What we know so far about Russian vaccine – and what not

In addition to the vaccines from Moderna, Biontech and Astrazeneca, the first federal states are now also planning to inoculate the Russian vaccine Sputnik V. But doubts about its safety are mounting. What is known so far?

Bavaria’s Prime Minister Markus Söder has already signed a preliminary contract for the Russian corona vaccine Sputnik V, according to which Bavaria should receive 2.5 million doses. Mecklenburg-Western Pomerania has also secured an option for one million vaccine doses. Health Minister Jens Spahn announced that he would speak to Russia about the vaccine.

However, the vaccine has not yet been approved in the EU, and there are also doubts from many sides about the effectiveness and safety of the active ingredient. The most important questions and answers at a glance.

What kind of vaccine is Sputnik V?

The vaccine developed by the Gamaleja State Research Center for Epidemiology and Microbiology in Moscow is a so-called vector vaccine and is therefore similar to the Astrazeneca vaccine. Both use weakened, harmless viruses to channel the information into the body.

The aim is to get the immune system to respond to defensive reactions SARS-CoV-2 to evoke. When it comes into contact with the coronavirus, the body is prepared and can better contain the infection. The Russian vaccine is administered in two doses 21 days apart.

Since when has Sputnik V been vaccinated in Russia?

In August 2020, Russia approved Sputnik V, the world’s first vaccine against the coronavirus. First, individual sections of the population, including teachers and doctors, were vaccinated – although relevant tests had been missing until then. The important phase III study, which determines the effectiveness and safety of the drug, is a prerequisite for approval. At least in the EU.

Russia’s approach to vaccinating people with a substance that has not been researched in large clinical studies contradicts the international standards and has been the subject of sharp criticism. Mass vaccination of the Russian population started at the beginning of December 2020.

How many people have already been vaccinated in Russia?

According to the government in Moscow, only five million Russians have been vaccinated so far, just 3.4 percent of the total population. This is very little compared to many other countries – especially considering that Russia has developed two other corona vaccines in addition to Sputnik V. Most recently, Russia’s Health Minister Mikhail Muraschko announced herd immunity in the Russian population by the end of July.

Which other countries are already vaccinating the active ingredient?

56 countries around the world have approved Sputnik V, as reported by the state direct investment fund RDIF (as of the end of March). He is involved in the financing of Sputnik V and takes care of the marketing of the vaccine.

In the EU, the preparation is already in use in Hungary and Slovakia, even without approval, the Czech Republic and Austria have signaled their interest – to the concern of Ema: A representative of the EU Medicines Agency warned EU states against this before the Ema test to use Russian vaccine. Crucial data from vaccinated people are not available, says Christa Wirthumer-Hoche on ORF.

What doubts are there about the vaccine?

Russia received international criticism for first place in the vaccine release. 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 (PEI).

The researchers published the first details on Sputnik V at the beginning of September 2020 in the renowned specialist 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 has been demonstrated, says researcher Polly Roy from the London School of Hygiene & Tropical Medicine in the journal “The Lancet”.

What studies are there already and what are the results?

It was not until February 2021 that the interim results of the phase III study were published in the journal “The Lancet”. Accordingly, the vaccine is certified to be 91.6 percent effective against symptomatic corona disease. An effectiveness of 91.6 percent means that 91.6 percent fewer diseases occurred in the vaccinated group than in the control group. Accordingly, Sputnik V has approximately the same effectiveness as the vaccines from Moderna and Biontech / Pfizer and a significantly higher than the agent from Astrazeneca. The data are considered meaningful because the study included more than 20,000 test subjects.

Nevertheless, some experts criticized the “Lancet” study. The total number of test subjects is lower than in the studies on the mRNA vaccines by Biontech/ Pfizer and Moderna. This means that the number of those who have become infected is also lower – and that is how the effectiveness of a vaccine is calculated. There were no serious side effects from Sputnik V in the vaccine group, according to “The Lancet”. How well the corona vaccine protects against the new virus variants is still unclear. According to the Moscow authorities, however, Sputnik V also works with the more contagious variant B.1.1.7 from Great Britain.

Could the study data be fake?

There were repeated indications that the data from Russia could have been manipulated. As Deutsche Welle reported in September 2020, around 40 researchers from Europe, the USA and Canada, but also from Russia itself, got together and published an open letter. In it, the real time of the Sputnik V study for test phases I and II was questioned.

As early as the summer of 2020, the scientists discovered that numerical patterns were repeated in the studies on Sputnik V, even though the different test subjects received different forms of the active ingredient. For example, they had exactly the same antibody levels on different days. In addition, the value of the T cells, the the Coronavirus should fight, be identical.

These results are “extremely unlikely from a statistical point of view, rather they have obviously been manipulated”, quotes the Deutsche Welle, the researchers around the well-known molecular biologist Enrico Bucci. “It’s like throwing the dice and getting exactly the same sequence of numbers several times,” Bucci says of the “Moscow Times”.

At the beginning of April, Bucci again published an appeal on Twitter:

Again, the scientists come to the conclusion that the data are conspicuous. The series of numbers that are repeated this time concern the effectiveness of the vaccine across all age groups, as reported by NTV. For example, the proportion of sick people in the vaccinated and the control group is always the same. On March 12th, the researchers reported their concerns to Ema and “The Lancet” is also planning to publish these findings.

–