Chinese Sinovac May Resume Covid-19 Vaccine Trial

Brazilian health regulator Anvisa on Wednesday authorized the resumption of advanced-stage Brazilian clinical trials for the Chinese Sinovac Covid-19 vaccine, which had been suspended due to the death of a study subject registered in Sao Paulo as a suicide.

Brazilian Medical Institute Butantan said in a statement it would restart testing later Wednesday.

Brazilian President Jair Bolsonaro, a longtime critic of China who baselessly dismissed the Sinovac vaccine as lacking in credibility, hailed Monday’s suspension as a personal victory.

Bolsonaro, however, reiterated on Wednesday evening that his government would buy any vaccine approved by Anvisa and the health ministry, which could ultimately include the Sinovac vaccine, if approved.

The decision to stay the trial – one of Sinovac’s three big late-stage studies – has been criticized by trial organizers, who said the move took them by surprise and was unnecessary to stop the study because the death was unrelated. to the vaccine.

The suspension further inflamed tensions between Bolsonaro and the governor of Sao Paulo, Joao Doria, who pinned his political ambitions on the Chinese vaccine that he intends to deploy in his state in January, with or without federal aid.

Anvisa, in her statement on Wednesday, said the initial information received on the case, which led to the suspension, was incomplete and lacked the cause of “the serious adverse event”. He strongly rejected suggestions that the decision could have been politically motivated.

“After evaluating the new data presented by the sponsor … Anvisa understands that she has sufficient reasons to authorize the resumption of vaccination,” the agency said.

“It is important to clarify that a suspension does not necessarily mean that the product under investigation does not offer quality, safety or efficacy,” added Anvisa.

Sinovac, in a statement, said: “We are confident in the safety of the vaccine, fully understand and appreciate Anvisa’s strict supervision and the timely resumption of clinical studies.”

Brazil has one of the worst Covid-19 epidemics in the world, with more than 5.7 million confirmed cases and 163,000 deaths linked to the disease caused by the new coronavirus. Bolsonaro has been criticized for his constant rejection of the virus and its dangers.

On Tuesday, Bolsonaro said Brazilians “must stop being sissies” over the virus, adding: “We are all going to die one day.”