Volunteer in AstraZeneca-Oxford COVID-19 vaccine trial has died, Brazil health authority says
A laboratory technicians handles vials as part of filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologics manufacturing facility of multinational corporation Catalent in Anagni, southeast of Rome, during the COVID-19 infection, caused by the novel coronavirus. – Catalent Biologics manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxfords Covid-19 vaccine candidate, AZD1222, providing large-scale vial filling and packaging to British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca. (Photo by Vincenzo PINTO / AFP) (Photo by VINCENZO PINTO/AFP via Getty Images)
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BRAZIL (NewsNation Now) — Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.
The regulator said testing of the vaccine would continue after the volunteer’s death. It provided no further details, citing medical confidentiality of those involved in trials.
Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment “there have been no concerns about safety of the clinical trial.”
AstraZeneca declined immediate comment.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said that the volunteer was Brazilian but did not say where the person lived.
Brazilian newspaper O Globo reported that the volunteer had been given a placebo and not the trial vaccine, citing unnamed sources. NewsNation could not independently confirm the volunteer was given the placebo but is reaching out to AstraZeneca.
AstraZeneca’s COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness, four sources told Reuters.
AstraZeneca’s large, late-stage U.S. trial has been on hold since Sept. 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.
Brazil’s federal government already has plans to purchase the UK vaccine and produce it at its biomedical research center FioCruz in Rio de Janeiro, while a competing vaccine from China’s Sinovac is being tested by Sao Paulo state’s research center Butantan Institute.
This story is developing.
Reuters contributed to this report.
