By Marco Aquino
LIMA (Reuters) – A volunteer in the local Peruvian trial of a coronavirus vaccine manufactured by Sinopharm Group Co Ltd in China has died of COVID-19-related pneumonia, the university that conducted the trial said on Tuesday said.
The Cayetano Heredia University, which is involved in the study, said on the instructions of the Peruvian health regulator, he blinded the volunteers’ participation in the trial staff and determined that she received the placebo rather than the vaccine.
“It is important to note that the death of the participant has not been related to the vaccine since she received the placebo, and we will therefore report to the relevant regulatory and ethical bodies and retain the course of this phase three study , “said the university. in a statement.
German Malaga, chief researcher at Cayetano Heredia University, told Reuters by telephone that the deceased volunteer was suffering from diabetes.
Malaga said trial investigators had so far issued two doses of the vaccine or placebo to 12,000 volunteers and were now following their responses.
“It develops without any setbacks. These things can happen, COVID is a disease that causes deaths,” he said.
“Our message to the volunteers is to look after themselves because we do not know if they have the vaccine or the placebo,” he added.
The university said in a statement that the volunteer “had received all the necessary care to treat this disease and its complications” and that he had been “fighting for her life” for more than a week.
“It is a painful loss for which we express our condolences to her family,” the statement said.
In December, Peru temporarily suspended trials with the Sinopharm COVID-19 vaccine due to a ‘serious adverse event’ that occurred in a volunteer in the study.
In Brazil, clinical trials with the Sinovac COVID-19 vaccine in China were suspended before they were allowed to resume late last year due to the death of a subject registered as a suicide in Sao Paulo.
(Reporting by Marco Aquino; Writing by Adam Jourdan; Edited by Leslie Adler)