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On the morning of November 11, 2020, local time, Brazil's National Health Supervision Agency (Anvisa) announced the authorization to resume clinical studies of the new corona inactivated vaccine Kellefort™️ III, supported by the Butantan Institute, a partner of Coching Bio.
an emergency suspension of clinical studies on the evening of November 9 after an earlier failure to receive a report from the Butantan Institute.
10 November, the Butantan Institute communicated with Anvisa, and the report of the Data Security Monitoring Committee (DSMB) was submitted to Anvisa on the same day.
decision to resume clinical studies was made in a very timely manner after evaluating the new data.
and resumption of research is a common event in clinical studies, and suspension does not necessarily mean that the product being studied has quality, safety or effectiveness issues, said Anvisa.
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