RIO DE JANEIRO, June 3 (Reuters) - 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.
(Reporting by Gabriel Stargardter; Editing by Lisa Shumaker)
Astrazeneca (AZN)
