Sinovac announces approval of human clinical trial for a vaccine candidate against COVID-19

F.P. Report

BEIJING: Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, on Wednesday announced that the Company has obtained approval to conduct a human clinical trial on an inactivated SARS-CoV-2 (commonly referred to as COVID-19) vaccine candidate.

The vaccine development commenced at the end of January 2020. Sinovac scientists have raced to complete comprehensive preclinical studies in partnership with leading academic research institutes in China. As part of this work, an animal challenge study has shown that the vaccine candidate protects animals without antibody-dependent enhancement (or ADE). In addition, the vaccine candidate can neutralize virus strains from different countries, which supports the potential of using the vaccine to prevent the spread of the disease globally.

Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, commented, “At present, the whole world is facing an unprecedented public health crisis. It is a matter of urgency to develop an effective vaccine to control the spread of COVID-19 globally, as quickly as possible. Sinovac has been working closely with the regulators in China in order to make this happen. Sinovac has always been committed to developing vaccines for global use when facing pandemics.”

Meanwhile, due to measures put in place to stop the spread of COVID-19, the Company’s daily operations have been impacted.

Domestic sales have ceased due to the suspension of vaccinations by the Chinese CDC since February, and exports are disrupted due to cancellations of cargo flights and inflated freight costs. Any prolonged disruption of Sinovac’s clinical trials, suppliers, or contract manufacturers could delay regulatory approvals or the commercialization of any current or future products.

Certain provinces and cities in China are starting to lift some of the restrictive measures, and delivery of vaccines in China has slowly started to resume. The Company is closely monitoring the situation in China as well as in the other countries in which it markets its vaccines.