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It will be tested on 190 healthy volunteers at the La Paz and La Princesa Hospitals, both in Madrid, and at the Marqués de Valdecilla Hospital in Santander.
The Spanish Agency for Medicines and Health Products (Aemps), of the Ministry of Health, has authorized this Friday in Spain the first phase 2 clinical trial (in humans) of a vaccine against covid-19, which could be on the market at the end of 2021.
The announcement of the trial was made by the Minister of Health, Salvador Illa, when the infections continue to escalate: this Friday another 9.779 infections were added, of which 3.829 have been diagnosed in the last 24 hours, and the number of deaths from The pandemic increases by 15 and reaches 29.011 deaths.
The vaccine is developed by Janssen (Johnson&Johnson company) and 190 healthy volunteers will participate in the trial in Spain.
Phase 1 has been carried out in the United States and Belgium, the latter country in which phase 2 will also be developed, together with Spain and Germany.
A total of 550 volunteers will participate in two groups - one from 18 to 55 years old and another from 65 and over - with the aim of evaluating the range of doses and the different administration guidelines of the vaccine, called Ad26.COV2.S, which It is one with which the European Union is negotiating.
The recruitment of volunteers will begin "immediately" at the La Paz and La Princesa Hospitals, both in Madrid, and at the Marqués de Valdecilla Hospital in Santander.
According to the research institute of the Marqués de Valdecilla University Hospital (Idival), the vaccine could be approved and on the market at the end of 2021, according to an "optimistic approach" by its director, Galo Peralta.
This Hospital begins the evaluation of candidates on September 1 in a very rigorous process, in which they will first be informed of the conditions of participation and the risks in a signed consent.
They will also have to pass a clinical interview and an exhaustive analysis process in order to be selected. "If he does not have exclusion criteria and is healthy, from there it is decided to include him," continued Peralta, who estimates that to find the 40 suitable volunteers we will have to have at least twice as many candidates.
Starting September 14, the experimental vaccine will begin to be administered.
The clinical trial will last several months and will be followed by a phase 3 trial, the last one before having the product authorized.
The announcement comes in parallel with the increase in infections in Spain, as Illa has acknowledged, although the majority of cases are young people who do not require hospitalization, which is partly due to the fact that many more diagnostic tests are being done.
In fact, in the last week more than 516.000 PCR tests have been carried out and this Monday almost 70.000 have been carried out.
Precisely, in Asturias, the PCR carried out on teachers and non-teaching workers and the need to know the evolution of the pandemic in the coming weeks has led to a few days delay of the dates planned for the start of the school year, which will be semi-in-person among third of ESO and Baccalaureate.
The Euskadi protocol for the start of the course also includes a staggered and in-person start of the courses: on September 7, Early Childhood, Primary and the first and second years of ESO will begin; on September 15, third and fourth years of ESO and Baccalaureate, and FP on the 14th.
This protocol was made known one day after the Government and the autonomous communities agreed on 29 measures and 5 recommendations, because the Basque government abstained, arguing that the responsibility for Education was transferred and that it was working on its own plan.
Also in the Valencian Community, the return to the classrooms will be done progressively between September 7 and 11, as announced by the Minister of Education, Vicent Marzà.
This Friday, several outbreaks have also been known in work environments, the most important of which has led to the closure of the Uvesa Group's meat plant in Tudela (Navarra) after the detection of 175 positive cases confirmed by PCR test.
In the Community of Madrid, restrictions on nightlife and smoking in the street will be immediately applicable after the Superior Court of Justice ratified the order of the government of Isabel Díaz Ayuso, considering that they do not require judicial authorization.
Madrid continues to account for the majority of new infections, 30 percent of those reported in the last 24 hours, and hospital pressure in the capital increases one point, to 14 percent.
