Brazil’s health regulator is facing political backlash after suspending final-stage trials of a Chinese-made coronavirus vaccine following an event that scientists involved in the study said was unrelated to the testing.
Late on Monday, Anvisa said that a CoronaVac trial of 9,000 people had been halted due to an “adverse event” on October 29. The trial was carried out jointly with São Paulo’s Butantan Institute, a biomedical research centre.
But on Tuesday the institute questioned why the trial had been halted, saying the event had no relation to the vaccine.
“It was a death, but from an external cause, with no relation to the vaccine. I repeat, a serious adverse event that is unrelated to the vaccine. This information has been available to Anvisa,” said Dimas Covas, president of the Butantan Institute.
Police are investigating the death as a suicide, according to the São Paulo public health secretary.
The development has raised questions about whether Anvisa is facing pressure from President Jair Bolsonaro, who for weeks has rallied publicly against the China-made vaccine, saying that Brazilians should not be “guinea pigs”.
Late last month, Antônio Barra, director of Anvisa, told local media there was “unpleasant and bothersome” political pressure, but that it did not affect the regulator’s work.
The decision to suspend the late-stage trials was a blow to one of Mr Bolsonaro’s key political rivals, João Doria, governor of São Paulo, who earlier on Monday said the state would import 120,000 doses of the China-made vaccine next week in anticipation of final approval from Anvisa.
Brazil’s largest and wealthiest state has also begun construction on a facility that will be able to produce 100m doses of the vaccine every year.
Following the decision by Anvisa, the Brazilian leader celebrated on social media, saying: “Another win for Bolsonaro.”
But Mr Covas, a scientist, shot back: “They suspended the study, caused uncertainty and fear and fostered an environment that is already not conducive to a vaccine made in China. And in exchange for what?”
Mr Covas added that the staff of his institute did not receive a phone call about the decision, only an email.
Flávio Dino, governor of the northern state of Maranhão, said “163,000 dead in Brazil. And Bolsonaro says he ‘won’? What is the victory? Bolsonaro remains the greatest ally of the coronavirus in our country.”
Ciro Gomes, a former presidential candidate, added: “Jail is too little for scoundrels who play politics with vaccines — which are the only way out to put an end to the biggest public and socio-economic health crisis in history.”
The announcement of the suspension of trials has also threatened to derail an effort by China to use its vaccines to strengthen ties with diplomatic partners and burnish its credentials as a provider of global public health goods.
Beijing and its leading vaccine developers have made grand promises to manufacture and deliver vaccines across the developing world, as part of a charm offensive to soothe anger over China’s early mishandling of the outbreak.
Sinovac, the group that developed the CoronaVac vaccine, has been at the forefront of China’s efforts. Its vaccine uses a chemically inactivated version of the virus to spark an immune response.
The company has been conducting phase-3, or final-stage, trials in Brazil, Indonesia and Turkey, following positive results in early-stage safety and efficacy clinical trials.
The spat in Brazil comes a day after a vaccine by US pharmaceutical company Pfizer and Germany’s BioNTech was found to be more than 90 per cent effective, raising hopes that the drug may be available by the end of the year. Brazil’s ministry of health, run by an army general close to Mr Bolsonaro, said it was in talks with Pfizer to buy their vaccine.
Hu Xijin, editor of the nationalist tabloid Global Times, wrote on Twitter: “Pfizer announced its progress on COVID-19 vaccine right after the election, this is odd. It is even weirder that trial of a Chinese COVID-19 vaccine was halted by Brazil later. I am worried that politics and excessive pursuit of economic interests are involved in vaccine R&D.”
Sinovac, alongside Chinese state-backed pharmaceutical groups Sinopharm and CanSino, which are also conducting phase-3 trials of their respective vaccines, has been forced to carry out its final tests overseas because the coronavirus outbreak has been nearly halted within China.
China has been administering experimental vaccines to its own population as part of “emergency use” efforts ahead of final-stage trials, a move that has raised ethical and safety concerns from some international public health experts.
Additional reporting by Carolina Pulice
Read more from source here…