ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has granted ’emergency use approval’ to the CanSinoBIO Recombinant Covid-19 Vaccine Adenovirus Type 5 Vector (Ad5-nCoV) and its marketing through private and public sector.
According to a DRAP official, the approval has been granted following the communication regarding 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 65.7pc at preventing symptomatic cases based on an analysis of 30,000 global participants. The vaccine was 90.98pc effective in preventing severe disease.
In the Pakistan subset, efficacy at preventing symptomatic cases is 74.8pc and 100pc at preventing severe disease. A vaccine needs to afford at least a 50pc 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.