Brazil allows resumption of Chinese coronavirus vaccine trial
Nov 12, 2020
Ankara [Turkey], November 12 : Brazil's health regulator Anvisa on Wednesday (local time) announced the resumption of clinical trials of China's Sinovac COVID-19 vaccine.
Quoting the latest official statement issued by Anvisa, Anadolu agency's said, "After evaluating the new data presented by the sponsor ... Anvisa understands that it has sufficient reasons to allow the resumption of vaccination."
"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 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 statement further read.
This comes days after the trial was suspended following " a severe incident".
In its earlier statement, the company had referred to the "incident", that occurred on October 29, without revealing further information.
"National Health Surveillance Agency ANVISA has temporarily suspended human testing of the Chinese vaccine Coronavac due to 'a serious adverse effect,'" Sputnik reported, citing Anvisa's statement.
Both the Sinovac and Pfizer vaccines are in the final stage of testing before regulatory approval.
