Shortly after the cause of the volunteer’s death was disclosed, Anvisa’s CEO, Antônio Barra Torres, said in a press conference that “there was no such information [de que o voluntário se suicidou] among the ones we received yesterday [segunda-feira]”.
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 police officers were called on the radio for a “corpse encounter occurrence”. Upon arriving at the apartment, the building’s janitor showed the victim passed out on the bathroom floor with a syringe near his arm and several vials of medicine. The 32-year-old’s body went to the Instituto Médico Legal (IML).
The necroscopic report must be released later because, in this case, the result depends on the toxicological examination, which takes longer to be ready.
- On Monday (9), Anvisa suspended CoronaVac tests citing an “adverse event” with a volunteer;
- The adverse event was the death of a volunteer;
- Butantan, which develops the vaccine, said he was surprised: ‘It is impossible for the vaccine to be related to the adverse event’, said the director of the agency;
- In the morning, Bolsonaro celebrated the pause in the test: ‘Another one that Bolsonaro won’;
- In the early afternoon, it was learned that the volunteer committed suicide.
Report identified suicide as the cause of the death of a CoronaVac volunteer – Photo: Reproduction
On Monday night (9), Anvisa suspended testing of the Sinovac vaccine, carried out in partnership 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 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 to have a relationship between this event and the vaccine, impossible, I think this definition ends this discussion a little, ” director of the Butantan Institute, Dimas Covas.
The statement was given by the director during a press conference at the headquarters of Instituto Butantan, after the São Paulo government met virtually with representatives of Anvisa 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 more below).
Coronavac volunteer’s death was suicide, police say
During this Tuesday’s press conference, representatives of the São Paulo government showed indignation 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 state secretary of health, Jean Gorinchteyn.
Dimas Covas said that the suspension, in addition to being unnecessary, causes “pain and suffering in volunteers”. “There would be no need for this type of measure, which could be resolved administratively, as was done this morning,” said Covas.
“If interrupting a clinical study that is doing very well causes suffering, causes pain, causes insecurity, in those people who have already undergone the study, it causes difficulty in those who want to undergo the study and who are in line to receive the vaccine or placebo In other words, it is the volunteers, the people who dedicated themselves to this study exactly to bring the hope of the vaccine “, said Covas.
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 dealing here with a serious adverse event that is unrelated to the vaccine. I repeat: a serious adverse event that is unrelated to the vaccine. This information has been available to Anvisa since the 6th, when the serious adverse effect was notified. “.
The director criticized the behavior of the Agency and the way the Institute received the news of the interruption of the tests.
“On the 6th, Anvisa received a document saying: ‘look, a participant in the clinical study had a serious adverse event not related to the vaccine’, point. What is expected in face of such a statement? ‘Look, ok, let’s evaluate, let’s get together, let’s see what were the causes of this adverse event, if you are saying it has nothing to do with the vaccine, let’s find out. “Is that what we expect. Is this what happened? No. I mean, this referral was done on the 6th, yesterday the 9th, at 8:40 pm, they send an email to Butantan saying that there would be a meeting today to deal with the serious adverse event, but at the same time 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 forwarded all clarifications to Anvisa and waits for the release as soon as possible. “She is now able to 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 later this week, possibly this Wednesday (11).
On Monday (10) the director of the Butantan Institute gave an interview to TV Cultura where he stated that the adverse effect is a death, however, the day after the interview, during the press conference, Dimas said 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 seen in a volunteer is not related to the vaccine. We cannot give you details because it involves secrecy. There is a whole ethical aspect that prevents us from giving the characteristics of the volunteer, or the volunteer. What I say to you is that these data are all handled by Anvisa, they are all provided to Anvisa ”.
Dimas Covas also said that Anvisa has all the information and that it could not “circumvent ethics” or “betray the trust” that the volunteer’s family has at the institute.
“At that moment it is up to Anvisa who has all the data to provide this information, we cannot here circumvent ethics, betray the trust that the family [do voluntário] has on us. We cannot give you the reason for the event, what led to 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 “event” on October 29. More than 10 days later, it determined that no new volunteers can be vaccinated until the agency can assess the data and “judge the risk / benefit of continuing the study”.
According to a list released 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 birth defect, any suspected 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 “it 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 respiratory disease. The 33-year-old patient also had no comorbidities.
Sinovac said that “we learned that the head 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 conducted strictly in accordance with the requirements of the GCP” (Good Clinical Practice, or “good clinical practice” in free translation).
President Jair Bolsonaro said, in a social network, that the episode is another one in which “Jair Bolsonaro wins.” In the same post he quoted the governor of São Paulo, João Doria (PSDB).
CoronaVac is one of the candidates for the coronavirus vaccine and is developed by Sinovac in partnership with Butantan, in São Paulo. With the study interrupted, no new volunteers can be vaccinated.
Butantan strange decision
On Monday night, the director general of the Butantan Institute, Dimas Covas, said that he received with surprise the news of the temporary suspension of human tests at CoronaVac in Brazil.
According to Covas, it is “a death unrelated to the vaccine” and, therefore, “there is no moment [ou motivo] for interrupting the clinical study “from phase 3.
How do vaccines work?
“First, Anvisa was notified of a death, not of an adverse effect. This is different. We even find this decision by Anvisa a little strange, because it is a death unrelated to the vaccine“, stated the director of Butantan.
“As there are more than 10,000 volunteers at this time, deaths can happen. At that moment, [o voluntário] you can have a traffic accident and die. That is, it is a death unrelated to 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 hopes to have more details on Tuesday morning (10).
Another volunteer death
On October 21, a Brazilian volunteer who participated in the tests of the Oxford vaccine against Covid-19 died of complications of Covid-19. The volunteer took a placebo (inactive substance), not a dose of the vaccine.
The tests were suspended, at the time, by AstraZeneca itself, which develops the vaccine in partnership with the University of Oxford.
Understand how Covid vaccine tests work
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