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‘Western’ Media Falsely Claim That Russia’s Covid-19 Vaccine Is Ready To Go
After President Vladimir Putin announced that Russia's Covid-19 vaccine candidate had gained an approval from its regulator, 'western' media went into a anti-Russian frenzy to sow fear and doubt about it.
All the above, just as this one, are based on a willful misinterpretation of the Russian announcement:
Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.
Mr. Putin, who told a cabinet meeting on Tuesday morning that the vaccine “works effectively enough,” said that his own daughter had taken it. And in a congratulatory note to the nation, he thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”
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By skipping large-scale clinical trials, the Russian dash for a vaccine has raised widespread concern that it is circumventing vital steps — and potentially endangering people — in order to score global propaganda points.
Russia has not approved a vaccine against Covid-19 and it is not skipping large-scale clinical trials.
The Russia regulator gave a preliminary approval for a vaccine candidate to start the large-scale clinical trial. This is similar to an emergency use authorization by the U.S. Food and Drug Administration.
Science Magazine is one of the few media who got it right:
In a startling and confusing move, Russia claimed today it had approved the world’s first COVID-19 vaccine, as the nation’s Ministry of Health issued what’s called a registration certificate for a vaccine candidate that has been tested in just 76 people. The certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be given to “a small number of citizens from vulnerable groups,” including medical staff and the elderly, a Ministry of Health spokesperson tells ScienceInsider. But the certificate stipulates that the vaccine cannot be used widely until 1 January 2021, presumably after larger clinical trials have been completed.
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A website for Sputnik V says a phase III efficacy trial involving more than 2000 people will begin on 12 August in Russia, the United Arab Emirates, Saudi Arabia, Brazil, and Mexico. Mass production of the vaccine is slated to begin in September.
The Russian vaccine candidate is based on two variants of the human adenovirus which can cause the common cold. These virus have also been used in other reliable vaccines. Their DNA has been modified to include the building plan for the spike protein that allows SARS-CoV-2 to enter human cells. When the modified adenovirus is applied it induces human cells to create the SARS-CoV-2 spike protein. That then sets off the immune system which will develop specific anti-bodies (IdG) and memory cells (T-cells) against the spike protein. Should the immunized person later get infected with SARS-CoV-2 its immune system will be ready to defeat the virus.
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The Russian vaccine candidate is administered in two shots. The primary one is based on a modified adenovirus-26. A secondary shot, three weeks later, is based on a modified adenovirus-5. Two different types of the virus are used because some people are already immune against some of its variants. The second shot is supposed to boost the immune response.
Science Magazine notes that there is some concern about the efficiency of the second shot:
Some vaccine experts have raised concerns about COVID-19 vaccines that use adenovirus 5 in this way. In 2007, researchers stopped an HIV vaccine trial that used adenovirus 5 to shuttle in the gene for the surface protein of that virus after they found that it increased the likelihood of its transmission.
Several of the other vaccines candidates that are currently undergoing testing also rely on a modified adenovirus. The vaccine candidate developed by the British Jenner Institute in Oxford together with AstraZeneca uses one that usually infects chimpanzees.
The Russian vaccine candidate will, like all others, have to go through the now announced third trial phase before it will get any general approval.
There is no excuse for the media to wrongly claim that Russia has approved a ready to go vaccine. The Sputnik Vaccine website explains in seven languages that the third trial phase of the clinical trials is still to come.
They know they are lying.
The WaPo article uses as its only source for Russia’s alleged “propaganda” a guy from an American foreign policy think tank. Well, why don’t quote a specialist?
They also mention that the WHO website doesn’t mention the vaccine as approved. This is normal, as the WHO website is slow on its updates (even the number of dead is delayed). That’s why the Hopkins site was so popular for tracking the number of dead.
Also, Putin never stated the vaccine was “approved”; he clearly used the word “registered”. The Health Minister’s speech also included the information that the 3rd phase was starting the moment he’s speaking.
The WaPo also quotes some doctors stating they “don’t know nothing about this Russian vaccine”. Well, no wonder, as the research will only be published next month (as was also stated with the registration announcement). The American doctors also probably didn’t even bother to search for the Russian findings. And this also explains why the WHO still doesn’t approve the Russian vaccine for use, as the research still isn’t published.
