Brazilian Health Regulatory Agency approves trial of Oxford COVID-19 Vaccine
On 2 June, the Brazilian Health Regulatory Agency (ANVISA) approved the inclusion of Brazil in the clinical trials conducted by Oxford University and supported by AstraZeneca, considering 2,000 volunteers to be tested in the country.
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On April 30, the University of Oxford and AstraZeneca announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.
A Phase I/II clinical trial of the Oxford vaccine began in April in the UK to assess safety and immune response in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. As the vaccine trials move to Phase III a larger population is being enrolled consisting of 10,000 participants in the UK with AstraZeneca enrolling 30,000 particpants in the US. On 2 June, the Brazilian Health Regulatory Agency (ANVISA) approved the inclusion of Brazil in the clinical trials conducted by Oxford University and supported by AstraZeneca, considering 2,000 volunteers to be tested in the country.
“The most important thing is to carry out this stage of the study now, when the epidemiological curve is still rising and the results may be more assertive,” said Lily Yin Weckx, coordinator of the Reference Center for Special Immunobiologicals (CRIE) at the Federal University of Sao Paulo Unifesp.
“We are delighted to be working with the talented team of investigators in Brazil on the COVID19 vaccine trial, as researchers and scientists around the world collaborate on clinical development work with unprecedented urgency to combat the global threat to human health that is coronavirus.” Says Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University.
Although the university is advancing fast on its ongoing response to address the unprecedented challenges of COVID-19, it is working with AstraZeneca to define next steps on the supply of the vaccine widely to make it accessible around the world in an equitable manner. The agreement includes a commitment to make the vaccine available on a not-for-profit basis during the pandemic and to ensure broad and equitable access around the world. To achieve this, Oxford University and AstraZeneca are collaborating with a number of countries and multilateral organisations, including organizations in Brazil to address local needs. Brazil is a priority for the study because of the ascendant curve of the COVID-19.
To date AstraZeneca has concluded agreements for at least 400 million doses and secured total manufacturing capacity for 1bn billion doses of the Oxford vaccine.