Brazil’s sanitary regulator allows resumption of CoronaVac trials

Brazil’s national sanitary watchdog Anvisa today (Nov. 11) authorized the resumption of clinical trials of vaccine CoronaVac, one of the vaccines being tested in Brazil by the Butantan Institute. The agency declared it had received new information from Butantan on the “serious adverse event (SAE),” which led the regulator to suspend the studies on Monday (9).

“After assessing the new information disclosed by the sponsor after the study was suspended, Anvisa believes it has enough subsidies to authorize the resumption of vaccination and is still monitoring the investigation into the conclusion of the case so that the possible link between the cause and the unexpected SAE may be ascertained,” Anvisa sent out a note saying.

In the statement, Anvisa once again argued for the measure adopted Monday, which took into account the information known by the agency then and which were submitted to the agency by the Butantan Institute.

According to the agency, the decision was based on procedures laid out as Good Clinical Practices for this kind of research, and had as its premise the “principle of precaution”—when scientific knowledge is not capable of eliminating damage risks.

While justifying the suspension of tests, Anvisa stated it lacked the necessary information on the gravity and causes of the event, as well as the stance taken by the Data and Safety Monitoring Board and the report linked to the SAE’s likely motivation, adding it received these data from Butantan yesterday (10).

SAE

On Tuesday, a number of news outlets reported that the serious adverse event was death from suicide, with no connection with the vaccine. However, at a press conference that same day, Anvisa President Antônio Barra Torres said the agency had not received this information through official channels.

“Faced with the serious adverse event, the independent committee must take action. Information has to come from a specific channel; other channels, however relevant their information might be, are not the independent committee,” he noted.

Anvisa also said it has not disclosed the nature of the SAE in respect for the privacy and integrity of research volunteers.

Earlier on, in São Paulo, at another presser on the issue, Butantan Institute President Dimas Covas stated the event was notified to Anvisa on November 6 in detail. He also referred to Anvisa’s decision as hasty. Covas pointed out that the information was relayed to Anvisa in compliance with the protocols stipulated by the regulator and the National Commission on Ethics in Research (CONEP), with all the information required for clarification and to avoid having to halt the study.

According to Butantan, the volunteer received the dose on October 29, 25 days before the adverse event took place. Covas also said that Butantan does not know whether the volunteer, who had been admitted at the Hospital das Clínicas of the University of São Paulo, and took either the vaccine or a placebo.

Also yesterday, Supreme Court Justice Ricardo Lewandowski ordered that Anvisa should, in 48 hours, provide the information on the studies and the progress made in the tests for the vaccines against COVID-19 in Brazil.