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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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