The National Institute for Food and Drug Surveillance (Invima), reported that it approved the clinical research protocol with drugs for the beginning of “Vaccine Solidarity Trial – an international randomized trial of vaccine candidates against covid-19”; study sponsored by the World Health Organization-WHO.
(There is no counter-indication for using Pfizer in pregnant women, Invima says.)
The authorization is given after jointly by the Clinical Research Group of the Directorate of Medicines and Biological Products and the Specialized Room for Medical Devices and In Vitro Diagnostic Reagents The Institute will evaluate the information provided for Colombia to join this clinical trial that aims to collect information regarding the efficacy and safety of various vaccines against covid-19, through the design of a highly innovative study.
Colombia was chosen among 20 candidate countries worldwide, and in the region it will be together with Argentina, Brazil, Chile, El Salvador and Mexico.
(Invima approves a new covid vaccine trial in Colombia).
The trial is designed with the objective of coordinating a rapid, efficient and reliable evaluation of the candidate vaccines under development against SARS-CoV-2, in relation to their safety and efficacy and to identify those that will be appropriate to delay the progression of the illness.
Initially Colombia will participate with two types of vaccines: MVC-COV190115 developed by the company Medigen Vaccine Biologics Corp, a live attenuated virus vaccine; and INO-4800, developed by Inovio Pharmaceuticals, which uses a deoxyribonucleic acid (DNA) technology and also links the use of an electroporation device called CELLECTRA ™ ️ 200.
It is expected that other types of vaccines will enter during their development with the participation of 120,000 volunteers worldwide and around 40,000 in Colombia, volunteers must be over 16 years of age who reside in places with a high incidence of the SARS-CoV-2 virus , or whose circumstances represent a significant risk of exposure, such as health workers, frontline workers, essential workers in areas that do not yet have access to vaccines, and will last approximately 15 months.
Initially The institution authorized to carry out this clinical trial is the Colsanitas SA Clinic, University Clinic Headquarters located in the city of Bogotá, with Dr. Julio Alberto Chacón Sarmiento as the main investigator of this trial.
However, institutions certified in Good Clinical Practices (GCP) or those that have the endorsement of a certified entity in accordance with the provisions of Resolution 730 of 2020 may participate in the clinical study.
This study is added to the 5 clinical trials of vaccines that are being carried out in Colombia.
BRIEFCASE
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