In 2022 the three CSIC vaccines against covid will arrive, but they recognize that it will not be easy to complete the trials in Spain

Phase 3 requires testing the efficacy and safety of the vaccine in tens of thousands of volunteers, and for this they have to become infected

The most advanced vaccine, that of Mariano Esteban, plans to start human trials after the summer

“We have a vaccine candidate, he has passed the animal requirements and we are in a position to start the clinical phases ”. The covid vaccine developed at the National Center for Biotechnology (CNB) by the team from Mariano Esteban will be the first to start human trials, predictably after the summer, as he himself explained in a colloquium organized this Monday by the Alternativas Foundation.

“We have verified in animals that the vaccine activates the immune response.” Have shown its high efficacy in mice and hamsters, and is now being tested with macaques. Meanwhile, the Galician company that will manufacture it, Biofabri, “has already produced the batch to start the clinical phases,” Esteban announces.

“All this arsenal must be taken to the regulatory agencies and that’s where we are today. We hope that throughout this summer you will approve it (the AEMPS) ”. Once everything is approved, the clinical trials with humans. And Esteban assures that they already have agreements with several hospitals to carry them out.

2022, the year of Spanish vaccines

Yours is one of the three vaccines for covid that the CSIC has in place, and the one that will hit the market first, although there is no specific date at the moment. It will be followed by Vicente Larraga and his team from the Margarita Salas Biological Research Center, which develops a DNA vaccine and the preclinical phase is ending, that is, animal testing. Larraga assures that “with good luck, at the end of the year or early 2022 we would be in a position to finish the clinical phase (human trials) and now We will be in a position to have a vaccine ”.

Later will come Luis Enjuanes’ vaccine, also from the CNB. Although when I see the light it will be one of the most complete and powerful in the world. But animal testing is still beginning. “The remainder of the year we will need for the preclinical trials (with humanized mice, hamsters and macaques), and for next year, we will certainly produce these replicons of the virus in order to start clinical trials. Until the middle of the year (2022) we will not be ready to go on the market ”.

That they arrive later confers advantages and disadvantages to these vaccines. Advantage? Which will be better than the current ones. Disadvantages? That the way to achieve it will be more complicated. Among other things, they will have a less susceptible population to be infected at the time of conducting the trials.

Improve current vaccines

If we start with the advantages, the three directors of the projects agree on the same thing. “What we have to do is improve the product. There are several vaccines on the market but they are far from perfect ”, warns Enjuanes. “We are introducing some improvements, if you go out later you have to bring advantages ”, adds Larraga. Which will be?

But there is more. The team led by Vicente Larraga has begun to explore a novel vaccination route, the intradermal route. “We are testing the intramuscular route -the most classic-, but also the airway -because it is a respiratory disease- and the intradermal route: a patch. Because the latter it would be simpler and does not require specialized personnel “Larraga announced in the debate.

Protect against variants

“U.S we have incorporated antigenic determinants into the vaccine that also account for the new variants that have emerged, such as the United Kingdom, South Africa and Brazil. Y soon we will also incorporate the Indian variant, because drug regulatory agencies are very demanding and they are asking us to do so ”, he explained.

What everyone is very clear is that, although current vaccines serve to contain the pandemic, “This disease has come to stay. We will have to continue fighting it next year, and the next, and the next … “Larraga said. That is why they consider it important that Spanish vaccines arrive, even if it is later.

Problems for phase 3

To get there, before they have to complete the three clinical phases in which the vaccine is tested in humans. And that’s where problems can appear. Both financing and logistics. Because one of the questions that arises is: Will there be a possibility of infection for the volunteers in which they are tested?

In the best of scenarios, we are talking about the end of this year in the case of Esteban, the beginning of the next for Larraga, and the middle, or even the end of 2022, in the Enjuanes vaccine. Yes, by then, current vaccines have greatly reduced the circulation of the virus, this may not be a minor problem. Because testing its effectiveness requires thousands of volunteers to become infected.

He warned Professor of Microbiology at the UCM Emilio Bouza, who was also participating in the debate. “The chances of getting infected from vaccinated and unvaccinated may be much lower, so we are going to have to wait for much longer study periods than now ”.

The stage of the phase 3 trials, in which the efficacy and safety of the vaccine must be tested in tens of thousands of people, of course it will be very different from those of these first vaccines. If there are fewer viruses circulating, it will be much more difficult to get infected.

“Using Spain as a base for a phase 3 seems unfeasible”, confessed Vicente Larraga. “We will have to look for countries where the epidemic is still active”, referring to Latin America, Asia or Africa. “I am afraid that there, the virus is not going to disappear so quickly.”

It is necessary to take into account, in addition, another difference with the first vaccines. “In clinical trials of these, there will not be a placebo group, but they will have to be compared with other vaccines”Bouza warned. In those phase 3 trials, there will not be one group of volunteers who will receive the vaccine and others who will not. Its level of effectiveness will be compared to that of “currently used vaccines”.

Roadblocks: funding and lack of industry

For now Mariano Esteban explains that they already have agreements with several hospitals for phase 1 and phase 2 trials. These phases can be done in Spain, and there the most important obstacle is financing, because in the human trials the cost is much higher than with animals.

“Millions of euros are already needed in the clinical phases. In a phase 1 trial, you lose about 10 million, for example, ”explained Esteban. “And a phase 2 with hundreds of volunteers increases the cost even more. In many countries, governments have been very active in collaboration in this process ”, he warns, taking as an example the United Kingdom or Germany with the AstraZeneca and Pfizer / BioNtech vaccines. “We have funding for clinical phases 1 and 2”, he assures.

Esteban took advantage of the debate to insist on a complaint, something suffered by the three vaccine projects. “We have lacked the infrastructure.” He explains that in Spain “we did not have a company, in Spain we are building it.” Because Biofabri, from the Galician biotechnological group Zendal, is the one that will produce its vaccine and that of Larraga. But until now, they were dedicated to veterinary vaccines. “Companies that made veterinary vaccines will now also make human vaccines, “Esteban explained.” We need more support in infrastructures, more economic support, and more stability also in human resources, “he complains.

Mouthwash he insisted on the same thing. “The problem is always the clinical phase, which needs many people and hospitals and is very expensive. “Although the virologist recalled that their role, that of researchers, ends sooner, once the vaccine is made in the laboratory. “The task of clinical trials and manufacturing belongs to other types of experts … The laboratories, what we have to do is improve the product ”.

But the veteran virologist does not show much concern about the problems these vaccines may encounter for their large-scale trials or manufacture. “If the product works, it doesn’t worry me much. Multinationals are not stupid, they have a lot of experience, and if they see that it works, we are sure they will be interested “. If they are interested, Enjuanes explained, they will be the ones who will be in charge of the development and production of the vaccine.

Source link