BRUSSELS. The EMA is ready to launch an investigation to verify whether the clinical tests of the Russian Sputnik V vaccine have violated international ethical and scientific standards, while in Brussels it emerges that the European green light for the Moscow remedy will probably postpone at least a month, in June, due to Russian delays in providing data and access to its factories to Union experts.
The Amsterdam-based EU drug agency is expected to open the ethics dossier next week, the Financial Times reported in the morning. European sources explain that the investigation aims to understand whether the tests conducted by the Russian authorities to speed up vaccine trials have forced public and military employees to lend themselves as guinea pigs for the serum on which the Kremlin has built an intense propaganda operation to improve the perception of Russia and Vladimir Putin. Dall’Ema confirm, but belittle by talking about routine investigation. However, when Russia is involved, every nuance can be charged with political significance.
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At the moment the EMA has started the Rolling review of the vaccine, the continuous analysis of the data provided by Moscow which, however, has not yet requested formal authorization for the marketing of the compound in Europe (it will be able to do so when the preliminary analysis in Amsterdam is concluded. ). The EU Agency is the first public authority in the world to examine Sputnik’s cards, so far only validated by the Lancet. Sources in Brussels close to the dossier explain that the performance of the Russian product seems promising from the point of view of safety and efficacy. However, the papers provided by Moscow are incomplete and the dialogue between the parties must be completed.
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Furthermore, as usual, EMA experts (aided by those of national agencies, such as Aifa) must inspect the Sputnik plants in Russia for the EU approval necessary to distribute the remedy in Europe. Establishments essentially have to demonstrate that they are capable of mass-producing a product that is as safe as samples supplied to public authorities for analysis.
EMA’s visit to Russia was scheduled for April 10, but the EU agency postponed the trip to Russia to May. The postponement, they explain in Brussels, was requested by the Russians. Who, evidently, do not feel ready to respect European standards despite the strong propaganda in favor of Sputnik, now passed in public opinion as the potential savior of Europe kept away by EU governments for geopolitical prejudices. Initially it was estimated that at best Sputnik would have received the EU green light in May, but the delay caused by the poor quality of the data provided by Moscow and the postponement of inspections moves the appointment to at least June.
In Europe at the moment only Hungary and Slovakia have bypassed the EMA with a national emergency clearance that allowed them to use Sputnik. Germany and Italy ask that the EU, once approved by the EMA, stipulate a single European contract for the purchase of the product as done with the vaccines currently on the market. The decision will only be made after the green light from the Amsterdam Medicines Agency. However, the Brussels institutions and the capitals have serious doubts about the Russian productive capacity. At the moment, Europeans are convinced that Moscow is pumping out pro Sputnik propaganda but does not have the industrial means to supply even their own country. So much so that for the EU institutions in the end it will be Europe that will produce Sputnik at the end of the year to help Russia vaccinate its own population, not vice versa.
In this context, the EMA now wants to verify whether the Russian trials have been ethically managed in compliance with the Gcp, the internationally agreed standard aimed at ensuring that drug trials are designed and conducted correctly. Russia had previously disclosed that military and state employees had been involved in testing the vaccine developed by a state laboratory and financed by the Russian Fund for Direct Investment, the Kremlin’s sovereign wealth fund. Reuters reported that some of the participants said they were pressured by their superiors to participate in the tests.
Kirill Dmitriev, head of the Russian Fund, denied the use of coercion: “There was no pressure and Sputnik V complied with all clinical practices,” he told the Financial Times. Ema reserves the right to verify not only the quality of the compound, but also the ethical standards behind it: “Gcp compliance provides the guarantee that the rights, safety and well-being of the participants in the trial are protected and that the data of the clinical trials are credible “.
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