Three vaccine trials organized in France since mid-December

From mid-December, three vaccine trials will be launched on 2,200 volunteers, recruited through a specially established platform this fall, Inserm (National Institute for Health and Medical Research) said on Wednesday.

“We are ready, we are waiting for the authorizations,” Odile Launay, an infectious disease specialist at the Cochin hospital (AP-HP) in Paris and coordinator of this platform, Covireivac, said during an online press conference.

Evaluate the vaccine-induced immune response

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 drug agency and a Committee for the protection of people). These two vaccines are already in phase 3 trials on tens of thousands of volunteers in other countries.

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 efficacy on a large scale, but to examine “in much more detail”, on targeted criteria, the immune response provoked by this vaccine, explained Professor Launay.

No studies for Pfizer / BioNTech vaccine

Therefore, among the 180 volunteers, 120 will be over 70 years old. It is important to evaluate the action of vaccines against Covid-19 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.

“Most likely there will be an authorization ahead of the results of our trial, but these results will remain extremely important” because they will provide additional “pieces of information”, Pr Launay stressed. On the other hand, Pfizer / BioNTech’s vaccine (the third most advanced along with those of Moderna and AstraZeneca) is not expected to be tested in France for the moment.

More than 41,000 registered volunteers

Phase 3 trials of the Janssen and AstraZeneca vaccines are carried out on the initiative of the manufacturers: Inserm has received several requests and has favored vaccines already preordered from Europe, without excluding the addition of others. then, explained Professor Launay. Moderna’s vaccine trial is of a different nature. This is a so-called “academic” trial in which Inserm would have liked to evaluate the most advanced vaccines, and only the American laboratory has responded favorably for the moment, he said.

“It is a pity that we have not been able to evaluate the (Pfizer) vaccine as we would like to do”, commented Professor Launay, according to whom “it is absolutely essential to continue research” on all vaccines. 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.