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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 China-based global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.
The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.
SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Paneflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.
Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines,recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.
With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.
For more information, please see the Company’s website at www.sinovac.com.