The Foundation to Fight AIDS and Infectious Diseases (FLS) and the Germans Trias i Pujol Hospital have begun this Thursday to administer the covid-19 vaccine to volunteers, within the framework of the first phase 3 clinical trial on this serum carried out in Spain.
The Spanish Agency for Medicines and Health Products authorized on November 18 the clinical trial in phase III of the vaccine of the company Janssen, belonging to the multinational Johnson & Johnson, the first trial of this type authorized in Spain, which evaluates the efficacy and safety of the vaccine and should also be tested at this stage in Belgium, Colombia, France, Germany, the Philippines, South Africa, the United Kingdom and the United States.
The Spanish hospitals that have to participate in the trial with the University of Navarra Clinic, La Paz University Hospital, Quirón Salud Madrid University Hospital, La Princesa University Hospital, Quirón Salud Barcelona Hospital, Vall d’Hebron University Hospital, Hospital Clinic de Barcelona and Germans Trias i Pujol Hospital in Badalona.
The vaccine has begun to be supplied in the Catalan hospital of Badalona as part of Ensemble 2 studio, which seeks to clarify whether it is effective in preventing infection by the SARS-CoV-2 virus. To the study participants, who will be randomly assigned to receive vaccine or placebo, they will be given two intramuscular injections in the arm two months apart and they will undergo medical follow-up via telephone.
As the FLS researcher José Moltó explained to Efe, after administering the vaccine to the first volunteer in the study (a health professional), they first had a series of analytics and a covid-19 test and, later, a medication has been assigned before the IV is given.
The trial, in which anyone of legal age can participate, is expected to last a maximum of two years and three monthsTherefore, the final results will not be available until then, although, as Moltó has indicated, intermediate analyzes will be carried out to know, in about four or six months, if the vaccine is effective in preventing serious infections. However, given the epidemiological situation, it is not ruled out that the Janssen vaccine may receive a “emergency authorization“after the first results, with which it can be approved throughout 2021.
In any case, Moltó has highlighted the importance of continuing to research to “generate information on other alternatives” since, he stressed, “we do not know if the effect will last six months, two years or twenty”. In fact, he explained that, depending on how long the effect on immunity lasts, it could happen that someone who gets vaccinated in January has to repeat the process in a while: “These are questions for which we have no answer today“, he has admitted.
Unlike Pfizer’s vaccine, which must be stored at -70 degrees, Janssen’s can be stored in a -20 or -30 degree freezer and once out, remains “stable” for about 28 days in a refrigerator at 4 degrees, which is an “advantage” when distributing it in mass vaccination plans.
For his part, the first volunteer to receive the vaccine, doctor Marc Corbacho, explained to Efe that is “perfect” and without symptoms and, although he is “aware” that there may be “some risk”, he has assured that he prefers to focus on the “positive”: “I may be protecting my relatives (…). It’s worth it.”
Corbacho has asserted that the vaccine has been given to him in a “controlled environment” and has regretted that many people are “afraid” and “lose focus.” “There are many people behind who know a lot, ethical committees that ensure that the participants in the trials are well protected and we have a problem that is the pandemic, which we do not control,” he stressed.
The start of the phase 3 trial comes after the volunteer recruitment campaign that the FLS launched through the internet to encourage participation in studies both covid-19 and HIV and that in just over a month has brought together more than 4,000 people willing to contribute to the research.
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