DRAP green-signals NIH for Phase III clinical trial of coronavirus vaccine

The Drug Regulatory Authority of Pakistan (DRAP) on Monday has given the approval to the National Institute of Health (NIH) to conduct the Phase III clinical trial of coronavirus vaccine .

A statement released from the NIH said that it has obtained “the formal approval from DRAP for Phase III Clinical Trial of Recombinant Novel Coronavirus Vaccine Adenovirus Type 5 vector (Ad5-nCoV) developed by CanSinoBio and Beijing Institute of Biotechnology China [BIB]”.

CanSino Biologics Inc— the Chinese bio pharmaceutical has already been conducting the trial in various countries, including China, Russia, Chile, Argentina, and shortly in Saudi Arabia and Pakistan.

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The Phase III clinical trial of CanSinoBIO Ad5-nCoV, the coronavirus vaccine, in Pakistan would be carried out under NIH Executive Director Maj Gen Aamer Ikram.

It has been reported that AJM Pharma Pvt Ltd CEO Adnan Hussain has signed an agreement to collaborate with the NIH. The Pharma’s Prof Hasan Abbas Zaheer would be the national coordinator of trials, with Maj Gen Ikram, who will be the principal investigator.

The trials would be carried out in Karachi’s Aga Khan University Hospital (AKUH) and The Indus Hospital, Lahore’s Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC) and University of Health Sciences (UHS), and Shifa International Hospital in Islamabad, according to the statement of NIH.

“A national Clinical Research Organization, Dimension Research CRO & SMO will monitor the progress of the clinical trial and also coordinate with the global CRO appointed by CanSinoBIO to ensure uniformity of the trial in all the participating countries and centers,” the statement said.

“The NBC of PHRC has given the ethical approval for the study,” it said adding that, noting that the trials were already approved by the US registry of worldwide clinical trials, the ClinicalTrials.gov.

The NIH highlighted that the trials’ progress would be monitored by the global scientific community, “can open the door towards public-private partnership”, and “will help to enhance indigenous vaccine manufacturing capabilities of Pakistan to achieve self-reliance and sufficiency”.

Over the past few months, the Chinese bio pharmaceutical, CanSinoBIO has made rapid advances in developing a recombinant novel coronavirus vaccine, using technology from Canada and China. It also became the first company in the world to initiate human trials.

Earlier, the results of the pharmaceutical’s Phase I and II clinical trials were published in May and July 2020, respectively, in the peer-reviewed journal, The Lancet.