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The National Health Surveillance Agency (Anvisa) of Brazil alerted this Wednesday of the death of a volunteer who was part of the tests with the experimental vaccine developed by the University of Oxford and the pharmaceutical company AstraZeneca, currently in the phase III clinical trials.
“In connection with the death of the Oxford vaccine testing volunteer, Anvisa was formally informed of this fact October 19, 2020″ Says Anvisa.
“Data related to the investigation carried out by the International Safety Assessment Committee was shared with the Agency. It is important to note that based on the ethical confidentiality commitments provided in the protocol, the regulatory bodies involved receive partial data related to the investigation carried out by this committee, which suggested that the study should continue, so the process remains under evaluation ”, he adds.
“For this reason, Anvisa reiterates that, in accordance with the national and international regulations of Good Clinical Practices, data on clinical research volunteers should be kept confidential, in accordance with the principles of confidentiality, human dignity and protection of the participants ”, the Agency indicates.
While so far it is unknown whether the volunteer received a placebo, or a dose of the vaccine, according to O`Globo it would be a 28-year-old man, doctor and resident of Rio de Janeiro.
At this stage, 50% of the study volunteers receive the immunizer produced by Oxford. In Brazil, approximately 8 thousand people have been vaccinated to date.
Let us remember that at the beginning of September, the University of Oxford and AstraZeneca had already suspended the tests due to an adverse reaction from a participant, although the process continued a week later.
In Chile, the vaccine will be tested in conjunction with the Las Condes Clinic and the University of Chile.
