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The National Institute for Food and Drug Surveillance (Invima) announced this Monday that authorized the recruitment in the country of volunteers to evaluate the efficacy and safety of the Ad26.COV2.S vaccine for covid-19 prevention from Johnson & Johnson (J&J).
This process will begin worldwide on September 21 and in Colombia it occurs after Invima officially received the results of the phase 1/2 study of this project last Thursday, thus confirming the security required to start phase III in the country.
(In context: What you should know if you want to volunteer for the covid vaccine)
It should be remembered that on August 25, Invima authorized in Colombia the development of the clinical trial ‘VAC31518COV3001 – Randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy and safety of Ad26.COV2.S for prevention of covid-19 mediated by SARS-CoV-2 in adults from 18 years of age ‘.
This phase III trial It will also be held in parallel in the United States, Chile, Colombia, Mexico, Peru and South Africa, with a total population of 60,000 participants, distributed proportionally among these countries.
In Colombia it will be held at the Fundación Cardiovascular de Colombia in Bucaramanga; the Center for Medical Assistance Research (Cimedical) of Barranquilla; the Center for Attention and Medical Research (Caimed) in Bogotá; the Fundación Hospital Universidad del Norte de Barranquilla; the Santander Ophthalmology Foundation (Foscal) in Floridablanca; and Solano & Terront Servicios Médicos Ltda (Uniendo) in Bogotá.
The Invima, in any case, indicated that “You can interrupt the performance of a clinical investigation at any time or demand the introduction of modifications in your project” in accordance with the provisions of article 6 of resolution 2378 of 2008, in order to comply with good clinical practices and the protection of human beings under test.
In what is approved by Invima, two stages are contemplated. The first, with two components: adult participants between 18 and 60 years old, without comorbidities associated with an increased risk of progression to intense covid-19; and another group with comorbidities that can generate severe forms of the disease. And the second, in adults over 60 years of age, with and without comorbidities that are associated with an increased risk of severe covid-19.
(Read also: This is the experimental vaccine for covid that will be tested in Colombia)
The Invima had clarified that J&J will be in charge of defining, in addition to the research centers, the criteria for selecting the volunteers, in such a way that no government or official sector actor gets involved in these elections.
“Participants in the clinical trial must sign an informed consent where they accept their voluntary participation in it. They must fully comply with each of the recommendations of the research team, in order to obtain robust data on the safety and efficacy of the drug / product under investigation, ”says Invima.
The entity recalls that in Colombia the payment and use of incentives for participants for the fact of joining an approved clinical trial is prohibited.
(We recommend: The definitive guide to take care of covid-19 in the new reality)
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