Spain authorizes its first human trial of an anticovid vaccine

Spain authorized this Friday the first clinical trial in humans for an anticovid vaccine, in which 190 volunteers will participate, while the advance of the pandemic continues to reach a record of infections, with 3,829 new cases in the last 24 hours, and the deceased already exceed the 29,000.

The Spanish Ministry of Health today registered another 9,779 positives, the largest increase in this second wave of coronavirus, and adds 33,850 cases this week, 439,286 since the beginning of the disease.

The care pressure rose one percentage point throughout the territory, going from 5 to 6 percent, after having produced 188 new admissions, and the beds occupied by patients with covid-19 are 6,224, of which 751 are from ICU, of according to the official balance.

Madrid continues to account for most of the new infections, 30 percent of those notified in the last 24 hours, and the hospital pressure in the Spanish capital increases one point, to 14 percent.

Throughout the region, the restrictions on nightlife and smoking on the street will be applied immediately after the Superior Court of Justice ratified today the order of the autonomous government that had been suspended by a magistrate a week ago, considering that they do not require judicial authorization.

First human trial

Today the Spanish Minister of Health, the socialist Salvador Illa, announced that Spain has authorized the first clinical trial in humans in the country for a vaccine against the coronavirus.

The vaccine is from the pharmaceutical company Janssen and 190 healthy volunteers will participate in the trial.

In addition to Spain, two other European countries, Belgium and Germany, will participate in this trial. The phase 1 trial has been done in the United States and Belgium.

In total, 550 healthy volunteers from the three European countries will participate to evaluate the range of doses and different administration guidelines.

The research will be conducted in adults and includes two groups of volunteers, one aged 18 to 55 and the other 65 and over.

In Spain, recruitment will begin "immediately" at the La Paz and La Princesa Hospitals, both in Madrid, and at the Marqués de Valdecilla Hospital in Santander (Cantabria, north), Illa said.

The clinical trial will last several months and will be followed by one in phase 3, the last one before having a product authorization. "And we are going to see how this evolves over the next few weeks and months," said the Spanish minister at a press conference.

This vaccine, called Ad26.COV2.S, uses a technology based on a non-replicative recombinant adenovirus to generate an immune response against one of the coronavirus proteins.

Trials are essential to guarantee the quality, safety and efficacy of vaccines, the Spanish Ministry of Health reported today in a statement.

Only with positive results, once evaluated by the competent regulatory authorities - in the case of Spain, the Spanish Agency for Medicines and Health Products (Aemps), and the European Medicines Agency (EMA for its acronym in English) would the marketing be authorized. in European territory, explained Illa.

The results in a few months

Regarding the duration of the trial, the Spanish minister said that the phases sometimes overlap and it may be that in months or even a month, there will be good results from phase 2 and it will go to 3, developing both at the same time.

In fact, the company plans to start phase 3 clinical trials shortly, he added.

After authorization of the trial, the researchers will begin recruiting volunteers who meet the inclusion criteria in the different centers included in the protocol.

The Spanish Agency for Medicines and Health Products maintains contact with different companies to carry out more clinical trials of this type in Spain.

Illa is confident of having the three million doses of the Oxford University vaccine by the end of December.

The Spanish Minister of Health rejected that there is a shield with the pharmaceutical companies and stressed that the legislation on vaccines is "scrupulously" respected at the European level, so that in Europe only those that are safe and effective can be supplied.