Ema has started the review of the Sputnik vaccine – here’s what it means to us

Many countries, over 40 in the world, have already authorized it. Even in Europe, there are those who do not intend to wait for the green light from the European Medicines Agency, such as Czech Republic, Slovakia The Hungary, who have already started or will start using it. The debate on the Sputnik V, the Russian vaccine most used abroad that at home has been on for some time. Since last summer, when Vladimir Putin defined it in August as the first in the world to be certified and registered. At home, of course.

In any case, theEuropean Medicines Agency decided to start the so-called rolling review, that is the process of continuous and progressive revision of the data that will gradually be available on the anti-Covid vaccine developed by the National Center for Epidemiological and Microbiological Research NF Gamaleja in Moscow. The request for revision came, specifically, from R-Pharm Germany, a German subsidiary of the Russian pharmaceutical group R-Pharm. «The EMA – reads the note – will evaluate the data as soon as they are available to decide if the benefits outweigh the risks. The rolling review will continue until sufficient evidence is available for the formal application for a marketing authorization. The EMA will assess the compliance of Sputnik V with the usual EU standards in terms of efficacy, safety and quality ». San Marino too is already using thousands of doses of the vaccine for its citizens and even in Italy the administrators and political leaders are multiplying, from Salvini to Zingaretti, who are clamoring to be able to use it.

“When the EMA has given its approval, we will be ready to supply Europe with 50 million doses,” he said Kirill Dmitriev, head of the Russian sovereign fund for direct investments which contributed to the development of whey. But not before June, assuming that the authorization has actually arrived for that month. Dmitriev says he has provided all the necessary data and on Twitter the national fund account explains that he is available to welcome the inspectors of the European agency to the factories where the vaccine is produced, one of the most controversial pieces of the past months.

What does rolling review mean? That the EMA continues with the work, will continuously examine the production documents, the medical records of the volunteers, the clinical studies until sufficient evidence is available to allow R-Pharm to present formal application for authorization to placing on the market. However, it does not mean that the European Commission can or should centrally purchase Russian vaccine supplies. So much so that Brussels immediately pointed out that “the approval process for the Russian Sputnik vaccine just started by the European drug agency does not imply that it automatically enters the EU vaccination strategy portfolio”. This was explained by Stefan de Keersmaecker, spokesman for the European Commission for Health.

As it is already happening, it will therefore be up to the member states decide whether or not to add that vaccine to their national offer, but comforted – compared to the current situation, with studies still insufficient and the need to view more complete raw data at the basis of clinical trials – by the possibly positive evaluation of the EMA. The spokesman for the commission, Eric Mamer, added that even if a vaccine is approved by the EMA, there is no obligation for the Commission to include it in its contracts. And it is very likely that the intermediate solution will end up being this: vaccine approved by the agency on a European scale but without centralized purchases by the Commission. Each making their own orders.

«The decision of the CHMP [Comitato per i medicinali umani] to start the progressive review – reads the EMA press release – is based on the results of laboratory studies and clinical studies on adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the Sars-Cov-2 coronavirus and can help protect against Covid-19 ”. As we had explained, the vaccine exploits two different adenoviruses, Ad26 and Ad5, obviously rendered harmless and used to carry the viral gene that codes for the Sars-CoV-2 spike protein: when it is produced, the immune system will produce antibodies and T cells to counteract it and prepare for any encounter with infection. The choice of the double vector is considered original and effective by many experts: it would allow to raise the level of effectiveness by neutralizing the natural and contained immune response against the vector with the use of a different adenovirus for the booster.