Staff Reporter
University of Health Sciences (UHS) Vice-Chancellor Professor Javed Akram has said that his varsity is all set to launch the phase-III trial of another Chinese coronavirus vaccine from next week. The university earlier ran the trial of Can Sino vaccine developed by Beijing Institute of Biotechnology. The trial registered 18,000 volunteers and is in the follow-up stage at the moment.
While presiding on a meeting in this regard on Thursday, the veteran physician said that the National Bio-Ethics Committee had approved a phase-III (involving humans) randomized, double-blind, placebo-controlled trial in local population with 18 years of age and above to determine the safety and efficacy of “ZF2001” – a recombinant novel coronavirus vaccine for prevention of Covid-19. A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results.
“We are expecting the trial’s approval from Drug Regulatory Authority of Pakistan (DRAP) during this week after which the recruitment of volunteer will start”, Professor Javed Akram said adding that a total of one thousand volunteers would be registered for the trial. He further said that three doses of the jab would be administered to each volunteer in three months after which the trial would enter the follow-up stage.
He said that each volunteer would have to visit the trial site seven times during the three months for which he or she would be paid an amount of Rs.16,000 for travel and food expenses. The trial would be completed in 18 months, he added. Professor Javed Akram informed that the vaccine is being sponsored by Chinese Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., with DRK Pharma Solutions as its local contract research organisation (CRO).
Vaccine-trial focal person Dr Shehnoor Azhar, DRK Pharma representative Dr Atif Mirza, health workers and Chinese experts were present in the meeting. UHS VC further said that research was more important than anything else for the university. “We want to check the safety and efficacy of all these vaccines for the local people”. He said that despite having the same protein base, the new vaccine was different from the CanSino vaccine as far as its administration and dosage was concerned.
Professor Javed Akram said on the occasion that he would like to thank in advance all the health workers and volunteers who would participate in this trial. He hoped that like CanSino, ZF2001 would not have any adverse effects on the health of the
subjects.
