11/08/2020 6:01 AM
Clarín.com
Society
Updated 11/08/2020 6:01 AM
In Argentina, three vaccines against the coronavirus are already being tested, in phase III of the clinical study, with volunteers who receive doses in our territory.
Now, a new formula against Covid-19 touches us closely.
But it generates controversy.
While the Spanish Ministry of Health rejected the trial of an experimental Spanish vaccine,
Argentina did approve it
in a very similar study.
It's the RUTI vaccine.
The health authorities of that European country
denied authorization
due to "the lack of scientific evidence" of the first favorable results.
Here, with the permission already signed, it will be tested on 370 health workers to evaluate its possible efficacy to stop the new coronavirus, in a phase II trial.
"Green light for La Ruti! We are the first Spanish vaccine to receive authorization to carry out an international trial for # Covid19. Join a great #MadeInRuti project."
With that tweet, on October 28, the RUTI vaccine celebrated the trial in our country.
The experimental drug was originally thought of as a therapeutic vaccine against tuberculosis by the scientist Pere-Joan Cardona, a researcher at the Germans Trias hospital in Badalona, and is developed by the small biotechnology company Archivel Farma, which in 2016 was acquired by the TGT business group. considered the king of cheeses in Spain.
As the company reported in late October, the vaccine
is expected to be effective against viral infections such
as the new coronavirus, for which it received approval from Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) to conduct the clinical trial.
This is a double-blind study with placebo, lasting nine months, financed from Barcelona by the Generalitat of Catalonia.
As
El País
de España
published this Friday
, the clinical trial - also aimed at 300 health professionals - that had been announced in April in the Spanish city of Badalona
never started
.
"The promoters, headed by the own inventor of the RUTI vaccine, Pere-Joan Cardona, did not request permits for the trial until July 7," the note says.
The Spanish Agency for Medicines and Health Products (AEMPS) -which would be like our ANMAT-, denied the authorization on October 14 due to
“lack of scientific evidence”
, as confirmed by a spokesperson for the organization to that Spanish newspaper.
The RUTI vaccine hypothesis is that its experimental formula, made with sterilized fragments of the bacterium that causes tuberculosis,
trains the innate immunity
, as the body's first line of defense is called, and could help stop Covid.
However, the AEMPS response points out "the lack of scientific evidence that this vaccine stimulates trained immunity" and the lack "of data that this trained immune response has been shown to confer protection against any disease in an animal model or in humans".
Without this evidence, they added, "you cannot start research in humans."
From Archivel Farma they affirmed that they are in time to present more experiments with animals and
obtain the authorization of tests in humans also in Spain
.
The provision issued by the ANMAT on October 20, meanwhile, states that "the Research Ethics Committee (CEI) took part, accredited by the corresponding jurisdictional Health Authority, which has approved the protocol, the informed consent model for the patient, as well as the participation of the principal investigator and the proposed center. "
And it affirms that "the technical report of the Directorate of Evaluation and Registration of Medicines, (DERM-INAME)
is favorable
" to authorize the investigation.
ACE
