Peru's Cayetano Heredia University, which is carrying out the COVID-19 vaccine trial of China's Sinopharm Group Co Ltd, said on 26 January 2021 that a Peruvian volunteer in the local trial has died from COVID-19-related pneumonia, Reuters news agency reported on Wednesday.
Cayetano Heredia University said that on the instructions of the Peruvian health regulator it had unblinded the volunteer's participation in the trial and determined she had received the placebo rather than the vaccine.
In a statement, the university said: "It is important to stipulate that the death of the participant is not related to the vaccine since she received the placebo and we will therefore report to the relevant regulatory and ethics bodies and maintain the course of this phase three study."
The university added in its statement that the volunteer had received "all the necessary care to treat this disease and her complications" and was "fighting for her life" for more than a week.
German Malaga, chief researcher at the Cayetano Heredia University, told Reuters that the deceased volunteer had suffered from diabetes.
According to Malaga, the trial investigators had so far issued two doses of either the vaccine or placebo to 12,000 volunteers and were now following their responses.
Reportedly, Peru had temporarily suspended trials of the Sinopharm COVID-19 vaccine in December 2020 due to a "serious adverse event" that occurred with a volunteer in the study.
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