Volunteers in Brazil have begun receiving a trial vaccine against COVID-19, in Latin America’s first phase 3 COVID-19 clinical trial. The trial officially began on Saturday 20th June and will enrol 5,000 volunteers across the country. Vaccinations will take place in Sao Paulo, Rio de Janeiro and a site in the Northeast of Brazil.
The Brazilian Health Regulatory Agency (ANVISA) approved the inclusion of Brazil in the clinical trials on 2nd June, which are being conducted in partnership with AstraZeneca. The trial is being sponsored entirely by Brazilian entrepreneurs.
Professor Sue Ann Costa Clemens, investigator and study coordinator from UNIFESP, said: ‘It is an honour for me, as investigator and for my country to be selected to support the clinical development of this candidate vaccine and help the world to face a global challenge. This study has contributed to a major achievement in public health already, as the Brazilian Ministry of Health signed on June 27, an agreement for local production of ChAdOx1 nCoV-19 with AstraZeneca Brazil.’
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University said: ‘It is a privilege to be working with the researchers at the Federal University of São Paulo – UNIFESP on the first COVID-19 vaccine trial in Latin America in the next stage of this important trial.
‘The global coronavirus pandemic still presents an unprecedented threat to human health worldwide, but equally unprecedented is the impressive way researchers and scientists around the world have been able to collaborate on the clinical development work to combat this threat.’
The Federal University of São Paulo – UNIFESP is collaborating with the University of Oxford and the Oxford Vaccine Group on the Brazil trial. The Brazilian Ox1Cov-19 Vaccine Trial aims to find a vaccine that will prevent infection by SARS-CoV-2, the virus that causes COVID-19. The technical name of the vaccine is ChAdOx1 nCoV-19, as it is made from a virus called ChAdOx1, which is a weakened and non-replicating version of a common cold virus (adenovirus). The vaccine has been engineered to express the SARS-CoV-2 spike protein.
The vaccine was developed at the University of Oxford’s Oxford Jenner Institute and is currently on trial in the UK, where over 4,000 participants are already enrolled into the clinical trial and enrolment of an additional 10, 000 participants is planned.
AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020.
With today’s agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe.
AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The Company is seeking to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support access to the vaccine at no profit during the pandemic.