"No vaccine against COVID that is not safe will ever be distributed, although it may be more or less effective"

The researcher from the National Center for Biotechnology – CSIC Sonia Zúñiga is working on one of the three projects that this organism is running in search of a vaccine against SARS – CoV – 2, which causes COVID – 19. Her line of work is to look for a "attenuated" version of the virus that does not cause the disease and does not spread.

Zúñiga believes that in the first half of next year some or some of the most internationally advanced works, such as those of Moderna, Oxford and Pfizer, will be ready for use, since these laboratories and companies have decided to take the risk of starting to manufacture the doses before the effectiveness of the vaccine has been fully verified. In any case, although the test and trial phases are overlapping, they are not being shortened, this researcher qualifies, who completely rules out that a product that does not comply with all the safety measures for human health that always demand.

"Then the effectiveness, as it depends. It may be a vaccine that perhaps protects 50% and it is considered that, depending on the case, that is enough. It may be a vaccine that does not prevent you from becoming infected, but that prevent you from having severe illness. Those are decisions that will have to be seen at the moment, when you see the effectiveness of the vaccines in the phase III trials, "he details.

The Government has said that for the first half of 2021 there may be one or more vaccines available in the European context, does it agree with that schedule?

Yes, we believe that with the data that is coming out of the results of the clinical trials of the most advanced vaccines, the modern American, the Oxford, the Pfizer vaccine, even the China - although it is perhaps the candidate with the least probability -, some of these or several will almost certainly be ready in the first half of the year 2021, among other things because the companies have taken the risk of already starting manufacturing while they are doing the tests to see if they really work. By the time the tests with positive results are completed, if any, the vaccines will already be manufactured, so they can be distributed immediately.

They do not expect to have the result of the last phase III clinical trial, but they are manufacturing them just in case. It's a risk? Yes, because later if your vaccine does not work, those doses will not be distributed. But they are companies that think they can take that risk and go for it.

The question arises how it is possible that they are being so fast with vaccines if until now the record was four years minimum and if there is any step that is being skipped.

No, you really don't skip a step, it has to be very clear that any vaccine that does not meet the safety requirements will never be distributed for use in humans. That is a red line, it will not be exceeded. Then effectiveness depends. It may be a vaccine that perhaps protects 50% and it is considered that, depending on the case, that is enough. It may be a vaccine that does not stop you from becoming infected, but that prevents you from having severe illness. Those are decisions that will have to be seen at the moment, when we see the effectiveness of vaccines in phase III trials.

But you can not shorten the time it takes to have all the data. That is, if a clinical trial lasts x months, it lasts x months. What you can do is start while the previous one is being finished. Moderna's vaccine is a very clear example. They started both phase I human clinical trials and preclinical animal trials, when normally preclinical tests are done on animals first, then clinical phase I and then phase II and finally phase III, when each is already completed. The way to speed up is to do it all at once.

So you don't think there is any danger to human health from this speed? The opinion is heard that it is better to wait for other people to try the vaccine for fear of these alleged potential side effects.

No. In this rapid process of vaccine manufacturing, the entire international scientific community, the WHO, is all very aware of the results. The moment there is any indication that this is not certain the clinical trial is stopped. And this happens many times with many medications or with many vaccines. And, of course, it is one thing that, if necessary, would also be done with these vaccines that are in the phase of clinical trials.

You have to have a little patience and be cautious, see the data and judge based on them, but I am sure that you will not be allowed to provide a vaccine, even in this case of such a tremendous epidemic that it is not safe. The need is there and a vaccine will deliver us from this, that is very clear, because in the end it is what makes the transmission of the virus stop.

My personal opinion is that in recent years there has been a certain anti-vaccine current. I think it has been so long since people died of many things for which we are now vaccinated as children who have forgotten. And a current has emerged that says "why am I going to be vaccinated, if in the end I am not going to get sick from this". Well, you are not going to get sick because the rest of the people are vaccinated.

Is it possible that the most optimistic forecasts are not met and that the vaccine takes longer than the authorities and scientists are considering as possible, the first half of next year?

