The Spanish Medicines Agency (AEMPS) has not authorized clinical trials in people of the vaccine developed by the National Center for Biotechnology (CSIC) and promoted by the virologist Mariano Esteban. 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.
Even if The Spanish advanced this Saturday that the suspension was due to lung injuries to a monkey, the CSIC denies in a note collected by El País that this is the reason and assures that “all the usual international protocols have been followed in the development of preclinical vaccine trials.” In fact, they add that “if the death of a macaque had occurred due to a lung injury after the administration of the vaccine, the clinical trial would not have been requested.”
The CSIC vaccine, based on a new technology compared to those used so far, is the most advanced of the Spanish ones and was going to become the first approved by the AEMPS. 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.
“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 researcher at the CSIC, to elDiario.es when asked in April about the general reasons that delayed 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, but quite the opposite. The relationship is great,” said then 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.”