Health regulator allows resumption of late-stage Brazilian clinical trials which were suspended after a study subject’s death.
Brazil health regulator Anvisa has allowed the resumption of late-stage Brazilian clinical trials for China’s Sinovac COVID-19 vaccine, which had been suspended after a study subject’s death, which had been registered in Sao Paulo as a suicide.
The decision to suspend the trial – one of Sinovac’s three large late-stage studies – was criticised by its organisers, who said the move had surprised them and there had been no need to stop the study as the death had no relation to the vaccine.
Brazilian medical institute Butantan said in a statement on Wednesday that it would restart the trials.
Brazil’s president, Jair Bolsonaro, a longtime China critic who dismissed – without evidence – the Sinovac vaccine as lacking credibility, had hailed Monday’s suspension as a personal victory.
Bolsonaro reiterated, however, 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, if approved.
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.
Anvisa, in its statement on Wednesday, said the initial information it received about the case, which led to the suspension, had been incomplete and lacked the cause of the “severe adverse event”. It dismissed suggestions the decision could have been politically motivated.
“After evaluating the new data presented by the sponsor … Anvisa understands that it has sufficient reasons to allow 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,” Anvisa added.
Sinovac, in a statement, said: “We are confident in the safety of the vaccine, fully understand and appreciate Anvisa’s strict supervision and timely resumption of the clinical studies.”
Brazil has one of the world’s worst COVID-19 outbreaks, with more than 5.7 million confirmed cases and 163,000 deaths.
Bolsonaro has come under fire for his constant dismissal of the virus and its dangers.
On Tuesday, he said Brazilians “must stop being sissies” about the virus, adding: “We are all going to die one day.”