Swift registration of the vaccine from coronavirus in Russia: for and against

On August 11, President Putin announced that a vaccine from coronavirus has been registered in Russia. The vaccine works, causes immunity and does not have serious side effects. She was vaccinated by Putin's daughter. They called the satellite-5 vaccine in honor of the cosmic achievements of the power. However, the vaccine nii named after Gamaley has no publications yet and has not passed the three phases of tests, that is, the stage when the vaccine is introduced to tens of thousands of people and find out how well it protects.

At the moment, there are seven vaccines in the world that pass the third phase. These are three Western vaccines-Oxford-Astra Zeneca, Moderna and Pfizer-Biontech. These are four Chinese vaccines - the Vaccine of the Beijing Institute of Biological products, the Utan Institute, Sinovas and Cansino. Cansino on July 25 was the first vaccine to receive permission for mass (but limited) use. She is chopped by the Chinese military. India also launches the third test phase of one of its vaccines.

It would be enough for us to say that Russia also made a vaccine and goes to the third phase. It would be a serious achievement. Nevertheless, PR is PR, and Covid is Covid.

Each of us now has a skinny question: what is the Hamalea vaccine really? Should I prick her for yourself? Your loved ones? What are the pluses? What are the disadvantages? Is it dangerous? Is it possible to “cut off the corners” during tests in a desperate situation and under what conditions the cutting of the corners turns into a fraud of the results?

We talked with virus, doctors and experts. And they tried to collect everything they said, in a few understandable theses.

This vaccine is today's mainstream

In the very concept of the adenovirus vaccine, in which one of the genes is replaced by a gene that produces a specifically covid S-beam, there is nothing charlatan. This is not a kagocel or arbidol. This is a good, solid work of scientists by the Research Institute. Gamalei, led by Denis Logunov. Logunov is a world -class scientist who worked for a long time in the West. “Undoubtedly, he would have made a big career in the West,” said Konstantin Chumakov, the son of an outstanding Soviet virus-virologist Chumakov, who did this career and is currently the deputy director of the science of the FDA vaccine department ( American health regulator. -Ed.- Ed. ).

Head of the Research Institute. Gamalei Alexander Ginzburg offered Logunov such conditions that he would have not had in the West for a long time. Logunov returned to Russia and received at his disposal everything that he needed: excellent equipment and an excellent team.

The vaccine developed by this team is built on the same principle as the Oxford vaccine. This is good. Because in the manufacture of vaccines, as in the invention of the wheel, special breakthroughs, in general, does not exist.

If we were told that Logunov had done something unprecedented, like Kagocel (alas, this is also the development of Gamalea), it would be alarming. But Logunov’s vaccine is a high -quality mainstream today.

This is a vector vaccine. They took the adenovirus and built into it a covid gene (in this case, it was a gene that encodes a specific for the crown of S-White). Before that, this gene was transferred from RNA to DNA. The gene, having entered the human body, will produce covid protein, the immune system will respond to it, and adenovirus in this case is simply a delivery tool.

The missile on which the warhead flew.

ADE

This vector vaccine can have many problems that do not depend on the Hamale Institute itself, but depend on the nature of the coronavirus. In other words, if these problems are, they will have all vector -type vaccines and even, possibly, all vaccines against coronavirus.

One of them is called ADE effect. Or antibody -dependent reaction increased.

Its essence is that vaccination does not weaken the disease, but enhances it.

The reason for the strengthening lies in the fact that poor -quality antibody is associated with the virus, as it should be, but instead of killing the virus, it, on the contrary, drags it into the cage. This is characteristic of a number of viruses, in particular, yellow fever, zika, denge, HIV. Unfortunately, it is also characteristic of a number of coronaviruses.

Long -term action of the vaccine

The second difficult question is about how long the vaccine will operate.

Usually the vaccine acts as follows: it produces antibodies that live in the blood for three weeks. Antibodies are produced by plasma cells. While there is a virus, cells produce antibodies. If the virus has disappeared, these plasma cells die off, but at the same time, part of them, as a rule, turns into memory cells. They go into the bone marrow and sit there. When you come across the same antigen next time, memory cells quickly wake up, plasma cells quickly occur from them, and they again quickly begin to produce antibodies.

The problem is that

For some antigens, this short -term immune memory (antibodies) does not turn into long -term (memory cells).

This, for example, happens with HIV, and therefore it is impossible to create a vaccine against HIV (that is, it is possible, but it does not act long). Memory cells simply do not arise for these viruses. It also happens with many colds, especially those that are caused by seasonal coronaviruses. “There is reason to be afraid that it will be the same with Covid as with HIV,” says Konstantin Chumakov, “because although this virus is completely different, his S-White is similar in structure to the same HIV protein-these are very glycosylated proteins covered with sugar, it is possible that they will behave in a similar way.”

But, even if the memory cells do not arise, this is not the end. The body has many ways to provide immunity, except antibody and plasma cells. For example, there is a huge family of T-lymphocytes, which themselves recognize the cell infected with the virus and kill it. In general, 20 percent of the genome are somehow connected with the immune system, and immunity is created by an entire army of various specialized cells that exchange cytokines with each other.

The Hamalea vaccine, in principle, should use all parts of the immune system, unlike some other vaccines testing. For example, Moderna’s vaccine is created on the basis of MRNA. There are great fears that the MRNC-vaccine will only use the antibodies mechanism (which Covid can have unnecessary) and not use other parts of the immune system.

As we have already said, this is not the problem of the Hamalea vaccine. This is the problem of coronavirus.

Now we move on to problems that are specific for the Russian vaccine.

Where is the third phase?

Hamalei vaccine was officially tested on 38 volunteers. (It is unofficially known that at least two Russian oligarchs were injected to themselves at least the head of the largest state bank, the head of the RDII, Kirill Dmitriev. And many more. Putin said that his daughter was injected to the vaccine.)

