LIMA — A volunteer who received the placebo in the local Peruvian trial of a coronavirus vaccine produced by China’s Sinopharm Group Co. Ltd. has died from coronavirus disease 2019 (COVID-19)-related pneumonia, the university carrying out the trial said on Tuesday.
Cayetano Heredia University, which is involved with the study, said 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.
“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 said in a statement.
German Malaga, chief researcher at the Cayetano Heredia University, told Reuters by phone that the deceased volunteer had suffered from diabetes.
Mr. Malaga said 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.
“It is developing without any setbacks. These things can happen, COVID is a disease that causes deaths,” he said.
“Our message to the volunteers is to take care of themselves because we don’t know if they have the vaccine or the placebo,” he added.
The university said 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.
“It is a painful loss for which we extend our condolences to her family,” the statement added.
In December, Peru temporarily suspended trials of the Sinopharm COVID-19 vaccine due to a “serious adverse event” that occurred with a volunteer in the study.
In Brazil, clinical trials of China’s Sinovac COVID-19 vaccine were suspended before being allowed to resume late last year due to a study subject’s death that was registered in Sao Paulo as a suicide. — Marco Aquino/Reuters