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A Brazilian volunteer who participated in the Oxford vaccine trials died, reported the National Health Surveillance Agency (Anvisa) on Wednesday (21).
The agency said it was notified of the death on October 19, and that it was informed that the independent committee that accompanied the case suggested that the study be continued. “The process is still under evaluation,” Anvisa said.
Anvisa did not clarify whether the volunteer took the vaccine or the placebo. The pharmaceutical company AstraZeneca informed the G1 that he still didn’t have a position on death.
Next, see the complete positioning disclosed by Anvisa:
In connection with the death of the Oxford vaccine test volunteer, Anvisa was formally informed of this fact on October 19, 2020. Data related to the investigation conducted 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 on the research carried out by this committee, which suggested continuing with the study. Therefore, the process remains under evaluation.
Therefore, Anvisa reiterates that, in accordance with national and international regulations on Good Clinical Practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity and protection of the participants.
Anvisa undertakes to comply with these regulations, in order to guarantee the privacy of the volunteers and also the reliability of the country to carry out studies of such relevance.
The Agency has fulfilled, will fulfill and will fulfill its institutional mission of protecting the health of the Brazilian population. “
