The National Health Surveillance Agency (Anvisa) authorized the resumption of CoronaVac tests this Wednesday (11). The release takes place two days after the suspension of the study in Brazil, due to the death of one of the participating volunteers.
“Seeking to comply with the principle of transparency, Anvisa informs that it has just authorized the resumption of the clinical study related to the CoronaVac vaccine, which has the Instituto Butantan as sponsor”, says the note from the agency, published on its official website.
In the statement, the local authority linked to the Ministry of Health also said it had analyzed the new data presented by Butantan, a partner of the Chinese laboratory Sinovac in the production of the immunizing agent against covid-19, after the suspension of the clinical trial. Thereafter, she obtained “sufficient subsidies” to allow testing to resume.
Anvisa also commented that it will continue to monitor the investigations into the case, until the definition of a “possible causal relationship between the unexpected serious adverse event (SAE) and the vaccine”. The text also emphasizes that the temporary suspension does not necessarily indicate the lack of quality, safety or efficacy of immunization.
The suspension of the CoronaVac test led to an intense dispute between Butantan and the agency linked to the federal government. On the one hand, the director of the Dimas Covas institute claimed to have informed Anvisa that the death was not related to the vaccine.
On the other hand, the director of the Antônio Barra Torres agency said that he had not received the details of the case and that, given the lack of information, he decided to interrupt the study, based on “technical reasons”.
Also involved in the clash was President Jair Bolsonaro, who used social media to comment on the case. In response to a follower, he wrote: “Death, disability, anomaly. This is the vaccine that Dória wanted to force all São Paulo residents to take. The President said the vaccine could never be mandatory. Another one that Jair Bolsonaro wins”.
Death recorded as suicide
The death of the volunteer in the CoronaVac tests, which motivated Anvisa to interrupt the study, apparently has no relationship with the clinical trial or the disease caused by the new coronavirus, as shown by preliminary information.
According to UOL and the Globe, the case, which took place in October, was registered as a suicide in the Civil Police’s police report. The report from the Forensic Medical Institute (IML), indicating the cause of death, is not yet complete, and it is important to remember that a confidentiality clause in the study prohibits the disclosure of details of cases like this one.
Both vehicles report that the deceased volunteer was a 32-year-old man. He participated in the tests at the Hospital das Clínicas in São Paulo and it is not known whether he received the doses of the immunizing agent or the placebo, as the control is carried out by an international commission, which does not usually disclose this type of information.
It is noteworthy that this was not the first interruption of a study of vaccines against covid-19 in Brazil. In October, an Oxford vaccine trial volunteer died of complications from the disease, prompting the AstraZeneca laboratory to halt research. It was resumed shortly thereafter, and in this case the volunteer had been given a placebo.