The National Institute of Health (NIH) has obtained approval from the Drug Regulatory Authority of Pakistan (DRAP) for Phase III clinical trial of coronavirus vaccine.
According to media reports, the NIH said in a statement 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].”
The test will be conducted by the International Centre for Chemical and Biological Sciences, Karachi, in collaboration with a Chinese company already conducting trials in China.
“This will be the first ever phase III clinical trial for any vaccine in Pakistan,” the statement said.
Great stuff #Pakistan.
Pakistan green-lights Phase III trials for #COVID19 vaccine
This will be first clinical trial of any vaccine in country. https://t.co/unFn4jDjdN
— Mohammad Ali (@iamcefur) August 18, 2020
“It is a multi-country multi-centre clinical trial which CanSinoBio is already conducting in China, Russia, Chile, Argentina and will shortly start in Saudi Arabia. The principal investigator of the multi-centre clinical trial in Pakistan is NIH executive director Maj Gen Aamer Ikram.
“AJM Pharma CEO Adnan Hussain signed an agreement with the NIH last month for collaborating on the phase III clinical trial of CanSinoBIO Ad5-nCoV in Pakistan.
The study will be conducted in prestigious medical research centres in the country – Aga Khan Medical University, Karachi; Indus Hospital, Karachi; Shaukat Khanum Memorial Hospital, Lahore; Shifa International Hospital, Islamabad, and UHS Lahore.”
Asad Umar’s reaction
Asad Umar, the Minister for Planning, Development and Special Initiatives who is also currently leading the National Coordination and Operation Centre on Covid-19, said he was hopeful that the trials on the vaccine would be successful.
“It is one of the potential vaccines which can become successful,” the minister said.
Mr Asad Umar said Pakistan was unable to participate in the phase-III trials held in different countries. He said that an opportunity had finally been created wherein volunteers could participate in the trials within the country.
Scientific Task Force on Covid-19
In another development, a member of the Ministry of Science and Technology’s Scientific Task Force on Covid-19 revealed that in the first phase 200 volunteers over the age of 18 will participate. These volunteers will be from diverse ethnic groups to ensure the vaccine is reliable for use by people from all backgrounds.
“The trial will commence from next week which will be participated by 200 volunteers, all over 18 years of age. We have selected volunteers from various ethnic groups to analyse their results. I believe Karachi is the most appropriate city as people from all backgrounds are settled there,” the committee member said.
On March 24, Minister for Science and Technology Fawad Chaudhry had constituted a committee — Scientific Task Force on Covid-19 — which was headed by renowned scientist Prof Dr Attaur Rehman.
Its other members are University of Health Sciences Vice Chancellor Prof Dr Javed Akram, Dr Ghazna Khalid, Prof Al Fareed Zafar, Prof Iqbal Chaudhry, Prof Dr Khalid Khan and Prof Mariam Riaz Tarar.