Brazil to Continue COVID Vaccine Trial After Volunteer Dies
A COVID-19 vaccine trial in Brazil will push through even after the death of one of its volunteers.
Brazil's health authority Anvisa announced that continuation of the vaccine trial on Wednesday. AstraZeneca and Oxford University developed the vaccine in question.
Oxford said that, after careful assessment of the Brazil death, they will continue testing, Al Jazeera reported.
They added that "there have been no concerns about safety" of the vaccine trial.
Authorities did not give any further details about the death, citing confidentiality protocols for vaccine trials.
In a separate statement, Federal University of Sao Paulo confirmed that the volunteer was Brazilian. They also said an independent review committee recommended the vaccine trials should continue.
"Everything is proceeding as expected," the university said, adding that there weren't any serious vaccine-related complications involving the volunteers.
The university helped in coordinating the phase three trials of the vaccine in Brazil.
CNN Brasil also reported that the volunteer was a 28-year-old male who lived in Rio de Janiero. He died from COVID-19 complications.
Meanwhile, AstraZeneca did not offer immediate comment on the individual case.
But they assured that the trials were assessed by investigators, an independent safety monitoring committee and regulatory officials.
Just like Oxford, they also said the assessments did not lead to any concerns about the continuation of the ongoing study.
Vaccine Trial Volunteer Likely Received a Placebo
It was not immediately clear if the volunteer received a vaccine or a placebo. But based on BBC's understanding, the volunteer did not get it.
A source told Reuters that if the volunteer was given a COVID-19 vaccine, the trial would have been suspended. The fact that those were continued suggests that the person who died was part of the control group.
Only half of the volunteers in the trial were actually given the COVID-19 vaccine. The other half was given the current licensed vaccine for meningitis.
The volunteers, along with their families, are not told which vaccine they received.
This method helps researchers compare the results of the two groups. The data gathered from both groups will determine if the vaccine was effective.
AstraZeneca and Oxford plan to involve 10,000 volunteers in their vaccine trial. There are 8,000 volunteers who have been recruited so far from six Brazilian cities.
A university spokesman said most volunteers were also given the first dose and many also received the second shot.
Shares for AstraXeneca fell 1.8% after the announcement.
Oxford/AstraZeneca Vaccine Shows Potential
Many are having high hopes that the Oxford/AstraZeneca will be able to produce one of the first vaccines to fall onto the market.
Its first two trials were successful while its phase three is being carried out in different countries.
Trials were paused in the UK because of a reported side effect but were resumed days later after safety assessments.
Phase three trials remain on hold in the U.S. while a regulatory body conducts its own assessment.
The federal government of Brazil also expressed interest in purchasing the UK vaccine. The vaccine will be produced in a biomedical research center in Rio de Janiero.
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