Spanish Health Secretary Salvador Illa has announced today that he has authorized the first trial in Spain for a covid19 vaccine. The trial, of a vaccine from Janssen (a Johnson&Johnson company), is a phase 2a trial that is planned to include a total of 550 healthy volunteers of which 190 will be recruited in Spain in three hospital centres. The research will be carried out on adults and includes two groups of volunteers, one from 18 to 55 years of age, and another of the over-65s. The Government’s Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) has explained that Spain’s contribution is to a “dose-finding study in which different administration patterns are also explored”.
This vaccine, Ad26.COV2.S, is based on what AEMPS describes as a solidly documented technology and a “non-replicative recombinant adenovirus to generate an immune response against one of the proteins of the coronavirus known as S protein” (from spike, also called spike protein in Spanish). The company has just finished phase 1 clinical trials and once its results have been analysed, the dose that the volunteers will receive in the phase 2 trial will be selected. The company also plans to start Phase 3 clinical trials shortly.
Spain forms part of the European Vaccine Strategy which is working to achieve a secure vaccine that is available to all. Spanish PM Pedro Sánchez says that Spain’s participation in the clinical trial is great news for the country. The PM said that “we must work together to develop a secure vaccine against covid19 and, moreover, that it is distributed fairly”. Sánchez congratulated the whole scientific community for what he called an important step forward. Such a vaccine will only be authorized in Spain by the European Medicines Agency (EMA) and AEMPS after evaluations of all the preclinical and clinical research carried out.