Brazil's health regulator allows resumption of Chinese vaccine trial
13 November, 2020
Brazill health regulator Anvisa on Wednesday (Nov 11) allowed resumption of late-stage clinical trials for China's Sinovac COVID-19 vaccine, which have been suspended because of the death of a report subject that was registered in Sao Paulo as a suicide.
Brazil's President Jair Bolsonaro, a longtime China skeptic who has baselessly dismissed the Sinovac vaccine as without credibility, had hailed Monday's suspension as a personal victory.
Your choice was severely criticised by the trial organisers, who said the move had taken them by surprise and that there had been no need to stop the analysis as the death had no relation to the 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 soon as January, with or without federal assistance.
Anvisa, in its statement on Wednesday, said the original information it received about the case, which resulted in the suspension, have been incomplete and lacked the reason for the "severe adverse event." It has strongly dismissed ideas the decision might have been politically motivated.
"After evaluating the brand new data presented by the sponsor ... Anvisa understands that it has sufficient reasons to permit the resumption of vaccination," the agency said.
"It is vital to clarify a suspension does not indicate that the merchandise under investigation does not offer quality, safety or efficacy," Anvisa added.
Brazil has one of the world's worst COVID-19 outbreaks, with over 5.7 million confirmed cases and 163,000 deaths related to the virus. Bolsonaro has come under fire for his frequent dismissal of the virus and its dangers.
On Tuesday, Bolsonaro said Brazilians "must stop being sissies" about the virus, adding "we all have been going to die 1 day."
Source: