Spain, protagonist in clinical trials to find the coronavirus vaccine
Source: www.immedicohospitalario.es
The three hospitals participating in the research; La Paz y la Princesa in Madrid and Valdecilla in Santander, have already recruited the participating volunteers.
Spain has reinforced its role as one of the major powers in conducting clinical trials of an effective treatment against the coronavirus. If it was already the first country in Europe and the fourth in the world in the number of trials with drugs to prove their efficacy against the virus, now it will also be a protagonist in the trials that are being carried out with one of the vaccines against SARS-CoV -2 that are being investigated around the world, the one being developed by the pharmaceutical company Janssen.
On August 28, the Spanish Medicines Agency authorized the Spanish subsidiary of the American company Johnson & Johnson to carry out its study in three Spanish hospitals (La Paz and La Princesa in Madrid and Marqués de Valdecilla in Santander) to evaluate a range of doses and vaccination intervals of your draft vaccine, named Ad26.COV2. The trial corresponds to phase II -of the three that are carried out in humans- and will participate healthy adults from 18 to 55 years inclusive and adults 65 years and older. The vaccine will be tested in this phase in two more countries in addition to Spain: the Netherlands and Germany. Spanish hospitals will provide 190 patients, and a total of 550 people will participate in this trial. The Minister of Health, Salvador Illa, has announced that the list of volunteers has already been completed. Hospitals will carry out these days screening of patients to select the most suitable and this same month of September the first vaccinations will begin. In total, the trial will last between 4 and 6 months.
“In addition to opening the participation of Spain in the investigation of potential vaccines against the coronavirus, this project is relevant because it underpins the leadership of the country in the early phases of the trials, phases I and II, which are the most complex,” says Amelia Martín Uranga, head of Farmaindustria’s Innovative Medicines Platform. “The fact that Spanish hospitals participate in the research of this vaccine will surely open the door for other important vaccine projects already underway to also have Spanish participation,” adds Martín. In fact, according to the latest WHO data, there are already 176 investigational vaccines, of which 33 are in the clinical research phase – being tested in humans – and seven of them are in phase III, the last of the necessary stages.
Several of these projects are being developed by companies associated with Farmaindustria and with a significant presence in our country. Among those in the last phase of research, the vaccines of the AstraZeneca and Pfizer companies and that of the Moderna laboratory stand out, which has reached an agreement with the Spanish company Rovi for the manufacture in our country of the filling and finishing of its candidate vaccine. Together with them and the aforementioned Janssen project, those of the American MSD, the Australian Seqirus and the European GSK and Sanofi are underway.
In addition to trials with the vaccine, up to 170 hospitals in Spain have clinical trials underway in search of a drug that can be effective against the coronavirus. Currently, fourteen pharmaceutical companies associated with Farmaindustria -three national, Laboratorios Rovi, Laboratorios Rubió and Reig Jofré, and another eleven international: Gebro Pharma, Novartis, Roche, Sanofi, AbbVie, Jazz Pharmaceuticals, Sobi, AstraZeneca, GSK, Lilly and ViiV Healthcare – They are participating in a large part of these clinical trials and collaborating in others of public initiative by providing the necessary medication.
What steps do patients take in a clinical trial?
The clinical trial is the definitive step for a potential drug or vaccine to reach the patients who need it. This is the process used to verify the safety and efficacy of new drugs, which will be the key to submitting them for approval by drug agencies. It is a complex process, which usually requires about 6-7 years of work and in which, together with the promoting pharmaceutical company, authorities, researchers, hospitals and, of course, patients are involved. This informative video made by Farmaindustria on the occasion of the World Clinical Trial Day summarizes in three minutes what it is, what it is for, how it is developed, what requirements and deadlines it needs and who is involved in carrying out these types of studies.
Patients are the great beneficiaries of trials, because thanks to them they can have early access to the most innovative treatments, not yet authorized, which in certain serious pathologies and when other treatments have failed can mean their own survival.
In addition to patients, conducting these studies in Spanish hospitals has very positive consequences for all the agents involved: for the health system, because the trials attract financial investments from pharmaceutical companies to the centers; for professionals, because they add reputation and experience by complementing their care work with the researcher, and for the pharmaceutical industry, because it can count on health professionals and adequate clinical facilities to promote its research and drug development activity.
At Distefar, as part of the sector, we are proud of the active role that Spain is playing in clinical trials to find the vaccine against the coronavirus.
