China National Pharmaceutical Group (Sinopharm) has started Phase 3 clinical trials of
its COVID-19 vaccine candidate in Peru at Cayetano Heredia University's Center for Clinical Studies, spokespersons of the academic institution reported.
On Wednesday, the first volunteers began to show up at 7:00 a.m. Upon arrival, they were escorted —to the university headquarters— by police members and soldiers.
According to German Malaga —principal investigator of the vaccine study at Lima-based
Cayetano Heredia University— 21 volunteers were vaccinated on Wednesday. They had to undergo a medical examination and sign an informed consent.
After getting the vaccine, the volunteers were taken to a recovery room, where they had to wait 25 minutes before going home.
Malaga informed that the number of volunteers testing the vaccine per day will be increased in the next few days.
The Phase 3 clinical trials involve up to 6,000 Peruvian volunteers, male or female, aged 18 to 75 years. They cannot have previously tested positive for COVID-19 or been asymptomatic carriers. Moreover, people with serious diseases such as tuberculosis cannot participate either.
However, people with hypertension, diabetes or heart problems can participate, as long as their diseases are very well controlled.
The volunteers will be administered two doses of the vaccine three or four weeks apart.
(END) LIT/RMB/MVB
Published: 9/10/2020