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“We all want a vaccine as soon as possible, but not at any price”

Red pill or blue pill? Take a risk with a experimental treatment that has not yet been shown to be safe and effective? Or wait months, or even years, for the evidence to support its validity? This debate, in the vast majority of cases, tends to be on the side of scientific evidence. But right now, due to pressure from the global health crisis triggered by covid-19, the answer is not so clear. On the one hand, there are those who argue that the urgency of finding solutions justifies that science skip some protocols. But on the other hand there are those who remember that it is precisely these processes that guarantee the final result. “Now more than ever we have to make an effort to maintain rationality. Finding a solution is essential, but we cannot afford a false step in the fight against the coronavirus,” he defends. Lluís Montoliu, researcher at the National Center for Biotechnology and member of the Ethics Committee of the Superior Council of Scientific Investigations (CSIC).

To what extent is it lawful to ask science, in the face of such an exceptional situation as the one we are experiencing, to throw its protocols out the window and accelerate the achievement of results?
Going directly from theory to practice is a risk. Although a study has given good results in a laboratory experiment, we cannot assure that it also does it in people. We all want a vaccine available as soon as possible, but not at any price. Before starting clinical trials in patients, we need to demonstrate that the cure we are implementing does not cause more damage than we intend to solve and that, in addition, it is really useful. And this is only achieved by going through cell tests in vitro and by experiments with animal models. All these phases take months, even years, to give results. And sometimes they fail just when it seems like they’re reaching the finish line. But it is precisely this process that guarantees that the end result is the best possible.

In the case of vaccines, what is the risk of skipping some parts of this process?
That you cannot assure the result. A few years ago, one of the vaccine models being developed for SARS gave the opposite result than expected. Vaccines are designed to protect individuals from infection. But in an experiment in mice it was observed that the application of that preparation resulted in an even more serious infection. And it’s not the first time something like this has happened. In the 1960s there were also experiments with immunizations for respiratory viruses that not only failed to increase protection, but predisposed to increased risk. Let’s also remember that vaccines are applied in healthy people, so it is very important to ensure the result …

“Before starting clinical trials in patients, we need to demonstrate that the cure does not cause more damage than we intend to solve”

Lluís Montoliu

Member of the CSIC Ethics Committee

So is there no way to speed up these studies?
Yes there is. The solution is to speed up some processes, not to eliminate them. We can, for example, propose animal experiments with smaller samples. And establish shorter follow-up periods to see if symptoms develop unexpectedly. This is done because, in case everything goes wrong, we take the risk of losing the life of a mouse. But not from a person.

Still, there are vaccine trials for covid-19 that are raised directly in & mldr;
And if something goes wrong, it will be a disaster. Imagine that ineffective vaccines begin to be applied and that patients begin to go outside believing that they cannot become infected and eventually fall ill. Or worse. Imagine that the vaccine results in significant adverse effects. This is the type of contraindications that are tried to avoid with detailed preclinical and clinical studies. If these trials fail, people will start looking for culprits and asking why no one did anything to prevent that harm. This could greatly damage confidence in science. And there will hardly be a turning back …

“The drugs being tested are drugs that had been created for other purposes and have already passed safety tests.”

Does the same happen in the case of experimental treatments for this coronavirus?
No. The drugs being tested to treat covid-19 infected patients are drugs that had been designed for other purposes and have already passed safety tests. The extent to which they can be effective in combating this infection is now being studied. But, at least, we already know that they are safe and that, in the indicated doses, they do not cause harm to patients. So it is likely that we will get to an antiviral sooner than to a vaccine.

In the case of medicines, it should also be borne in mind that the urgency of having to treat currently ill patients is treated & mldr;
Clear. But we need these drugs to be backed by evidence. In the most extreme cases, the legislation also provides that a Compassionate use of experimental treatments. But they should only be used in a timely manner, when the patient does not respond to any of the validated treatments. And, meanwhile, continue investigating the efficacy of these drugs in laboratories.

So what is the lesson that you think should prevail right now?
The message is clear. It is in times of pressure that we have to be more demanding of ourselves. We have always claimed robust scientific evidence to validate a treatment. And now even more.

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