[ad_1]
The expert reports of the IML (Medical Legal Institute) and the IC (Institute of Criminalistics) point out that the CoronaVac volunteer died of intoxication by chemical agents. Opioids, sedatives and alcohol were found in the victim’s blood, according to the report. Twitter.
The death of the 32-year-old volunteer who prompted the investigation to stop the CoronaVac vaccine was not related to testing or COVID-19 by authorities linked to the investigation. According to the Twitter Found, the case is treated as suicide by people involved in the study and was thus recorded in the report of the Civil Police.
The case was used by Anvisa (National Health Surveillance Agency) to interrupt the vaccine research carried out by the Butantan Institute, in association with the Chinese laboratory Sinovac, last Monday (9). Anvisa claimed that the decision was technical at the time.
Anvisa published the resumption of the tests
Yesterday, Anvisa announced authorization to resume testing with the CoronaVac vaccine. The agency had suspended phase 3 studies after reporting a “serious adverse event,” the death of a volunteer who tested the covid-19 immunizer.
Dimas Covas, director of the Butantan Institute, welcomed the authorization to resume the tests. He said it is “excellent news”, reaffirmed that the vaccine is safe and thanked Anvisa.
“We hope at this time to continue with this process as soon as possible, since we know that one day with a vaccine makes a difference. We need this vaccine as soon as possible and therefore our urgency to complete this study. Therefore, I thank our Anvisa for their understanding and for the speed with which the resumption of clinical studies was authorized, ”Dimas declared yesterday.
The general manager of Anvisa, Antônio Barra Torres, said on Tuesday (10) that the decision on the suspension was technical and motivated by the “incomplete” and “insufficient” data sent by the Butantan Institute on the event.
In a note issued yesterday, Anvisa said that the suspension is expected in studies of this type and complied with the planned protocols.
“It is important to clarify that a suspension does not necessarily mean that the product under investigation is not of quality, safety or efficacy. The suspension and resumption of clinical studies are common events in clinical research and all studies aimed at the registration of authorized drugs in the country are previously evaluated by Anvisa in order to preserve the safety of the study volunteers ”, says the note.
“Anvisa ensures once again the commitment with the Brazilian population to certify the quality of the data of the clinical studies and the safety of the volunteers, also giving maximum speed to the process,” he added.
