Covid-19 vaccine: study begins in Cali

After pharmaceutical company Janssen, a subsidiary of Johnson & Johnson, gave approval to the Center for Pediatric Infectology Studies in Cali, Ceip, to apply its vaccine against Covid-19, phase clinical trials began this week. III of the organic in the city.

This was confirmed by the specialist in infectious diseases and director of the CEIP, Pío López, who pointed out that vaccinations have started to be carried out since last Tuesday, November 3. During the first few days, 30 people have already been linked to the study and a total of 500 volunteers are sought for vaccination.

“This is a ‘double-blind’ study, so 250 people will receive a placebo and another 250 will receive the vaccine. We will be doing the follow-up for two years, then we will call participants weekly to see how they are doing and what progress they are seeing, ”said López, who pointed out that there are already more than 1,000 people on the list participating in the clinical study.

The trial will be divided into four groups: under 60 without comorbidities, under 60 with underlying pathologies, over 60 without health problems and over 60 with controlled diseases.

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“The people not participating in the study are those who are sick or have symptoms of Covid-19. Even those who have already had the disease cannot participate in the study. Nor would we want people with autoimmune diseases to participate, such as lupus or rheumatoid arthritis, ”López added.

It should be remembered that the clinical trial of this vaccine was suspended worldwide in mid-October after one of the participants presented an adverse reaction. However, the practices were resumed in several countries between September and October.

“When this case appeared, an independent data commission, which is a group of people who are out of the laboratory, did an adverse event analysis and saw that there was no relationship between the vaccine and what it is. success to the patient, so he gave the green light again to the trials, as did the FDA (Food and Drug Administration, for its acronym in English) and Invima, “said the specialist.

Clinical trials in Colombia currently take place in the research centers of Bucaramanga, Barranquilla, Floridablanca, Bogotá, Cali and Medellín.

The study will be conducted on 60,000 volunteers aged between 18 and 60 in the United States, Chile, Colombia, Mexico, Peru and South Africa.

Janssen’s director of medical affairs for Latin America North, Carlos Alvarado, at the time explained to El País that interim results from the earlier stages of this vaccine “demonstrated that a single dose induced a strong neutralizing antibody response in almost all older participants. 18 years old and was generally well tolerated. Immune responses were similar in all age groups studied, including the elderly ”.

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Alvarado also indicated that the first set of results from the study should be available by the end of the year. “The first batches of a SARS-CoV-2 vaccine will be available for emergency use in early 2021, which is substantially shorter than the typical vaccine development process,” said Janssen’s spokesperson. North Latin America.

How to participate in the study?

To participate in the Covid-19 vaccine trial, you can register on the website of the Center for Pediatric Infectious Disease Studies in Cali (http://ceiponline.org/).

There you will find a large “banner” that says “Vaccine against SARS-CoV-2, which causes COVID-19”, in which you must click to read the terms of the study and the data processing policies.

Next, you need to fill out a pre-registration form with basic information, such as full name, ID type and number, age and telephone number.