Mettis Global News
Mettis Global News
Mettis Global News
Mettis Global News

Trending :

NIH to launch phase-III clinical trial for COVID-19 vaccine

Share on facebook
Share on twitter
Share on linkedin
Share on whatsapp

August 17, 2020: The National Institute of Health (NIH) has attained the formal approval from the Drug Regularity Authority of Pakistan (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.

According to the NIH, it will be the first ever phase-III clinical trial for any vaccine in Pakistan. It is a multi-country multi-center clinical trial being conducted by CanSinoBio already in China, Russia, Chile, Argentina and shortly in Saudia Arabia.

The Principal Investigator of the multi-center clinical trial in Pakistan is NIH Executive Director Maj Gen Aamer Ikram. AJM Pharma CEO Adnan Hussain signed an agreement with the NIH, Islamabad last month for collaborating for the Phase-III clinical trial of the CanSinoBIO Ad5-nCoV in Pakistan.

It is a tripartite activity between NIH, CanSinoBio and AJM Pharma. The study will be conducted in prestigious medical research centers in the country, including Aga Khan Medical University and Indus Hospital, Karachi, Shaukat Khanum Memorial Hospital, Lahore, Shifa International Hospital, Islamabad and UHS Lahore. The NBC of PHRC has given the ethical approval for the study.

These clinical trials have also been approved by Clinical Trial Org. https://clinicaltrials.gov/ (the global clinical trial highest regulatory body). The progress of the phase-III clinical trial in Pakistan will be keenly followed by the global scientific community as well as the people all over the world.

This initiative can open the door towards public private partnership to involve the private sector and will help to enhance indigenous vaccine manufacturing capabilities of Pakistan to achieve self-reliance and sufficiency.

These trials will not only project a very positive image of the country but also assure Pakistan to preferential vaccine supply and pricing.

CanSino Biologics Inc is an innovative Chinese bio-pharmaceutical company dedicated to exploring best solutions to the prevention of diseases through cutting edge research and development, advanced manufacturing and commercialization of innovative vaccine products for human use worldwide.

In the last few months, CanSinoBIO has made rapid advances in developing a Recombinant Novel Coronavirus Vaccine employing technology from China and Canada.

CanSinoBIO was the first company in the world to move to Phase-II of the vaccine clinical trial and initiate human trials. They published their Phase-I results in May 2020 and Phase-II trial results on July 20, 2020 (The Lancet).

AJM Pharma (Pvt.) Ltd. has signed an agreement with CanSinoBIO for organizing the phase-III clinical trials of their vaccine in Pakistan. AJM Pharma, established in 2004, is a reputed national pharmaceutical company and specializes in multiple segments including Oncology, Thalassemia, Nephrology and Gastroenterology. Prof. Hasan Abbas Zaheer will be the National Coordinator of the clinical trial on behalf of AJM Pharma.

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.

Being the part of this activity Pakistan will be among the priority countries to have an early access to get the COIVD -19 vaccine through NIH, Ministry of National Health Services.932

APP

Posted on: 2020-08-17T23:40:00+05:00

36371