Yasir Habib Khan

 

Pakistan has kick-started last-stage human trials of China's 3-shot ZF2001 vaccine amid alarms of the third wave of COVID-19. 

 

Trials launch came into effect after the Drug Regulatory Authority of Pakistan (DRAP) approved ZF2001's last-stage trials better known as Phase III Clinical Trials in order to pave its way for emergency use authentication shortly. 

 

A phase III randomized, double-blind, placebo-controlled clinical trials in 18 years of age and above is ongoing to determine the safety and efficacy of ZF2001, a recombinant novel coronavirus vaccine (CHO Cell) for the prevention of COVID-19.

  

As per official target, around 10000 volunteers being admitted as trial participants will be receiving three shots of ZF2001 within 60 days in dedicated centres of University of Health Sciences (UHS), National Defense Hospital and Agha Khan Hospital. 

 

Trial participants (both males and females) are stipulated to be hailing from different strata of society with diversified livelihoods, literacies, rural/ urban backgrounds, localities and others.

   

ZF2001 vaccine human trial spokesperson in UHS Dr Shehnoor Azhar told Gwadar Pro and CEN that trials are being conducted under framework protocols in line with international standards and WHO.

  

"Trial participants are being provided with all relevant information with regard to vaccine understanding, medial perception, procedural modules, assessment criterion, follow-up prerequisites and all other specificities," he added. 

  

The Chinese Vaccine has been co-developed by Anhui Zhifei Longcom Biologic Pharmacy Co. Ltd, and the Institute of Microbiology of the Chinese Academy of Sciences. Anhui Biopharmaceutical, a company with its presence in biological product industry since 2002, has officially presented its proposal to the Pakistani Embassy in Beijing asking for third phase trial to join healthy competition among foreign firms which won emergency use authentication in Pakistan.

 

On an inquiry, Dr Shehnoor revealed that after signing the informed consent form, the volunteers receive the relevant examinations after an inquiry by investigator of the medical history (including COVID-19 history), recent medication (vaccine) history, allergy history and concomitant medications, and demographic data collection by the investigators, including physical examination (skin and mucous membranes, lymph nodes, head, neck, chest, abdomen, spine/limbs), novel Coronavirus (SARS-COV-2) nucleic acid test and antibody test, urine pregnancy (women of childbearing age) test, and vital signs (blood pressure, axillary/oral temperature, pulse) evaluation. 

 

Screened eligible subjects, he said, are randomly assigned to the experimental group and the placebo control group, and vaccinated as per 2 months immunization schedule. Blood samples (5ml) will be collected before the first dose of vaccination, he added. 

 

ZF2001 is the second Chinese vaccine of which last stage human trials are being conducted. On January 26, Pakistan completed the last stage trial of China’s CanSino Biologics Inc's (CanSinoBIO), single-shot vaccine with 18000 volunteers. 

 

CanSino Biologics Inc's (CanSinoBIO) Covid-19 vaccine showed 74.8 pc efficacy in preventing symptomatic cases and a 100pc success rate in stopping severe diseases among Pakistanis in an interim analysis, said Special Assistant to the Prime Minister (SAPM) on Health Dr Faisal Sultan. In the global trials, the efficacy of the vaccine at preventing symptomatic cases was 65.7 pc and 90.98 pc at preventing severe disease, he shared on Twitter.

 

Pakistan has become the first recipient in the world of the third Chinese vaccine “ZF2001” after welcoming two other Chinese vaccines, CanSino and Sinopharm. 

 

Sajid Shah, spokesperson of the Ministry of National Health Services has said that since one company can never meet the demands of such a huge population, it is pragmatic approach to allow a number of companies to make things happen.

 

Debunking myth and neutralizing mist of disinformation about Chinese drug makers and their vaccines’ performance, Dr Javed Akram, Vice Chancellor of UHS and member of Scientific Task Force on Covid-19 claims what has been swirling around to smear Chinese vaccines is a pack of lies. “So far thousands of shots of CanSino have been administered, and not a single case is detected with adverse effects or death," he added.  

 

About vicious propaganda to downgrade Chinese vaccines in comparison with US and European vaccines, he termed the debate as invalid saying every vaccine has its own merits and demerits and none of them could be given preference to one another. “It is misleading to say that some vaccines either Chinese or Western are unfit for human," he added. 

  

It is pertinent to mention that ZF2001 is a three-shot vaccine, CanSino is a single-shot vaccine and Sinopharm is a two-shot vaccine. 

 

CanSino, Recombinant Novel Coronavirus Vaccine Adenovirus Type 5 vector (Ad5-nCoV), has been developed by CanSinoBio and Beijing Institute of Biotechnology China. Sinopharm vaccine has been developed by the Beijing Institute of Biological Products, a subsidiary of state-owned conglomerate Sinopharm.