The vaccine developed by Mariano Esteban and Juan García Arriaza, from the CNB-CSIC, has proven to be effective in protecting monkeys from the different variants of the coronavirus. An achievement that, at this point in the pandemic, will not allow them to take their preparation into the arms of the Spanish. The CSIC team has just published its good scientific results while giving up convincing the Spanish Medicines Agency (AEMPS) to test it on people. Meanwhile, the vaccine from the Catalan pharmaceutical company Hipra continues its trials with 3,000 volunteers in Spain, Italy and Portugal.
The break occurred at the end of July 2021, when Esteban’s was the vaccine that received the most support from the Government. At that time, the AEMPS requested more information from the CSIC to approve this leap from trials on macaques to tests on people. The CSIC assured that it was finalizing its response, but it never finished taking that step, according to the agency: “At the time they gave up, the clarifications that the AEMPS had requested to authorize the phase I trial had not yet been presented, the first step in human clinical research.
At the CSIC they defend that the preclinical results support its future application in trials, but “because the majority of the Spanish population is vaccinated against SARS-CoV-2, the promoters CSIC and Biofabri have decided to withdraw the application.” “This does not prevent the vaccine from being considered in other countries and settings, where the vaccination rate is very low and highly stable vaccines are required, and be used either individually or in combination with other vaccines,” they add. The CNB-CSIC researchers continue with the development of this vaccine, despite everything, “to increase its degree of efficacy against emerging variants”.
The promoters have informed the AEMPS of their withdrawal because there is no point in continuing the development in Spain for two reasons, the agency now explains, “because of the difficulty of carrying out the trials with such a high vaccination rate and because it was not going to arrive in time to cover any need not covered by other licensed vaccines.” Meanwhile, the Hipra vaccine has just started its phase III trials in collaboration with 15 Spanish hospitals. And it does so with people who have already received the full guideline from Pfizer, Janssen, Moderna or AstraZeneca, according to the European Medicines Agency.
In the summer of 2021, when the process of searching for volunteers for this CSIC vaccine was paralyzed, the Minister of Science, Diana Morant, assured that she had dedicated 21 million euros to the development of Spanish vaccines. Esteban’s laboratory, 76 years old, had had a budget of more than 3 million euros and 11 specialists to develop his drug in this preclinical phase. Yesterday, Morant defended that stopping the clinical trial falls within “the normality of research.”
The CSIC congratulates in a note that “the vaccine confers 100% protection against the infection caused by SARS-CoV-2 in the three animal models, controlling the replication of the virus in the respiratory tract and in the lungs, pulmonary pathology and preventing the cytokine storm. The AEMPS explains that it is common for a large part of the scientific developments not to be fully developed, but that it is a “very useful work, since it contributes to the generation of scientific knowledge and to the strengthening of the Spanish innovative fabric”.
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