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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.


Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis.

SINOVAC's COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The Healive®, a hepatitis A vaccine manufactured by the Company, passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine, that was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) was prequalified by WHO.

SINOVAC was the first company that granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.

SINOVAC has been continually dedicating itself to new vaccine research and development, with more combination vaccine products in the pipeline, and constantly exploring opportunities in the international market. SINOVAC looks forward to conducting more extensive and in-depth trade and cooperation with more countries, enterprises, and professional institutions.

For more information, please see the Company’s website at


Sinovac Biotech Ltd.

Helen Yang

+86-10-8279-9871 or


Fax: +86-10-6296-6910

ICR Inc.

Bill Zima

U.S.: 1-646-308-1707