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By Reuters
ISLAMABAD – Pakistan’s drug regulator has given 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) of China 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.
NIH and AJM signed an agreement last month and are awaiting approval from the Pakistan Medicines Regulatory Authority (DRAP), which the NIH says it has already received.
“DRAP has a target organization of 10,000 participants for our clinical trial,” Hassan Abbas Zaheer, AJM 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 report through Roxanne Liu, written through Gibran Peshimam; edited through Himani Sarkar)
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