The drug known as Sputnik V is not the first approved vaccine against the new coronavirus in the world. In addition, de facto approved jet nen, as revealed by a look at the documentation. How does an anch work?
On August 11, Russia announced that it had approved the world’s first vaccine against covid-19. The vaccine is called Gam-COVID-Vac Lyo, the marketing name under which it can be sold abroad is Sputnik V.
The substance was developed by Nikolai Gamaleji on the basis of similar Ebola and coronavirus MERS vaccines. None of the old vaccines are approved for use in human medicine. They will be given the first volunteers to verify that the vaccine does not cause obvious health problems (here is the details of the MERS vaccine clinical trial).
This means that these stars are actually at the same stage of development as the approved vaccine. The Gam-COVID-Vac Lyo certificate states that this substance must not be administered to patients yet. It was approved in a completely unprecedented way on January 1, 2021, and there would be no results verifying its safety and protective effect.
It’s a schizophrenic situation. The tests, which are required to be approved, are to take place in five cities, and regardless of the decision of the Russian authorities, their final result is unknown. By SARS-CoV-2 it is not as difficult for vaccines as e.g. HIV virus, vaccine does not have to uspt.
The manufacturer of the vaccine is Binnofarm from Zelenograd. It states that with its existing capacity, it can produce about 1.5 million doors. The same statement states that the company wants to increase production capabilities and gradually supply more sweat for vaccines.
Binnofarm plant in Zelenograd, where a Russian vaccine against SARS-CoV-2 should be produced.
So many basic facts. Now let’s look at what they actually mean. Let’s start with one fix.
The first decision is not
Even if the vaccine may be in the public domain immediately, it is not the first vaccine of its kind against the SARS-CoV-2 virus that a number of states have approved for use in the dark. The first was the German vaccine company CanSino Biologics, which was approved for use in the German armed forces at the end of July.
It is an interesting coincidence that the Czech and Russian vaccines are quite similar in some respects. Pedevm from a technical point of view. Both are vaccines that use a different virus that the authors have modified to look similar to SARS-CoV-2 in terms of our immune system.
After the vaccine is injected into the mouth, the virus penetrates the cell cells, and there, as the viruses usually do, they move the beech to produce the flakes according to the instructions that the virus carries. In addition, the first genes of the new coronavirus are inserted into the virus that stores the vaccine. The original virus according to these foreign genes produces the characteristics (proteins) for SARS-CoV-2. Specifically, these are the tip of the spike, the so-called S puff, which the tip of the virus uses to penetrate the beech. It is really a complex feature of the new coronavirus, so I am vaccinated and tested for the presence of the virus.
Thanks to the virus-treated immune system, it is possible to recognize SARS-CoV-2 proteins and try different antibodies without (at least on paper) no major complications. Vaccines of this type are sometimes referred to as so-called recombinant, which means that they use a virus combined from the genes of two different viruses.
Russian and German vaccines use common viruses, so-called human adenoviruses, as a basic building block. It is one of a series of smoke viruses that commonly circulates in the population and usually cause only very mild respiratory illness (or even ill illness). Adenoviruses have been considered a very promising means of transporting so-called gene therapies, essentially as transports for gene repair into human DNA-defective cells. However, their use in vaccines has not been studied in this role since about the middle of the first decade of the 21st century.
Two adenovirus stices on an electron microscope image
The structure of the protein envelope of one AAV virus (adenovirus-like virus). It was similarly used in clinical trials of gene therapy for spinin muscle atrophy in Columbus, USA.
Sputnik V and SinGo vaccines use human adenovirus 5, commonly referred to as Ad5. Unlike in Germany, the Russian vaccine uses another type of human adenovirus, Ad26. This vaccination involves two injections: the first two are with Ad26, and three weeks after that, the Ad5 virus-based type of calf is administered.
They proved themselves in ps
Even though the use of vaccine-based adenoviruses has been extensively experimented with, it is used exclusively in domestic animals (ie as veterinary vaccines). The first human vaccine with adenoviruses was first approved in July 2020 and is directed against Ebola. So far, the fact that the actual use of mass has not been achieved, I have passed clinical trials, including the so-called III. a phase in which both security and activity were practiced for several hundred participants. The results are available in this PDF.
