A volunteer in AstraZeneca and Oxford University’s coronavirus vaccine trial has died, Brazil’s health authority Anvisa announced Wednesday (Oct. 21).
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 been, the trial would have been suspended.
Oxford 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.
In a statement to NBC News, AstraZeneca also confirmed the trial would go on.
“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,” the statement said.
“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.”
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.
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.
Allowing testing to resume likely means the FDA believes illness suffered by the British patient was not linked to the experimental vaccine.
However, the FDA is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, a source told Reuters.
However, it is unclear if the death of the Brazilian patient will reverse this decision.
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