Sinovac's SARS-CoV-2 Vaccine Was Approved for Conditional Ma

Source from: The Official Website of Beijing Sinovac Biotech Co., Ltd.

According to the news from National Medical Products Administration on February 6, SARS-CoV-2 Inactivated Vaccine (Vero cells) developed by Beijing Sinovac Biotech Co., Ltd. was approved for marketing with conditions. The vaccine is suitable for preventing diseases caused by SARS-CoV-2 infections.

Source from: The Official Website National Medical Products Administration

On February 5, Sinovac announced the preliminary statistical analysis results of phase III clinical data on its official website.

Since July 21, 2020, Sinovac has carried out Phase III clinical studies in Brazil, Chile, Indonesia, and Turkey. Using the same batch of vaccines (medium dose 600 SU), following the same immunization procedures (0,14 procedures), Phase III clinical studies independently carried out in accordance with the requirements of Good Clinical Practice (GCP), the total number of enrollment reached 25,000.

Among them, Phase III clinical studies conducted in Brazil and Turkey respectively evaluated the protective efficacy of Sinovac SARS-CoV-2 vaccine in high-risk groups (medical staff engaging COVID-19 patients) and the general population.

As of December 16, 2020, a total of 12,396 subjects were enrolled in the Brazilian study of medical staff aged 18 and above, and 253 effective cases were obtained during the monitoring period. According to the 0,14-day procedure, protective efficacy against diseases caused by COVID-19 14 days after vaccination with 2 doses is: 100.00% protective efficacy for hospitalized, severe and dead cases; 83.70% protective efficacy for COVOD-19 cases with obvious symptoms and requiring medical attention; 50.65% protective efficacy for all COVID-19 cases including mild cases that do not require medical attention.

The target population for Phase III clinical trial in Turkey is 18-59 years old medical staff at high risk (918 enrolled subjects), and the general population at normal risk (6453 enrolled subjects). A total of 7371 subjects were enrolled, of which 1,322 subjects completed two doses of vaccination and entered the 14-day observation period after the second dose of vaccination. Based on the analysis of 29 cases, the protective effect of preventing COVID-19 after 14 days of vaccination with 2 doses of the vaccine according to the 0,14 day procedure is 91.25%.

Based on the above results, Sinovac Biotech formally submitted a conditional marketing application to National Medical Products Administration on February 3, 2021, and was approved for marketing conditionally on February 6.