Impact of comparator selection on signal detection in adverse events following immunization in China

doi:10.19803/j.1672-8629.20240076

Abstract

Abstract: Objective To investigate the impact of comparator selection on results of signal detection in order to contribute to signal detection in adverse events following immunization (AEFI) in China. Methods All the vaccines and specified vaccines selected were subject to signal detection using two control groups separately, one of which was composed of other types of vaccines, and the other consisted of vaccines of the same type. The number of signals detected using either control group was recorded. Numbers of the same signals, those of new signals and those of missed signals compared with the two control groups were calculated. Results The number of signals detected using all other vaccines on the same technical platform as control (n=501) was reduced compared with the control that used other different vaccines(n=254). Using other different vaccines of the same type as control, the percentage of new signals related to polysaccharide vaccines was the highest [24.39% (10/41)]. The AEFI category of new signals included common reactions(n=10), rare reactions(n=3) and coincidental events(n=2). Using other vaccines on the same technical platform as control, recombinant protein vaccines manifested the highest percentage of missed signals [94.92% (56/59)]. The AEFI category of missed signals included coincidental events(n=53), rare reactions(n=23) and common reactions(n=13). Using other vaccines on the same technical platform as control, the overall sensitivity decreased during detection of both common reactions and rare ones, but increased when it came to common reactions in live attenuated vaccines and polysaccharide vaccines. Overall specificity increased. Conclusion Significant variations are found in signal detection using all other vaccines as control and using all other vaccines of the same type as control respectively. Compared with signal detection using all other vaccines as control, the ability to detect common reactions is increased using all other vaccines of the same type as control. However, signals of rare reactions may be missed. The use of all other vaccines as control is recommended in order to detect rare reactions.

Key words: adverse events following immunization (AEFI), vaccine safety, signal detection, control, sensitivity, specificity, technical platform

CLC Number:

R979.5

XIA Lanfang, LI Keli, WANG Lei, LI Yan, WANG Huaqing. Impact of comparator selection on signal detection in adverse events following immunization in China[J]. Chinese Journal of Pharmacovigilance, 2024, 21(7): 798-804.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240076

https://zgywjj.magtechjournal.com/EN/Y2024/V21/I7/798

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