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Sputnik V: How good is the Russian vaccine?

Questions and answers about the vaccine that the European Medicines Agency (EMA) is currently reviewing.

What are the political concerns?

In mid-August 2020, Russia released Sputnik V, the world's first corona vaccine for widespread use in the population. "Vaccination is always politics, it's never just about medical issues," says historian Malte Thießen, who has been concerned with the history of immunization since the first smallpox vaccination. He speaks of reservations in the western part of the EU. The poisoning of Kremlin critic Alexej Navalny may also be a reason for some citizens not to want a product from Russia to be injected. Choosing the name Sputnik for a vaccine is already "first class propaganda", according to Thießen. Sputnik 1 was the name of the world's first satellite launched, with which the Soviet Union shocked the western world in 1957.

What doubts do scientists have?

The first global vaccine release for Russia was the subject of international criticism. Scientists mainly complained about the lack of conclusive data. The reason is that the approval took place before the results of so-called phase III studies were available. This contradicts the usual procedure. Because in the test with several thousand test subjects, rare side effects could be detected, according to the Paul Ehrlich Institute.

The researchers published the first details on Sputnik V in early September 2020 in the journal "The Lancet". Accordingly, the vaccine stimulates an immune response. Antibodies against the virus were detected in a total of 76 participants in test phase I / II. This was followed by criticism of Russia's approach, but also sigh of relief: The result now available is unambiguous. The scientific principle of vaccination had been demonstrated, said researcher Polly Roy from the London School of Hygiene & Tropical Medicine the journal "The Lancet".

How does the Sputnik V vaccine work?

The vaccine developed by the Gamaleja State Research Center for Epidemiology and Microbiology in Moscow is a so-called vector vaccine and thus similar to the Astrazeneca vaccine. Like this, it can be transported and stored at refrigerator temperature.

Both use weakened, harmless viruses to channel the information into the body. The aim is to get the immune system to trigger defense reactions against Sars-CoV-2. When it comes into contact with the coronavirus, the body is prepared and can better contain the infection.

The Russian vaccine is given in two doses 12 weeks apart. Two different cold viruses (adenoviruses) are used as a means of transport (vector) for the two vaccine doses. This is to prevent immune reactions to the vector virus of the first vaccination dose weakening the effect of the second dose.

The side effects of Sputnik V include pain at the injection site, headache and body aches, fatigue and sometimes flu-like symptoms. There have also been reports of fever and chills.

How good is Sputnik V?

In an "interim analysis" of the important test phase III with around 20,000 volunteers, Russian researchers came to an effectiveness of 91.6 percent. The results were also published in February 2021 in the medical journal "The Lancet". They coincide with earlier statements.

An effectiveness of 91.6 percent means that 91.6 percent fewer diseases occurred in the vaccinated group than in the control group. This means that Sputnik V has roughly the same effectiveness as the vaccines from Moderna and Biontech / Pfizer and significantly higher than the agent from Astrazeneca. According to the Moscow authorities, Sputnik V also works with the more contagious British variant B.1.1.7. The vaccination protection is built up 21 days after the second vaccination.

Thomas Mertens, Chairman of the Standing Vaccination Commission (Stiko), rates the Russian vaccine Sputnik V as fundamentally promising. He described the Russian researchers as "very good". Russia also has a long tradition of vaccine development. However, the previously published data on Sputnik V have only been summarized very briefly in the specialist publications.

In Russia itself, Sputnik V is a slow seller, there is great skepticism about vaccinations. According to a survey by the Russian Levada Institute published in mid-May, 62 percent of those surveyed were not ready to be vaccinated with Sputnik V. So far, around ten percent of the population has been vaccinated once, and almost 7 percent of Russia's 146 million inhabitants have already received both doses of the vaccine.

How much of it does Russia sell and to whom?

65 countries worldwide, including India, which is currently badly affected by the pandemic, have approved Sputnik V so far, the state direct investment fund RDIF announced (as of May 18). RDIF is involved in the funding of Sputnik V and takes care of the commercialization of the vaccine.

In Brazil, however, Sputnik V is not used for the time being. The authority responsible for pharmaceuticals, Anvisa, stated that it was not only the effectiveness of the vaccine that was difficult to check. In addition, there is a lack of quality control data. Last but not least, active carrier viruses were found in samples for the second dose of the vaccine. Actually, these are only allowed to be inactivated in the vaccine.

In the EU, the preparation is already in use in Hungary and will soon be in Slovakia without approval. Other European countries such as the Czech Republic and Austria had signaled their interest - to the concern of the EMA: Christa Wirthumer-Hoche from the EU Medicines Agency warned EU states to use the Russian vaccine before the EMA test. Crucial data from vaccinated persons are not available.

In Slovakia, people can be vaccinated with Sputnik V from June. The Slovak Minister of Health announced approval for the use of the vaccine in mid-April. Slovakia had already received its first delivery from Sputnik V six weeks earlier. So far, not a single one of the 200,000 vaccine doses delivered has been vaccinated, as the Slovak Medicines Authority had expressed doubts about the Sputnik-V batch. The purchase of the Russian vaccine triggered a government crisis in Slovakia, which led to the resignation of then Prime Minister Igor Matovic and his Minister of Health, Marek Krajci. Laboratory tests have now dispelled doubts about the batches.

The small state of San Marino, which is not an EU member, is now offering a vaccination with Sputnik V for tourists. The price for the required two doses of the vaccine is 50 euros, wrote the Italian newspaper "Corriere della Sera".

According to the RDIF, 50 million people in the EU could be supplied with Sputnik V by the middle of the year. The Russian vaccine for the EU is also to be produced here. According to unconfirmed information from RDIF, production agreements have already been concluded with companies in Germany and other European countries such as France, Italy and Spain. Bavaria's Prime Minister Söder announced at the beginning of April that the pharmaceutical company R-Pharm Germany in Illertissen, Swabia, was planning to manufacture the Sputnik vaccine. The production facility is to be expanded in the Neu-Ulm district in the coming months. Because there are still approvals pending from the district authorities, there is currently a construction freeze.

Is Sputnik V advancing the speed of vaccination in the EU?

Despite all efforts to establish Sputnik V in the EU, it could be that the Russian vaccine will ultimately only play a subordinate role in increasing the speed of vaccination in the EU. Because until the manufacturing capacities for Sputnik V in Europe have been built up to a significant extent, other vaccines will be available on a large scale. For example, the Biontech plant in Marburg, Hesse, which went into operation in February, promises to produce 250 million cans by the end of the first half of the year.

In addition, the US company Johnson & Johnson has also been delivering its approved vaccine to Europe since the end of April. So Sputnik V is unlikely to have a major impact on the vaccination campaign in the EU. Several production sites in the EU would make it easier for Russia to supply Sputnik V to more countries around the world.

(With material from dpa, AFP)