Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

Abstract

Objectives To evaluate the safety of 13-valent pneumococcal conjugate vaccine (PCV13) after its licensure. Methods Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2017 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 the positive signal. Results NAEFISS received 3332 AEFI cases following PCV13, with a reporting rate of 17.58/10000 doses. Of the reported AEFI, 652 were serious AEFI cases and the reporting rate was 3.44 for serious AEFI. The reporting rate of fever was the highest among all the clinical diagnosis (7.39/10000 doses). The positive signals were obtained for injection site reaction (ROR-1.96SE: 1.55), hypotonic hyporesponsive episode (HHE) (ROR-1.96SE: 1.62) and febrile seizure (ROR-1.96SE: 1.52). Conclusion The present results supported previous observations that the PCV13 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 four-year time period.

Analysis of Adverse Events Post-13-Valent Pneumococcal Vaccination among Children in Hangzhou, China

“…CNAEFIS operates according to China’s national AEFI guidelines, which are supported by various laws, including the Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Drug Administration Law of the People’s Republic of China, Vaccine Administration Law of the People’s Republic of China, National Immunization Program Operational Guidelines, Regulations on the Prevention and Response to Public Health Emergencies, and other laws and regulations [ 16 ]. The objectives of CNAEFIS include monitoring abnormal changes in known AEFIs, identifying potential risk factors, evaluating the safety of newly marketed vaccines, and providing evidence to improve vaccine quality and vaccination services [ 14 ].…”

“…Non-severe AEFIs included those that either required no intervention or may have necessitated medical consultations and led to minor disruption of daily activities or loss of work time. In contrast, serious AEFIs were described as adverse health episodes that had significant clinical repercussions, such as fatality occurrences, patient hospitalization, extended stays in healthcare settings, sustained or major disabilities or functional limitations, life-threatening conditions, or the appearance of congenital disorders [ 14 , 16 ]. In China, we assembled groups of AEFI experts to evaluate the causal relationships of cases and classify them according to the WHO manual.…”

“…PCV13 was approved for marketing in China in 2017. Hu et al conducted a vaccination safety study in infants soon in Zhejiang after the PCV13 was approved [ 14 ]. However, considering the Weber effect, the initial reporting rate of adverse events after the launch of a new vaccine may be relatively high but will gradually stabilize over time [ 14 ].…”

“…Hu et al conducted a vaccination safety study in infants soon in Zhejiang after the PCV13 was approved [ 14 ]. However, considering the Weber effect, the initial reporting rate of adverse events after the launch of a new vaccine may be relatively high but will gradually stabilize over time [ 14 ]. Therefore, after the launch of the PCV13 and once the sensitivity of adverse event reporting reaches a stable state, research should be conducted to reflect the actual occurrence of adverse reactions to the vaccine more accurately and to better evaluate the safety of the vaccine in the real world.…”

Barriers to healthcare workers reporting adverse events following immunization in Zhejiang province, China

“…The national AEFI surveillance system (NAEFISS), which is a passively collected spontaneous electronic database, has been in operation since 2005. 7 Although the reporting sensitivity has improved from 9.2/100,000 doses for the time period of 2008–2011 to 56.64/100,000 doses in 2019 in Zhejiang province, 8 the reporting rate of AEFI detected through the passive surveillance system is likely to be lower than the true rate, due to the bias of under-reporting. A previous study indicated that the role of healthcare workers (HCWs), who interacted with persons experiencing adverse events, was indisputable in initiating the reporting and investigation process.…”