Sinovac Announces Phase III Results of Its COVID-19 Vaccine
- Category: Vaccines
- Published on Saturday, 06 February 2021 15:35
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BEIJING, China I February 05, 2021 I Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced phase III results. Sinovac had started its phase III trials on CoronaVac, its COVID-19 vaccine, on July 21, 2020. Trials were conducted in Brazil, Turkey, Indonesia, and Chile. In compliance with the principles of Good Clinical Practice (GCP), the trials were conducted with the vaccine candidate produced from the same lot and following the 0, 14 day schedule. There have been a total of 25,000 participants enrolled in the trial across those four countries.
The phase III trials conducted in Brazil and Turkey evaluated the efficacy of the vaccine candidate in healthcare workers who provide treatment to COVID-19 patients. Both trial studies were randomized, double-blind, and placebo-controlled. The two trials shared the same primary endpoint of an efficacy rate 14 days after the vaccination with either vaccine candidate or placebo.
As of December 16, 2020, there were 12,396 health workers over 18 years old enrolled. A total of 253 positive cases were collected during the observation period. After 14 days following vaccination with 2 doses of vaccine following a 0, 14 day schedule, the efficacy rate against diseases caused by COVID-19 was 50.65% for all cases, 83.70% for cases requiring medical treatment, and 100.00% for hospitalized, severe, and fatal cases.
There are two stages of the phase III clinical trial in Turkey. Participants comprised health care workers in the first stage (K-1) and the general population in the second stage (K-2), with all participants ranging from 18 to 59 years old. As of December 23, 2020, there were 918 participants enrolled in K-1 and 6,453 participants in K-2, for a total of 7,371 participants. Among them, 1,322 participants completed the two-dose vaccination and entered the 14-day observation period after receiving the second dose of the vaccination. Based on an analysis of 29 cases, the efficacy rate for COVID-19 prevention was 91.25% after 14 days following the two-dose vaccination, in adherence with the 0, 14 day schedule.
Sinovac has officially filed conditional market authorization for CoronaVac with China’s National Medical Products Administration (NMPA). Sinovac continues to actively seek regulatory approval for CoronaVac in other countries while contributing to making the COVID-19 vaccine accessible and affordable on a global basis to ensure the prevention and control of the COVID-19 pandemic.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac's product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent Pneumococcal Polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including COVID-19 vaccine, CoronaVac, a Sabin-strain inactivated polio vaccine and combined vaccines. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China. For more information please see the Company’s website at www.sinovac.com.