Status: April 8, 2021 2:48 pm.

Russian vaccine Sputnik V has already been vaccinated in 50 countries. Europe has long hesitated, and now many of them cannot get approval quickly. But why is Sputnik V so controversial?

Opinions about the Russian vaccine Sputnik V are divided – a means of a “good vaccine” or “campaign”. Meanwhile, voices are being raised in Germany that the vaccine is not only gaining a place internationally, but that the vaccine must be approved soon.

“Getting vaccinated is good in principle,” said Thomas Mertens, head of the Standards Vaccine Commission, STIKO. Although he does not know what data is available on Sputnik V from the European Pharmaceuticals Agency EMA, Mertens said collectively Morning magazine from ARD and ZDF. Only he knows the data published in the special magazine “The Lancet”. “They’re so cute.” If Sputnik V is tested and approved in Europe, there will be no objection to the vaccine.

Discussion on Sputnik V vaccine purchase

Gabriel Dungal, P.R., Daily Headlines 10:15 pm, 8 April 2021

Some countries no longer want to wait for the EMA

But it is not yet clear when that will happen. EMA has already received application from Russian pharmaceutical manufacturers and has opened the testing system. Christa Virtumar-Hoch, chair of the EMA Board of Directors, warned against national emergency approvals.

But impatience grows. Hungary gave national recognition to Sputnik V in February and is now using the product. Slovakia and the Czech Republic have also ordered the cans and announced that they do not want to wait for EMA approval for their use – now Federal Health Minister Jens Spann also wants to negotiate the Sputnik vaccine with Russia without EU involvement.

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Russia was the first country to be vaccinated against corona

It started with Sputnik on August 11, 2020. At that moment, Russian President Vladimir Putin rushed forward and announced the successful completion of the world’s first record of a corona vaccine.

Criticism did not take long to come. The information released by scientists at the Kamaleja Epidemiological and Microbiological Research Center in Moscow, which developed the vaccine, is not transparent, there are very few subjects and clinical studies are not yet complete.

Leaf Eric Sander, an epidemiologist at the Berlin Foundation, discovered all of these strange things, he said in an interview. tagesschau.de. You need full research data to confirm that the benefits of such a vaccine outweigh the risks.

How does Sputnik V work?

It is now known how the vaccine is structured. Like the Astrogeneka and Johnson & Johnson vaccines, Spotnik V is a vector-based vaccine. This means that carrier viruses, such as adenoviruses that are harmless to humans, are used to bring pieces of the corona virus into the body. Human body cells absorb this genetic information and make the protein of the virus. The immune system reacts and produces antibodies.

But Russian scientists have used another tactic, Sander says – they use two different carrier viruses: one for the first vaccine and another for the second vaccine. This will allow the immune system to develop strong immunity to the vaccine. The principle of having two different adenoviruses is known and already established, Sander says.

Disadvantages can occur if one of the two adenoviruses that has already occurred in the past has delivery interruptions.

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How is Sputnik V rated?

The numbers announced by Russian scientists are promising. In the medical journal The Lancet, scientists published interim reports from 20,000 test subjects. Accordingly, the vaccine has an efficacy of 91.6 percent. This means that 91.6 percent fewer diseases occurred in the vaccinated group than in the non-vaccinated group, i.e. the control group.

Epidemiologist Sander says you need to be careful with these numbers. It is difficult to compare different vaccines based on this number because not all studies of efficacy have the same observation period. They were made in different countries and under different study conditions. It is important to know whether the vaccine protects against a serious illness.

There are some discrepancies

Side effects were explored and published in the “Lancet” study. It says it talked about flu-like symptoms in most subjects. In addition, many reported hand pain and temporary weakness and fatigue. The vaccine is well tolerated by all ages.

At this point, however, many scientists are still not satisfied. In Molecular biology Enrico BucciInvited by an organization for scientific integration in Italy Resis The tracks, however, see many more contradictions. Source data has not yet been released, so there is still a lack of transparency.

So far, four deaths have been reported as a result of the Sputnik vaccine. Details about the circumstances are only available from two people. In addition, it is unclear how many test subjects actually participated in the study, and there are questions about calculating performance.

EMA has not yet found significant study results

It is these ambiguities that the EMA in Amsterdam must now deal with. On March 4, he began the selection process for EU-level approval. This requires a completely transparent data set for the recommendation for approval.

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If Russian researchers are able to resolve the ambiguities, STIKO boss Mertens will be right and the vaccine could be approved in the EU. This can take weeks to months. So far, it is reported from Amsterdam, important study results are still missing.

Russia promises to provide 50 million doses of vaccine

The Russian government says it has vaccinated 40 million people in Russia by June. By the beginning of April, more than ten million Russians had already received the first dose of the vaccine. In total, about 145 million people live in Russia.

It remains to be seen whether Russia can deliver more than the Russian market and other countries such as Hungary and Pakistan. In addition, according to Sander, some other vaccines are yet to be approved, so it is not certain whether the vaccine from Russia will actually make a big difference.

Still – Sputnik V could become the first Western Sarah corona vaccine approved in the EU. In response to the start of the EMA test, Russia announced that it would provide 50 million doses of the vaccine to the EU from June.

With information from Anja Martini, tagesschau.de

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