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With “Sputnik V”, Russia has approved the first corona vaccine worldwide. The final safety test was apparently simply skipped.
While health experts from all over the world do not expect a vaccine until the end of 2020 at the earliest, Russia announced already at the end of July that it might possibly approve a vaccine as early as mid-August. On 11 August, President Vladimir Putin announced on state television that the time had come. The Russian health authority was the first in the world to approve a vaccine against the corona virus for widespread use.
The Russians’ rush has a stale aftertaste. This was despite the World Health Organization (WHO) warning that Russia should not deviate from the usual methods of testing a vaccine for safety and efficacy. Putin contradicted the resonant insinuation that international criteria should be disregarded: The vaccine “works effectively enough, forms a stable immunity and – I repeat – has undergone all necessary tests”. Even one of his daughters took the preparation called Gam-Covid-Vac Lyo, the “New York Times” quotes him as saying.
But what is true about Russia’s announcements? What about the allegations? The most important answers at a glance.
Gam-Covid-Vac Lyo was developed at the Gamaleja Institute for Epidemiology in Moscow and is a so-called vector vaccine based on viruses that cannot be dangerous to humans. It is used to inoculate characteristic sections of the pathogen’s genome – in the case of the Covid-19 vaccine Sars-CoV-2 – which the body then recognises as foreign and forms antibodies against them, which prevent infection if they actually come into contact with the virus.
The approach is similar to the vaccine developed by Oxford University and Astra-Zeneca. In the case of Gam-Covid-Vac Lyo, two different adenoviruses are used as vectors. This family of viruses is more frequently used in vaccine development – also in connection with other corona viruses such as Mers.
The concept has been used in vaccine research for some time and is therefore no longer new. The use of already known vectors also has the advantage that their safety has already been tested in earlier studies. They also have the reputation of reliably stimulating the immune system.
However, there is a risk with vector vaccines that the immune system of the vaccinated person also fights the vectors themselves, which can lead to side effects. It is also possible that the vaccination will not work. However, this risk can be minimized – provided the manufacturer is aware of this. To do this, however, the vaccine candidate must have gone through all phases of vaccine development. Whether this has happened in the case of Russia is unclear.
Not much. While competitors kept on reporting on their progress, Russian announcements in recent weeks have almost come out of the blue for the West. So far, no data from major clinical trials have been published. As “Spiegel.de” reports, all that is known so far is “that the vaccine has been tested on 38 people since mid-June” and is scheduled to be completed in August. Nothing is yet officially known about the results of the work.
There are only the statements of Kirill Dimitriyev, head of the Russian State Fund (which finances the research work of the Gamaleja Institute), according to which the persons who received Gam-Covid-Vac Lyo developed immunity 21 days after the first dose, which doubled after receiving the second injection.
Allegedly none. However, this is unlikely. This is because practically all vaccinations that are injected cause redness or slight pain at the injection site. Although these are not dramatic complications, they must be documented, writes “Spiegel.de”. If this does not happen, the report is skeptical. Even the statement that the developer of the preparation, Alexander Ginzburg, administered the vaccination to himself in order to emphasize its safety does not change this.
There is a lack of meaningful tests to be able to make statements about tolerability and efficacy in the entire population – including older people or those with previous illnesses.
According to the “New York Times”, those responsible also provide no information as to whether they can rule out the possibility that the injection might not protect the vaccinated persons, but might even make them more susceptible to a severe course of Covid-19. This is a possibility that researchers outside Russia have not yet excluded, according to their own statements.
— Hector Pascua, Source: News Agencies
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