Trial of Oxford Covid-19 Vaccine approved by Brazilian Health Regulatory Agency

On 2nd June, Brazil has been included in clinical trials being conducted by Oxford University, supported by AstraZeneca.

The Brazilian Health Regulatory Agency approved Brazil’s inclusion in the trials which will see 2,000 volunteers tested in the country.

On 30th April, 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.

Phase I and II clinical trials of the Oxford vaccine began in April to assess safety and immune response in over 1,000 healthy volunteers aged 18 to 55.

Following the first two phases, phase III will see a larger population being enrolled; 10,000 participants in the UK with AstraZeneca enrolling 30,000 in the US.

In addition, 2,000 volunteers will be enrolled in Brazil.

Lily Yin Weckx, coordinator of the Reference Center for Special Immunobiologicals (CRIE) at the Federal University of Sao Paulo Unifesp said:

“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.”

Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University said:

“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.”

The University of Oxford state that they are working with AstraZeneca to make the vaccine ‘accessible around the world in an equitable manner’.

They also state that the vaccine will be ‘available on a not-for-profit basis during the pandemic’.

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.