Safety analysis of inactivated SARS-COV-2 vaccine (VERO cells) during emergency vaccination in Hefei

ABSTRACT

Objective To study the safety of inactivated SARS-CoV-2 vaccine (Vero cells) (SARS-CoV-2 vaccine) in Hefei during the emergency vaccination period, and to provide reference for the promotion and vaccination of this vaccine in the whole population in the later period. Methods A total of 19 vaccination clinics in Hefei were selected as active monitoring sites for immunization safety. Focus groups aged 18-59 years who were vaccinated with SARS-CoV-2 vaccine in Hefei from 15 December 2020 to 10 February 2021 were observed. The incidence, types and severity of adverse reactions after vaccination were descriptively analyzed. Results A total of 18 574 people were effectively observed, and 33 433 doses of SARS-CoV-2 vaccine were inoculated. 713 cases of general adverse reactions occurred, with an incidence of 2.13%. The incidence of adverse reactions in the first dose was 2.57%, which was higher than that in the second dose (1.58%, χ2=38.92, P < 0.001). There was no statistical significance in the incidence of general adverse reactions of inactivated vaccine produced by the two companies (χ2=3.08, P=0.082). Among the adverse events such as redness and swelling at the injection site, induration at the injection site, and fever, the incidence of grade 1, 2 and 3 adverse events were 0.65%, 1.42%, and 0.06%, but there were no ≥ grade 4, rare and extremely rare adverse events. Conclusion Domestic inactivated SARS-CoV-2 vaccine (Vero cells) is great safe. © 2021, Publication Centre of Anhui Medical University. All rights reserved.