The Brazilian clinical trial for a Chinese Covid-19 vaccine has been suspended after health authorities reported a “severe adverse” incident.
Brazilian health regulator Anvisa said the incident took place on 29 October, but did not give further details.
The CoronaVac vaccine, developed by the Chinese firm Sinovac Biotech, is one of several in final-stage testing globally.
Sinovac says it is “confident in the safety of the vaccine”.
The firm has already been using it to immunise thousands of people at home in an emergency use programme.
Brazil has been one of the countries worst affected by coronavirus, recording more than 5.6m confirmed cases – the third highest tally in the world after the US and India – and nearly 163,000 deaths so far, according to data collated by Johns Hopkins University.Why was the trial halted?
On Monday Anvisa said it had “ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident”.
It did not reveal what happened, nor where it took place. Late-stage trials for the Sinovac vaccine are also being conducted in Indonesia and Turkey, but neither of these countries have announced a suspension.
Indonesia’s state-owned Bio Farma said on Tuesday that its own Sinovac vaccine trials were “going smoothly”, according to Reuters news agency.Dimas Covas, the head of Butantan, the medical research institute conducting the Brazilian trial, told local media that the trial’s suspension was related to a death. However, he insisted that the death was not related to the vaccine, Reuters said.
Sinovac said on Tuesday that it was communicating with Brazil about the reported incident.
“We learned the head of Butantan Institute believed that this serious adverse event (SAE) is not related to the vaccine,” it said in a statement. “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.”
Butantan has said it will hold a news conference on Tuesday at 11:00 local time (14:00 GMT).
A pause in a clinical trial is not unusual. In September, the UK paused trials for another Covid-19 vaccine after a participant had a suspected adverse reaction.