Original Article
Safety of an inactivated 2019-nCoV vaccine (Vero) in adults aged 60 years and older
Han Bihua, Wu Zhiwei, Li Minjie, Jin Fei, Gao Zhao, Pan Lulu, Ma Jingchen, Jin Hui, Zhao Yuliang, Li Qi
Published 2022-09-06
Cite as Chin J Prev Med, 2022, 56(9): 1295-1301. DOI: 10.3760/cma.j.cn112150-20220119-00069
Abstract
ObjectiveTo analyze the safety of an inactivated 2019-nCoV vaccine (Vero cell) in adults aged 60 years and older.
MethodsA randomized, double-blind, placebo-controlled clinical study was conducted in May 2020 The eligible residents aged 60 and above were recruited in Renqiu city, Hebei Province. A total of 422 subjects (phase Ⅰ/Ⅱ:72/350) were enrolled. Two doses of the trial vaccine or placebo were randomly administered according to a 0 and 28-day immunization schedule. Subjects were randomly divided into two groups in Phase Ⅰ. Within each group, participants received vaccine or placebo in a ratio of 2∶1. Subjects were randomly divided into four groups in phase Ⅱ to receive low-dose, medium-dose, high-dose vaccine and placebo, respectively, in a ratio of 2∶2∶2∶1. A combination of regular follow-up and active reporting was used to observe adverse reactions within 28 days after vaccination, and compare the incidence rate of adverse reactions in the trial and control groups.
Results422 subjects were (66.45±4.70) years old, and 48.82% were male (206/422). There were 100, 124, 124 and 74 patients enrolled into the low-dose, medium-dose, high-dose vaccine groups and the placebo group, respectively. One person without the vaccination was removed, and 421 participants who received at least one dose of vaccine were included in the safety analysis. Within 28 days after the first or second dose, a total of 20.67% (87/421) subjects had adverse reactions (both solicitation and non-solicitation). About 76 patients suffered grade 1 adverse reactions [18.05% (76/421)] and 22 patients suffered grade 2 adverse reactions [5.23% (22/421)]. No grade 3 or above adverse reactions occurred. A total of 19.71% (83/421) subjects had solicited adverse reactions. The most common grade 1 adverse reaction was injection site pain, followed by fever and fatigue. The most common grade 2 adverse reactions were fever and fatigue, followed by muscle pain and injection site redness. A total of 2.61% (11/421) subjects had unsolicited adverse reactions. A total of 1.66% (7/421) subjects had serious adverse events after vaccination, and no serious vaccine-related adverse events were reported.
ConclusionsThe inactivated SARS-CoV-2 vaccine is safe for people aged 60 years and above.
Key words:
2019-nCoV; Randomized controlled trial; Aged; Inactivated vaccine; Safety
Contributor Information
Han Bihua
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Wu Zhiwei
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Li Minjie
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Jin Fei
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Gao Zhao
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Pan Lulu
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Ma Jingchen
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Jin Hui
Renqiu City Center for Disease Control and Prevention,Renqiu 062550, China
Zhao Yuliang
Institute for Vaccine Clinical Research, Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
Li Qi
Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China
