Published 18:47 IST, November 12th 2020
Brazil allows China's COVID-19 vaccine trials to resume after ‘serious adverse event’
Brazil’s health regulator Anvisa has allowed the resumption of China’s COVID-19 vaccine trial in the country. The trials for the drugs were supended on Nov 9.
Brazil’s health regulator Anvisa has allowed the resumption of China’s COVID-19 vaccine trial in the country. The trials for Sinovac Biotech produced drugs were halted on November 9 after one of the patients died. However, it was found that the death wasn’t related to the vaccine but was a case of suicide by the subject.
The decision to suspend trials was highly criticized with many dubbing it to be politically motivated. The move also attracted flak from the organizers of the trial who claimed that they were surprised because the death was not related to the vaccine. The Beijing based pharma company is currently in the late trial stage of its vaccine candidate.
In a public statement, issued late on November 11, Anvisa, stated the initial information it received about the case, which led to the suspension, had been incomplete and lacked the cause of the severe adverse event. “After evaluating the new data presented by the sponsor … Anvisa understands that it has sufficient reasons to allow the resumption of vaccination,” the agency added. In addition, it also clarified that a suspension did not necessarily mean that the product under investigation does not offer quality, safety or efficacy.
'We are confident'
"We are confident in the safety of the vaccine, fully understand and appreciate Anvisa's strict supervision and timely resumption of the clinical studies. We believe a vaccine with good safety and efficacy profile can be supplied only if the clinical studies are conducted in accordance with the highest standards. We look forward to completing the following clinical research as soon as possible under the strict governance and monitoring by Anvisa, and finally control the pandemic through vaccination", wrote Sinovac on its website hailing the decision.
In contrast, the suspension was hailed as a personal victory by the Brazilian President Jair Bolsonaro. A Staunch critic of China, Bolsonaro has many times discredited the Chinese vaccine without providing any evidence. Meanwhile, the total cases in Brazil have cross 5.7 million and 163,000 have died since the outbreak.
Updated 18:46 IST, November 12th 2020