Spanish Agency for Medicines and Health Products authorises first phase III clinical trial for vaccine against COVID-19 in Spain

This is a multinational pivotal trial with a double-blind design (the masked vaccine or placebo is administered such that its identification is prevented to the naked eye), which will study the safety and efficacy of a two-dose system for this vaccine. To carry this out, up to 30,000 volunteers will be recruited from nine countries (Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States). In Spain, this trial will take place at nine hospitals which will start to recruit volunteers as soon as possible that comply with the criteria for specific inclusion in its protocol.

The study will initially vaccinate participants without concomitant diseases which are associated with a higher risk of progression to serious COVID-19. Following the assessment by an Independent Monitoring Committee of the safety data of these participants, the study will move on to include participants with concomitant diseases which are associated with a higher risk of progression to serious COVID-19. 20% of patients will be under the age of 40 and 30% above the age of 60. During the trial, all the volunteers will be closely monitored and all cases of COVID-19 that develop will be identified. This will allow a preliminary analysis to be made with intermediate data. However, it will be necessary to wait for the clinical trial to be completed to analyse all the data and make final conclusions.

These clinical trials form part of the requirements that must be carried out for all vaccines researched to demonstrate their quality, safety and efficacy. Only after their evaluation and should the regulatory standards be complied with will their sale be authorised.

This vaccine, known as Ad26.COV2.S, is based on a soundly documented technology with a non-replicative recombinant adenovirus, to generate an immunological response to one of the coronavirus proteins known as protein S (from spike, also known as the proteína espiga in Spanish).

The Ministry of Health, through the AEMPS, is in touch with different companies that have proposed the inclusion of Spanish centres in their clinical trials to contribute to the global efforts to search for a vaccine against COVID-19. The start of the clinical trials is another milestone in this path that should end with the authorisation and supply of effective and safe vaccines to the public.

Non official translation