The Spanish Medicines Agency (AEMPS) has not authorized clinical trials in people of the vaccine developed by the National Center for Biotechnology (CSIC). As published by El PaísBoth the CSIC and the Madrid hospital in La Paz, which had begun looking for a hundred volunteers for the tests, confirm the stoppage of the process, although they do not give details of the reasons. “At the moment we have not had an official notification from the Medicines Agency, but depending on what they communicate to us, we will make a series of allegations in this regard. This is the official and not unofficial point of view,” he explains to elDiario.es virologist Mariano Esteban, head of the Poxvirus Group in charge of developing the vaccine.
Even if The Spanish advanced this Saturday that the suspension was due to lung injuries to a monkey, Esteban denies that this occurred. “No macaque has died from the vaccine, that news is false. This is a process: first you administer the vaccine, then the virus to check if the vaccine has effect, then a process of euthanasia and finally the tissues are analyzed. Information is sent to the Spanish Medicines Agency and they assess the data that has been presented. Until we have that information we cannot define the causes “, clarifies the scientist.
Both the CSIC and the Galician company Biofabri -which is in charge of manufacturing the vaccine batches for human trials- assure in a statement that all the usual international protocols have been followed in the development of preclinical vaccine trials, and that, based on the results in terms of safety and efficacy, it has been considered appropriate to request the clinical phase trial.
At the CSIC, three vaccine projects against COVID-19 are currently being developed, of which Esteban’s is the most advanced and during the tests with mice it achieved 100% efficiency. She was on the verge of starting the clinical phase in humans and, if she did, she would have been the first of the four Spanish women to make the pharmacological leap and become a real option just as Spain struggles to get enough doses from foreign ones. If the death of a macaque had occurred due to a lung injury after the administration of the preparation, the clinical trial would not have been requested, they emphasize.
“The AEMPS asks us questions and asks us to add more data. We make a document, but then that document is revised and that is what we have been completing,” said Mariano Esteban, a CSIC researcher, to elDiario.es when asked at April for general reasons delaying the clinical phase in humans. “We are in the phase of filing the details with them. They put a lot of effort into you, but that is very good and I am very in favor. We have no complaints about it, quite the opposite. The relationship is great,” said the scientific.
The details with which the AEMPS is more demanding, according to Esteban, is in “safety and proven efficacy in the preclinical phase”. “Then they review all the bibliography, what has been published in this regard, and they let you know if there is any reference that you have missed. They are very strict when ordering. For scientists, this is part of our daily assets”, says the scientist before adding that there is “not a single request that has gone forward without comment, which is very positive. The agencies are there to help, not to create problems.”
Source: ElDiario.es – ElDiario.es by www.eldiario.es.
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