A volunteer in the Brazilian arm of AstraZeneca and the University of Oxford’s coronavirus vaccine trial has died, the country’s health authority Anvisa said on Wednesday.
The participant is believed to be a 28-year-old man from Brazil, according to Bloomberg.
He allegedly was not in the group that received the vaccine with sources telling Reuters that if he had, the trial would have been suspended.
Oxfored stated the trial will continue after the death of the volunteer, adding an independent review had revealed no safety concerns.
‘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,’ a spokesman for the university said in a statement.
AstraZeneca did not immediately reply to a request for comment.
The 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.
Brazil has the second deadliest outbreak of coronavirus, with more than 154,000 killed by COVID-19, following only the United States.
It is the third worst outbreak in terms of cases, with more than 5.2 million infected, after the United States and India
Upon the news, AstraZeneca shares turned negative and were down 1.7 percent.
It comes as the US Food and Drug Administration (FDA) keeps the American arm of AstraZeneca’s trial on hold.
The late-stage study was paused on hold on September 8 when a British participant was rushed to the hospital after suffering a serious reaction.
An internal safety report revealed the patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.
The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.
This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel – and can even lead to permanent paralysis.
Testing had resumed at all other sites, but not in America.
On Tuesday, it was revealed that the FDA had completed its review of safety data and was planning to let the trial resume in the US.
However, it is unclear if the death of the Brazilian patient will reverse this decision.
‘He allegedly was not in the group that received the vaccine with sources telling Reuters that if he had, the trial would have been suspended.’ uh huh, I wonder if the other ‘volunteers’ are trying to opt out of the trial
These “volunteers” must have a death wish. Why anyone with good health would sign up to be a guinea pig is beyond me. Regardless, I believe this vaccine (no matter who manufactures it) is a toxic concoction formulated to do one thing, and one thing only; significantly reduce the human population.