract

Objectives The aim of this study is to describe the reporting rate of adverse events following immunization (AEFI) with pentavalent vaccine: diphtheria-pertussis-tetanus-poliomyelitis-Haemophilus influenzae type b (DPT-IPV/Hib), and to determine whether the reporting rate of AEFI following DPT-IPV/Hib was higher than the average level of the other vaccines. Methods Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2015 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR‑1.96SE >1 (standard error [SE]) was considered as positive signal. Results NAEFISS received 5726 AEFI reports following DTP-IPV/Hib, with a reporting rate of 20.01/10000 doses. Of the reported AEFI, 202 were serious vaccine product-related reactions, including two cases of anaphylactic shock, five cases of Guillain Barre Syndrome (GBS) and two cases of acute disseminated encephalomyelitis. The reporting rate of fever/redness/induration was the highest among all the clinical diagnosis (14.97/10000 doses). The positive signals were obtained for allergic rash (ROR-1.96SE: 1.36), febrile convulsion (ROR-1.96SE: 1.32) and GBS (ROR-1.96SE: 1.16). Conclusion The present findings bolstered that the DTP-IPV/Hib administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a six-year timespan.

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

“…We observed no significant difference in reported AEFI incidence between boys and girls, which is generally consistent with previous reports ( 23 , 24 ). We found that the reported incidence of AEFI in 2020 was highest from 2019 to 2022.…”

“…Their argument is the recipients and their guardians pay more attention to the reaction after the first dose of vaccine ( 25 , 26 ). However, there are some studies that support our conclusions ( 24 , 27 ). The view they take is the subsequent dose was more likely to cause allergic reactions due to the body sensitization by the early dose.…”

Safety and Immunogenicity of Enterovirus 71 Vaccine (Vero Cell) Administered Simultaneously with Trivalent Split-Virion Influenza Vaccine in Infants Aged 6–7 Months: A Phase 4, Randomized, Controlled Trial

“…A 5-year persistence study of EV71 vaccination showed that the GMTs of EV71 neutralizing antibody of the vaccine group was significantly higher than the placebo-controlled group (369.57 vs. 55.58, p < 0.01), and EV71 antibodies still maintained good immune persistence 5 years after two doses of immunization [12]. A large-scale safety monitoring study in Zhejiang Province found that the reported rate of AEFI was 267.90 per 100,000 persons, and there were no serious AEFI cases, and most common reactions were fever, redness, and induration, indicating that EV71 vaccine was safe [13]. A real-world effectiveness study showed that the average morbidity rate of EV71-related HFMD in Chengdu (Sichuan Province) in 2017-2018 was 60% lower than that in 2011-2017 when the EV71 vaccine was not available, and the number of severe HFMD cases was 52% lower, demonstrating that EV71-related HFMD significantly decreased after vaccination [14].…”

Surveillance for adverse events following immunization with DTaP-containing combination vaccines in Linping, China, 2019–2022

“…Additionally, the public or the caregivers could notify any of the above authorized reporters to report an AEFI. AEFI reports were gathered by local, county-level CDCs, which were responsible for completing AEFI case reporting cards and submitting data to the national AEFI surveillance system ( 25 ). A single AEFI report might be assigned more than one term and be referred to more than one suspected vaccine.…”