The fact that the vaccine was “rushed” should also not be surprising for the West. Not long ago, they were propagandizing the fact that we would have a vaccine by January precisely because of the fact that, among other things, the WHO had given its tacit blessing to accelerate the protocol – among other things, by cutting corners in the trial phases. I remember the Western MSM being very enthusiastic about it, and, some days ago, Bloomberg even published an article about an Indian billionaire already building the line of production to mass produce the still not ready Oxford vaccine. The billionaire himself called it “a bet”. All of a sudden, this enthusiasm is gone. Why is that?
Besides the obvious geopolitical reasons (Russophobia, etc.), there may be economic ones. In his famous “forbidden op-ed”, Kirill Dmitriev stated that:
The use of two vectors is the unique technology, developed by the Gamaleya Center scientists, which differentiates the Russian vaccine from other adenoviral vector-based vaccines under development around the world. Vaccines based on adenoviral vectors also have clear advantages over other technologies such as mRNA vaccines.
Prospective mRNA vaccines, undergoing clinical trials in the United States and other countries, do not use vectors for delivery and represent an RNA molecule with coronavirus protein code wrapped in a lipid membrane. This technology is promising but its side effects, especially an impact on fertility, have not yet been studied in depth. No mRNA vaccine has yet received regulatory approval in the world. We believe that in the global vaccine race to fight coronavirus adenoviral vector-based vaccines will be the winners but even in this category the Gamaleya vaccine has the edge.
The probable case is that the USA is pouring billions of USD in companies that are going all-in in unproven (and very dangerous) technologies because they want a vaccine that can be patented and thus charge its weight in gold to other countries. My bet is the USA sees the prospect of a new vaccine as an opportunity to mitigate its huge trade deficit with the rest of the world. This came at the cost of losing a lot of time (and money).
The companies which are working with an adenoviral vaccine – Oxford, J&J and CanSino – simply have inferior know-how:
Other countries follow in our footsteps developing adenoviral vector-based vaccines. Oxford University is using an adenovirus from a monkey, which has neither been used in an approved vaccine before unlike human adenoviruses. U.S. company Johnson & Johnson is using adenovirus Ad26 and China’s CanSino – adenovirus Ad5, the same vectors the Gamaleya Center is using, but they are yet to master the two-vector approach. Both companies already received large orders for vaccines from their governments.
Note that, even though they are inferior to Gamaleya, they are still bound to receive billions of USD in vaccines by their respective governments. The point is that we’re in a desperate situation: we only need a vaccine that works, not a miraculous silver bullet that will eradicate the virus once and for all.
One can explain why CanSino has inferior know-how, but why are Oxford and J&J – two big companies (and yes, I consider Oxford a company nowadays) – inferior to Gamaleya? Dmitriev answers that himself:
The Gamaleya Center used adenoviral vectors to develop vaccines against influenza and against Middle East Respiratory Syndrome (MERS). Both vaccines are currently in advanced stages of clinical trials. These achievements show that Russian labs did not waste their time in the last few decades while the international pharmaceutical industry often underestimated the importance of new vaccines research in the absence of global health threats prior to the COVID-19 pandemic.
That is: Big Pharma wasted decades in vaccine research (and thus lost know-how) simply because it was not profitable. Diseases that can be eradicated with one or two shots (and only affect poor people) doesn’t concern Big Pharma. This is not surprising, as capitalism is a system that exclusively operates for profit, not for human needs.
Posted by: vk | Aug 12 2020 12:05 utc | 8
@20 – hope our host doesn’t get annoyed. From Yandex translate:
Denis Logunov, the Creator of the Russian coronavirus vaccine, gave the first big interview to Medusa. He told whether to wait for vaccinations by September 2020
Denis Logunov-Deputy Director for research at the Gamalei Center-at the age of 43 managed to become a corresponding member of the Russian Academy of Sciences, lead a group of developers of the first Russian coronavirus vaccine and inject it into himself. Logunov refuses to talk about the feelings of this experiment — because he “does not like HYIP” and gives an interview for the first time in his life. His vaccine has already been administered to 76 volunteers: each of them kept a “volunteer diary”, which noted side effects — fever, rash, redness at the injection site. Fortunately, nothing more serious. Authorities hope that the vaccine will be ready by September. In an interview with Medusa scientific editor Alexander Yershov and special correspondent Svetlana Reuter, Logunov said that in September, the vaccine can only get temporary registration, and its mass production will not begin until the end of 2020. The researchers are talking about the details of the vaccine development for the first time — the results of their work have not yet been published in the scientific literature.
