{"id":24180,"date":"2022-11-21T22:38:00","date_gmt":"2022-11-21T14:38:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24180"},"modified":"2025-01-30T22:41:39","modified_gmt":"2025-01-30T14:41:39","slug":"kangtai-biological-completes-phase-iii-clinical-data-analysis-for-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24180","title":{"rendered":"Kangtai Biological Completes Phase III Clinical Data Analysis for COVID-19 Vaccine"},"content":{"rendered":"\n

China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601<\/a>) 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\u2019s efficacy and safety in a global, multi-center, randomized, double-blind, placebo-controlled trial.<\/p>\n\n\n\n

Study Details<\/strong>
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.<\/p>\n\n\n\n

Efficacy and Safety<\/strong>
The data analysis results showed that the vaccine\u2019s 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.<\/p>\n\n\n\n

Regulatory and Market Context<\/strong>
Kangtai Biological\u2019s 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<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the completion of the…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[30,17,13,2361,1007,12],"class_list":["post-24180","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biotech","tag-clinical-trial-results","tag-covid-19","tag-kangtai-biological-products","tag-she-300601","tag-vaccine"],"yoast_head":"\nKangtai Biological Completes Phase III Clinical Data Analysis for COVID-19 Vaccine - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"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). 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