Volunteer in Brazil Coronavirus Vaccine Trial Dies of Covid-19, Unclear If They Received Placebo

Volunteer in Brazil Coronavirus Vaccine Trial Dies of Covid-19, Unclear If They Received Placebo
An aerial view of a nearly empty Saara region in Rio de Janeiro, Brazil (Photo: Buda Mendes, Getty Images)

A 28-year-old Brazilian resident participating in a covid-19 vaccine trial run by AstraZeneca and the University of Oxford has died of complications related to the coronavirus, a local media outlet reported Wednesday. Health officials and those leading the study have not confirmed whether the volunteer had received the experimental vaccine or a placebo prior to his death. According to a spokesperson for UK-based drugmaker AstraZeneca, the trial will continue as planned.

The death was reported by news outlet O Globo. According to their report, the volunteer died last Thursday. Brazil’s public health and regulatory agency, the National Health Surveillance Agency (ANVISA), was informed of the death Monday and is evaluating the case with the cooperation of the vaccine’s developers, O Globo reported.

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The person had been participating in a large international clinical trial of the jointly developed vaccine, which uses a weakened version of a common adenovirus as its delivery method. Early last month, trials in the UK and elsewhere were temporarily paused after a woman in the vaccine group had developed neurological symptoms. However, the independent committee overseeing these trials concluded that the woman’s case was either unlikely to be connected to the vaccine or that there wasn’t enough evidence to confirm one way or the other. Soon after, the trials were restarted most everywhere, though not in the U.S. as of yet.

While neither ANVISA nor the medical centres involved in the Brazilian volunteer’s care would confirm the person’s status in the trial, O Globo cited anonymous sources who reportedly said the volunteer was in the placebo group, meaning they did not receive an experimental vaccine. Bloomberg News, citing an anonymous source, also reports that the participant received a placebo.

In a statement emailed to Gizmodo, 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. 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.”

The University of Oxford has not responded to a request for comment.

Brazil has been one of the hardest-hit areas of the world during this pandemic. As of Wednesday, more than 150,000 people there have died from the viral illness — a number second only to the U.S. official death toll of 221,000.