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SAO PAULO / BEIJING (Nov 10): Brazil’s health regulator suspended a clinical trial for China’s Sinovac coronavirus vaccine citing a serious adverse event, surprising trial organizers who responded that there had been one death, but It was not related to the vaccine.
Health regulator Anvisa said on Monday the event took place on October 29, but did not specify whether the incident occurred in Brazil or another country. He also did not give an indication of how long the suspension of the grand, last-stage trial could last.
Dimas Covas, director of the Sao Paulo medical research institute, Butantan, which is conducting the trial, said the decision was related to a death, but added that he found the regulator’s announcement strange “because it is a death not related to the vaccine”.
“As there are more than 10,000 volunteers at this time, deaths can occur … it is a death that is not related to the vaccine and as such it is not the time to interrupt the trials,” Covas told local station TV Cultura .
Butantan plans to hold a press conference on Tuesday at 11 am local time (1400 GMT).
Sinovac did not immediately respond to requests for comment.
The Sinovac vaccine has been criticized by Brazilian President Jair Bolsonaro, who has dismissed it for lacking credibility. Bolsonaro, who regularly expresses anti-Chinese sentiment, has previously said that the federal government will not buy the vaccine.
Earlier Monday, he appeared to refute those comments, saying the government would buy any vaccine that was approved by the Health Ministry and regulator Anvisa.
However, Bolsonaro’s stance has marked a clear political battle line with Sao Paulo Governor Joao Doria, who has said that his state will import and produce the vaccine.
Doria, who is expected to challenge Bolsonaro in the upcoming 2022 presidential elections, said that a public inoculation program in Sao Paulo with the Sinovac vaccine would likely be implemented in January.
It is not uncommon for clinical trials to be temporarily suspended after a volunteer becomes ill so that the trial organizers can check whether it is related to the drug being tested.
Sinovac’s vaccine is among three Covid-19 experimental vaccines that China has been using to inoculate hundreds of thousands of people under an emergency use program. A Chinese health official said on October 20 that no serious side effects have been observed in clinical trials.
The Brazil trial was the first of Sinovac’s big late-stage trials to get under way. Late-stage trials are also underway in Indonesia and Turkey. Indonesia’s state-owned company Bio Farma said Tuesday that the Sinovac vaccine trials “were going smoothly.”
Brazil has seen more than 160,000 people die from Covid-19 and has had more than 5.6 million confirmed cases.
Read also:
Indonesia’s Bio Farma Says China’s Sinovac Covid-19 Vaccine Trials ‘Going Smoothly’
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