RIO DE JANEIRO (AFP, REUTERS) – Brazil’s health regulator said on Monday (Nov 9) it had suspended clinical trials of a Chinese-developed Covid-19 vaccine after an “adverse incident” involving a volunteer recipient, a blow for one of the most advanced vaccine candidates.
The setback for CoronaVac, developed by Chinese pharmaceutical firm Sinovac Biotech, came on the same day 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.
The regulator, Anvisa, said in a statement it had “ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident” on Oct 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”.
However, Sao Paulo’s medical research institute Butantan, which is conducting the Sinovac trials in Brazil, said it “was surprised” by the decision and would hold a news conference on Tuesday at 11am local time (10pm Singapore time on Tuesday).
The head of Butantan, Dr Dimas Covas, speaking to local broadcaster TV Cultura, said the decision was related to a “death” but said he found the regulator announcement strange “because it’s a death unrelated to the vaccine.”
“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,” Mr Covas said.
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.
Mr Bolsonaro has labelled CoronaVac the vaccine from “that other country,” and pushed instead for a rival vaccine developed by Oxford University and pharmaceutical firm AstraZeneca.
Last month, Mr Bolsonaro shot down a plan by his own health minister to buy 46 million doses of CoronaVac, saying, “The Brazilian people will not be anyone’s guinea pig” and referring to it as “Joao Doria’s Chinese vaccine.”
Mr Doria announced earlier Monday that the first 120,000 doses of CoronaVac would arrive in Sao Paulo on Nov 20.
His state has a deal with Sinovac to buy a total of 46 million doses – six million produced in China and the remainder produced in Sao Paulo, which broke ground last week on a factory to produce the vaccine domestically.
“Officials in the state government fear Bolsonaro will use technical decisions to delay the timeline of the vaccine for political reasons,” newspaper Folha de Sao Paulo reported, citing unnamed Mr Doria allies.
Anvisa did not immediately respond to a request for comment from AFP.
The Sinovac, Pfizer and Oxford vaccines are all in Phase III trials, the final stage of testing before regulatory approval.
And all are being tested in Brazil, the country with the second-highest death toll in the pandemic, after the United States, with more than 162,000 people killed by the new coronavirus.
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