The Brazilian National Health Surveillance Agency (Anvisa) announced today that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca. In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by an international security assessment committee. The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. A report in the Brazilian newspaper O Globo, however, says the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line combating COVID-19 in three hospitals in Rio de Janeiro. He reportedly died last Thursday due to complications from COVID-19. It is unknown whether the volunteer received the vaccine or placebo. Contacted by Medscape Medical News for comment, AstraZeneca responded in a statement that the company can't comment on individual cases in an ongoing clinical study. It noted that all significant medical events are assessed by the study's investigators, an independent safety monitoring committee, and regulatory authorities, adding that "these assessments did not lead to any concerns about the continuity of the ongoing study." The research facility conducting the trials in Rio de Janeiro, Instituto D'Or de Ensino e Pesquisa (IDOR), also issued a statement affirming that "the rigorous analysis of the data collected so far did not raise any doubts regarding the safety of the study, and its continuity is recommended." The facility's statement also pointed out that "this is a randomized, blind study, in which 50% of the volunteers receive the vaccine produced by Oxford." According to IDOR, approximately 8000 volunteers have been vaccinated to date in Brazil. It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time. "It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine," said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape. Source
