Participant in AstraZeneca's Brazilian Covid-19 trial dies

AstraZeneca Covid-19 vaccine trial volunteer dies: Brazil

The Covid-19 immunisation is in the advanced sages of trial, with volunteers in countries including Brazil, the United Kingdom and the USA; in a statement, Oxford said it had investigated the claims that a volunteer had died but insisted there were "no concerns about safety" around the vaccine.

"All required review processes have been followed", a spokesperson for AstraZeneca said.

Pfizer Inc and Johnson & Johnson are seeking input from a U.S. Food and Drug Administration advisory committee on retaining and attracting volunteers for COVID-19 vaccine trials after a vaccine becomes available, if they know they might receive a placebo.

Brazilian newspaper Globo and worldwide news agency Bloomberg said he was in the control group and had received a placebo rather than the test vaccine, citing sources close to the trials.

In its guidance on EUAs for vaccines, the FDA said earlier in October that a drugmaker should continue to collect data in any ongoing trials for as long as feasible, even after getting an authorization, and work toward submission of a formal approval application as soon as possible. It provided no further details, citing the medical confidentiality of those involved in trials.

The D'Or Teaching and Research Institute (IDOR), which is helping organize the tests in Brazil, said the independent review had "raised no doubts about the safety of the study, and recommended it continue".

The Serum Institute of India has advanced the furthest in clinical trials in India, now conducting phase 3 trials of Covidshield, which has been jointly developed by the UK's AstraZeneca and the University of Oxford. The Brazilian volunteer was participating in a stage-three trial - the final step before mass production - though it's unclear whether they were administered the vaccine itself or simply a placebo.

In September, AstraZeneca paused all of its global trials due to an illness in another participant.

Study participants must be doctors, nurses or other health sector workers who come into regular contact with the virus.

CNN Brasil reported that the volunteer was a 28-year-old man who lived in Rio de Janeiro and died from COVID-19 complications.

He graduated from medical school past year, and was in good health prior to contracting the disease, family and friends told the newspaper.



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