COVID-19, Spain authorizes first human clinical trial of a vaccine
Spain, the Spanish Agency for Medicines and Health Products of the Ministry of Health authorized the first clinical trial in humans in the country for a vaccine against COVID-19.
The Spanish Minister of Health, Salvador Illa, announced at a press conference, in which he added that the vaccine is from the pharmaceutical company Janssen and 190 healthy volunteers between 18 and 55 years old will participate in the trial.
In addition to Spain, two other European countries will participate in this trial: Belgium and Germany. 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.
Recruitment will begin immediately and clinical trials will be carried out at the La Paz and La Princesa Hospitals in Madrid and at the Marqués de Valdecilla Hospital in Santander.
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 in the coming weeks and months," Illa said.
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. Only with positive results, once evaluated by the competent regulatory authorities, would the commercialization be authorized in European territory, said the Spanish minister.