With only one million first doses scheduled for February, France is bearing the brunt of the European vaccine shortage.
This Tuesday, the High Authority for Health (HAS) will give its opinion on that of AstraZeneca, which has just obtained its marketing authorization on the Old Continent.
Emmanuel Macron must meet with representatives of the pharmaceutical industry on Tuesday or Wednesday in order to try to speed up production.
A global tension on the supply which puts the Russian and Chinese vaccines back at the heart of speculation.
What vaccines are we talking about?
The “Covid-19 vaccines scientific committee”, which guides the French strategy, has had three files, two Chinese and one Russian, for several months already.
"The vaccines evaluated are those which claim the European market," explains Stéphane Paul, immunologist at the CHU de Saint-Etienne and member of the committee.
Sinovac and CanSino took steps around July and Sputnik a little later.
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For now, none of these products has found its place among the 225 million doses ordered by France.
Russia on Friday proposed to provide "100 million doses in the second quarter" to the Union "subject to the approval of the EMA" (the European medicines agency).
This serum has already been approved by fifteen countries, including Algeria, Tunisia and the United Arab Emirates.
Moscow plans to immunize 20 million people by the end of March.
China, for its part, has already announced that it has vaccinated 15 million people with these different serums.
They have already been tested, injected or ordered on a massive scale in many countries such as Turkey, Brazil, the United Arab Emirates, Mexico, but also Serbia and Hungary.
"A preliminary request has been filed with the EMA by the Russians for Sputnik V, but not for the other vaccines," recalls Marie-Paule Kieny, president of the Covid-19 vaccines committee and director of research at Inserm.
How effective are they?
This is the whole question.
The manufacturers evoke a protection which goes from 78% for Sinovac to 91.4% for Sputnik V. “We must really be wary of the publications, estimates François Maignen, pharmacist specializing in the safety of the drug.
On the Covid, we see anything and everything: press releases, data not submitted to a medical journal, journals of questionable value ... It's all the difference with the EMA, which gives a marketing authorization and who has the opportunity to carry out inspections, to check whether the data are true… ”
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With this objective, the European and French authorities have been monitoring candidates since the summer.
"The scientific and technical mission to Moscow that I chaired [at the end of November] concluded that the Sputnik V vaccine was effective," emphasizes Marie-Paule Kieny.
If their files comply with the quality demands dictated by the EMA, there is no impossibility for these vaccines to be approved.
"And to procrastinate:" The quality aspects of vaccine development, its production - including raw materials - and clinical and preclinical data are fundamental.
I don't know the data and guarantees for Russian and Chinese vaccines available at this point.
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Germany has however offered to support the validation process and Gabriel Attal, the spokesperson for the French government, stressed Monday morning: “A vaccine, we do not look at his nationality.
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Stéphane Paul details the state of French investigations on the vaccines studied: “Until now, the manufacturing conditions in Russia did not comply with good European practices.
Russia is asking the international community for help to improve and is playing on transparency.
On the Chinese side, CanSino has been very open to the international community, but it is a small company.
Its second phase of testing is interesting, there is no brake, but we do not yet have the data for phase 3. Regarding Sinovac, which like Sinopharm is based on an inactivated virus, there is a vagueness, because nothing has been published and a Turkish trial has shown 90% effectiveness, while a Brazilian trial evokes 50% ... "
When could they arrive in France?
If Russia managed to obtain approval and deliver 100 million doses before the end of June, these would represent a significant addition to the European Commission's order book.
The body expects the delivery of 300 million doses in the second quarter from suppliers with whom it is already engaged.
In theory, nothing is impossible, as Christophe Bardin, a hospital pharmacy practitioner, also a member of the Covid-19 vaccines committee, explains: "If the file is well sewn, square, it can be done quickly, with a minimum of about four weeks.
If data is missing, the laboratory may need to do additional testing.
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"At this stage, it does not seem opportune to order these vaccines if the objective is to have deliveries in 2021", estimates for his part Professor Kieny who points to "the expected time for their approval", just like the fact that “the Russian population to be immunized is large, and that the government favors bilateral agreements with the countries it wishes to influence.
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For Chinese formulas, the prospects seem even more distant, for scientific but also political reasons slipped by the immunologist Stéphane Paul: “We had a societal discussion within the committee to know if the European population would accept a Chinese vaccine while the virus originated in this country.
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