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.