CoronaVac Vaccine Volunteer Cause of Death Was Suicide | Saint Paul

According to the police report recorded at 4:02 pm on October 29 at a police station in the West Zone of São Paulo, military policemen were summoned by radio for a “meeting with corpses.” Upon arriving at the apartment, a person showed the victim passed out on the bathroom floor with a syringe near his arm and several vials of medicine. The body of the young man went to the Medical Legal Institute (IML).

The necroscopic report must be delivered at 5 pm because, in this case, the result depends on the toxicological test, which takes longer to be ready.

Previously, the government of São Paulo declared, in a press conference, that impossible to link the “serious adverse event” that affected the CoronaVac clinical study volunteer with the immunizer.

On Monday night (9), Anvisa suspended the tests of the Sinovac vaccine, carried out in association with the Butantan Institute, after being notified of a “serious adverse event” in a volunteer.

“The data is transparent. Why do we know and are sure that it is not a vaccine related event? As I said, from the clinical point of view of the case and we cannot give details, unfortunately it is impossible, it is impossible that this event is related to the vaccine, impossible, I think this definition ends this discussion a bit, “he said. director of the Butantan Institute, Dimas Covas.

The statement was given by the director during a press conference at the Butantan Institute headquarters, after the São Paulo government met virtually with Anvisa representatives to discuss the suspension of tests. On Monday night, Dimas Covas said the volunteer died, but said the death had nothing to do with the vaccine. (read below).

During the press conference on Tuesday, representatives of the São Paulo government showed outrage at the measure and argued that there is no relationship between the adverse event and the immunizing one.

“There was no relationship between the vaccine and the serious adverse event presented”, defended the secretary of state health, Jean Gorinchteyn.

Dimas Covas said that the suspension, in addition to being unnecessary, it causes “pain and suffering in the volunteers”. “There would be no need for these types of measures, which could be resolved administratively, as was done this morning,” Covas said.

“If interrupting a clinical study that is going very well causes suffering, pain, insecurity, in those people who have already undergone the study, it causes difficulty in those who want to undergo the study and who are online to receive the vaccine or the placebo. In other words, they are the volunteers, the people who dedicated themselves to this study exactly to bring the hope of the vaccine, ”Covas said.

Anvisa was notified in early November

Also according to Dimas Covas, Anvisa was notified of the adverse event in the volunteer on November 6. “We are facing a serious adverse event that is not related to the vaccine. I repeat: a serious adverse event that is not related to the vaccine. This information is available to Anvisa from day 6, when the serious adverse effect was reported. “.

The director criticized the behavior of the Agency and the way in which the Institute received the news of the interruption of the tests.

“On day 6, Anvisa received a document that said: ‘look, a participant in the clinical study had a serious adverse event not related to the vaccine,’ he said. What is expected of such a statement? ‘Look, okay, let’s evaluate, let’s meet, let’s see what were the causes of this adverse event, if you’re saying it has nothing to do with the vaccine, let’s find out. “Is that what we expect. Is this what happened? It was held on the 6th, yesterday the 9th, at 8:40 pm, they send an email to Butantan saying that today there would be a meeting to attend the serious adverse event , but at the same time they announced the suspension of the study. night, 20 minutes later this news was on national television, 20 minutes after we were notified by email, the news was on national television “.

Dimas Covas also said that the government sent all clarifications to Anvisa and hopes for the release as soon as possible. “Now you can make the decision to resume the study as soon as possible,” said the director.

The director’s expectation is that, after clarification, the Anvisa resumes studies at the end of this week, possibly this Wednesday (11).

On Monday (10) the director of the Butantan institute gave an interview to TV cultura where he said that the adverse effect is a death, however, the day after the interview, during the press conference, Dimas said that he did not speak. that it was a death, or not, and that he could not give details of what happened.

“The serious adverse effect observed in a volunteer is not related to the vaccine. We cannot give you details because it implies secrecy. There is a whole ethical aspect that prevents us from giving the characteristics of the volunteer, or the volunteer. What I am telling you is that all these data are handled by Anvisa, they are all provided to Anvisa ”.

Dimas Covas also said that Anvisa has all the information and that it cannot “evade ethics” or “betray the trust” that the volunteer’s family has in the institute.

“At that time it is up to Anvisa who has all the data to provide this information, here we cannot evade ethics, betray the trust that the family [do voluntário] has about us. We cannot give them the reason for the fact, what motivated the events, because this information can be very painful for the family and we have to respect that aspect. What we say and repeat: the event is not related to the vaccine ”.

Anvisa reported that it was notified of the “fact” on October 29. More than 10 days later, it determined that new volunteers cannot be vaccinated until the agency can evaluate the data and “judge the risk / benefit of continuing the study.”

According to a list published by the agency, serious adverse events are considered “death, potentially fatal adverse event, persistent disability or invalidity, hospital admission of the patient, congenital anomaly or congenital defect, any suspicion of transmission of an infectious agent through a medical device and clinically significant event “.

On Tuesday (10), Sinovac, the Chinese pharmacist responsible for the development of CoronaVac, said in a statement that he is “confident in the safety of the vaccine” against Covid-19.

According to journalist José Roberto Burnier, News, the volunteer’s death was not caused by a respiratory illness. The 33-year-old patient also did not present comorbidities.

Sinovac said that “we learned that the director of the Butantan Institute believed that this serious adverse event has nothing to do with the vaccine.”

The company stated that the phase 3 clinical study in Brazil “is carried out strictly in accordance with the requirements of the GCP” (Good Clinical Practices or “good clinical practices” in free translation).

President Jair Bolsonaro said, on a social network, that the episode is another in which “Jair Bolsonaro wins.” In the same position, he summoned the governor of São Paulo, João Doria (PSDB).

CoronaVac is one of the candidates for the coronavirus vaccine and is developed by Sinovac in association with Butantan, in São Paulo. With the study discontinued, no new volunteers can be vaccinated.

Butantan’s strange decision

On Monday night, the director general of the Butantan Institute, Dimas Covas, said he was surprised by the news of the temporary suspension of human testing at CoronaVac in Brazil.

According to Covas, this is “a death other than the vaccine” and, therefore, “there is no moment [ou motivo] for discontinuing the clinical study “of phase 3.

“First, Anvisa was notified of a death, not an adverse effect. This is different. We even find this decision by Anvisa a bit strange, because it is a death other than the vaccine”Said the director of Butantan.

“As there are more than 10,000 volunteers at this time, deaths can occur. At that time, [o voluntário] you can get in a car accident and die. In other words, it is a death other than the vaccine. This is the case here. There was a death that has nothing to do with the vaccine, ”said Dimas Covas on TV Cultura.

The director also stated that Butantan has already asked Anvisa for clarification on the interruption and that he expects to have more details on Tuesday morning (10).

Another voluntary death

On October 21, a Brazilian volunteer who participated in the testing of the Oxford vaccine against Covid-19 died of complications from Covid-19. The volunteer took a placebo (inactive substance), not a dose of the vaccine.

The tests were suspended, at that time, by AstraZeneca itself, which develops the vaccine in partnership with the University of Oxford.

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