Sinovac Touts Positive Preliminary Results of Phase I/II Clinical Trials for Inactivated Vaccine Candidate Against COVID-19
16 June 2020 - - China-based biopharmaceutical products provider Sinovac Biotech Ltd. (NASDAQ: SVA) has received positive preliminary results of phase I/II clinical trial for the company's COVID-19 vaccine candidate, named CoronaVac, which showed favourable immunogenicity and safety profiles, the company said.

The phase I/II clinical trials were designed as randomised, double-blind and placebo-controlled studies. In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials. Of those, 143 volunteers are in phase I and 600 volunteers are in phase II.

There have been no severe adverse event reported in either the phase I or phase II trials. The phase II clinical trial results show that the vaccine induces neutralising antibodies 14 days after the vaccination with a 0,14 day schedule.

The neutralising antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce positive immune response.

The company expects to submit a phase II clinical study report and a phase III clinical study protocol to China's National Medical Products Administration in the near future and commence application of phase III clinical trials outside of China.

As previously reported on June 11, 2020, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study. The company expects to share the full data on our clinical trials with the public through academic publications.

As announced previously, Sinovac's development of a vaccine against COVID-19 began in January 2020 in partnership with leading academic research institutes in China.

The company received approval from China's NMPA on April 13 to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China.

Sinovac Biotech is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialisation of vaccines that protect against human infectious diseases.

Sinovac's product portfolio includes vaccines against enterovirus71, hepatitis A and B, seasonal influenza, 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 a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, a quadrivalent influenza vaccine and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine.

Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The company is registering its products in over 30 countries outside of China.