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Brazil's National Health Surveillance Agency Authorizes Resumption of the Phase III Clinical Trial of CoronaVac™
Brazil's National Health Surveillance Agency Authorizes Resumption of the Phase III Clinical Trial of CoronaVac™, the Inactivated COVID-19 Vaccine Developed by Sinovac Life Sciences Co., Ltd.
November 11, 2020 (Sao Paulo) - Brazil's National Health Surveillance Agency (Anvisa) authorizes resumption of the phase III clinical trial of CoronaVac™, the Inactivated COVID-19 Vaccine, which is sponsored by our partner Butantan Institute.
We have learned that Anvisa failed to receive the data sent by Butantan Institute in time, and it urgently suspended the clinical study on November 9. Butantan Institute communicated with Anvisa on November 10, and the report from Data and Safety Monitoring Board (DSMB) was submitted to Anvisa on the same day. After evaluating the new data, Anvisa made a very timely decision to resume the clinical research.
The suspension and resumption of such studies are common in clinical research. A suspension does not necessarily mean that the product under investigation has any issue of quality, safety or efficacy, Anvisa said.
This event fully demonstrates that clinical research supervision by Anvisa is sensitive, timely and effective. We are also glad to see that clinical research of CoronaVac™ is proved to be scientific and standardized by Anvisa, National Commission on Ethics in Human Research (Conep), DSMB, the public and media.
We are confident in the safety of the vaccine, fully understand and appreciate Anvisa's strict supervision and timely resumption of the clinical studies. We are grateful for the professional attitude and hard work of our partner the Butantan Institute. We believe a vaccine with good safety and efficacy profile can be supplied only if the clinical studies are conducted in accordance with highest standards. We look forward to completing the following clinical research as soon as possible under the strict governance and monitoring by Anvisa, and finally control the pandemic through vaccination.
We express our full respect to all the volunteers who participated in this clinical study and highly appreciation to the investigators who conducted the study.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.
SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.
SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.
With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.
For more information, please see the Company's website at www.sinovac.com.