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Drap okays marketing of CanSinoBIO vaccine
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February 18, 2021
ISLAMABAD: 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 sectors. 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).
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 (SAEs) and, therefore, CanSinoBIO has been allowed by IDMC to continue to advance the global phase-III clinical trial of the Ad5-nCoV.
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