ISLAMABAD (Reuters) – Pakistan’s drug regulator gave the green light to the country’s first Phase 3 clinical trial for a COVID-19 vaccine, which is being developed through CanSino Biologics (CanSino) and the Beijing Institute of Biotechnology.
The trial is expected to begin next month, according to an official coordinating the exercise.
The government-run National Institute of Health (NIH) will lead the Ad5-nCoV candidate trial with the pharmaceutical company AJM, CanSino’s representative.
China has already approved the use of the vaccine through its army after initial and intermediate trials, and complex trials are underway for Mexico and Saudi Arabia.
CanSino said last month that it was in talks to launch Phase 3 trials in Saudi Arabia, Russia, Brazil and Chile.
The NIH and AJM signed an agreement last month and are awaiting approval from the Pakistan Medicines Regulatory Authority (DRAP), which the NIH claims to have received.
“DRAP has approved a target organization of 10,000 participants for our clinical trial,” Hassan Abbas Zaheer, AJM’s trial coordinator, told Reuters by email.
The examination will be carried out at primary medical care centres in Pakistan, Karachi, Islamabad and Lahore.
Zaheer added that the clinical trial will last “a few months” and that the knowledge generated in all the countries involved will be collected and analyzed through CanSino.
Pakistan has so far recorded 289,831 cases of COVID-19 and 6,190 deaths, but has noticed that the number of infections decreased significantly in August after peaking in June.
Additional reports through Roxanne Liu, written through Gibran Peshimam; Edited through Himani Sarkar
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