Russian corona vaccine: risky experiment

Christiane Fux studied journalism and psychology in Hamburg. The experienced medical editor has been writing magazine articles, news and factual texts on all conceivable health topics since 2001. In addition to her work for, Christiane Fux is also active in prose. Her first crime novel was published in 2012, and she also writes, designs and publishes her own crime plays.

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Russia has pushed ahead in the global race for a corona vaccine. President Vladimir Putin announced the world's first government approval of a vaccine against Sars-CoV-2 on Tuesday. The first doctors and teachers should be vaccinated soon.

International experts, however, have serious concerns because the vaccine has not been adequately tested for its effectiveness and possible side effects.

Putin's daughter already vaccinated

"The Russian vaccine against the coronavirus is effective and creates a stable immunity," Putin said, according to the Interfax agency. The registration took place on Tuesday morning, it said. One of his two daughters has already been vaccinated, Putin said. With its name “Sputnik V” it is intended to commemorate the first satellite in space that the Soviet Union launched in 1957 off the USA.

The vaccine was developed by the Gamaleja State Institute of Epidemiology and Microbiology in Moscow. So far, only a few people have received it as part of a study.

Approval without important phase III testing

Clinical trials in three phases usually precede the approval of vaccines. In the first, it is tested for its tolerance; in phase II, a few test subjects are checked to see whether the immune system is building up antibodies as hoped. Whether it can really effectively protect against infection outside of the laboratory is only tested in phase III with usually several thousand test subjects. This test phase has only just started for the Russian active ingredient.

Worry about side effects

Regular approval without the extensive data from a phase III test would appear risky, said Klaus Cichutek, President of the Paul Ehrlich Institute. This is the only way to uncover possible rare side effects, among other things. In Germany, approval is only granted after the last phase has been completed.

Experts also fear that failure of the active ingredient or side effects could also reduce confidence in other vaccines. That does not correspond to the international guidelines. The World Health Organization (WHO) also made it clear in advance: "Of course, every vaccine must go through all series of experiments and tests before it is approved and delivered." There are clear guidelines for the development of vaccines.

"Risky human experiment"

"I consider the approval of a vaccine without the crucial third series of tests to be a high-risk experiment on humans," said the President of the German Medical Association, Klaus Reinhardt, "Rheinische Post" (Wednesday). "It is irresponsible to vaccinate entire populations at this stage of development." The impression arises that it is a matter of a populist measure by an authoritarian state that wants to demonstrate its scientific capabilities to the global community, according to Reinhardt.

Corona vaccines are being searched for in more than 170 projects worldwide and several research teams have published promising interim results. However, experts generally only expect a marketable vaccine in the coming year.

No scientific data presented

The Gamaleja Institute announced in May that it had developed a vaccine. According to our own account, the first tests were successful. The preparation was therefore tested on 50 soldiers who volunteered. However, Russia has not yet published any scientific results on the vaccine for an independent evaluation.

Without specific data, it is difficult even for specialist colleagues to assess the quality and effectiveness of the vaccine. "I am very, very cautious about the approval," says virologist Jonas Schmidt-Chanasit from the Bernhard Nocht Institute for Tropical Medicine in Hamburg. “Especially when vaccines come from systems that are not so free, an independent assessment is particularly important. Otherwise every company can tell something. "

How safe is "Sputnik-V"?

The active ingredient is registered in a database for clinical studies under the name “Gam-COVID-Vac Lyo”. The vaccine is a so-called vector vaccine. A harmless virus - here adenoviruses - is used as a transporter to smuggle genetic information for a protein of the Sars-CoV-2 virus into the body.

The aim is to get the immune system to form antibodies against the protein and to trigger other defense reactions. Upon contact with Sars-CoV-2, the body is then prepared and can better contain the infection.

Can a corona vaccine even work?

It is not yet known whether a vaccine against corona can cause these protective reactions in the body and how long they may last. It is not uncommon for vaccine candidates that are initially promising to fail to provide the desired protection in later investigations.

However, a vaccine can also be valuable if it does not prevent infection, but at least prevents severe disease. Basically, experts assume that there will not be one vaccine against Corona, but several. Experts anticipate that this will not be the case until the end of the year at the earliest.

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