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The National Health Surveillance Agency (Anvisa) reported, on Monday night (9), that it determined the interruption of the clinical studies of the Coronavac vaccine, after the occurrence of a “serious adverse event”.
Coronavac is produced by the Chinese Sinovac in association with the Butantan Institute and is undergoing clinical trials in Brazil.
In a note, the Butantan Institute said it was surprised. In an interview with TV Cultura, the director of the Butantan Institute, Dimas Covas, said that it is the death of a volunteer who was not related to the vaccine. The government of the State of São Paulo issued a note in which it said that it regretted “having been informed by the press”, and “not by Anvisa”, about the interruption of the tests (see notes at the end of the text).
According to a note published by Anvisa, the event that occurred on 10/29 was communicated to the agency, “which decided to interrupt the study to evaluate the data observed so far and judge the risk / benefit of continuing with the study.”
Anvisa points out that this type of interruption is foreseen in the regulations and is part of the procedures of good clinical practice, expected for clinical studies carried out in Brazil.
“With the study interrupted, new volunteers cannot be vaccinated. It is prohibited to communicate more details of the study in accordance with the confidentiality commitments assumed in the vaccine development protocol ”, says the note.
Anvisa does not detail what specific event was observed, but lists those that are considered “serious adverse events”: death; potentially fatal adverse event (one that, in the opinion of the notifier, puts the person at immediate risk of death due to the adverse event that occurred); persistent or significant disability / disability; requires hospitalization of the patient or prolongs hospitalization; congenital anomaly or birth defect; any suspected transmission of an infectious agent through a medical device; and clinically significant event.
Note from the Butantan Institute
The Butantan Institute clarifies that it was surprised, on Monday night, with the decision of the National Health Surveillance Agency (Anvisa) and that it is investigating in detail what happened with the progress of the Coronavac clinical studies.
Butantan also informs that it is at the disposal of the Brazilian regulatory agency to provide all the necessary clarifications on any adverse event that the clinical studies have presented so far.
morning [terça-feira]At 11 am, there will be a press conference at the institute’s headquarters. “
Note from the São Paulo government
The Government of São Paulo, through the Butantan Institute, regrets having been informed by the press and not directly by Anvisa, as is often the case in clinical procedures of this nature, about the interruption of the Coronavac vaccine tests. Butantan awaits more detailed information from the clinical staff of the National Health Surveillance Agency on the real reasons that determined the strike. Tomorrow, at 11 am, already in possession of this information from Anvisa, there will be a press conference at the headquarters of the Butantan Institute.
