Brazil suspends Sinovac COVID-19 vaccine trial due to adverse event

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Brazil’s health regulator has suspended a clinical trial for China’s Sinovac coronavirus vaccine citing a serious adverse event, surprising trial organizers who countered that there had been one death but that it was not related to the vaccine.

Health regulator Anvisa said on Monday that the event took place on October 29 but did not say whether the incident took place in Brazil or in another country. He also gave no indication of the length of the suspension of the late grand trial.

Dimas Covas, the head of the Sao Paulo Butantan medical research institute that is leading the trial, said the decision was linked to a death, but added that he found the regulator’s announcement strange “because it is a death unrelated to the vaccine. “

“As there are more than 10,000 volunteers at the moment, deaths can occur … It is a death unrelated to the vaccine and as such now is not the time to stop the trials, “Covas told local television station Cultura.

Butantan plans to hold a press conference on Tuesday at 11 a.m. local time (2 p.m. GMT).

Sinovac did not immediately respond to requests for comment.

The Sinovac vaccine has been criticized by Brazilian President Jair Bolsonaro, who dismissed it as lacking in credibility. Bolsonaro, who regularly expresses anti-Chinese sentiment, previously said the federal government would not buy the vaccine.

Earlier Monday, he appeared to reverse those comments, saying the government would buy all vaccines approved by the Department of Health and regulator Anvisa.

Bolsonaro’s stance, however, established a clear political battle line with Sao Paulo Governor Joao Doria who said his state would import and produce the vaccine.

Doria, who is expected to challenge Bolsonaro in the next presidential election in 2022, said a public vaccination program in Sao Paulo with the Sinovac vaccine would likely be rolled out as early as January.

It is not uncommon for clinical trials to be temporarily suspended after a volunteer has fallen ill so that trial organizers can check if this is related to the drug being tested.

Sinovac’s vaccine is one of three experimental COVID-19 vaccines that China is using to inoculate hundreds of thousands of people under an emergency use program. A Chinese health official said on October 20 that serious side effects had not been seen in clinical trials.

The trial in Brazil was the first of Sinovac’s major end-stage trials to start. Advanced stage trials are also being conducted in Indonesia and Turkey. Indonesian state-owned company Bio Farma said on Tuesday its Sinovac vaccine trials “were going smoothly.”

Brazil has seen more than 160,000 people die from COVID-19 and has more than 5.6 million confirmed cases.



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