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Three Covid-19 vaccine studies are expected to begin in France from mid-December on 2,200 volunteers recruited through a specially set up platform this fall, Inserm (National Institute of Health and Medical Research).
“We are ready, we are waiting for the authorizations“Odile Launay, infectious disease specialist at Cochin hospital (AP-HP) in Paris and coordinator of this platform, Covireivac, said during an online press conference.
Two of these trials will be phase 3 trials, namely the most advanced phase: they concern the vaccine from the Janssen laboratory (a subsidiary of Johnson & Johnson) and that developed by the company AstraZeneca and the University of Oxford.
These two trials will involve 1,000 volunteers each from mid-December, subject to the necessary authorizations (from the ANSM agency for the drug and from a Personal Protection Committee). These two vaccines are already being tested 3 on tens of thousands of volunteers in other countries.
41,000 registered volunteers
The third trial concerns one of the most advanced vaccines in its development, that of the Modern American laboratory. It is evaluated in phase 3 on 30,000 people in the United States, but the French trial will be on a smaller scale, in phase 2 and on 180 volunteers, starting in late December or early January.
The aim is not to evaluate its effectiveness on a large scale, but to examine “in a much finer way“, on targeted criteria, the immune response caused by this vaccine, explained Professor Launay.
Therefore, among the 180 volunteers, 120 will be over 70 years old. It is important to evaluate the action of vaccines against Covid in the elderly because they are among those at risk.
The European Medicines Agency (EMA) must take a decision no later than 12 January for a possible authorization of Moderna’s vaccine.
For the moment, only one phase 1 trial is underway in France (first administration on a limited number of healthy subjects, from 10 to 100), that of the Institut Pasteur. In total, more than 41,000 volunteers registered on the Covireivac platform.
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