Russia's President Vladimir Putin during a video conference on August 11th
Photo: Alexei Nikolsky / ITAR-TASS / imago imagesRussian President Vladimir Putin announced the world's first state approval of a vaccine against the coronavirus on Tuesday. "The Russian vaccine against the coronavirus is effective and creates a constant immunity," the Interfax agency quotes him. The registration took place on Tuesday morning. One of his two daughters has already been vaccinated, said Putin.
The vaccine was developed by the Gamaleja State Institute of Epidemiology and Microbiology in Moscow. The problem: So far, the drug has only been tested on a few people. Internationally, it is actually intended to test the effects and side effects of a vaccine before approval in the context of large clinical studies.
The World Health Organization (WHO) said in the run-up to the events: "Of course, every vaccine has to go through all the trials and tests before it is approved and delivered." Experts are concerned that Russia is taking too high a risk in the race for the first corona vaccine.
Germany: Approval only after tests with thousands of participants
Regular approval without the extensive data from a phase III test with at least several thousand test subjects would appear risky, said Klaus Cichutek, President of the German Paul Ehrlich Institute. In this last stage, among other things, possible rare side effects could be detected. The number of subjects is usually several thousand to tens of thousands. In Germany, approval is only planned after this phase has been completed.
According to Russia's Minister of Health Michael Muraschko, the Gamaleja Institute and the Winnopharm company will produce the drug. First teachers and doctors are to be vaccinated, according to the authorities, the process should start in August or September. The substance should also be exported abroad. Regardless of the approval, the third, important test phase of the product is currently underway in Russia.
Russia: No scientific data published yet
Scientists and companies are looking for corona vaccines in more than 170 projects around the world, and several research teams have published promising interim results. However, most experts do not expect a marketable vaccine until the end of this year or the beginning of next year at the earliest.
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 had volunteered. However, Russia has not yet released any scientific data on the vaccine for independent evaluation.
Kremlin chief Putin put pressure on the development early on. According to Muraschko, a second vaccine against Sars-CoV-2 is currently being clinically tested. More are to follow.
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