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Volunteer in AstraZeneca’s coronavirus vaccine trial dies in Brazil

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 has been named as Dr João Pedro Feitosa, a 28-year-old physician from Brazil. 

He is not believed to have been 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. 

Anvisa, Brazil’s health authority, announced on Wednesday that a volunteer in AstraZeneca and Oxford University’s coronavirus vaccine trial has died. Pictured: Brazilian pediatrician Dr Monica Levi, who received the COVID-19 vaccine, works at the Specialized Clinic in Infectious and Parasitic Diseases and Immunizations in Sao Paulo, Brazil, July 24

Reports indicate the volunteer was a 28-year-old man who did not receive the jab prior to his death. Pictured: A volunteer receives an injection in AstraZeneca's COVID-19 vaccine trial at the Chris Hani Baragwanath hospital in Johannesburg, South Africa, June 24

Reports indicate the volunteer was a 28-year-old man who did not receive the jab prior to his death. Pictured: A volunteer receives an injection in AstraZeneca’s COVID-19 vaccine trial at the Chris Hani Baragwanath hospital in Johannesburg, South Africa, June 24

Health officials say testing of the vaccine will continue despite the volunteer's death, but it is unclear if the vaccine is linked to the deat. Pictured: AstraZeneca's offices in Macclesfield, Cheshire, England, July 21

Health officials say testing of the vaccine will continue despite the volunteer’s death, but it is unclear if the vaccine is linked to the deat. Pictured: AstraZeneca’s offices in Macclesfield, Cheshire, England, July 21

Anvisa said testing of the vaccine will continue after the volunteer’s death, but provided no further information, citing medical confidentiality of those involved in trials.    

In a statement to CNBC, a spokesperson from Oxford said there are no worries about the safety of their jab. 

‘There have been no concerns about safety of the clinical trial’ after an assessment of the Brazilian case, Oxford spokesperson Alexander Buxton said.

‘The independent review in addition to the Brazilian regulator have recommended that the trial should continue.’ 

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. 

Volunteer in AstraZeneca's coronavirus vaccine trial dies in Brazil

Volunteer in AstraZeneca's coronavirus vaccine trial dies in Brazil

Volunteer in AstraZeneca's coronavirus vaccine trial dies in Brazil

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. 

 

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