Brazil is set to start this week the testing with the potential vaccine being developed by the University of Oxford, UK, against COVID-19, said the Federal University of São Paulo (Unifesp), which will participate in the study, and Brazil’s national sanitary watchdog Anvisa.
The permit to have the tests conducted in the country was published by Anvisa in an extra issue of Brazil’s Official Gazette on Tuesday (Jun. 2). Two thousand people will take part in the tests, Unifesp declared, which will also be carried out by the Health Ministry.
“The most important thing is to carry out the first phase of the study now, while the epidemiological curve is still on the rise and results may be more assertive,” said Lily Yin Weckx, coordinator at the Reference Center for Special Immunobiologicals (CRIE) of Unifesp. Lily Yin Weckx is the main scientist in the study.
For the testing phase in São Paulo, 1 thousand volunteers will be selected from those working on the front line combating COVID-19, as they are most exposed to the disease. The volunteers must not have been in contact with COVID-19.
According to Unifesp, the tests, which will be funded by Lemann Foundation, will contribute to have the vaccine registered in the UK by the end of this year, The formal registration, however, will only take place after studies are over in all participating countries, the university stated.
The request to have the tests conducted was submitted to Anvisa by AstraZeneca in Brazil, controlled by the pharmaceutical conglomerate AstraZeneca, and seeks to “determine the vaccine’s safety, effectiveness, and immunogenicity.”
“Initial, non-clinical studies on animals and clinical, stage-one studies on humans to assess the vaccine’s safety were conducted in the UK and results show that the vaccine’s safety profile was acceptable,” Anvisa declared.
As the COVID-19 pandemic in the UK, continental Europe, and the US are seen to take a downward trend after its peak and transmission rates of the coronavirus are losing steam, an important task for scientists has been to seek volunteers in places where the outbreak of the disease can still be observed.