"Society in Spain is altruistic, as demonstrated by organ donation. If there are not many volunteers in the trials, it is because they are not disseminated"

• Health How patients can participate in the research of new medicines

• Second-generation Covid vaccines immunization: "The more adapted and updated it is, it will include parts of the virus against which we have not been immunized"

It has been a year since the first puncture in Spain against Covid.

Araceli Rosario Hidalgo, 96, an inmate at the Los Olmos Residence, received the covid-19 vaccine, a messenger RNA-based formula developed by Pfizer-BioNTech.

The approval by the drug regulatory agencies of this and other covid vaccines allowed an immunization campaign that has changed the course of the pandemic.

But these approvals would not have occurred without having the conviction of the safety of the products that were inoculated to millions of people;

As with all other medicines,

A few months before the first vaccines against Covid reached the most fragile population in the face of the SARS-CoV-2 coronavirus -especially the elderly like Araceli-, the Spanish Agency for Medicines and Health Products (Aemps) authorized the first trial clinical study in Spain of another vaccine to deal with covid-19.

It was a candidate developed by the Belgian pharmaceutical company Janssen, (owned by Johnson & Johnson), and which used an adenoviral vector to introduce the information into the body that triggers the immune response.

This vaccine had a special attraction: it only required one dose.

But to demonstrate its safety and efficacy,

.

The pharmaceutical multinational turned to three Spanish centers to participate in phase II of the trial: the hospitals of La Princesa, La Paz (both in Madrid) and the Marqués de Valdecilla (Santander).

This trial and the rest of those carried out with Covid vaccines have been radically different from any of those that are usually carried out.

The person in charge of the Clinical Trials Unit of the University Hospital of La Princesa (Uechup),

, recalls that, "to begin with, the minister came out announcing it on television."

Francisco Abad is responsible for the Clinical Trials Unit of the University Hospital of La Princesa (Uechup).

The unit, one of the oldest in Spain, is celebrating its 25th anniversary these days.

Directed by Abad, also head of the Clinical Pharmacology Service, together with

(specialist in Clinical Pharmacology), and coordinated by

, in this quarter of a century it has grown at different levels, and has become part of the story of how a pandemic was fought.

Phase II of the Janssen vaccine study was followed by phase III, where a total of 2,000 people in Spain contributed.

The Princess recruited 460 volunteers.

One of them was

, who volunteered in February 2021 to receive the vaccine, at a time when vaccines were only available to the vulnerable population and health professionals.

Actually, he was repeating the experience, because he

.

In that pandemic

, clinical research went much more unnoticed than with covid-19.

The director of the Unit, Francisco Abad, believes that "the media dissemination of the studies with the Covid vaccines has led to a

that has realized the importance of research; in other circumstances, the The non-healthcare environment often doesn't know about these studies, but it's been the main topic of news here."

In fact, the volunteers who belonged to the health field were only 10% in the study carried out by La Princesa.

Raquel Saiz, nurse and clinical trials volunteer. JOSÉ LUIS PINDADO

"Society in Spain is

, as organ donation demonstrates. If there are not many volunteers in the trials, I think it is because they are not widely disseminated; on the other hand, in the pandemic, an

has been seen from the population ".

Bird flu study

In the avian flu study, Pedro received the vaccine (it was compared against a seasonal flu vaccine), but in the covid trial he received physiological saline.

"I didn't know what they were giving me, but I thought that

."

This volunteer, outside the health field beyond a few friends, was not affected by

and information poisoning: "There are people who do not distinguish between opinion and scientific information, anything is possible in the field of personal interpretation," he says , although he acknowledges that it helps to have a daughter studying a scientific career.

"I know that in these types of studies

, practically non-existent, it's more the hassle of having to come and get pricked. I took advantage of breaks at work, which is close to the hospital, to do the analysis. It's a toll assumable: I see it as a

, of society with research", he reflects.

