NIH gets approval from DRAP for Phase-III clinical trial of coronavirus vaccine

(Karachi) The National Institute of Health (NIH) has obtained formal approval from the Drug Regulatory Authority of Pakistan (D) for the Phase III clinical trial of a Covid-19 vaccine developed by CanSinoBio, a China-based vaccine developer, and the Beijing Institute of Biotechnology, media reported on Monday.

A statement issued by NIH stated that this will be the first ever phase III clinical trial for any vaccine in Pakistan. “It is a multi-country, multi-centre clinical trial being conducted by CanSinoBio already in China, Russia, Chile, Argentina and shortly in Saudi Arabia.”

It added that the principal investigator of the clinical trial would be Major General Aamer Ikram, who is the NIH executive director, adding that the AJM Pharma chief executive officer, Adnan Hussain, had signed an agreement with the institute last month for collaborating on the clinical trial of the vaccine, known as recombinant novel coronavirus vaccine adenovirus type 5 vector (Ad5-nCoV).

“It is a tripartite activity between NIH, CanSinoBio and AJM Pharma. The study will be conducted in prestigious medical centres in the country, including the Aga Khan Medical University and the Indus Hospital in Karachi, the Shaukat Khanum Memorial Hospital and the University of Health Sciences in Lahore and the Shifa International Hospital in Islamabad.”

The National Bioethics Committee (NBC) of the Pakistan Health Research Council (PHRC) has given ethical approval for the study while the clinical trial has also been approved by the highest global regulatory body, it said.

“This initiative can open the door towards public-private partnership to involve the private sector and will help to enhance indigenous vaccine manufacturing capabilities to achieve self-reliance,” the statement said.

“Being a part of this activity, Pakistan will be among the priority countries to have early access for the Covid-19 vaccine through NIH.”

Pakistan will receive coronavirus vaccine from China, one of its closest allies, to vaccinate the most vulnerable among its population, including the elderly, healthcare workers and people with medical conditions associated with serious cases of Covid-19.

China has reached one of its first agreements to test its coronavirus vaccine in populations beyond its borders.

About one-fifth of the country’s population could be covered by the allocation while Pakistan is also negotiating with another Chinese company to conduct trials of its vaccine in the country.

Pakistan will conduct Phase 1 trials of the vaccine and then move rapidly to the final stage Phase 3 trial. The final phase would require tens of thousands of volunteers. China has developed three coronavirus vaccines which are in the Phase 3 trials.