To be honest, all the possibilities are on the table, there is still not enough data. There are so many vaccines in development in different states that I want to be optimistic and think that some or some of them are going to arrive by at least the end of next year. But hey, it's a prediction, and it may not happen. The good thing is that, in the meantime, I sincerely believe that different medications and antivirals will arrive that will serve to combat the disease in the event that people become infected and develop the disease with greater or lesser severity.

The CSIC is one of the organizations dedicated to obtaining these vaccines against COVID-19, how are the works going?

In the CSIC there are three groups that are basically making vaccines, two of them are somewhat more advanced because they are easier to do and, especially, in the National Center for Biotechnology the vaccine of the group of Professor Mariano Esteban, who uses a vehicle that is the smallpox virus to express a protein, a fragment of this new virus. The other is that of Dr. Vicente Larraga. They have already done some immunogenicity tests in mice, with promising results, and are now waiting to be able to carry out preclinical tests on animals and to start the production phase of the vaccine to be able to go to clinical trials. [esperan pedir los permisos para hacer pruebas en humanos a final de año].

Then there is the vaccine of our group, that of the coronavirus laboratory of the National Center for Biotechnology, directed by Luis de Juanes and Isabel Sola. We have been working with coronaviruses for more than 35 years and working with these killing viruses for more than 17 years. But our vaccine is more complicated to generate because it is based on the virus itself. We have made a copy by genetic engineering of the virus, we have made the synthetic virus in the laboratory and now we are removing elements that are what can cause severe disease, so that in the end we will obtain a virus that is attenuated, does not cause disease and also We are removing elements that allow it to spread, so the vaccine candidate will not spread. This is more complex to do, because you have to remove elements and test. We are in the preliminary stages of testing in cells, in the laboratory, and if all goes well, by the end of the year we could start some animal testing.

Can the COVID-19 vaccine be effective against eventual mutations of the virus?

This virus, like any virus that has an RNA genome, has a tendency to change and can afford some flexibility and sporadic changes here and there. But for a mutation to really take over, it has to spread. What about these viruses? They are so large in genome that they cannot afford any change. So, they are viruses that accumulate fewer mutations than other viruses with the RNA genome.

In this case, there is a very good example. It seems that a variant of the virus has been imposed that has a mutation in the spicule protein. In most countries it is the one that is circulating, but that does not mean that the former is not circulating. But neither does that make the virus better, worse, or more difficult to attack with the vaccine or with any antiviral treatment. So far none of these mutations, which are very few, two or three at most, has been seen to have a role in how the vaccine will be able to combat them. I would say that at this time there is no worrying mutation situation so that the vaccine will not be able to be effective against any strain of the virus or against any virus that is circulating.

I understand that the preferred population for this vaccine will be the one most exposed to severe cases of COVID, such as the elderly.

Yes, that would be logical, that when there was a vaccine, the population at risk would be vaccinated. But for that the vaccines that are now in clinical trials have to show that they are safe in this population. So far, none of the phase I clinical trials that have been published for any of the vaccines that are advanced include a population over 55 years old, they are doing so now in phase II trials. If they are not effective in this type of population, perhaps we would be in a scenario where younger people who are more asymptomatic but who spread the virus would be vaccinated.

Do you think that it could be the case that a company in a country like the USA manages to develop a vaccine and that it takes time to distribute it to the population that needs it because its government monopolizes it, as has happened with some treatments?

Each laboratory works on a type of vaccine. That's good, because that's probably why in the end there will be one or more vaccines. A vaccine can work very well in the laboratory and then be difficult to produce or it can be very easy to produce, but it does not work very well by immunizing the population. It is always good that there are several strategies around the world, because in the end then the person in charge of ensuring that vaccines reach all countries is the World Health Organization. There is no need to worry that every laboratory in every country in the world is generating its vaccines, because in the end those that work will reach the entire population worldwide.

But the US has left the WHO

It is one thing for the country to quit the WHO and another thing if it does that (not distribute vaccines), because then its vaccine will not be given, because at the end of what the World Health Organization is going to ensure is that there is vaccines, whatever they are, of whatever type, to be able to supply them to all the countries that need it. This is something that is generally done with all vaccines, not just those that are being developed now and it is the mission of this organism.