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The
Spanish Agency for Medicines and Health Products (Aemps)
has authorized the
phase 3 clinical trial
in Spain of the
vaccine
against Covid-19 from the
Johnson & Johnson company
, as reported by the
Ministry of Health
on Wednesday
.
This is the first
phase 3 trial
, with two doses, for a
Covid-19
vaccine of
this type that is authorized in Spain and will be carried out in nine hospital centers that will begin, as soon as possible, the recruitment of volunteers that meet the inclusion criteria specified in their protocol.
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.
The study will initially vaccinate participants without comorbidities that are associated with an increased risk of progression to
severe
Covid-19
.
After the evaluation by an independent surveillance committee of the safety data of these participants, it would eventually include participants with concomitant diseases that are associated with an increased risk of progression to
severe
Covid-19
.
It is a pivotal, multinational trial, with a double-blind design (the vaccine or a placebo is administered masked in such a way as to prevent its identification with the naked eye), which will study the safety and efficacy of a two-dose regimen of this vaccine.
To do this, up to
30,000 volunteers
from nine countries (Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States) will
be recruited
.
According to the criteria of The Trust Project
Know more
Vaccinations
Coronavirus
Covid 19
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