The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the first phase III clinical trial for the COVID-19 vaccine of the company Janssen, belonging to the multinational Johnson & Johnson, the Ministry of Health has informed. This is the first phase III trial of this type authorized in Spain, in which the efficacy and safety of this vaccine will be evaluated, which will also be tested in eight other countries, for which about 30,000 volunteers will be recruited.
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In Spain, the trial will consist of two doses of vaccine and will be carried out in nine hospital centers that will begin, as soon as possible, the recruitment of volunteers who meet the inclusion criteria specified in their protocol. In addition to Spain, the participating countries are: Belgium, Colombia, France, Germany, the Philippines, South Africa, the United Kingdom and the United States.
The study will initially vaccinate participants without comorbidities, which are associated with an increased risk of progression to severe COVID-19. As reported by Health, it is a multinational trial (in which the vaccine or a placebo masked in such a way as to prevent its identification with the naked eye) that will study the safety and efficacy of a two-dose regimen.
After the evaluation by an independent surveillance committee of the safety data of these participants, it will eventually include participants with concomitant diseases that are associated with a greater risk of progression to severe COVID, Health has reported.
30% of the volunteers will be over 60 years old
20 percent of the patients will be under 40 years old, and 30 percent over 60 years old. Throughout any trial, close monitoring of all volunteers and identification of all cases will be carried out.
The Ministry has recalled that “only after the analysis of the data by the competent regulatory authorities, and a favorable evaluation of the benefit-risk balance, would the commercialization in European territory be authorized”.
These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate their quality, safety and efficacy.
The Ministry of Health, through the AEMPS, maintains contact with different companies that have proposed the inclusion of Spanish centers in their clinical trials to contribute to the global effort in the search for the vaccine against covid-19.