The Higher Council for Scientific Research (CSIC) and Biofabri have decided to withdraw the application to the Spanish Medicines Agency (AEMPS) to carry out a clinical trial of their vaccine against Covid-19, “before the difficulties to complete it in Spaingiven the very high percentage of the vaccinated population and the incidence of the new omicron variant”. Last July, the AEMPS decided to suspend ‘sine die’ which at that time was the first Spanish vaccine after lung lesions were detected in a monkey.
In any case, CSIC and Biofabri have decided that research on this vaccine, led by researchers Mariano Esteban and Juan García Arriaza at the National Center for Biotechnology (CNB-CSIC), “continues to adapt your vaccine model to the new variants“.
“After analyzing the current vaccination situation against SARS-CoV-2 virus infection in Spain, we have assessed the window of opportunity to carry out this clinical trial, and we have decided to withdraw the evaluation dossier that we have presented to the AEMPS”, as confirmed by CSIC sources to Europa Press, after the information provided by Medical Writing.
In August 2021, the AEMPS requested a series of “clarifications” on some specific aspects of the clinical trial from the researchers. “It is a routine procedure, it is quite routine that in any trial this type of clarification is requested. The current state is that clarifications have been requested on a number of issues. We will be waiting for these clarifications to occur,” the Minister of Health, Carolina Darias, commented at the time.
Although it was rumored that the clinical trial in humans was not authorized because the vaccine caused lung injury to a monkeythe CSIC denied that the paralysis of the process was due to the death of this animal.
The Minister of Science and Innovation, Diana Morant, explained in January why the AEMPS did not approve the move to human trials for the vaccine. The explanation is that science is like that, it has its processes. In the investigation, the results that one would like are not always achieved,” the minister explained at an informative breakfast organized by Europa Press on January 31.
The phase 1 trial, for which around a hundred volunteers were going to be counted on, was going to be carried out at the Hospital de la Paz, which had already started recruiting. In phase I 112 volunteers were going to participate and the effect of the doses would be analyzed, while in phase II the immunogenicity and safety results would be evaluated in 500 volunteers. Finally, in phase III, between 20,000 and 30,000 healthy people were going to be recruited in whom the efficacy of the vaccine could be evaluated.
The project of Esteban y Arriaza consisted in using a highly attenuated virus of the smallpox family as a vaccine vehicle to introduce the spike protein of SARS-CoV-2, which is what allows the virus to enter cells. In this way, it would be possible to immunize people so that they generate antibodies against that protein.
In any case, the minister congratulated Esteban and “all the lines of research that fought and contributed to learning more about the virus.” “Science has not been only vaccines, it has given many scientific results that we have taken advantage of to live with the virus,” she specified.
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