Health authorities in Brazil have allowed medical institute Butantan to resume its late-stage clinical trials for China’s Sinovac Covid-19 vaccine. The trials had been suspended due to a study subject’s death.
The case was registered in Sao Paulo as a suicide, and Brazil’s health regulator, Anvisa, said late Wednesday that the initial information was incomplete and lacked the cause of the “severe adverse event.”
The regulator dismissed suggestions that the suspension of trials of CoronaVac, which is being developed by Chinese pharmaceutical firm Sinovac Biotech, could have been politically motivated. There are sufficient reasons to allow the resumption, it said. “A suspension does not necessarily mean that the product under investigation does not offer quality, safety or efficacy,” Anvisa stressed.
The suspended trial was one of Sinovac’s three large late-stage studies, and their organizers hailed the “timely resumption” of the clinical studies. “We are confident in the safety of the vaccine,” Sinovac added.
China critic President Jair Bolsonaro hailed the suspension of trials on Monday, but said later on Wednesday that his country would purchase whatever vaccine is approved by the Health Ministry and Anvisa, and it could include the Sinovac vaccine.
The resumption of trials could also appease Sao Paulo Governor Joao Doria, who plans to roll out the Chinese vaccine in his state as early as January, even without assistance from federal authorities.
Brazil has over 5.7 million confirmed coronavirus cases and 163,000 deaths.
Anvisa’s initial decision to suspend the CoronaVac trials on Monday was seen as a setback for the Chinese firm as it came on the same day US pharmaceutical company Pfizer said its own vaccine candidate had shown 90 percent effectiveness during trials.
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