That is, the vaccine has passed what is called the first and second phase of testing. Phase 1 - security assessment (is there a strong side effect), phase 2 - an assessment of immunogenicity (whether antibodies produces). On the occasion of Avaral, these phases are permissible to combine.

The Oxford vaccine, similar in terms of action, also passed the first and second phase for 543 volunteers (plus the same in the control group received a placebo).

At the same time, the Oxford vaccine is now undergoing the third phase, the Russian one is already registered. Question: Why is the Russian vaccine ready, but Oxford - not?

The answer is that the Russian vaccine is not ready, it is registered.

“In the United States, now a vaccine passing the third phase of tests is experienced by 30 thousand volunteers,” says Chumakov. -In Russia, given the level of the epidemic in order to obtain a statistically reliable result, there should be about 50 thousand people. Russia saved on these 50 thousand. Instead of gaining volunteers, sign Informed Consent, reimburse them with expenses, take forced doctors and teachers and vaccinate them. ”

Where are the publications?

The test results of the Oxford vaccine are published in the prestigious The Lancet. The results of the first and second phase of the Hamalea vaccine are not published anywhere, in contrast to the test results of their previous vaccine against the Ebola. “This is unimaginable for me,” says the famous Russian cardiologist Yaroslav Ashikhmin. “I just don't understand how possible.” Now there are special medical parameters, take them, they will quickly make everything out and write to you, Covid is a hot theme, any magazine will tear off this article with hands, if you give it to some less prestigious magazine, they even quickly organize Peer Review, well, great, a vaccine from Covid, they also need to be cited. ”

Lack of publications -

This is not just strange. This is a red signal.

As I said, Logunov is a brilliant scientist who worked for a long time in the West. What conceivable reasons could encourage him to skill in generally accepted rules? It is so wild that my interlocutors put forward a variety of explanations. Konstantin Chumakov even suggested that the matter is not in Logunov, but in paranoid secretion that poisoning the Russian research institutes now.

This version was partially confirmed by Ilya Yasius, the head of the scientific examination of the venture pharmaceutical fund Inbio Ventures. “This institution is connected with the Ministry of Defense, they all have the first department, and the closed atmosphere does not allow them to publish the results so quickly,” says Ilya Yasius. At the same time, the clear recalled that the results of the first and second phase of the vaccine from Ebola were published, although not in the most prestigious journal.

The lack of publications in this case is a bad sign. Because if we already do not know anything about the safety of this vaccine, then where is the guarantee that we will ever learn about its effectiveness?

We saw that Russian statistics on Covid had nothing to do with reality and depended on the orders of the authorities. What is the chance that the statistics on the satellite vaccine will be related to reality?

“Until now, not a single adenovirus vaccine has been introduced in the world,” says Chumakov, “this first. Adenovirus can itself be a dangerous thing. He himself can cause a cytokine storm. ”

If God forbid people with weak immunity either the elderly or sick, this vaccine will be in a certain number of cases to cause severe complications, then how do we find out in the country where the dead from coronavirus was diagnosed with stroke? What will we see in the column "cause of death"? Which doctor dares to write a “vaccine” after the highest statement?

There is only good news (for those who get involved) there is only one: if you have pricked and nothing happened to you right away, then the likelihood of some bad consequences in the future is very small.

What about industrial production?

Finally, there is one more circumstance. The most, in my opinion, is dangerous.

Suppose Logunov and his team made a good vaccine. It protects from the virus and does not give side effects. Where is the guarantee that the Russian pharmaceutical industry will be able to repeat this experience on an industrial scale?

Tell me, what expensive and complex medicines were made for the first time in Russia in the last two decades? And if in Russia they do not know how to produce such drugs, then where is the guarantee that they can make a normal vaccine in it?

Do you know how a vaccine is made on an industrial scale?

Answer: The bioreactor is taken. It grows cell culture. It can be human cells or monkeys, or dogs. These are cells that can share endlessly. If you say that cancer cells are endlessly divided! You will be right, but only partly. Your stem cells are also immortal, but they are not cancer. So do not be afraid, you will not get sick of cancer vaccine, even if it were made on cancer cells, for the same reason that you will not get cancer if you eat chicken patient with cancer. For cancer, your own DNA should break, not a stranger.

In general, let me exaggerate on the rights of the writer.

Imagine that one large, big tumor is cooked in the reactor. Or, if it is easier for you, one large, big kidney of the human embryo. In it, as in a nutrient medium, they sow the virus.

And then you need to choose the right mode. Temperature, environment, time. “This is a difficult process,” says Konstantin Chumakov, “first the parameters are selected for a small reactor one and a half liters. Then - ten liters, twenty. " Industrial bioreactors may have three thousand tons. This is called phased scaling. And each time the parameters change. It is possible to buy imported equipment, but it is impossible to buy knowledge of modes.

The president’s daughters (and oligarchs) pricked what was done in the laboratory. But what will be injected later?

“Anything can happen when scaling,” says Ilya Yazy, “a sufficient titer of virus may not be developed. The virus can mutate. " He can die in one part of the reactor and survive in another.

Once again: in Russia there is simply no independent experience of such production. The test tube is one, the reactor is another. “It’s like if people learned to collect a bicycle, and they said about them that they made a spaceship,” says Konstantin Chumakov.

The Hamalei vaccine is planned to be produced at the old AFK Sistema Plant. Well, well. Remember how the “system” produced the latest nanochips?

Total

Scientists Nii named after The Gamaley did a good, high -quality work that puts them on a par with other leading virological centers. This is great. What they did is not arbitral to you.

Alas, partly their work was spoiled by the toxic political environment.