Brazil health regulator approves clinical trials of Oxford COVID-19 vaccine

Reuters , Wednesday 3 Jun 2020

Brazil's health regulator Anvisa has approved human clinical trials for a potential coronavirus vaccine developed by scientists at Oxford University and supported by AstraZeneca Plc, it said on Wednesday.

With COVID-19 epidemics in Britain, mainland Europe and the United States coming down from their peak and transmission rates of the coronavirus dropping, scientists have turned to places like Brazil, where the disease is still rife, to test potential vaccines.

The Oxford University vaccine, supported by AstraZeneca, is among the first COVID-19 vaccines to move into Phase II, or mid-stage, trials, along with one from the U.S. biotech company Moderna Inc. To speed up development, researchers are carrying out at the same time both Phase II and Phase III trials, which involve a broader age group.

"This is a randomized controlled phase III study to determine the safety, efficacy ... of the non-replicating ChAdOx1 nCoV-19 vaccine," Anvisa said in a statement announcing the approval of the clinical tests.

"Initial non-clinical studies in animals and phase I clinical studies in humans to evaluate the safety of the vaccine were carried out in England and the results demonstrated that its safety profile was acceptable."

In a separate statement, the Federal University of Sao Paulo said it would be involved in the trial, which would recruit 2,000 volunteers. The Lemann Foundation would cover the costs of the medical infrastructure and equipment, the university said.

The Federal University of Sao Paulo said it would recruit 1,000 front-line COVID-19 volunteers who had not contracted the disease. It was unclear if other universities or research institutions in Brazil were also involved.

Brazil's Health Ministry did not immediately respond to a request for comment.

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