PBC24 Desk : South American county Brazil has postponed a late-stage trial of a Chinese vaccine. Chinese vaccine is considered to be the one of the leading vaccine to invent a cure. The authorities refused to continue its trial phase as they showed a “serious adverse” reaction in a participant’s physique.
The decision provoked a political firestorm Tuesday after President Jair Bolsonaro, who has been critical of China and spoken dismissively of its vaccine, CoronaVac, called the suspension a political victory. Instituto Butantan, the Brazilian institute assisting with the CoronaVac trial, called the suspension unwarranted, arguing that it had been triggered by the death of a trial participant, but that the death was unrelated to the vaccine.
A police report obtained by The New York Times says the participant’s death, which occurred Oct 29, is being investigated as a suicide. A senior government official for the State of São Paulo, which runs Instituto Butantan, said that fact led health experts at the institute to conclude that it did not raise red flags about the safety of the vaccine. São Paulo state, the largest in Brazil, is led by Gov João Doria, a political rival of Bolsonaro who has criticised the president’s cavalier handling of the pandemic.
Gustavo Mendes, director of pharmaceuticals at Anvisa, Brazil’s health regulatory agency, said in an interview Tuesday that regulators have yet to conclude that the volunteer’s death was unrelated to the vaccine.
“It was a precautionary measure,” he said. “Unfortunately, it’s being politicised.” He added: “Halting a study until there is more information is what is expected of a regulatory agency.”
Corona Vac, which is being developed by the Chinese company Sinovac, is one of 11 experimental vaccines, produced by some of the world’s foremost pharmaceutical companies, currently in Phase 3 trials. As the world grapples with another major wave of coronavirus infections, the race for a vaccine has intensified and been made all the more competitive by fractious geopolitics. On the same day that Brazil suspended the Sinovac trial, the American company Pfizer announced that an early analysis of its coronavirus vaccine trials suggested that its drug was more than 90% effective in preventing the virus that causes COVID-19.
Sinovac’s drug was seen in China as a leading candidate. But in Beijing’s push to get a Chinese vaccine to be the first on the global market, officials stretched the definition of “emergency use.” They have permitted tens of thousands of people to receive the Sinovac vaccine and two other locally made vaccines, despite having not yet concluded Phase 3 trials.
Adverse effects are not unusual in Phase 3 trials. AstraZeneca and Johnson & Johnson both paused their trials after several volunteers fell seriously ill, resuming them six weeks later, in October, after concluding that the illnesses were not related to the vaccines.
In a statement issued Tuesday, Sinovac said Instituto Butantan had deemed the “serious event” not related to the vaccine. The company said it was “confident in the safety” of its vaccine.
The Chinese vaccine study has inflamed a political rivalry between Bolsonaro and Doria, who is widely expected to run for president in 2022. If the vaccine is approved, it would be manufactured by the institute.