SINOVAC Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed by SINOVAC Life Sciences Co., Ltd., a subsidiary of the Company, was approved for emergency use under the World Health Organization Emergency Use Listing (“EUL”) procedure. Prior to this, the Strategic Advisory Group of Experts on Immunization (“SAGE”) had recommended two doses of CoronaVac® for adults aged 18 and above with an interval of 2 to 4 weeks.
The 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.
In 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.
Mr. 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.
In June 2020, CoronaVac® became the first vaccine approved for emergency use in China and was further approved for conditional marketing use on February 5th, 2021.
On April 1st, 2021, the third phase of a CoronaVac® bulk production manufacturing facility was completed and began operations, allowing the annual production capacity to exceed 2 billion doses. SINOVAC’s manufacturing control system of CoronaVac® has been inspected by China, Brazil, Indonesia, Chile and Saudi Arabia, as well as the WHO. Large-scale production of hundreds of batches have proven the stability and reliability of SINOVAC’s vaccine manufacturing control system. At this time, SINOVAC has provided CoronaVac® to nearly 40 countries and regions, including mainland China, directly and indirectly. The total supply has already exceeded 600 million doses. Moreover, according to incomplete statistics, over 430 million doses have been administrated worldwide. SINOVAC has become the largest domestic supplier and exporter of China’s COVID-19 vaccine. The safety and effectiveness of CoronaVac® has been verified all over the world.