Brazil's Sau Paulo to roll out China's CoronaVac without Federal regulators 'approval'

The Brazilian state of Sao Paulo could roll out China’s Sinovac COVID-19 vaccine without approval from the national health regulators, Governor João Doria mentioned in a televised interview on November 23. In a video address on the website metropoles, Doria said that China’s Sinovac experimental candidate will be approved by the state to inoculate the population if it gets approved by authorities "in the US, in Europe and, above all, in Asia." According to NASDAQ, the federal health regulator Anvisa has been under threat and political interference from critics of Brazilian President Jair Bolsonaro. 

Last week, the Brazil health regulator Anvisa was pressurized for resumption of late-stage Brazilian clinical trials for China’s Sinovac COVID-19 vaccine. The human phased clinical trials were halted after the death of a voulnteer, which was registered by the health authorities in Sao Paulo as a suicide. The health ministers ruled out the ‘Serious Adverse Event’ (SAE). While there are non-serious adverse events and Serious Adverse Events (SAEs) with respect to clinical trials according to the Clinical and Translational Science Institute, both, or either create obstructions with respect to safety and efficacy of the tested product, according to the federal guidelines. However, the suspension of the trials was condemned by the Bolsonaro administration as they pressed on the researchers to resume the trials dismissing the relation of the death to the vaccine. 

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Federal regulatory approval 'this week'

Meanwhile, according to a Fidelity report, Brazil's Sao Paulo state expects a federal regulatory approval for China's COVID-19 vaccine latest by the end of this week. Governor Doria touted that as many as 9000 volunteers have already been registered to test the vaccine CoronaVac, and the Brazilian government will start the national inoculation program by June 2021. Sao Paulo, the epicenter of the COVID-19 pandemic has been one of the hardest-hit in Brazil and is one of six states participating in the clinical trials of CoronaVac developed by pharmaceutical firm Sinovac Biotech.

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