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Credit, REUTERS / Amanda Perobelli
In Brazil, the CoronaVac studies are carried out jointly by Sinovac and Instituto Butantan
The National Health Surveillance Agency (Anvisa) was correct in determining the discontinuation of clinical trials of the CoronaVac vaccine after the death of a study participant. Now, however, the municipality must quickly publish the return of studies with the immunizer developed by the Chinese pharmaceutical company Sinovac.
The opinion is a consensus between two former Anvisa presidents consulted by BBC News Brazil: Doctors Gonzalo Vecina and William Dib.
The tests with the CoronaVac vaccine were interrupted this Monday (11/11), after the communication that one of the participants in the clinical tests was found dead in São Paulo, at the end of October. The volunteer, however, would have committed suicide, according to a police report from the São Paulo Civil Police. Death, therefore, would have nothing to do with the vaccine.
Heard separately by BBC News Brazil, the two former Anvisa presidents said the agency needs to publish the return of the studies soon, especially if there are already reports from forensic doctors confirming that the death of the 32-year-old volunteer was due to suicide. .
In Brazil, the CoronaVac studies are carried out jointly by Sinovac and the Butantan Institute, a research center linked to the government of the State of São Paulo.
William Dib is a doctor at the Universidade Estadual Paulista (Unesp) and chaired Anvisa in 2018 and 2019. Gonzalo Vecina Neto is now a professor at the Faculty of Public Health at the University of São Paulo (USP). He presided over Anvisa at the time of the founding of the regulatory agency, from 1999 to 2003.
The two also criticized President Jair Bolsonaro’s speech (without a party) on the case. This Tuesday (11/10), the representative celebrated the discontinuation of CoronaVac’s clinical trials. Bolsonaro was “disrespectful” and “politicized” the case, in the opinion of the doctors.
“Death, disability, anomaly. This is the vaccine that (the governor of São Paulo, João) Doria wanted to force all São Paulo residents to take. The president said that the vaccine could never be mandatory. One more that Jair Bolsonaro wins”, the president said, responding to a supporter who asked him about it on Facebook.
This Tuesday (11/10), the Minister of the Federal Supreme Court (STF), Ricardo Lewandowski, gave 48 hours to the National Sanitary Surveillance Agency (Anvisa) to explain at what stage of the tests the immunizer developed by Sinovac is at. and the Butantan Institute.
Dib: Bolsonaro’s celebration shows politicization of the process
Credit, APR
‘The test of politicization is the celebration of the president, right?’ William Dib told BBC News Brazil.
“Anvisa, the Anvisa servers, I have no doubt that they are doing their job in a technical way. And the decision is well justified. What you cannot do is wait long to make, or not, the decision to return the investigation. “William Dib told BBC News Brazil.
“The proof of politicization is the celebration of the president, right? The president, by commemorating a death and a delay in the process, shows that the issue (around the vaccine) was politicized for a long time,” he said.
“The justification that there was a problem with the computer system is not something that can be challenged. We cannot say that we had or did not,” Dib said.
On Tuesday afternoon, Anvisa officials said a hacker attack last week prevented the agency from learning of the volunteer’s death earlier; the Butantan Institute previously said it had told the agency about the death on November 6. The volunteer was found dead in late October.
“Now, this does not mean that (the interruption) will be delayed by months (the development of the vaccine). It will be delayed by a day or two. Now, you have to make the decision (to resume your studies) as soon as possible. show that there is no such process of politicization when it comes to technical things, scientific things. Science has to be above party ideologies, political wills, “said Dib.
“We are talking about lives on planet Earth, it is not only in Brazil. When the issue is suspended here in Brazil, the world is on alert regarding this investigation,” he said.
Neighbor: testing should resume as soon as possible
Credit, Playback / YouTube / Ministry of Health
‘The vaccine does not have any component that leads to depression. So, he just committed suicide because of the vaccine, ‘says Vecina
“The search for a vaccine is very complex, because a vaccine is a medicine that we give to those who are not sick. We give vaccines to those who are healthy. Then vaccines cannot run any risk, ”said Dr. Gonzalo Vecina Neto.
“And then a guy (the volunteer) dies. The first thing is to stop everything. Because someone who received the vaccine died. (At first) I don’t know what he died of. ‘Oh, he killed himself.’ Let’s see. to find out if he died with the drug that was next to him, on the floor. You have to be careful “.
“If I were in Anvisa I would probably do this too. For all. Even when? Until the Medico-Legal Institute (IML) tells me that he died and I am sure that he died not from the vaccine, but yes. because he committed suicide, “Vecina told BBC News Brazil.
“The vaccine does not have any component that leads to depression. Therefore, he hardly committed suicide because of the vaccine.”
“I hope that, as soon as Butantan receives the documentation from the IML, it will send that documentation to Brasilia and Anvisa and the External Committee will approve the continuity of the vaccine,” Gonzalo Vecina Neto said in an interview with BBC News Brazil.
“Now, we must act quickly to release the continuity of the investigation,” he said.
When asked what would be a reasonable time frame to resume the clinical trial, Vecina was emphatic.
“Tomorrow (Wednesday, 11/11),” he said.
“It is well explained that the volunteer did not die from the vaccine. Now, it remains to receive the complete information from Butantan to make known the continuity of the investigation,” said he, who is a professor at the Faculty of Public Health of the University of São Paulo (USP). .
“In the middle of that, we are in a hurry to get a vaccine. And we have a president who is disrespectful with the mortality that we already had (caused by Covid-19), disrespectful with the guy who offered to be part of this investigation, who died; Disrespectful towards an institution like the Butantan Institute, which has existed for more than 100 years, ”he criticized.
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