Friday Nov 13, 2020
SAO PAULO: A late-stage clinical trial being carried out in Brazil of a coronavirus vaccine developed by China's Sinovac Biotech Ltd was not affected by two-day suspension due to the death of a participant later ruled as suicide, the head of the Sao Paulo institute running the study said Thursday.
The trial was paused late Monday after the death of a participant, which was registered in Sao Paulo as a suicide.
The decision by regulatory agency Anvisa to suspend the trial — one of Sinovac’s three large late-stage studies — was criticised by the organisers, who said the move had taken them by surprise and that there had been no need to stop the study as the death had no relation to the vaccine.
On Wednesday, Anvisa said the study could resume.
Dimas Covas, the head of the Butantan biomedical research institute, told reporters that the institute’s trust in Anvisa had not been dampened by the incident, although he added that the relationship between the two needed to be improved.
“We still have a lot of applications underway at Anvisa and this relationship has to be strengthened,” Covas said.
“We cannot communicate with Anvisa through press releases. We hope that there will be absolute transparency on both sides,” he added, referring to the way Butantan had found out about the decision to suspend the trials.
Brazilian President Jair Bolsonaro, a longtime China critic who has baselessly dismissed the Sinovac vaccine as lacking in credibility, had hailed the suspension as a personal victory.
But Bolsonaro reiterated on Wednesday evening that his government would purchase whatever vaccine is approved by Anvisa and the Health Ministry, which could ultimately include the Sinovac vaccine.
The suspension further inflamed tensions between Bolsonaro and Sao Paulo Governor Joao Doria, who has pinned his political ambitions on the Chinese vaccine that he aims to roll out in his state as early as January, with or without federal assistance.