Press release
World Health Organization Authorizes SINOVAC’s CoronaVac® for Emergency Use
BEIJING--(BUSINESS WIRE)-- SINOVAC Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today
About this update from Sinovac Biotech, Ltd.
[{"type":"text","content":" BEIJING--(BUSINESS WIRE)--\nSINOVAC Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed by SINOVAC Life Sciences Co., Ltd. (“SINOVAC”), a subsidiary of the Company, was approved for emergency use under the World Health Organization (“WHO”) Emergency Use Listing (“EUL”) procedure. Prior to this, the Strategic Advisory Group of Experts on Immunization (“SAGE”) had recommended CoronaVac® for use in adults 18 years and older in a two-dose schedule with an interval of 2 to 4 weeks.\n\nThe WHO EUL procedure is a technical review process to assess and review unlicensed vaccines and other products to expedite their availability to people affected by public health emergencies. SINOVAC had submitted clinical and non-clinical research data, as well as manufacturing and control (“CMC”) data, to the WHO review group to evaluate the quality, safety, efficacy data and risk management plan of CoronaVac®. In February 2021, the WHO conducted an on-site inspection of SINOVAC’s manufacturing facilities of CoronaVac®, as well as its quality management system. SAGE also conducted a systematic review of CoronaVac® and concluded that the benefits of using SINOVAC’s inactivated coronavirus vaccine are greater than the known risks, recommending the use of this vaccine.\n\nIn addition, the European Medicine Agency (“EMA”) has initiated the rolling review of CoronaVac®. This marks the first step in the process for CoronaVac® to obtain EU approval for use.\n\nMr. Weidong Yin, the Chairman, President, and CEO of SINOVAC, said, “The phase III clinical research and follow-up real-world studies in Brazil, Turkey, Indonesia and Chile represent good examples of the collaborative, global action against the pandemic. These studies have provided a solid scientific foundation for CoronaVac® to be approved by more than 40 countries, as well as the WHO. These achievements could not have happened without the efforts of global partners and scientists. As the COVID-19 pandemic persists, SINOVAC will continue to participate in pandemic prevention and control actions, acknowledging the value of China's COVID-19 vaccine as a global public good and contributing to the international triumph over the COVID-19 pandemic.\n\nIn ...