By Marco Aquino
LIMA (Reuters) – A volunteer in the local Peruvian trial of a coronavirus vaccine produced by China’s Sinopharm Group Co Ltd died of COVID-19-related pneumonia, said the university conducting the trial on Tuesday.
Cayetano Heredia University, which is involved in the study, said that, following instructions from the Peruvian health regulator, it had revealed the volunteer’s participation in the study and determined that she had received the placebo instead of the vaccine.
“It is important to stipulate that the participant’s death has not been related to the vaccine since she received the placebo, and therefore we will report to Organs relevant regulatory and ethics bodies and continue the course of this phase three study,” the university said in a statement.
German Malaga, chief researcher at Cayetano Heredia University, told Reuters by telephone that the deceased volunteer suffered from diabetes.
Malaga said the trial researchers had distributed two doses of the vaccine or placebo to 12,000 volunteers and are now tracking their responses.
“It is developing smoothly. These things can happen, COVID is a disease that causes deaths ”, he said.
“Our message to the volunteers is to take care 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 necessary care to treat this disease and its 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,” added the statement.
In December, Peru temporarily suspended testing of the Sinopharm COVID-19 vaccine due to a “serious adverse event” that occurred with a study volunteer.
In Brazil, clinical trials of the Chinese vaccine Sinovac COVID-19 were suspended before being resumed at the end of last year due to the death of a study subject who was registered in São Paulo as a suicide.
(Reporting by Marco Aquino; Writing by Adam Jourdan; Editing by Leslie Adler)