The Spanish Agency for Medicines and Health Products (Aemps) has authorized the Phase 3 clinical trial in Spain of the Janssen company’s Covid-19 vaccine (Johnson & Johnson). This is the first phase 3 trial of a coronavirus vaccine authorized in our country.
It is, says the Health statement, a pivotal, multinational trial, with a double-blind design, that is, the vaccine or a placebo is administered masked in a way that prevents its identification with the naked eye, which will study the safety and efficacy of a two-dose regimen of this vaccine. For it up to 30,000 volunteers from 9 countries will be recruited (Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States).
In Spain, this trial will be carried out in nine hospitals that they will begin, as soon as possible, the recruitment of volunteers who meet the inclusion criteria specified in their protocol.
In this trial, says Health, participants will be initially vaccinated without concomitant diseases associated with a increased risk of severe coronavirus progression. After the evaluation by an independent Committee of surveillance of the safety data of these participants, it would eventually include participants with comorbidities that are associated with an increased risk of progression to severe Covid-19. 20% of the patients will be under 40 years old, and 30% over 60 years old. During any trial, close monitoring of all volunteers and identification of all Covid-19 cases that occur will be carried out. This will allow preliminary analyzes to be carried out with intermediate data. However, it will be necessary wait until the clinical trial has finished to be able to analyze all the data and draw final conclusionss.
These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate its quality, safety and efficacy. Only after they have been evaluated and if they comply with regulatory standards, will they be authorized for commercialization.
This vaccine, called Ad26.COV2.S, is based on a well-documented technology with a non-replicative recombinant adenovirus, to generate an immune response against one of the coronavirus proteins known as protein S (from spike, also called spike protein in Spanish), says the statement.