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The cause of death of the volunteer who participated in the CoronaVac vaccine trials it was for a combination of drugs that are not related to the immunizer. It was an acute poisoning by chemical agents.
Anvisa suspended the vaccine tests on Monday (9) due to an “adverse event” in a volunteer and, on Tuesday (10), the release of the police report showed that the cause of death of a volunteer was suicide. The next day, the agency published the resumption of testing. (read below).
The rules governing vaccine testing prohibit both volunteers and laboratories from disclosing consequences or events related to testing. But the press discovered that it was this death that led Anvisa to suspend CoronaVac tests in Brazil for more than 24 hours.
TV Globo had access to the report of the toxicological examination carried out by the Legal Medical Institute (IML) on the body that the police found in the bathroom of an apartment on October 29. (read below).
The toxicological examination detected the presence of alcohol in the blood, a large amount of sedatives and a surgical analgesic 100 times more powerful than morphine. He did not use illicit drugs.
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 called by radio to respond to an “encounter with corpses.”
Upon arriving at the apartment, the officers were greeted by the building’s concierge, who showed a 32-year-old man on the bathroom floor; Near his arm, there was a syringe and several vials of medicine.
On Wednesday (11), the National Health Surveillance Agency (Anvisa) announced that tests of CoronaVac, the vaccine developed by the Chinese laboratory Sinovac for Covid-19, were resumed after suspending immunization tests due to the death of the volunteer .
In Brazil, the vaccine will be produced by the Butantan Institute, which is linked to the São Paulo government and also coordinates CoronaVac tests in the country.
When making the announcement of the interruption of studies, Anvisa cited a “serious adverse event”, but did not give details about the specific reason that motivated the suspension.
Shortly after the release of the volunteer’s cause of death, the general director of Anvisa, Antônio Barra Torres, said at a press conference that “objectively, there was no such information [de que o voluntário se suicidou] among those we received yesterday [segunda-feira]”.
According to the World Health Organization (WHO), there are currently ten vaccines in the third and final stage of human testing; one of these immunizers is CoronaVac.
Before being released to the population, a vaccine must go through three stages of clinical trials that prove its safety and effectiveness. At each stage, more volunteers are recruited and the researchers analyze the test results to ensure that the immunizer can be licensed.
Anvisa was notified in early November
According to the director of Butantan, Dimas Covas, Anvisa was notified on November 6 about the adverse event that involved the volunteer in the CoronaVac tests.
“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. “Covas said.
The director of Butantan 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 that said: ‘Look, a participant in the clinical study had a serious adverse event not related to the vaccine.’ Point. What is expected of such a statement? ‘Look, okay, let’s evaluate, let’s get together, 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,’ “he explained.
“This is what we hope for. Is this what happened? No. I mean, this referral was made on the 6th. Yesterday the 9th, at 8:40 pm, they sent an email to Butantan saying that there would be a meeting today for discuss the serious adverse event. But at the same time, he announced the suspension of the study. Eight forty at night, 8:40 pm, 20 minutes later this news was on the national network. 20 minutes later we were notified by email, the news it was on national television. ”
On Tuesday, 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.
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 Practice, or “good clinical practice”, in Portuguese).
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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