The Spanish Agency for Medicines and Sanitary Products of the Ministry of Health authorized this Friday the first human clinical trial in the country for a coronavirus vaccine that has caused a pandemic. This was announced today by the Spanish Minister of Health, Salvador Illa, at a press conference, in which he added that the vaccine is from the janssen pharmaceutical company and in the trial will involve 190 healthy volunteers between the ages of 18 and 55. 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 assess the dose range and different management guidelines. The research will be conducted in adults and includes two groups of volunteers, one aged 18 to 55 and one aged 65 and over. Recruitment will begin «immediately» and clinical trials will be conducted at the Hospitales La Paz and La Princesa in Madrid and at the Hospital Marqués de Valdecilla de Santander (Cantabria, northern Spain).
The clinical trial will last several months and will be followed by a phase 3, the latter before having an authorisation of the product. «And we’re going to see the next few weeks and months how this evolves,» Illa said. This vaccine, called Ad26.
COV2. S uses a technology based on a non-replicative recombinant adenovirus to generate an immune response to one of the coronavirus proteins. Trials are essential to ensure the quality, safety and efficacy of vaccines.
Only with positive results, once assessed by the competent regulatory authorities, would the Spanish minister be authorised to market on European territory, the Spanish minister said. The Spanish Agency for Medicines and Healthcare Products maintains contact with different companies to carry out further clinical trials of this type in Spain.