DRID – The Spanish Medicines Agency has not yet given permission to proceed to the clinical phase of the most developed covid vaccine from Spanish soil to date. The new vaccine was developed by the Spanish National Centre for Biotechnology (CSIC).
That is a major setback for Spain, because the expectations of this so-called MVA-COVID19(S) vaccine are high. In January this year, the Spanish Ministry of Science reported an effectiveness in laboratory animals of 100%.
The experimental vaccine by Spanish scientists Mariano Esteban and Juan García Arriaza is based on a weakened version of the Vaccinia virus. This belongs to the smallpox family. The virus has been genetically modified in such a way that it is also effective against the coronavirus. Animal studies have shown two doses of this vaccine are also required for maximum effectiveness against the coronavirus.
Initially, the lab phase was delayed because there was a shortage of monkeys to test the new vaccine. Subsequently, the CSIC received 12 monkeys from the Biomedical Primate Research Centre in Rijswijk for the research. After the animal test phase, the Spanish drug agency AEMPS would approve to start the clinical trial phase with humans.
Monkey would have died after being vaccinated
However, there is still no green light for this final research phase. According to the newspaper El Español, this could be related to health problems of one of the monkeys. Although Esteban firmly denies this and reports the presumed death of one of the animals is not true. If health problems had arisen as a result of the vaccine during the laboratory phase, Esteban said approval for the clinical phase would not have been applied for. Furthermore all international protocols have been followed in the pre-clinical trials of the vaccine. Based on the results in terms of safety and effectiveness, the clinical trial phase could be started, according to CSIC. However, the CSIC has not commented further on a possible reason why the AEMPS has not yet given its approval.
The Spanish researchers announced six months ago they wanted to conduct the first clinical tests with 112 subjects. First, the vaccine’s safety and immune response would be tested in humans. Thereafter, if the results were good, the clinical phase would continue this year with another 20,000 volunteer subjects.
The Spanish vaccine was developed in collaboration with Biofabri, a company specialising in veterinary vaccines. Esteban received a €3million corona vaccine development budget and 11 scientists to participate in the pre-clinical research.
Various projects in Spain for covid vaccine development
The CSIC currently has three different research projects for the development of a covid vaccine, of which Esteban’s project is at the most advanced stage. In addition, Spanish scientists Luis Enjuanes and Isabel Sola are working on an m-RNA vaccine (such as Pfizer and Moderna) that is still in the laboratory phase. Minister Darias of Health announced a few weeks ago that if laboratory results are positive, the clinical phase of this study could start as early as the second half of 2021.
Spain plays an active role in vaccine development
A third major study is being conducted in Spain by pharmaceutical company Hipra, which is developing a protein-based vaccine. This vaccine must also be effective against new virus variants. Hipra has already tested the vaccine on various animal species with good results so far. “When we see the participation of the Spanish industry in the development of new vaccines, we can say that Spain is playing an active role in the solution of this pandemic,” said the minister.