The National Institute for Food and Drug Surveillance (Invima) approved clinical trials of the vaccine CoV2 preS dTM-AS03 (D614), from French pharmaceutical company Sanofi Pasteur and the British group GSK.
With this permission, the drug will be tested in the country and for this about 3,000 volunteers are needed.
For now, it is known that the trial will consist of administering two doses of the vaccine 21 days apart to a group of volunteers. Likewise, a placebo in two doses will be applied to another group, at the same time.
(See: New rules to vaccinate: by age and ‘peak and ID’ in some cases).
The tests in Colombia will be carried out in 7 research centers in different cities of the country. Two of them have already been confirmed in Barranquilla: the Fundación Hospital Universidad del Norte and the Clínica de la Costa.
(See: Colombia, 2.59 million vaccines from meeting June target).
For now, it is known that those who want to participate in the trials must be over 18 years old and will have to contact the research centers directly.
Dr. Carlos Reyes, medical director of Sanofi Pasteur Andean Region, Central America and the Caribbean, explains that Colombia was included in the investigation taking into account its previous experience in this type of project, the characteristics of its population and the behavior of the disease in the country.
“It is very important that this type of study be carried out in our countries because it allows us to evaluate population and epidemiological aspects, as well as safety and efficacy in our region.”Said the expert.
(See: Colombia is approaching 100,000 deaths from covid: what is happening?).
in total they will be those who participate in the vaccine trials worldwide.
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These trials correspond to phase III of the investigation and will focus on the efficacy of the vaccine against the original Wuhan strain and against the South African variant. They will be held in various countries around the world.
If everything goes well, the vaccine could be licensed by the fourth quarter of 2021. Thus, its production will begin in the coming weeks so that, once approved, access to the doses is as fast as possible.
(Lea: San Andrés, the first place in the country to achieve herd immunity).
Sanofi too is in the process of producing 400 million doses of vaccines from other companies, that have already been approved, such as BioNTech, J&J and Moderna.
BRIEFCASE
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