All Medusa materials about coronavirus are open for distribution under a Creative Commons CC by license. You can reprint them! The license does not apply to photos.
First — a summary of the interview
Volunteers were easy to find. The vaccine we made is a vector — based one, which means that we use a carrier virus that delivers the genetic information of a new coronavirus to the human body and triggers an immune response to it. The method is based on our work to create this kind of vaccine against the Ebola virus, and before the pandemic happened, we had already been developing a vaccine for the middle East respiratory syndrome MERS for three years — and we had no doubts about what to do. Work began in February, and the creation of the vaccine itself took two weeks.
Before starting human trials, it was studied in detail in several animal species, including two species of monkeys. We tracked everything: the production of antibodies, and the reaction of cells in the immune system. Now the tests on two groups of volunteers, 76 people in total, are coming to an end. This is less than stated in the same UK, but believe me, a thousand people there will not be vaccinated for a long time. We are not the press, we cannot be responsible for what is published about us, and we are not the Ministry of health — we cannot influence the decision to register. There will be a broad study on thousands of people, we do not shy away from this. But right now, registration under limited conditions is needed so that people at risk can participate in the study — we are not going to protect healthy volunteers with this vaccine. By the end of 2020, our Institute should have millions of vaccines per year. My goal was not to be the first in the world, but to protect my loved ones.
“People are tired of being afraid”
— Is it easy to find volunteers for clinical research?
— Oh, Yes, there was no problem with that.
— Even the head of the Russian direct investment Fund, Kirill Dmitriev, your investor, in all interviews, proudly tells how he was given the vaccine.
— We are a Federal institution of the Ministry of health of Russia. Our investor is the state.
— Why do you think people were so willing to accept the introduction of an unknown drug? Fear of getting sick? Tired of being afraid?
— First of all, I think we are really tired of being afraid. Secondly, over time, people begin to come to terms with the coronavirus, realizing that it will not go away. You know, there are controlled infections, and there are unmanaged infections. And at first, the infection was out of control. Now-give or take — there are at least means to reduce the viral load and it is clear that we need to live with this virus somehow.
— Meanwhile, one drug or another is being declared a panacea in the world, and there is very little or no convincing evidence of its effectiveness.
— The problem is that always when everything is done with wheels, the evidence suffers.
— How did you feel about the coronavirus?” Afraid?
“Yes, of course. For me, the initial figures were quite convincing. I remember the numbers of mathematical modeling for the flu — and people often get confused in the numbers, they believe that after the flu in intensive care, too, many die. In such cases, I explain that you need to look at the overall mortality rate, and not at the statistics of deaths in intensive care. And the overall mortality rate is much higher than for the flu: for the flu — 0.04%, maximum-0.1%, COVID-19-several times more.
There are questions about the voluntary nature of the research
In Russia, drugs for coronavirus are regularly tested, violating ethical norms — and possibly the law. Here are the four main problems
— The volunteers you vaccinated were carefully screened for any signs of coronavirus and kept out of contact with the outside world. Now imagine this: your vaccine is given to a person who is already infected but has no symptoms yet. It’s impossible to check everyone before vaccination and protect them from contact, right? And what happens in this case? Will the injection trigger an immune response that will lead to dangerous consequences?
— It’s not just our vaccine, or not our vaccine. Such complications are called ADE-effect (antibody-dependent enhancement), it is, for example, characteristic of the Dengue virus.
There are hundreds of articles written about ADE, there is no point in retelling them — it is also found in Ebola. To avoid this effect, a person should not be given an inactivated vaccine — it only causes an antibody immune response, and then, when it weakens, the ADE effect. It will not cause the formation of cellular immunity that we need. Therefore, when creating the COVID-19 vaccine, we made a vector vaccine instead of an inactivated one.
— Let’s say you’re talking to a curious child. What is an inactivated vaccine?
— You took the virus, grew it, inactivated it, and killed it. They made a vaccine with it. Entered. A vaccine made on this principle can only cause antibody protection.
