Trials with volunteers of one of the most promising investigational Spanish vaccines against Covid will have to wait. The reason why the clinical trial has been postponed at Hospital La Paz is that the Spanish Medicines Agency (Aemps), dependent on the Ministry of Health, has not yet given the green light to the clinical trial, as explained by the Higher Council for Scientific Research (CSIC), the body that develops the vaccine. The CSIC is waiting for your authorization after presenting all the results of animal experimentation, performed in humanized monos, hamsters and monkeys.
The delay is not due to a vaccine safety problem due to the death of one of the animals with which it was experimented, according to the information published in ‘El Español’. “It is totally false that the administration of the vaccine has caused the death by lung lesions of one of the macaques used in preclinical trials,” Mariano Esteban himself, the researcher at the National Center for Biotechnology who directs the research, explained to ABC. The scientist Juan García Arriaza, also involved in the same investigation, also denies the information to this newspaper and assures that they have no communication from the Medicines Agency with the suspension “sine die“of the essays.
The MVA-COVID-19 (S) vaccine, developed by Mariano Esteban’s team at the National Center for Biotechnology together with the Biofabri laboratory, had already completed the animal research phase and was about to start clinical trials at Hospital La Peace. This Madrid health center has already I was recruiting volunteers and he was the only one in Spain that was going to carry out the first stage of research in humans. The tests were scheduled for the end of this month of August. Wanted people between 18 and 39 years old that they were not vaccinated and had not contracted Covid at any time during the pandemic.
This Saturday, information has been published that assured that after the delay of the trial doubts about the safety of the vaccine were hidden, after death, from lung injuries, from one of the macaques that received the CSIC vaccine. This last phase of the research was carried out outside of Spain, at the Rijswijk Center for Biomedical Research in Primates, in the Netherlands.
“All protocols have been followed”
The CSIC assures in a statement that both its institution and the Biofabri laboratory «have followed all the usual international protocols in the development of preclinical vaccine trials, and that based on their results in terms of safety and efficacy, it has been considered appropriate to request the trial of the clinical phase. If a macaque died from lung injury after the vaccine was administered, the clinical trial had not been requested».
Esteban’s team vaccine, the most advanced of those produced in our country to date, worked in humanized mice against “lethal doses of the coronavirus.” The good results on the animal model were published in the Journal of Virology.
The CSIC prototype is based on an attenuated version of the Vaccinia virus, used in the eradication of smallpox.
George is Digismak’s reported cum editor with 13 years of experience in Journalism