A 28-year-old volunteer in AstraZeneca's coronavirus vaccine trial has died, but a report says he was in the control group and given a placebo
Sean Elias/Handout via Reuters
- A volunteer in AstraZeneca's vaccine trial in Brazil has died.
- The man, 28, died from complications of COVID-19, Brazil's O Globo newspaper and CNN Brasil reported. He is the first person to die during any company's COVID-19 vaccine trial.
- According to O Globo, he was in the control group and had been given a placebo instead of the trial vaccine.
- A representative for the Oxford Vaccine Group, which is developing the vaccine with AstraZeneca, told Business Insider it would continue the trials because "there have been no concerns about safety."
- Visit Business Insider's homepage for more stories.
A participant in AstraZeneca's coronavirus vaccine trial in Brazil has died, marking the world's first death from a COVID-19 vaccine trial.
The deceased was a 28-year-old man from Rio de Janeiro who died of complications from COVID-19, Brazil's O Globo newspaper and CNN Brasil reported Wednesday.
Both outlets reported that he had volunteered to take part in AstraZeneca's clinical trials for its vaccine, which is being developed with the Oxford Vaccine Group.
According to O Globo, the man had been in the trial's control group and was given a placebo instead of the trial vaccine. Anvisa, Brazil's health body, said it was told of the death on Monday, CNN Brasil reported. The agency has declined to reveal the participant's identity.
The Oxford Vaccine Group has told Business Insider that the trial will continue.
"Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue," said Joanna Bagniewska, a spokeswoman for the group.
Reuters
"All significant medical incidents, whether participants are in the control group or the COVID-19 vaccine group, are independently reviewed," she added.
The Federal University of São Paulo, where AstraZeneca's Brazil trials are being held, also told Reuters: "Everything is proceeding as expected, without any record of serious vaccine-related complications involving any of the participating volunteers."
The trial would have been suspended if the person who had died had been given a dose of the trial vaccine, Reuters reported.
Some 10,000 people have signed up to take part in AstraZeneca's Brazil trials, with 8,000 given either the trial vaccine or a placebo so far, O Globo reported.
The death in Brazil follows news in early September that AstraZeneca had paused a UK trial for six days after a participant fell ill.
On October 12, Johnson & Johnson also paused its vaccine trial after a participant experienced an unexplained illness.
Pausing vaccine trials is a common precaution taken by scientists and drugmakers.
AstraZeneca's vaccine candidate is one of a handful in the latter stages of clinical trials.
from Business Insider https://ift.tt/31NgXEP
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