Pakistan green-lights Phase III trials for Covid vaccine

The Ministry of National Health Services Regulation and Coordination has received formal approval from the Drug Regulatory Authority of Pakistan (DRAP) for Phase III clinical trials of the corona vaccine.

According to a statement from the NIH, the medical facility 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]".

“This will be the first ever phase III clinical trial for any vaccine in Pakistan.”

The vaccine, developed by the Cansino Biologists and Beijing Institute of Biotechnology China, has been approved for clinical trials of the coronavirus vaccine Phase 3.

This will be the first phase 3 clinical trial of any vaccine in Pakistan.

According to a spokesman for the National Institutes of Health, this is a multi-country multi-center clinical trial that Cansino Bio has already launched in China, Russia, Chile, Argentina and will soon launch in Saudi Arabia.

The Principal Investigator of Multi-Center Clinical Trials in Pakistan is Major General Amir Ikram, Executive Director, NIH, Islamabad.

The study is a tripartite activity among the National Institutes of Health, Cansino Biocompany and A. J. M Pharma.

The study will be conducted at renowned medical research centers of the country including Aga Khan Medical University Karachi, Indus Hospital Karachi, Shaukat Khanum Memorial Hospital Lahore, Shifa International Hospital Islamabad and UHS Lahore.

Initiatives such as the Phase 3 clinical trial in Pakistan will not only enhance Pakistan's ability to develop vaccines locally and pave the way for private-public partnerships, but will also project a positive image of the country around the world.

It will also ensure preferential supply of vaccines at reasonable prices in Pakistan.

Cansino Bio Company was the first company in the world to conduct clinical trials of corona vaccine Phase 2 and trials of vaccine on humans.

The company published its Phase 1 trial results in May 2020 and Phase 2 results in July 2020.

As part of this study by the National Institutes of Health, Pakistan will be on the list of priority countries that will have early access to the corona vaccine.

China will also supply a coronavirus vaccine candidate developed by a unit of China National Pharmaceutical Group (Sinopharm) to Pakistan as part of a trial agreement, reported the Wall Street Journal (WSJ).

State-owned Sinopharm is set to work with the University of Karachi on vaccine trials, according to the WSJ report, which said Pakistan will receive enough doses early in distribution to vaccinate about one-fifth of its population.

The initial doses will be used to vaccinate the most vulnerable among the Pakistani population including the elderly, healthcare workers and people with medical conditions associated with serious cases of Covid-19, the report added.

Sinopharm’s Covid-19 vaccine appeared to be safe and triggered antibody-based immune responses in early and mid-stage trials, according to researchers.

The candidate has already moved into a late-stage trial, one of a handful of candidates being tested on several thousand people to see if they are effective enough to win regulatory approval.

Sinopharm is testing the potential vaccine in the United Arab Emirates in a Phase 3 trial expected to recruit 15,000 people, as China has too few new cases to be a useful trial site.

The shot did not cause any serious side effects, according to a paper published in the Journal of the American Medical Association (JAMA) by scientists who are part of Sinopharm and other China-based disease control authorities and research institutes.

(With additional input from news desk)