Brazil COVID-19 vaccine trial continues after volunteer dies

Eldonita de Ed Newman
2020-10-21 21:02:33

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AstraZeneca's share price fell after the death was reported.  (Photo: Jason Alden/Bloomberg)

Brasilia, October 21 (RHC)-- Brazil’s National Health Surveillance Agency (ANVISA) said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, but added that the trial would continue.

It was not immediately clear whether the volunteer received the vaccine or the placebo.  The regulator said testing of the vaccine would continue after the volunteer’s death.  It provided no further details, citing the medical confidentiality of those involved in trials.

“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,” the British university said in a statement.

The Federal University of Sao Paulo, which is helping coordinate phase three clinical trials of the vaccine in Brazil, separately said that the volunteer was Brazilian.

CNN Brasil reported that the volunteer was a 28-year-old man who lived in Rio de Janeiro and died from COVID-19 complications.  

AstraZeneca shares turned negative and were down 1.7 percent.

The federal government already has plans to purchase the vaccine and produce it at its biomedical research centre 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.

The U.S. paused trials of the vaccine from AstraZeneca, which is based in the United Kingdom, after reports of serious illness during the UK trial, pending a review from the US Food and Drug Administration (FDA).

Sources told Reuters earlier this week that the U.S. trial could resume as early as this week, following the completion of the FDA review.  The FDA did not immediately respond to a request for comments on whether the death of the Brazilian volunteer would impact the resumption of the trial in the United States.
 



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