A “serious adverse event” that led Brazil’s health authorities to halt clinical trials of a Chinese-developed Covid-19 vaccine was not related to the vaccine trial itself, the director of Brazil’s Butantan biomedical institute said on Tuesday.
Brazil’s National Health Surveillance Agency (Anvisa) suspended the trial on Monday after an incident on October 29. A note from Anvisa said the trial had been paused in order to better evaluate the data and assess the risk.
On Monday Anvisa said it had “ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident”.
It did not reveal what had happened, nor where it had taken place. Late-stage trials for the Sinovac vaccine are also being conducted in Indonesia and Turkey, but neither of these countries have announced a suspension.
Indonesia’s state-owned Bio Farma said on Tuesday that its own Sinovac vaccine trials were “going smoothly”, according to Reuters news agency. Dimas Covas, head of the Butantan institute conducting the trials, told local media that the trial’s suspension was related to a death, but insisted that the death was not linked to the vaccine.
This was backed up by Jean Gorinchteyn, Health Secretary for the state of São Paulo, who told a news conference that the death was an “external event” that was not related to the vaccine.
Mr Covas said that there had been no adverse reactions to the vaccine.
“We found this Anvisa decision strange, because it is unrelated to the vaccine. There are more than 10,000 volunteers at this moment,” Mr Covas told TV Cultura.
He said the suspension had caused “indignation” and that the organisers of the trials had not been consulted. In a press conference on Tuesday, Mr Covas said he hoped trials would resume soon.
Sinovac said on Tuesday that it was communicating with Brazil about the reported incident.
“We learned the head of Butantan Institute believed that this serious adverse event [SAE] is not related to the vaccine,” it said in a statement. “The clinical study in Brazil is strictly carried out in accordance with GCP [Good Clinical Practice] requirements and we are confident in the safety of the vaccine.” President Bolsonaro has long criticised the vaccine because of its Chinese links and said it would not be purchased by his country. He has also engaged in a political fight with the governor of São Paulo, Joao Doria, who has publicly backed the trial.
Writing on Facebook, the president said the halt of the CoronaVac trial was “another victory for Jair Bolsonaro”.
The vaccine, developed by Chinese firm Sinovac Biotech, is one of several in final-stage testing globally. Sinovac says it is “confident in the safety of the vaccine”.
The firm has already been using it to immunise thousands of people at home in an emergency use programme.
Brazil has been one of the countries worst affected by coronavirus, recording more than 5.6m confirmed cases – the third highest tally in the world after the US and India – and nearly 163,000 deaths, according to data collated by Johns Hopkins University.
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