Safety monitoring in inactivated COVID-19 vaccines by clinical pharmacists from a single center in China

Abstract

Given that vaccine-induced adverse effects were mostly based on previous laboratory research and clinical trials, real-world data on the safety of coronavirus disease 2019 (COVID-19) vaccination were lacking. This study reported the adverse events (AEs) among inactivated COVID-19 vaccine recipients. Data were collected from a total of 2,808 hospital employees and their family members in Wuhan, China, with all of them receiving the first dose of inactivated COVID-19 vaccines from two pharmaceutical companies. The first dose was given between 29th April and 13th May 2021. A total of 2,732 vaccinees received the second dose between 27th May and 8th July 2021. The whole process of receiving the vaccine was monitored by clinical pharmacists, and the information on AEs including demographics, occurrence, types, and severity was recorded through an online questionnaire and telephone follow-up. Most of the common AEs were mild and tolerable, and the overall incidence of AEs was lower than the data from the safety profile in clinical trials. Moreover, the incidence of AEs in the first dose (21.30%, 598) was higher than that in the second dose (16.07%, 439). Furthermore, the first injection had more severe AEs (4, 0.14%) than the second injection (2, 0.07%). The AEs involved the skin, muscle, respiratory tract, gastrointestinal tract, cardiovascular system, and other tissues and systems. The most common AE was pain at the injection site (first dose: 10.19%, second dose: 12.55%). All the vaccinees with AEs for both doses recovered fully in the end. It was noted that some AEs might cause blood coagulation disorder and bleeding risk. Therefore, ongoing monitoring of AEs after COVID-19 vaccination is essential in evaluating the benefits and risks of each vaccine.