The Pharmacy and Poisons Board of Kenya has received seven applications related to COVID-19 vaccine clinical trials.
The applications have stated that the use of different products including convalescent plasma, vaccine, monoclonal antibody, repurposed drugs and radiotherapy will be involved in testing their impacts.
Health Chief Administrative Secretary Dr Rashid Aman announced that Kenya has received seven applications. Three applications have been reviewed and approved while four are under review.
“Approval for the studies come with strict conditions including submission of monthly progress reports, and are also subject to regular monitoring to ensure compliance with legal, regulatory and GCP compliance,¨ said Dr Aman.
The Pharmacy and Poisons Board instituted internationally accepted Emergency use/Compassionate use Authorisation (EUCUA procedure), for quick authorization of treatments and diagnostics to combat the effects of COVID-19 disease.
The board also carries out studies to monitor previously unreported adverse effects of medicines and medical products after they have been licensed for use.
This normal practice by medicine authorities is called pharmacovigilance.
To assure the safety of COVID-19 patients during their course of treatment, the PPB is conducting countrywide pharmacovigilance of Health Products and Technologies used in the management of COVID-19.