The Brazilian drug trial of the COVID-19 vaccine stopped after a “severely adverse” issue was revealed by the health officials.
The incident occurred on 29th October stated by Anvisa, the Brazilian health regulator.
The CoronaVac vaccine, formulated by Sinovac Biotech, a Chinese company, is in the final-stage testing globally.
The firm has already done trials on thousands of people in emergency usage. According to the data provided by Johns Hopkins University, Brazil stands as the third most affected country from the novel virus after the US and India. It records almost 5.6m confirmed cases and nearly 163,000 deaths.
Why did the trial stop?
Anvisa did not reveal much about the details. But she stated that it had “ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident”.
However, the drug trials are also in its last stages in Indonesia and Turkey. Whereas none of the countries neither mentioned any unfortunate happening nor the suspension in trials.
Bio-Farma, the state-owned pharmaceutical company told on Tuesday that its own Sinovac vaccine trials were “going smoothly”.
On Tuesday, Sinovac said it was speaking with Brazil regarding the tragedy that was registered.
“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.”
The interruption is not uncommon during clinical trials. Moreover, in September, after a participant had a possible adverse reaction, the UK suspended trials for another Covid-19 vaccine.