Feb 17, 2021: Drug Regulatory Authority of Pakistan (DRAP) has granted ‘Emergency Use Approval’ to the CanSinoBIO Recombinant COVID-19 Vaccine Adenovirus Type 5 Vector (the “Ad5-nCoV”) and its marketing through private and public sector.

According to an official of DRAP, the approval has been granted following the communication of the results of the interim analysis of the global phase III clinical trial of Ad5-nCoV to the Health Ministry by the Independent Data Monitoring Committee (IDMC).

He said that the “Ad5-nCoV” has successfully met its pre-specified primary safety and efficacy criteria in the interim analysis. There were no vaccine related serious adverse events (SAE) and therefore CanSinoBIO has been allowed by IDMC to continue to advance the global phase III clinical trial of the Ad5-nCoV.

The final CanSino Biologics Inc.’s experimental coronavirus vaccine stage clinical trial had an efficacy rate of 65.7% at preventing symptomatic cases based on an analysis of 30,000 global participants adding a one-shot candidate to the world’s growing arsenal against Covid-19. And it was 90.98% effective in preventing severe disease.

In the Pakistan subset, efficacy at preventing symptomatic cases is 74.8% and 100% at preventing severe disease. A vaccine needs to afford at least a 50% protection rate to be considered effective, as mandated by the world’s leading drug regulators and the World Health Organization.

This phase III clinical trial of Ad5-nCoV is a global multicenter, randomized, double-blind, placebo controlled, and adaptive designed phase clinical trial are being conducted to evaluate the efficacy, safety and immunogenicity of the Ad5-nCoV in adults over 18 years of age.

All participants received a single dose of either Ad5-nCoV or a placebo vaccine on Day 0 and followed to monitor vaccine candidate efficacy and incidence of SAE for duration of 52 weeks.

The primary efficacy objective is the efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) symptomatic COVID-19 disease, regardless of severity, occurring 28 days to 52 weeks after vaccination.

COVID-19 disease rates in Ad5-nCoV group are compared with COVID-19 rates in the control group. The primary safety objective is to evaluate the incidence of SAE and medically attended adverse events within 52 weeks after vaccination in all participants.

The phase III clinical trial of Ad5-nCoV, part of the multi-country multi-center clinical trial being conducted by CanSinoBIO, was initiated in Pakistan on September 22, 2020. Later the study was extended in Mexico, Russia, Argentina and Chile.

The total global target of the Clinical Trial is 40,000 volunteers, including 17,500 volunteers from Pakistan, and is being conducted in 78 clinical trial sites across five countries over three continents. The study is led by a global principal investigator (“PI”), global co-PI and country co-PIs from seven countries, and strictly complies with high ethical standards and rigorous scientific principles.

The progress of the Phase III Clinical Trial in Pakistan as well as globally has being keenly followed by the global scientific community and people all over the world, National Coordinator, CanSinoBio vaccine Phase III clinical trial in Pakistan, Prof Hasan Abbas Zaheer said.

He added the clinical trial in Pakistan is a public private partnership between the National Institute of Health (NIH), a premier public health organization of the government and a private sector partner, AJM Pharma (Pvt.) Ltd., a reputable name in the national pharmaceutical sector.

The study is being conducted in five prestigious medical research centers in the country; Aga Khan University Hospital, Karachi, Indus Hospital, Karachi, Shaukat Khanum Memorial Hospital, Lahore, University of Health Sciences, Lahore and Shifa International Hospital, Islamabad, he added.

Dr Hasan said that this is the first time that such a vaccine trial is being conducted in Pakistan yet the response of the public in volunteering in this national cause has been terrific and Pakistan was able to complete its recruitment target within a short period of four months.

CanSinoBIO has agreed to supply 35 million doses to Mexico while Malaysia is in talks to get 3.5 million shots. In June 2020 the vaccine was used in China for immunizing its military following its Emergency Use Approval in China.

Successful pioneering organization of the clinical trial in Pakistan enables Pakistan preference with the vaccine. Plans are afoot to develop filling and labeling facility of the vaccine in Pakistan, through Public-Private Partnership, which will not only speed up the availability but also considerably reduce the costs.

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