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men the morning of this Wednesday, the vaccine that Johnson & Johnson develops with its pharmaceutical company Janssen against COVID-19 began to be tested in Colombia. In Santander the first 18 people were injected.
The event was registered with the Fundación Cardiovascular de Colombia. The neurologist and epidemiologist Federico Arturo Silva, director of the FCV Clinical Studies Unit, explained that these people received the candidate vaccine in the upper arm. “It is an intramuscular vaccine.”
The expert stated that those who receive this dose may experience a headache, fever and general malaise, as when it comes to other vaccines. “We have a team of more than 30 people dedicated to caring for patients and are awaiting any type of reaction they may have.”
After signing a consent form, the volunteers underwent medical check-ups to ensure their good health. “We take all precautionary measures,” Silva said.
The study
Three weeks after the FCV and the Foscal Clinic enabled their contact and registration channels for those over 18 years of age interested in participating in the third phase of the clinical study of the COVID-19 vaccine, which is being carried out by Johnson & Johnson, Together with its pharmaceutical company Janssen, Santander started immunization.
According to data provided by the two clinical centers, around 1,300 volunteers expressed their desire to contribute to this clinical study.
The Director of the FCV Clinical Studies Unit stated that so far they have 900 people registered, of which only 500 will be included in this first stage of the study in the region.
However, he explained that those who remain on the waiting list or continue to register will be taken into account in the following phases. Tomorrow, Wednesday, the application of scientific development is expected to begin.
Also read: Only 13% of those infected with COVID-19 in Santander have the active virus.
“There is a new potential study to start between November and December, a third to start in January and a fourth in March 2021. Therefore, people who wish to collaborate can continue to register,” he said.
On the other hand, Paul Anthony Camacho, Director of Investigations at Foscal, indicated that there have been 400 people registered so far.
“We are in the entire process of enlisting the personnel and the facilities where these participants will be served.”
He also explained that for each person who enters the study, at least two more must be interviewed, since the eligibility criteria are very strict.
“Initially Foscal was scheduled to include 200 patients in the study, however it is possible that the number will increase. We plan to interview between 900 and 1,000 people. We cannot run, we have little time to invite participants but we must select people very well, we are concerned that in trying to be included they omit relevant information about their health, which could later generate a complication for their health and for the study ”, emphasized the Director of Investigations of the Foscal.
First advances
According to the director of the FCV Clinical Studies Unit, this Wednesday the application of the vaccine developed by Johnson & Johnson began, in order to measure its effectiveness.
The volunteers they will have are over 18 years of age. The idea is that the volunteers enter the study in several sequences, the youngest ones who do not have risk factors will be taken into account first.
“We already have the vaccine in our institution, it arrived on Saturday. We are in the process of the volunteers signing the informed consent and being screened to verify that they meet all the requirements, ”explained Federico Arturo Silva.
For his part, Foscal hopes that in the course of this week the medicine will arrive to start the immunization.
“The great auditor of the entire process are the research ethics committees. There were some difficulties on the part of the sponsor for the arrival of the medicine and that is why we did not start in September but now in October. Everything is already approved for vaccination. Only one medical center has been started in the country. Santander would be the second department to start, however we are very on par in the country, ”Camacho mentioned.
How long does the study take?
Víctor Castillo Mantilla, president of the FCV, explained that the development of a vaccine is made up of different phases. The first is a laboratory phase in which pharmacy chemists and developers advance a molecule.
The second phase is carried out in animals to look for safety and reaction to the vaccine, as well as an immunological reaction.
After the two phases comes the third, which is in which Santander participates.
“The third phase within the development regulations has three stages: the first is applied by 40 to 50 people. What are you looking for? That there is no adverse reaction, such as the patient dying or having a major complication, “said Castillo Mantilla.
This stage of the trial usually takes between two and three months.
Phase two of the search for the vaccine applies to 300 and 500 people, with a duration of six months to a year.
“This phase what it seeks is to find the ideal dose to generate the immune response, what it also seeks is to quantify the dosage. If you need one or two ampoules, “he added.
The third stage of phase 3 corresponds to the massive application of the vaccine and can last between two and 10 years and is applied between 10,000 and 70,000 volunteers.
Do you want to volunteer?
If you want to join the initiative that will be carried out in Foscal in alliance with the pharmaceutical company Janssen, all you have to do is register by sending an email with your details to the email: [email protected].
If, on the other hand, you want to support the FCV trial, you can communicate your interest in being a volunteer by calling the telephone number 639 9292 Ext. 306 – 341 – 343, writing to WhatsApp chat 300 238 4581 or by email: Estudiosclinicos @ fcv .org.
The FCV staff will assist you every day from 7:00 am to 5:00 pm
This third phase will be carried out with 60,000 volunteers from the United States, Chile, Colombia, Mexico, Peru and South Africa.
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