A box of China’s Sinovac is held during a news conference at Instituto Butantan in Sao Paulo. File/Reuters

Gulf Today Report

Chinese Sinovac Biotech pharmaceutical firm on Tuesday stood by the safety of its coronavirus vaccine, CoronaVac, after Brazil's health regulator has suspended a clinical trial. A severe adverse event, surprising the trial organisers who countered there had been a death but it was unrelated to the vaccine.

The setback for CoronaVac came on Monday as US pharmaceutical giant Pfizer said its own vaccine candidate had shown 90 per cent effectiveness — sending global markets soaring and raising hopes of an end to the pandemic.

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The Brazilian regulator Anvisa said it had "ruled to interrupt the clinical study of the vaccine after a serious adverse incident" involving a volunteer recipient on October 29.”

It said it could not give details on what happened because of privacy regulations, but that such incidents included death, potentially fatal side effects, serious disability, hospitalisation, birth defects and other "clinically significant events."

Brazil's health regulator has suspended a clinical trial for coronavirus vaccine.

"We are confident in the safety of the vaccine," Sinovac said in a statement, adding that the adverse incident was "unrelated to the vaccine.”

The health regulator, Anvisa, said the event occurred on Oct. 29 but did not specify if it took place in Brazil or in another country. It also did not give an indication of how long the suspension might last.

According to the media reports, CoronaVac has been caught up in a messy political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a top opponent of far-right President Jair Bolsonaro.

The Sao Paulo state government said in a statement it "regrets that it learned of the decision from the press, instead of directly from Anvisa," and was waiting along with the Butantan Institute for more information on "the real reasons for the suspension."

The trial is one of three large late-stage trials underway for the Sinovac vaccine. The vaccine has, however, faced controversy in Brazil with President Jair Bolsonaro dismissing it as lacking credibility.

The setback to Sinovac's efforts contrasts with good news from Pfizer Inc which said its experimental COVID-19 vaccine is more than 90 per cent effective based on initial trial results.

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