The pandemic does not stop the search for new antibiotics at the University of Zaragoza
November 18, 2020
Experts recommend investigating nutrition as a strategy against covid
November 19, 2020
This is the first phase III trial of this type authorized in the Peninsula, in which the effectiveness and safety of this treatment for covid-19 will be evaluated.
The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the first phase III clinical trial for the vaccine against covid-19 from the company Janssen, belonging to the multinational Johnson&Johnson, the Ministry of Health has reported.
This is the first phase III trial of this type authorized in Spain, in which the effectiveness and safety of this vaccine will be evaluated, which will also be tested in eight other countries, for which some 30.000 volunteers will be recruited.
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.
In the study, participants without concomitant diseases that are associated with a higher risk of progression to severe Covid-19 will initially be vaccinated.
As reported by Health, this is a multinational trial (in which the vaccine or a placebo is administered masked so that its identification with the naked eye is prevented) that will study the safety and effectiveness of a two-dose regimen.
After the evaluation by an independent surveillance committee of the safety data of these participants, participants with concomitant diseases that are associated with a higher risk of progression to severe covid will eventually be included, Health has reported.
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 cases will be carried out.
The Ministry has recalled that "only after analysis of the data by the competent regulatory authorities, and a favorable evaluation of the benefit-risk balance, would marketing be authorized in European territory."
These clinical trials are part of the requirements that all vaccines under investigation must carry out to demonstrate their quality, safety and effectiveness.
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 a vaccine against covid-19.
