A Brazilian volunteer, who participated in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University, has died, Brazilian health authority Anvisa said.
Oxford university reportedly confirmed the plan to continue the trial after careful assessment that there have been no concerns about safety of the clinical trial.
According to Brazilian newspaper O Globo, the volunteer was part of the control group and had been given a placebo and not the trial Covid vaccine. The clinical trial would have been suspended if the volunteer had received the COVID-19 vaccine.
The volunteer was a 28-year-old man, who died from COVID-19 complications.
Brazil's Federal University of Sao Paulo, which is helping to coordinate phase 3 clinical trials in Brazil, also said the trial would continue.
The university said, "Everything is proceeding as expected, without any record of serious vaccine-related complications involving any of the participating volunteers."
As per reports, 8,000 of the planned 10,000 volunteers in the trial have already been recruited in six cities in the country, and given the first dose, while many received the second shot also.
The potential vaccine, AZD1222, is being developed by the pharmaceutical giant in partnership with Oxford University, and its spin-out company, Vaccitech. It is in late stage in the U.S., UK, Brazil, and South Africa with additional trials planned to start in Japan and Russia.
On September 6, AstraZeneca had voluntarily paused all global trials following a potentially unexplained illness in a U.K. volunteer, to allow review of safety data by independent committees, and international regulators.
AstraZeneca later resumed the trail first in the UK following confirmation by the Medicines Health Regulatory Authority or MHRA that it was safe to do so.
In July, the company had revealed that the ongoing phase I/II study of AZD1222 was showing good immune responses against the SARS-CoV-2 virus in all participants.
Johnson & Johnson is another company, which had paused the phase III study of its COVID-19 vaccine candidate, JNJ-78436735 in early October, due to an unexplained illness in a study participant.
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