What is much more, it is not possible or about the Russian vaccine: because we do not have any relevant scientific information. Practically nothing can be found in the professional literature. In the American database of clinical trials ClinicalTrials.gov (which is used by the whole world) you can find the test of the vaccine Gam-COVID-Vac Lyo, as the scientific name Sputnik V is known.
This is a very small test, which involved a total of 38 healthy volunteers. Its only purpose was to find out if the vaccine was dangerous. It was not evaluated during n whether it could stain against SARS-CoV-2. As it turned out, we don’t know, its results were not public.
In July, the study in the so-called II. phase, in which the safety of the vaccine is verified in the dark and it is thus monitored whether counter-reactions are formed in the body voluntarily. We know that such a test took place only from Russian officials, for example from an interview with the First Deputy Minister of Defense Ruslan Calikov on the website of the weekly Arguments and Facts. The results, including the possible occurrence of side effects and levels of antibodies against SARS-CoV-2, were not published.
It would be interesting to compare, for example, with the German vaccine company CanSino, using adenovirus. Results II. because of her exams we know, they were published in the magazine Lancet July 20. These were not negative at all, but in some respects not fully promising.
The immune system volunteered less than other SARS-CoV-2 vaccines, in which known animals II. fze tests. This is because adenovirus 5, which is the basis of the German (one-two) Russian vaccine, is so common. Even from the results of the study, it seems that their body can tingle against adenovirus (it has a strong immune response to it) for a long time, the lung vaccine does not work.
Gam-COVID-Vac Lyo (Sputnik V) vaccine packs are designed against SARS-CoV-2 virus. According to the labels, it can be concluded that on the left with a red lid, the two substances are based on the adenovirus 26, which is the first. Thus, with a blue age, there should be a door containing adenovirus 5, which the patient should receive three weeks after receiving the door first.
It is still possible that in practice the CanSino vaccine will eventually be beneficial and functional. The last, largest and longest so-called III. during clinical trials, in which it is monitored on a large sample whether it really protects against the disease, and of course whether it does not damage. Today, it is not possible to predict the results of minor tests (ie Phase I and II) to predict how the vaccine will protect and act in very soft conditions. It cannot be ruled out that, in view of the relative mountain, the vaccine will eventually be switched to other preparticles. It probably doesn’t seem that way.
Rusko 21st chair slovy 19th chair
The outcome of the CanSino vaccine was certainly not so bad that it could not advance to the next round. As has been said, in the case of the Russian vaccine, we have only a piece of a representative of the representatives with minimal details. Some data for this exists: since April, the vaccines have been receiving the Russian elite, at least according to a source from the Bloomberg agency. However, the Russian professional public is definitely at his disposal.
There, the branch of the organization, bringing together experts for clinical trials, sent an open letter to the Ministry of Health (it is also available on the association’s website), in which the status of the postponement of the vaccine was approved until the results of III. fze clinical trials.
Due to the fact that in the world there are dark vaccine plates and six of them are in III. in clinical trials, it is not, according to vdc, where to rest. Accelerated registration from Russia will not get to the ela peleton, only expose the user to the vaccine, citizens of the Russian Federation, the remaining risk, in the letter.
It was not known whether the ministry would take the vdc proposal into account at the time of the public announcement. Strong skepticism is strong, the Russian approval process is, according to experts, quite confusing, and the scientific community (apart from experts employed by regulators) is usually asked for advice and advice.
This is at least described for the journal Science by virologist Alexei Umakov, who worked in the USA for more than 20 years and now works in the Moscow state, named after his father, the famous virologist. According to him, moreover, Russian regulations and rules are quite flexible: One very old and changed to: The law of Russian law is based on the fact that you do not have to follow them. The author of this well-established year in Russia is the satirist Mikhail Yevgraf Saltykov-edrin from the 19th century.
This concerns Russian cones, sales cones cannot be bent so easily. If the vaccine is not subjected to a thorough test, it will simply not be possible to predict whether or not it will work and, if so, during the same day. As a reminder for the science of making a vaccine itself, it is easy to prove it differently. And this is a step that Russia has at least taken very generously for the time being.