There was a flurry of news alerts today that a participant in the Brazilian cohort of the AstraZeneca COVID-19 vaccine trial had died. This created an enormous rush of commentary on this event and reporting that the Brazilian regulators had stated that the trial would continue regardless. Since the trial is still on clinical hold in the United States because of a prior case of transverse myelitis (an inflammation of the spinal cord that led to paralysis) in a participant in the trial, the news of a death in this same trial in Brazil was met with consternation.
Soon afterwards there were reports that suggested the patient who died had not even received the vaccine and may have been in the placebo arm of the trial. Some unverified reports identified the subject as a young physician who died from COVID-19. None of these news accounts has yet been validated by regulators, and these facts must be corroborated before any discussion of the impact of this death on the trial takes place.
Subjects do die in clinical trials for reasons totally unrelated to the drug or vaccine being tested. While by standard clinical trial protocols these deaths are identified as “significant adverse events” or SAE’s, they are eventually identified in the trial analysis as not being related to the drug or vaccine being tested. Most times, accidental deaths from trauma, such as car accidents, are easily distinguished from drug related problems, especially in patients given placebos. Some events, such as cardiac or liver problems, can be difficult to separate from drug effects.
Part of the problem with the accelerated timeline and notoriety of COVID-19 vaccine trials is that every event becomes a news release. Companies and regulators often don’t have time to evaluate the nature of an event before the public is notified. Often officials are prohibited from commenting by rules governing the research.
AstraZeneca stated, “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.”
In this case, we need to withhold judgment until the exact events surrounding the subject‘s death are fully and publicly documented.