SAO PAULO (Reuters) – The two-day suspension of a late-stage clinical trial in Brazil for a COVID-19 vaccine developed by China’s Sinovac has not impacted the study, the head of the Sao Paulo institute running the trial said on 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 criticized by the organizers, 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 and on Thursday said it would send a delegation to China between Nov. 30 and Dec. 11 to monitor production lines that make vaccine supplies. Those supplies are expected to be used by two different medical institutions in Brazil to produce the candidate vaccines developed by Sinovac and AstraZeneca.
Dimas Covas, head of the Butantan biomedical research institute, told reporters that the institute’s trust in Anvisa had not been dampened by the suspension, 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.
He denied he had celebrated the volunteer’s death on a broadcast on Facebook on Thursday. He also said, without providing any evidence, that the suicide could have been “a side effect from the vaccine.”
“It could be anything,” he said of the cause of the suicide.
But Bolsonaro’s government has said it will 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.
(Reporting by Eduardo Simoes, Ricardo Brito and Marcelo Rochabrun, writing by Stephen Eisenhammer, Editing by Rosalba O’Brien)
