Brazil suspended trials for one of China's coronavirus vaccines after someone died, but researchers say the death was not related to the drug
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Bill Bostock
Nov 10, 2020, 16:59 IST
A Sinovac employee manually inspects syringes of its COVID-19 vaccine candidate at its factory in Beijing on September 24, 2020.Ng Han Guan/Associated Press
Brazil paused its clinical trials of Sinovac's coronavirus vaccine candidate on Monday, following a death.
Brazil's Butantan medical research institute has been working with the Chinese private biotech on clinical trials of its vaccine in São Paolo since July.
But Anvisa, Brazil's health regulator, said on Monday that a "serious adverse event" occured on October 29 and that the trial was now suspended.
Buntantan director Dimas Covas said a death had taken place, but that it was unrelated to the vaccine, Reuters reported. Sinovac said on Tuesday it was "confident in the safety of the vaccine."
The news of the trial suspension came hours after Pfizer announced that its rival trial vaccine, developed with BioNTech, had 90% efficacy.
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Brazil suspended clinical trials of one of China's coronavirus vaccines on Monday, following a death that researchers said was unrelated to the drug.
The government's Butantan Institute, based in São Paulo, has been conducting clinical trials for Sinovac using its prototype vaccine since July 3.
But in a statement released on Monday, Anvisa, the Brazilian health regulator, said that a "serious adverse event" occured on October 29, and that the trial had been suspended.
Dimas Covas, the director of the Butantan Institute, told local network TV Cultura that a death had occured, but that it was unrelated to the vaccine, according to Reuters.
"As there are more than 10,000 volunteers at this moment, deaths can occur ... It's a death that has no relation with the vaccine and as such it is not the moment to interrupt the trials," he said.
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Anvisa said it would not release any more information about the death.
"Data on clinical research volunteers must be kept confidential, in accordance with principles of confidentiality, human dignity and protection of participants," it said.
"With the study interrupted, no new volunteers can be vaccinated."
"We learned the head of Butantan Institute believed that this serious adverse event (SAE) is not related to the vaccine," it said.
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"We are confident in the safety of the vaccine."
The Butantan Institute is to hold a press conference at 11 a.m. local time (9 a.m. ET) on Tuesday, according to the BBC.
The news of the trial suspension came hours after Pfizer announced that its rival trial COVID-19 vaccine, developed in partnership with BioNTech, announced it had 90% efficacy.
A representative for the Oxford Vaccine Group, which is developing the vaccine with AstraZeneca, told Business Insider at the time it would continue the trials because there were "no concerns about safety."
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