The Hospital Universidad del Norte, located in the municipality of Soledad, was endorsed by the National Institute for Food and Drug Surveillance (Invima) to participate in the clinical trial for the third phase of the Covid-19 vaccine, which is developed by Janssen Pharmaceuticals.
The health institution, which is located in the municipality of Soledad, is part of the list of six centers that already have the approval by the health authority to start the tests in the first weeks of September, after they are presented the results of the study in the previous phase.
Diego Castresana-Díaz, director of the Hospital Universidad del Norte, highlighted that participation in this trial is an endorsement of the scientific work carried out from his research center.
“We have participated in a large number of studies through the Research Center. Furthermore, these processes are always endorsed by a very strict ethics committee, which also monitors ”, he stated during a virtual press conference.
While Hugo Macareno, scientific director of the Hospital Universidad del Norte, said that this study seeks to determine the efficacy and safety of the vaccine to prevent the disease, which already leaves more than 23 million infected and 820 thousand deaths in the world.
“The inclusion criteria for this study are very rigorous. These studies will be with people between 18 and 68 years old, mainly those who are more exposed to the virus, “said Macareno.
The medical professional was emphatic in maintaining that among the exclusion criteria to participate in the clinical trial is having suffered the disease.
“The idea is that among the volunteers there are health workers, which is one of the populations that is most exposed to the virus. If a person is chosen to be part of this program, they must continue to use the precautionary measures ”, she indicated.
Silvia Aguilera, coordinator of scientific studies at Hospital Universidad del Norte, indicated that they are waiting for the sponsor of the study to determine the number of volunteers that are needed.
“Worldwide, 60 thousand people will take part in the test. The number that will be treated in each of the centers has not yet been defined and as soon as we have that data we will be able to define the strategies for their recruitment, ”said the medical professional.
Aguilera added that the main objective of phase three of the trial of this vaccine is “to validate the efficiency and safety in a representative group.”
“This test is very important to know how the virus behaves in the region. As a research center we are going to do everything possible so that this vaccine can be reliable and safe ”, he added.
In Barranquilla, the Cimedical clinical research center also received the endorsement to be part of this process.
Juan José Jaller, medical scientist at Cimedical, explained that the idea is that people over 18 years of age in good health and with a high risk of contagion participate. Each volunteer will have six face-to-face visits and weekly follow-ups to monitor if they are infected.
“This previous experience generates security, it also has the backing of the Johnson & Johnson group,” Jaller said in dialogue with EL HERALDO.
It should be noted that the people who will participate in the clinical trial will not receive any financial remuneration.
The invima speaks
The National Institute for Food and Drug Surveillance (Invima) indicated that the approval for the development of this clinical trial is done “exceptionally”, to advance in logistical aspects related to the importation of the vaccine, medical supplies and training of the research team in the institutions approved to participate in the process.
The entity said that, in this way, the country is expected to be ready to begin recruiting participants from the month of September. The estimated primary completion date is March 2023, although initial results are expected in January next year.
“Colombia’s participation in this clinical trial is thanks to the efforts made by the national government to control the effects of the pandemic and to improve response times in regulatory procedures related to emergency care,” said Julio César Aldana, CEO of Invima.
Likewise, the official stressed that “the measures adopted allowed the materialization of a public health policy, placing Colombia on the world stage of viable countries to start clinical trials with these vaccines.”
In addition to the Hospital Universidad del Norte and the Cimedical clinical research center, the country approved the start of the clinical trial at the Fundación Cardiovascular de Colombia (Bucaramanga), Caimed (Bogotá), Fundación Oftalmológica de Santander (Floridablanca) and Solano & Terront Medical Services (Bogotá), Invima indicated in a press release sent to this medium on Tuesday.
9 centers await the endorsement
The National Institute for Food and Drug Surveillance (Invima) reported that nine research centers throughout the country are awaiting verification of compliance with the requirements to be part of the clinical trial.
The Clínica de la Costa de Barranquilla is part of this small group together with the Valle del Lili Foundation (Cali), Medplus Prepaid Medicine (Bogotá), Pediatric Infectious Disease Center (Cali), Santa Fe Foundation (Bogotá), Pablo Tobón Uribe Hospital (Medellín), Fundación Centro de Investigación Clínica CIC (Medellín), Program for Studies and Control of Tropical Diseases (Medellín) and High Complexity Scientific Assistance (Bogotá).
These centers seek to join the six that have already received the endorsement to carry out this study.
Globally, the third phase will initially take place in five other countries: the United States, Chile, Mexico, Peru and South Africa.
The clinical trial is expected to take place with a total population of 60,000 participants, proportionally distributed among these countries.