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Sputnik, what happened to the Russian vaccine against Covid

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Sputnik, what happened to the Russian vaccine against Covid

Sputnik V, a vaccine probably useful in combating the pandemic but passed off as the ne plus ultra in the prevention of Covid-19. This could be, in a nutshell, the story of the year and a half of life of the product developed by the Gamaleya National Center of Epidemiology and Microbiology in Moscow. A vaccine with a lot of propaganda but few reliable data.

The rush to the vaccine

From the early months of 2020 it immediately became clear that in the pandemic emergency the world needed a vaccine. It is no coincidence that as soon as the sequence of the Sars-Cov-2 virus, deposited in public databases at the beginning of January 2020, was known, various realities immediately started working in an attempt to develop an effective one. A spasmodic research that led to the first products being available within a year. On the one hand, vaccines developed with mRNA technology, and on the other, those with viral vector technology.

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How does Sputnik V work?

Today, we well know, in our country only mRNA vaccines are administered (Comirnaty by Pfizer and Spikevax by Moderna) and to a lesser extent the latest arrivals, those with protein subunits produced by Novavax. But until a few months ago, viral vector vaccines, namely the products of AstraZeneca and Janssen, also played a decisive role in bringing down cases, hospitalizations and deaths. Sputnik V, never approved in Europe, belongs to the same category. As with mRNA vaccines, the ultimate goal is to make the immune system produce antibodies directed against the SARS-Cov-2 spike protein. What changes in the case of viral vectors is the method by which this occurs.

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This type of vaccine is in fact characterized by two components: a virus rendered harmless (the box) containing a small portion of DNA that is used to produce the spike protein. The Sputnik V vaccine, unlike the other viral vector vaccines, uses two different “boxes”. In the first injection, the virus Ad26 is used for the first dose and Ad25 for the second, 21 days after the first. A choice, that of using two different vectors, useful to reduce the risk that, after the first dose, the organism produces antibodies against the first “box” with a consequent reduction in the effectiveness of the vaccination. The Sputnik V vaccine, therefore, is actually the combination of two vaccines.

Halfway publications

On paper, therefore, the Russian vaccine would have nothing to envy to its brothers. But the research, fortunately, is made numbers in hand. Those numbers that must be shared with the scientific community and regulatory agencies. And this is where Sputnik V begins to creak. Mind you, in the hottest months of the pandemic, many of the data shared in important studies did not always, due to the haste with which they were obtained, proved to be reliable. With the Russian vaccine, however, this was particularly evident. In September 2020 the first two analyzes were published on the pages of The Lancet: two open-label non-randomized studies, each involving 38 people. No serious adverse events were reported and the vaccine appeared to induce robust immune responses in the participants. Publications that have aroused many doubts among insiders due to some not very credible data. Doubts to which the Gamaleya had promised to respond with further data that, in the months, have never been seen.

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Two years of Covid, the chronology of the epidemic


After a few months of attention, Sputnik V returned to being talked about internationally with a provisional report on the phase III study in February 2021. A report that indicated an efficacy of over 90%, the result of an experimentation on over 14 thousand people. But even in this case the relationship is not at all clear as it is studded with many small errors – as reported in an open letter by several scientists including Professor Enrico Bucci of Temple University – far too crude to appear in a publication of a phase III study.

The authorization to trade

Then there is another aspect to consider about the anomaly followed by the Russian vaccine in the approval process. While all the other vaccines that were being tested in phase III had submitted applications to the regulatory authorities at the same time, Sputnik V only knocked on the doors of the EMA at the beginning of March 2021. In the meantime, several non-European low and middle-income countries without agencies Independent regulators hastily approved the vaccine without going through phase III data. The situation is different for the rest of Europe: to date, one year after the request to the EMA, everything is still frozen. But where the situation has been approved, on the supply side, it is not so rosy: the Russian Direct Investment Fund, in countries such as the Philippines and Argentina, was unable to deliver the promised doses in the necessary time. A not insignificant problem if we consider that a different vial is required for the second doses (the “first dose” vials cannot be used because the vaccine requires a booster with a different viral vector).

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The effectiveness

During the last year, net of the propaganda on the extraordinary efficacy of the vaccine around the world, there has been some more data to support the good efficacy of the vaccine. In September 2021, an observational study conducted by an independent group of researchers found an efficacy of 81% in avoiding hospitalization. Efficacy obtained in the summer when the Delta variant was the predominant one. Certainly comforting data that do not, however, erase the reluctance on the part of producers in providing complete data to EMA and WHO to proceed with marketing.

The advertising

But when we talk about Sputnik V we cannot fail to mention our country as well. Last January a pre-print study conducted by the Spallanzani Institute of Rome in collaboration with Gamaleya tried to demonstrate the superiority of Sputnik V over the Pfizer-BioNTech vaccine and in particular how two doses of the Russian product would induce an antibody response. longer lasting against Omicron than the competition. A study, based on a sample of 17 people and with heavy methodological errors, which does not at all demonstrate the superiority of Sputnik V. What remains today of the Russian vaccine is the story of a decent vaccine victim of its own propaganda. But while other viral-vector vaccines proved useful in the emergency, Sputnik V pushed more on the propaganda of being superior than on transparent sharing of the data collected in terms of safety and efficacy.

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