Once criticized and marginalized, the Russian vaccine is now in the spotlight. Latest coup to date: Tuesday, it was judged to be 91.6% effective against symptomatic forms of covid-19, according to a published study in the medical journal The Lancet, validated by independent experts. Almost as much as the vaccines from Pfizer / BioNTech and Moderna (around 95%), already in circulation in France. And more than that of AstraZeneca (70%), which has just been validated by the HAS.
In recent weeks, voices have been raised in Europe for the European Medicines Agency (EMA) to rapidly assess the application for placing Sputnik V on the European market, filed in mid-January. The vaccine is already used in Russia and in a few countries (including Argentina, Mexico or Algeria).
Germany, which intends to catch up with the delay caused by the shortage of doses, actively supports an accelerated review. If Sputnik V is validated, “we can discuss joint production and use,” Angela Merkel even said on January 22. “All those who obtain an authorization from the EMA will be absolutely welcome, I spoke precisely on this point with the Russian president”, assured the Chancellor, on February 2.
1 Do States have the obligation to go through the Union and the European Medicines Agency?
In view of the effectiveness of the Russian vaccine, the temptation to override the Commission and the directives of the European Medicines Agency may be strong. To buy vaccines, the Member States of the European Union have so far decided to come together to conclude purchasing contracts. This mission has been entrusted to the European Commission.
In this context, the Member States have undertaken not to conduct parallel negotiations with vaccine manufacturers with whom discussions are underway at EU level. States are also forced to wait for the green light from the EMA to obtain and administer the doses. This was the case with those of Pfizer, Moderna and AstraZeneca. And this will be the case with those of Sanofi-GSK, Johnson & Johnson, CureVac, Novavax and Valneva, when their safety and efficacy have been demonstrated.
The Russian vaccine was not the subject of a contract. A Member State can therefore negotiate directly with the laboratory. And a European directive of 2001 allows it “to temporarily authorize the distribution of an unauthorized drug” by the EMA on its territory, in order to respond to a pandemic likely “to cause damage”. This authorization is valid for six months, with a possible extension of another six months.
During this period, in the event of an accident, the country bears full civil and administrative responsibility for the unauthorized vaccine. It must also ensure that the doses do not circulate in the rest of the Union. At the end of the period, a marketing authorization by the European agency is required.
This provision had enabled the UK to urgently authorize Pfizer’s vaccine in early December, without waiting for the opinion of the European Medicines Agency, while the country was still subject to EU rules.
The procedure has just been started again, this time by Hungary and precisely on the Russian vaccine. Budapest has criticized for several weeks the “slowness” of the vaccine approval process. Nevertheless, the Hungarian Public Health Center will have to issue an opinion in the coming weeks before the first injections.
2 Can France do without the opinion of the European agency?
As for Hungary, France could order directly from Russia and rely on its drug agency, the ANSM, to authorize the temporary marketing of Sputnik V. However, this decision is not favored. of the executive, who wishes to follow the classic route.
Emmanuel Macron also recalled Tuesday evening, on TF1, the rule he has set for the country: “For a vaccine to be authorized, it must be approved. Depending on these results and the evidence, we will approve it or not. “
A caution which is not surprising. France has already pre-ordered many vaccines under grouped contracts, even if the doses are slow to arrive. We thus evoke a potential stock of 220 million doses for France. That is to say a little more than three doses per inhabitant, more than enough to vaccinate the French population. “It would be immoral for Europe or France to try to preempt all the vaccines produced in the world for their benefit”, points out Marie-Paule Kieny, virologist and French public health expert, president of the Covid-19 vaccine committee, at BFMTV.
In addition, Russia’s ability to produce so many vaccines for the whole world has not yet been demonstrated. “The Russians are well organized in their research and their production, but I do not believe that they can provide the doses for themselves, in addition to Europe, Brazil and Africa”, raises Bernard Bégaud, professor of pharmacology at the University of Bordeaux and former member of the Medicines Agency, interviewed by LCI.
Finally, the study by The Lancet focuses on the efficacy of the vaccine on symptomatic cases only. “Further research is needed to determine the efficacy of the vaccine on asymptomatic cases and on disease transmission,” the medical journal continues. Extensive research that takes time. “It is not a political decision, it is a scientific decision,” Emmanuel Macron recalled Tuesday, to justify his reservations as they stand.
But the shortage of doses and delays in supply are forcing countries to change gear. Monday, Gabriel Attal had already underlined on franceinfo that France, like Germany, no longer completely closed the doors to the Russian vaccine. But conditioned its use to a European approval. “If the EMA considers it safe and effective, the French High Authority for Health will carry out the same assessment and it could obviously be offered to French citizens, if that were the case.” The European procedure is expected to last several weeks.
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