Just two months ago, Covireivac was launched, a new platform in France aimed at recruiting 25,000 volunteers to participate in clinical trials on vaccines against Covid.
More than 40,000 registered later and three projects selected by the Covid-19 Vaccines Scientific Committee, the team says it is
“ready to start.” “We are only waiting for the green light from the National Medicines Safety Agency and the Personal Protection Committee, which ensures that participants are properly informed.
It should not be long, ”
said Pr Odile Launay, coordinator of the platform and CIC Cochin Pasteur in Paris on Wednesday.
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With other vaccination experts invested in the project, Professor Launay presented on Wednesday the three trials that will lead the way.
Two fall under phase 3, for industrial firms needing data on the efficacy and safety of their product with a view to applying for a marketing authorization (AMM).
Around a thousand French people will thus participate in mid-December in the trial of the AstraZeneca laboratory, which has developed an attenuated viral vector vaccine with the University of Oxford.
They will receive a full dose twice a month apart
(AstraZeneca also tested a first half dose, it seems by mistake, but this will not be the case here, Editor's note).
These data will aim to confirm the 70% efficiency communicated by the firm.
A second trial, of the same magnitude, will be conducted at the same time with the vaccine from the Janssen laboratory.
In this context, volunteers will receive two doses two months apart, to assess whether the protection offered is longer than in a single dose regimen.
It should be noted that, in these two phase 3 trials, some of the participants will be injected with a placebo, as is customary to measure efficacy.
The third trial will focus at the end of December on the RNA vaccine from the American company Moderna, which has just submitted an MA file to the European Medicines Agency.
Supported by APHP researchers, this time it will aim to refine our knowledge of the immune response it induces, especially in those over 70 years old.
The latter will therefore be in the majority among the selected volunteers (120 out of a total of 180, no placebo).
“As we age, our immune response is generally poorer.
However, age is a major risk factor for the severe form of Covid.
It is therefore essential to study this population ”,
underlines Professor Jean-Daniel Lelièvre, head of the infectious diseases department at Henri-Mondor hospital in Créteil.
The trial will also analyze the immunity in the nasal mucosa to assess the risk of transmission of the virus from vaccinees.
Continue research
“The phase 3 clinical trials, which provide general efficacy data, are followed by other studies on specific subpopulations. The new elements thus obtained are likely to modify vaccine strategies, ”
explains Jean-Daniel Lelièvre.
Contacted by Covireivac, the Pfizer-BioNTech duo, whose RNA vaccine has just received its first Marketing Authorization in the United Kingdom, has however not allowed other laboratories to evaluate its vaccine before its arrival on the market.
“We regret it a bit, but we will probably set up a test once the MA has been obtained,”
says Odile Launay.
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“Over time, several vaccines will be presented to us with variable efficiency, cost, production capacities and ease of use,”
emphasizes the infectious disease specialist.
We haven't finished asking questions about them.
It is therefore essential to continue research. ”
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