The results of the phase II trial and the interim analysis of phase III allowed the vaccine to be commercialized, although, Francisco Abad points out, two-dose vaccines have finally been chosen.

There are no data comparing the two types, although studies suggest that the Janssen vaccine maintains antibody levels for longer.

The truth is that the current situation, with the change in hegemonic virus strains, has displaced its use.

Monitoring continues until March

However, the study will continue to monitor the volunteers until March, "with the idea of ​​obtaining

long-term antibodies," says the pharmacologist, who acknowledges that "it will be difficult to analyze them."

In the trial there are people who received a placebo and then were vaccinated with the drug from Pfizer or Moderna;

others who only received Janssen's, and those who, after that dose, were vaccinated with another mRNA vaccine.

However, the fact that it is a large trial, with some 30,000 subjects worldwide, "may help to obtain sufficient data to draw conclusions."

The study with this vaccine has made the Unit visible to the population, but in the health field, its group of professionals already had great

.

In this quarter of a century, it has gone from four part-time people to the 18 full-time professionals that now make up the staff, a multidisciplinary team with clinical pharmacologists, doctors, nurses, laboratory technicians, study coordinators, quality, and administrative assistants. .

The Unit has carried out

, five of them for the first time in humans;

more than ten with vaccines;

two with nutritional foods, and 283 bioequivalence clinical trials.

In these studies, it is analyzed whether the medication is well tolerated, whether the dose can produce an effect, and in the case of bioequivalence, the generic is compared with the branded product.

The profile of healthy volunteers is from 18 to 55 years without pathologies.

This is the case of

, nurse and volunteer.

"I heard about it from a friend who had been in a study, and I was encouraged. At first it sounds a bit weird, but once they explain it to you, you know it's safe."

Raquel has participated in a bioequivalence study with a cholesterol drug and in the vaccine against respiratory syncytial virus (RSV).

hospital admissions

If the study requires hospital admission or more specific tests, there is usually a compensation of a few hundred euros.

This, together with the time that must be invested in schedules that are often incompatible with work, explains why many of the volunteers are students, especially in the field of health.

"My family didn't think it was bad, although I understand that it may look strange from the outside, but the truth is that many volunteers repeat themselves," he says.

"I would like to

in other studies, but now that I am working it is more difficult because of the shifts. And I would encourage other people to participate. The trials are safe and are carried out in a hospital setting."

Throughout these years, the La Princesa Unit has only had to refer to "some scare," says Francisco Abad, referring to dizziness during extractions -"and even before the puncture"- or to some allergic reaction.

However, "we are always prepared," he says.

"Above all, in studies with first

-

. We do them two by two with volunteers and we always start with doses ten times lower than the minimum that produces some effect in animals and increase gradually with exhaustive surveillance".

More than 60% of the investment in R&D of pharmaceutical companies in 2021 was allocated to clinical trials, according to data from Farmaindustria.

The bulk of this investment is in studies in an advanced phase, although, in the opinion of Francisco Abad, "

. Generally, the laboratories have their parent companies outside of Spain and It is there where they carry out the studies in the early stages, but lately they are also beginning to carry them out in Spain, attracted by our recruitment capacity and good health coverage. In addition, we also work with companies that come from the academic environment to develop a molecule."

Balance between evaluation and availability

Along with the trials in the initial phases, the unit is collaborating with more than 53 clinical trials from different services such as Cardiology, Dermatology, Digestive, Endocrinology, Hematology, Infectious, Neurology, Oncology and Radiation Oncology.

The long development time of a drug is often questioned, regardless of its high costs, but for the pharmacologist these times are justified, taking into account that

of clinical research.

"Shortening the trial periods could mean having patients exposed to drugs that are not well evaluated. What happened with the pandemic was exceptional, because the situation justified it and because there were many people involved in the process, the deadlines could be shortened, But you always have to maintain a

between the proper evaluation of the drug and being able to have the drug as soon as possible."

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