Spain is outside the research and industrial elite in vaccines against the coronavirus. No Spanish initiative has yet reached the human trials phase, a stage in which there are already 64 products from 21 different countries, according to information from the World Health Organization (WHO). All this arsenal from pharmaceutical companies and leading research centers around the world makes it very difficult for a Spanish alternative to arrive on the market, since not only does it arrive late but it should improve on what already exists in order to obtain financing from some partner among pharmaceutical companies to carry out the trials and produce it on an industrial scale.
There are currently two vaccines for Covid-19, that of Pfizer / BioNTech and Moderna, approved in the EU. Others also have authorization in some countries, such as that of the British multinational AstraZeneca, the Russian Sputnik V, the Chinese of Sinovac, Cansino and Sinopharm and the Indian Bharat. To get to market, they must first demonstrate safety and later efficacy by testing them on thousands of people.
Spanish initiatives are not yet in that clinical stage. They are in preclinical or animal testing. Among the most advanced national projects, two of the National Center for Biotechnology (CNB) of the CSIC stand out (one associated with the Spanish company Zendal); another from Navarrabiomed; from IrsiCaixa, and two from Idibaps-Hospital Clinic de Barcelona. They are among the more than 170 initiatives in the world in preclinical, according to the WHO.
The barrier that national vaccines will encounter is to convince an industrial partner to bet on them when there are already others on the market, which also in the case of Pfizer and Moderna are based on the cutting-edge messenger RNA technology and have proven effective protection of about 95% of cases.
“The probability that a Spanish vaccine reaches the market will depend on the financial resources necessary to carry out clinical development quickly and ensure its manufacture”, says Olga Fidalgo, partner of life sciences from the consulting firm KPMG. “The competitive environment should not be minimized, but neither should we ignore the fact that the ideal vaccine is not available and that, for now, vaccination will be gradual in accordance with the progressive availability of authorized vaccines,” he says. “The probability that one of the Spanish companies under development is a collaboration option for a pharmaceutical company will depend on the robustness of the preliminary data that they can provide versus other more advanced or already marketed vaccines and the degree of improvement they provide,” he adds.
“In a step below, still in the preclinical phase, Spain has at least a dozen projects that seek a vaccine from different perspectives”, says Jaime del Barrio, senior advisor of health & life sciences from the firm EY. “The fact that vaccines are approved and are successful, in principle, can act as a brake on other research, since the prevalence of the virus will decrease,” he explains. “In this sense, the conjunctural collaboration of the Administration and public and private institutions is not enough to launch a vaccine to the market, the pharmaceutical industry is essential, and its capacity, even though it is very large, is limited and subject to priorities,” he recalls.
The Ministry of Science led by Pedro Duque has insisted on several occasions on the importance of developing a national alternative to create that chain that goes from research to the pharmaceutical industry, especially in the case of possible future pandemics.
“For a country, betting on its own production ensures self-sufficiency and, therefore, you have to keep working. In Spain there is little tradition of this type of studies reaching the clinic and for this reason it is worth trying ”, agrees Mario Mellado, director of the CNB. “This is the challenge, from the point of view of the country, an initiative that ensures self-sufficiency is very relevant,” he adds.
“The structural problems of Spanish science weigh down this type of project and several of the groups of researchers who are now immersed in this career know a lot about this and who have seen on previous occasions how their research, even being successful, has not reached the market” recalls Del Barrio. Even so, the problem is not only one of financing the industry, because while dozens of basic research centers around the world have advanced in record time, in Spain the laboratory task has not yet been completed.
The US has especially shone in this fast-paced battle thanks to its cutting-edge research centers and its powerful pharmaceutical industry, actors involved in 21 of the candidates who have reached human trials (see graph). It is followed by China (14) and Germany (including the already approved BioNTech and CureVac). Similarly, with four alternatives per country, the R&D of the United Kingdom (AstraZeneca as the best example), India, South Korea and the exceptional case of Cuba has proven effective, with duplicate initiatives from two public institutes. Canada, Russia, France, Australia, Russia, Taiwan, Japan, Israel, Turkey, Belgium or Indonesia are also on that elite list, which includes other less common cases such as Vietnam, Kazakhstan or Thailand.
Among the most advanced in Spain is the one led by Luis Enjuanes, from the CNB, who a week ago in an interview indicated that he hoped to start clinical trials in March, for which he negotiates with the Belgian company Univercells.
“There is no doubt that the quality of research and science in Spain is excellent and that there are very promising Spanish vaccines under investigation. The key is not scientific quality or productive capacity, the key will be the financing of clinical trials “, they point out from Zendal, a company associated with the CNB initiative headed by Mariano Esteban and which is also a partner of the American Novavax, of which will make the antigen.
“Possible? Yes Easy? No. In Spain we have a world-class basic research fabric, but the gap between this research and its subsequent development is very large and this continuum is not improvised ”, summarizes Del Barrio.