The 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 Organisation (WHO).
This phase III clinical trial of Ad5-nCoV is a global multicenter, randomized, double-blind, placebo controlled, and adaptive designed phase clinical trials 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 a 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.
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.
