China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the completion of the analysis of key Phase III clinical data for its in-house developed COVID-19 inactivated vaccine (Vero cells). The study assessed the vaccine’s efficacy and safety in a global, multi-center, randomized, double-blind, placebo-controlled trial.
Study Details
The Phase III study, which began in June 2021 in Malaysia, the Philippines, and Ukraine, aimed to enroll 28,000 participants aged 18 and above. Participants received two doses of the vaccine on day zero and day 28. As of the critical data analysis date, 30,881 people were enrolled, including 15,436 in the vaccine group and 15,445 in the placebo group. A total of 641 cases were monitored as the main endpoint after the full course of vaccination.
Efficacy and Safety
The data analysis results showed that the vaccine’s protective effect against confirmed cases of COVID-19 of any severity was 51.54%, meeting the COVID-19 vaccine effectiveness standard required by the WHO. The vaccine demonstrated a 100% protective effect against severe cases and death. Genotyping results indicated that the Omicron strain accounted for 92.29% of endpoint cases, while the Delta strain accounted for 7.71%. There was no significant difference in the incidence of serious adverse events between the test group and the placebo group.
Regulatory and Market Context
Kangtai Biological’s COVID-19 inactivated vaccine obtained emergency use authorization (EUA) in May 2021 and was launched in the Chinese market one month later. The vaccine was approved as a homogenous booster shot in February of this year, further expanding its use in the fight against COVID-19.-Fineline Info & Tech
