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In a statement, the National Health Surveillance Agency (Anvisa) reported that it decided to stop the clinical trial of the Coronavac vaccine “after the occurrence of a serious adverse event” on October 29.
Anvisa did not provide further information on the incident, referring only to the fact that the category of “adverse event” may include death, potentially fatal side effects, persistent or significant disability or disability, hospitalization or other “clinically significant event”.
“With the discontinuation of the study, new volunteers will not be able to be vaccinated,” the agency said, adding that it will “evaluate the data observed so far and judge the risk / benefit of continuing” the tests.
The suspension of Coronavac’s clinical trials, involving 9,000 volunteers, came a day after US pharmaceutical giant Pfizer announced that its COVID-19 vaccine was 90% effective in tests.
The candidate vaccines from Pfizer and Sinovac are in phase 3 trials, the last phase before receiving regulatory approval.
Both are being tested in Brazil, the second most affected country by the pandemic, with more than 162,000 deaths.
Coronavac, which is also being tested in China, Turkey, Bangladesh and Indonesia, has been the subject of a political battle in Brazil between one of its biggest supporters, São Paulo Governor João Doria, and its main political opponent, President Jair Bolsonaro, who in October prohibited its purchase.
The head of state referred to the Sinovac vaccine as coming from “that other country” and instead promoted the vaccine developed by the University of Oxford with the British pharmaceutical company AstraZeneca.
The Government of São Paulo teamed up with Sinovac to coordinate the last phase of clinical trials in Brazilian territory and signed a contract that included the acquisition and distribution of 46 million doses of the vaccine.
Bolsonaro, who is skeptical about the seriousness of the pandemic and declares himself anti-communist, also determined that vaccination against covid-19, which has already caused almost 156,000 deaths and more than 5.3 million infected in Brazil, will not be mandatory . .
The whole situation generated a strong controversy in the country and turned the distribution of the future vaccine into a highly politicized battle between the so-called “Bolsonarismo” and the opposition, both conservative and left.
