China’s Sinovac coronavirus vaccine trial suspended in Brazil after participant dies

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Brazil is one of the countries in which China is testing its vaccine – REUTERS

Brazil has suspended clinical trials for China’s coronavirus vaccine after a participant died.

Instituto Butantan, the research centre in Sao Paulo developing the vaccine in partnership with Sinovac, a private Chinese firm, said it was surprised by the decision. 

Dimas Covas, director of the institute, told Brazilian media that a study volunteer had died, though the death was not linked to ongoing trials. 

“As there are more than 10,000 volunteers at this moment, deaths can occur,” said Mr Covas. “It’s a death that has no relation with the vaccine and as such it is not the moment to interrupt the trials.” 

Brazil’s health regulator Anvisa said in a statement late on Monday that an “adverse, serious event” had occurred on Oct 29, but it didn’t say there had been a death. Nor did it elaborate on what happened or why it was revealing this more than a week later. 

Vaccine studies have been suspended in recent months after serious adverse events to allow experts to investigate. Suspensions have impacted vaccines jointly developed by AstraZeneca and the University of Oxford, and another by American firm Johnson & Johnson, though trials later resumed after scientists deemed it safe to continue. 

In Brazil, the second hardest-hit by the pandemic with more than 160,000 deaths, access to the coronavirus vaccine has been politicised by a rivalry between president Jair Bolsonaro and Sao Paulo state governor Joao Doria. 

Mr Doria is expected to challenge Mr Bolsonaro for office in 2022 elections, and has supported development of the Sinovac vaccine, vowing to inoculate all residents of his state as early as March next year. 

Earlier on Monday before Anvisa announced the trial suspension, Mr Doria said that workers had broken ground on a facility that will produce 100 million doses annually of the Sinovac vaccine. Sao Paulo will import 120,000 doses of the vaccine, expected to arrive Nov. 20.

Butantan, the Brazilian institute partnering with Sinovac, is also supported by the state of Sao Paulo. 

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The decision to hold the trial in Sao Paulo sparked protests – REUTERS

Mr Bolsonaro has instead supported the Oxford-AstraZeneca vaccine, pledging in August to set aside 1.9 billion Brazilian real (£267.5 million) to purchase and produce those doses when they become available.

In October, he announced that Brazil would not buy the Sinovac vaccine just one day after health minister Eduardo Pazuello said the Chinese firm’s vaccine would be included in the national immunisation programme.

Sinovac’s vaccine has already been widely used in China, even before clinical trials conclude as part of a government emergency programme. 

Hundreds of thousands have been inoculated, raising concern among experts that the health and safety risks of vaccines administered outside of clinical trials would be challenging to document. 

These worries have been heightened as vaccine development – a process that normally would take years – has been squeezed into months as countries seek to contain a pandemic that has infected more than 50 million globally. 

Sinovac, headquartered in Beijing, has insisted its two-shot coronavirus vaccine is indeed effective and safe and that there have been no significant adverse events. Outside of Brazil, Sinovac is also being trialled in Turkey and Indonesia.

On Tuesday, a spokesman for Indonesia’s state-owned firm, BioFarma, said that trials were “going smoothly” and that there were no plans to cancel them after the Brazil suspension.

Chinese vaccine developers have been pushing forward in hopes of winning the global race to immunise the public against the coronavirus – a move, if successful, that would help Beijing deflect public anger against its cover-up of the pandemic. China has four vaccines in late-state human trials, more than any other country in the world. 

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Cuomo COVID-19 vaccine comments ‘unconscionable’: HHS Secretary Azar

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WASHINGTON — Health and Human Services Secretary Alex Azar on Monday called New York Gov. Andrew Cuomo’s threats to block the distribution of a COVID-19 vaccine in the Empire State “absolutely unconscionable.”

In an interview with Fox News on Monday morning, Azar also said that it was Cuomo, not President Trump, who was in charge of distributing the vaccine in New York.

“It’s just absolutely unconscionable that somebody would want to delay a vaccine to the American people that’s safe and effective just for political partisan reasons,” Azar said after Cuomo earlier Monday called a Pfizer breakthrough on a vaccine “bad news.”

“Here’s the really interesting thing, Operation Warp Speed is working very closely with Gov Cuomo’s Health Commissioner, Dr. Howard Zucker and his team, because guess who’s actually in charge of distributing within any state? The governor is,” Azar continued.

In an interview with “Good Morning America” on Monday morning, Cuomo blasted Trump’s vaccine plan as “flawed” and went so far as to declare: “We can’t let this vaccination plan go forward the way that Trump and his administration is designing it.”

“The bad news is that it’s about two months before Joe Biden takes over, and this means [the Trump] administration is going to be implementing a vaccine plan,” Cuomo said.

Medical giant Pfizer announced overnight that their COVID-19 vaccine is more than 90 percent effective at fighting the infection, a major milestone in the global fight against the pandemic.

But Cuomo has repeatedly threatened to slow-roll the distribution of any vaccine developed under a Trump administration, claiming the process was “politicized” and vowing to create a review board to double check any federally approved treatment.

While Pfizer has signed on to Operation Ward Speed, the Trump administration’s plan to fast track delivery of a COVID-19 vaccine, the company did not take any money from the federal pot to help pay for research and development.

Responding to Cuomo’s latest remarks that Trump’s distribution plan was “flawed,” Azar suggested that Cuomo was out of touch with his own health experts.

Andrew CuomoGetty Images

“His team is doing a really good job of working with us and his team can set up a distribution system and a prioritization within their state,” Azar said.

When asked if other governors were trying to stop distribution under this president, the HHS secretary said Cuomo was alone.

“No, the other governors that we’re working with are excited and they want to be in charge of the distribution,” Azar said.

“Does that include Cuomo?” asked anchor Sandra Smith.

“Well, it includes his staff,” retorted Azar. “He ought to talk to them and learn what their plans are.”

A spokesman for Cuomo did not immediately return a request for comment.

Trump, who shares an acrimonious relationship with the governor, unloaded on Cuomo in September, calling him a “lowlife,” and said the vaccine had been developed by the “finest labs in the world.”

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