The first Spanish vaccine delays the start of trials with volunteers

The sought-after Spanish vaccine against Covid-19 is delayed a little longer. The most advanced option, the one led by researcher Mariano Esteban, from the Higher Council for Scientific Research (CSIC), and supported by the company Biofabric (Zendal group), postpones the planned start of clinical trials (human trials) for a few weeks. In this way, Spain remains the only great economic power without this type of study with its own national product.

In January, the CSIC announced that the candidate of the virologists Esteban and Juan García Arriaza would begin the trials with volunteers in a few weeks after having practically concluded the laboratory tests. Then March was mentioned as the most probable date to start the tests. However, the most likely date is now in June after seeing the need to redesign the process.

“The delay has been caused because we have reviewed the design of the vaccine for greater immunity,” they acknowledge from the Zendal group, which will be the company in charge of producing the product in O Porriño (Pontevedra). “Clinical trials are scheduled to begin in June,” they add. From the CSIC, for its part, they decline to comment until there are news.

Zendal has already started the production of this CSIC vaccine in its Pontevedra plant of the first test batches. This Galician company is also associated with the American biotechnology company Novavax to produce the antigen for one of the most advanced options (in phase III, prior to commercialization).

From the Aemps (Spanish Agency for Medicines and Health Products) it is explained that they foresee that the group headed by Esteban and Arriaza request authorization to start clinical trials shortly. “The Aemps has not received at the moment any request for authorization of a clinical trial of the project of the research group led by Mariano Esteban. However, communication with them is fluid and they are progressing at a good pace, so we hope that they will be able to present it soon ”, highlights a spokesman for the Ministry of Health.

The delay in the start of clinical trials leaves to Spain still in the group of countries without national vaccine at that stage. As this newspaper highlighted in January, more than 20 countries, among which are all those with the highest GDP except Spain, already have products in studies in hospitals or already authorized. The US stands out as a powerhouse thanks to companies such as Pfizer, Janssen, Moderna or Novavax, as well as the different Chinese options (including Cansino, Sinovac or Sinopharm), the British AstraZeneca, the German CureVac and BioNTech or the Russian Sputnik.

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 or to improve vaccines already existing for Covid-19.

Other major economies on the planet such as India, France, Italy, Canada, South Korea or Australia have managed to pass the laboratory stages and are already advancing in clinical trials before their candidates can be authorized.

Even smaller economies like Cuba, Israel, Vietnam, Thailand, Indonesia, Turkey or Kazakhstan already have their own versions in trials.

There are currently 14 commercially licensed SARS-CoV-2 vaccines in the world or with emergency use permits. In addition, there are 91 in clinical study, according to the World Health Organization (WHO) in its latest update on April 23.

Several options

The candidate of Mariano Esteban and Juan García Arriaza is provisionally called MVA-CoV-2 and uses the modified Ankara vaccinia virus (MVA) as a vehicle to transport a SARS-CoV-2 protein (the S protein) that stimulates the immune defense against coronavirus.

Another of the CSIC teams with a more advanced candidate is that of researcher Luis Enjuanes, who is also expected to start clinical trials in the near future.


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