After serious adverse effects were reported, Brazil halted the late-stage trial of a Chinese coronavirus vaccine, Bloomberg reported Wednesday.
The Brazil Health Agency said Tuesday that the trial of Sinovac Biotech Ldt’s vaccine, called Coronavac, was interrupted after an incident occurred Oct. 29, Bloomberg reported. The health agency declined to give more information about the incident but said that the trial was paused in compliance with regulation while the agency decides if it should continue.
BREAKING: The trial of Chinese Covid-19 vaccine Coronavac has been halted by Brazil, citing a serious adverse event. China has already given the vaccine to people. https://t.co/MXIYuL8inJ pic.twitter.com/GKqMnjjpCE
— Bloomberg (@business) November 10, 2020
A Brazilian research center partnered with Sinovac, Sao Paulo’s Instituto Butantan, said that they would investigate what happened and indicated that they were surprised by the news, Bloomberg reported. One of the volunteers participating in the trial has died, but their death is unrelated to the vaccine, Director Dimas Covas said. (RELATED: Stocks Skyrocket Amid Potential COVID-19 Vaccine News)
AstraZeneca Plc and Johnson & Johnson also had to pause their trials recently due to serious adverse effects. Both trials were resumed following an investigation, Bloomberg reported.
A “serious adverse effect” could include death, immediate risk of death, incapacitation or hospitalization, according to Bloomberg.
Under an emergency order, China has already issued vaccines, including Coronavac, to hundreds of thousands of people, according to Bloomberg.
“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,” Sinovac said on their website. “The clinical study in Brazil is strictly carried out in accordance with GCP requirements and we are confident in the safety of the vaccine.”
Brazilian president Jair Bolsonaro criticized China, claiming that “due to its origin” people wouldn’t feel safe with a Chinese vaccine. China lacks credibility to come up with solutions to help the coronavirus pandemic, Bolsonaro said according to the report.
China dismissed the criticisms. China’s Foreign Ministry said that China and Brazil have “sound cooperation on epidemic control.”
Pfizer Inc. and BioNTech SE both released data showing that in a trial of tens of thousands of volunteers, their vaccine prevented 90% of coronavirus cases, raising hopes that a vaccine could be developed quickly.
