The volunteer who tragically died in a trial of Oxford University’s coronavirus vaccine has been identified.
Dr Joao Pedro Feitosa, 28, passed away on October 15 in Brazil due to complications from Covid-19.
The medic, who has been pictured in local media and a Federal University of Rio de Janeiro (UFRJ) obituary, was taking part in the AstraZeneca trial in the country.
The pharmaceutical giant is developing the vaccine in partnership with Oxford University.
A source told Reuters that the trial would have been suspended if the volunteer received the COVID-19 vaccine.
This suggests Joao – who graduated in July 2019 – was part of the control group that was given a meningitis vaccine.
The National Health Surveillance Agency’s (Anvisa) president-director Antonio Barra said that tests would continue, Istoe reports.
Part of the UFRJ’s tribute to João reads: "The Rectorate of UFRJ – together with the entire university community – offers sincere condolences to the family and friends of our former student in the midst of this moment of sadness that took the life of Joao, who had just graduated and spared no effort to act in tackling the Covid-19 pandemic, which has accumulated over 40 million cases worldwide.”
It remains unclear how Joao contracted the disease.
An AstraZeneca spokesperson said: “We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed.
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"All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities.
"These assessments have not led to any concerns about continuation of the ongoing study."
Oxford University confirmed: “All significant medical incidents, whether participants are in the control group or the Covid-19 vaccine group, are independently reviewed.
"Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue."
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So far, 8,000 of the planned 10,000 volunteers in the trial have been recruited and given the first dose in six cities in Brazil and many have already received the second shot, a spokesman for The Federal University of Sao Paulo said.
The country has experienced the second deadliest outbreak of the coronavirus, with more than 154,000 killed – following the US.
It has the third-largest number of cases, with more than 5.2 million infected, after the US and India.
Anvisa said in a statement: "In relation to the death of the Oxford vaccine testing volunteer, Anvisa was formally informed of this fact on October 19, 2020.
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"Data related to the investigation carried out by the International Safety Assessment Committee was shared with the agency.
"It is important to highlight that, based on the ethical confidentiality commitments provided for in the protocol, the regulatory agencies involved receive partial data referring to the investigation carried out by this committee, which suggested that the study should continue, thus the process remains under evaluation.
"Therefore, Anvisa reiterates that, according to national and international regulations of Good Clinical Practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity and protection of participants.
"Anvisa is committed to complying with these regulations, in order to ensure the privacy of volunteers and also the country's reliability for carrying out studies of such relevance."
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