Brazil’s health regulator, Anvisa, announced Wednesday that it will allow trials to resume for a Chinese coronavirus vaccine candidate.
Following a setback Monday, after the death of a volunteer, Anvisa authorized the resumption of tests because the death was registered as a suicide.
The agency said the suspension decision was made when the cause of the death was not clear and information was provided Tuesday by the Butantan Institution, a biomedical center that runs the phase 3 trials.
"After evaluating the new data presented by the sponsor ... Anvisa understands that it has sufficient reasons to allow the resumption of vaccination," it said in a statement.
"It is important to clarify that a suspension does not necessarily mean that the product under investigation is not of quality, safety or efficacy," the agency said. "The suspension and resumption of clinical studies are common events in clinical research and all studies aimed at registering medicines that are authorized in the country are previously evaluated by ANVISA in order to preserve safety for the study volunteers."
The announcement came a day after President Jair Bolsonaro looked down on the danger of the virus again by saying Brazil should "stop being a country of sissies" because of the pandemic.
He said he was sorry about coronavirus deaths, but "all of us are going to die one day."Anadolu Agency website contains only a portion of the news stories offered to subscribers in the AA News Broadcasting System (HAS), and in summarized form. Please contact us for subscription options.