Beijing, Nov 10 (efe-epa).- Chinese pharmaceutical company Sinovac on Tuesday said it was confident that its candidate Covid-19 vaccine was safe after late-stage clinical trials in Brazil were halted due to a “serious adverse event.”
Brazil’s national health monitor Anvisa on Monday announced the temporary suspension of the phase 3 trials of Coronavac, which are being carried out in collaboration with the Butantan Institute in Sao Paulo.
Sinovac responded to the news with a statement on Tuesday, saying: “After communicating with the Brazilian partner Butantan Institute, we learned the head of Butantan Institute believed that this serious adverse event (SAE) is not related to the vaccine.”
“The clinical study in Brazil is strictly carried out in accordance with GCP (good clinical practice) requirements and we are confident in the safety of the vaccine.”
Anvisa on Monday said it had decided to halt the trials to evaluate the “data observed so far and judge the risk/benefit of continuing the study.”
It did not detail the nature of the “serious adverse event,” which it said took place on 29 October, due to confidentiality rules.
Anvisa added that the interruption of the clinical trials, which involve some 9,000 volunteers in the South American country, was part of standard procedure.
No-one will receive a dose of Coronavac in Brazil until the process has been cleared to resume.
Coronavac is in phase 3 trials in China, Brazil, Turkey, Bangladesh and Indonesia.
Phase 3 is the last stage before a manufacturer can apply for regulatory approval.