The Higher Council for Scientific Research (CSIC) and Biofabri have decided to withdraw the application to the Spanish Medicines Agency (Aemps) to carry out a phase I trial with the vaccine against Covid-19, MVA-CoV2-S, just when published their positive results of protection against SARS-CoV-2 infection in mice, hamsters and macaques. The reason given is that the conditions were not met “given the very high percentage of the vaccinated population.” Mariano Estebanleader of the research group for this vaccine, together with Juan García Arriaza at the National Center for Biotechnology (CNB-CSIC), explains that “the fact of not doing the clinical trial does not mean that we stop working on the vaccine”, and regrets that
“In Spain, one of the biggest problems is that we don’t believe in ourselves.”
It gives the feeling that there is only money for a Spanish vaccine.
It should fill us with pride that four vaccines have been developed in Spain, three of them at the CSIC. It seems very good to me that the Hipra vaccine be promoted, but we must also give opportunities to others because, we are seeing that the current mRNA vaccines, although they work very well, offer shorter protection against SARS-CoV-2 duration. We are studying the possibility of combining with other vaccines to improve the effectiveness of vaccination.
It was said that this vaccine was going to be late.
Don’t be late! I am convinced that we are going to need more vaccines, like the ones we have at the CSIC.
If so, why not move forward with your clinical trial?
The fact of not doing the clinical trial does not mean that we stop working on the vaccine. The results of a US study with a vaccine similar to ours with very good results have just been published.
Your vaccine was ready in early 2021. Why has it taken so long to do preclinical trials??
We already had the vaccine in April 2021. The problem was that we did not have the infrastructure, nor the working conditions… But we quickly got going. We did the preclinical tests in the biological safety laboratory. The problem is that in Spain we do not have macaques. We applied to the US but they charged us 1 million dollars for 12 macaques and we went to the Center for Non-Human Primates in the Netherlands and thanks to the previous collaboration we had had, we were able to complete the study that has just been published.
In Spain, one of the biggest problems is that we don’t believe in ourselves. We scientists are fighters and we are very capable at a scientific level; This pandemic has exposed it. The contribution of Spanish science has been very good at all levels; diagnostic methods, antivirals, such as Pharmamar. And of course, vaccines. Our work capacity is equal to or greater than that of many countries, but what happens is that we have a problem with research personnel, infrastructure, and financing.
Spain remains at medium-high risk. Is the situation to rule out a clinical trial with a vaccine that has been shown to be 100% effective in macaques?
We have to consider other vaccines. The CSIC platform has three very good examples: ours, based on a variant of the vaccine that was used for smallpox; synthetic DNA vaccine Vicente Larragaand that of RNA from Luis Enjuanes and Isabel Sola. These three platforms complement each other and cover a broader spectrum.
How can this decision affect the other two vaccines that the CSIC has?
We continue with our vaccine, the only thing is that the planned clinical trial is not being carried out. We are open to any type of national or international collaboration. Now we are more focused on the variants, that is, on achieving a universal vaccine with a broader spectrum of action. But our vaccine is produced and available. It is good that Spain has a portfolio of vaccines that can be used in countries where vaccination rates are very low.
Is it complicated to start a clinical trial in other countries where it is necessary?
There is experience with HIV or Malaria vaccines in Africa. It is important for Spain to lead this type of vaccine action against viruses or emerging diseases, as it was with Ebola. We must be prepared to face any pandemic or epidemic because we are the gateway to many of them. This pandemic has shown that Spain has to prepare itself at an epidemiological, health, medical and business level.
Could these three vaccines be used in combination?
Yes of course. We have shown that the combination with two different vaccines achieves broader and more lasting immune responses. Likewise, there is evidence that the combination of the AstraZeneca vaccine with the Pfizer one produces a response immune system 20 times more powerful in vaccinated people. It is clear that we must go in that direction.
We must be aware that it is a virus that is evolving. Just look at what is happening in China, with cities of 20 million people confined.
What do you think about talking about getting the Covid-19 flu?
It is logical. We are all fed up. We want to return to ‘normal’ life and not think about the virus anymore. It’s okay for us to think that life has to go on. But although Omicron, being milder, is boosting our immune system if we get infected, we have to monitor the evolution of the pandemic without neglecting ourselves.
If we think of a scenario of an annual vaccine, wouldn’t it be cheaper to use those of our own production?
Of course. We are seeing it at the energy or supply level. We have to go back to what we are capable of producing. And if we have the ability to design vaccines, we must remain competitive, despite low funding.