Suicide, not 'adverse effects,' halted Brazil's Sinovac trial

 

Health secretary says death of volunteer has 'nothing to do' with injection SAO PAULO/BEIJING (Reuters) -- Brazil's health regulator suspended a clinical trial of China's Sinovac coronavirus vaccine due to a severe adverse event, delighting President JairBolsonaro, who has repeatedly criticized the vaccine's credibility and said it would not be purchased by his government.

Brazil's health regulator, Anvisa, suspended the trials late on Monday saying the event occurred on Oct. 29.

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The state government of Sao Paulo, where the trial is being run, said the death of a trial volunteer had been registered as a suicide and was being investigated.

A police report of the incident was seen by Reuters. The suspension further inflamed tensions between Bolsonaro and Sao Paulo Governor Joao Doria, who has pinned his political ambitions on the Chinese vaccine which he aims to roll out in his state as early as January, with or without federal assistance.

On Tuesday, Anvisa said it would maintain the suspension and did not give any indication of how long it might last, adding it required more information on the incident.

It dismissed any suggestion the move was politically motivated, saying the decision was purely technical. The trial's organizers criticized Anvisa's decision, saying they had not been notified in advance and that there was no reason to stop the trial.

Although a trial volunteer had died, it had nothing to do with the vaccine, Jean Gorinchteyn, Health Secretary for the state of Sao Paulo told a news conference on Tuesday.

"We had an external event that led to the regulator being notified," Gorinchteyn said. "This vaccine is safe."

Dimas Covas, the head of Sao Paulo's medical research institute Butantan, which is conducting the Sinovac trial, said the vaccine had shown no serious adverse effects. Speaking at the same news conference, he said he hoped the trial would be resumed later on Tuesday or Wednesday.

Anvisa said the initial information it received from Butantan had not specified that the death was a suicide. "We had no choice but to suspend the trials given the event," the head of the agency Antonio Barra Torres said.

Ref: Nikkei Asian Review