Vector vaccines, and our coronavirus vaccine is based on this principle, also cause a cytotoxic immune response — immune cells appear that target cells infected with the virus. It is not entirely correct to transfer talk about the ADE effect to a vector vaccine-studies have shown that there is no ADE effect for vector vaccines. No one is saying that this effect should not be investigated further and should not be looked at, but the Oxford and Chinese [vector] vaccines [against SARS-CoV-2] studied on primates do not show any ADE effect. We also tested our own vaccine for this effect on primates. And, although we can not fully say whether humans will have the same picture as primates, now we should be wary of the possibility of the ADE effect, but no more.
— What does ‘vector’ mean?”
— You take a virus [vector] — non-dangerous, not embedded in the genome, which all mankind faces during life-adenovirus. Then you make it even safer by cutting off a chunk of its genome, or rather two. With such modifications, it is not able to reproduce in normal human cells, but it can get there and bring what you tell it to carry, what you “embed” in its genome — in our case, a gene that is foreign to the adenovirus, but important for the coronavirus, encoding the S-protein (the”spike”protein). The adenovirus can deliver it effectively, and after two or three weeks, there will be no traces of the vector in the body. Time history: delivered-worked out a foreign protein in human cells — got the result.
— Marshrutka.
— Yes. We took the gene encoding the S-protein and translated it from RNA to DNA. We inserted this gene into the genome of the adenovirus and got a vector.
“Half an hour’s work, and the vaccine is ready.
— Almost. Two weeks.
“There were no creative torments. Copywriter in the literal sense”
– Tell us how you made this vaccine.
— We created it in the standard way for all vector vaccines. Such vaccines did not appear out of the blue, they have been actively used since the 1990s. According to this principle, we made a vaccine against the Ebola virus, which was registered in our country.
— You chose a vector-based vaccine based on adenovirus. Why? Because you’ve worked with her before?
— When we made the decision about the vaccine, it was clear that it should be a vaccine that induces a cytotoxic immune response. A fairly simple solution — anyone would have followed my path. When choosing between DNA, RNA, and viral vectors for delivering vaccines — and we work with all types-we chose viral vectors because they are more effective. We conducted a lot of experiments with different carriers and compared them with vector ones, and already at the start it was clear that this is the sky and the earth.
— When you have decided that everything is ready, we enter the race, we make a vaccine and it will be exactly like this?
— I have to explain one thing here: we have been making a vaccine against [middle East respiratory syndrome virus] MERS for three years.
— And you got it ready?”
– Yes. We made a vaccine against MERS and tried different options. This was a lot of work, and we have reached the second phase of clinical research. Therefore, when another coronavirus appeared, the closest relative of the beta-coronavirus group, we had no doubt what to do and how to do it. There were no creative torments. Copywriter in the literal sense.
— When did you start working?” In April? In March?
— in February. The idea that we turn on and do something came up just then. In January, no one really understood what we were dealing with. I attended a who conference in February and it became clear that we were dealing with a serious problem.
— Did the who understand what happened?
— In the 20th of February-Yes. I will not criticize who, there are other people for this. They are probably right about something, but it is also difficult for who — it often does not receive objective information, it is not a state body that makes decisions for everyone. Its employees are doing everything they can-they have put together model committees, clinical and preclinical research committees, all of which are used openly around the world. The who is probably running late in terms of speed — we are closing the borders, we are not closing them-but this is a political decision that cannot be made quickly.
— You copied your vector vaccine for MERS. Why didn’t you use a vector that can multiply in cells — it could potentially make the immune system last longer?
— Let’s just say that a vector that needs to multiply will cause more pronounced side effects. If it does not multiply, then you will have standard adverse events after vaccination — temperature, pain at the injection site. If you make a vaccine on a vector that multiplies, then you let the Genie out of the bottle. What are we doing? We inject the vaccine in two stages – first one vector, then the other. This scheme is known in the world — I think it is not used now for some economic reasons. But in our situation, we understand that a two-time introduction is better than a single one. We tested this with mers and Ebola vaccines.
— Recent research by British and German scientists shows that the number of antibodies to the coronavirus in the blood decreases much faster than expected. Does this interfere with vaccination in any way?
— These works prove the obvious thing-immunity decreases over time. It is important that no one knows what will happen next. First, why do we think that the decrease in antibodies in the blood is a marker that the immune system has disappeared? Antibodies in the blood are always reduced — we can not reach the peak of the immune response for one infection and then for the second, third, fourth — in this case, all the forces of the body will be spent. About two months after the rise in the level of antibodies to the infection, you have a strong drop in it.
And here the main question arises: will such a sick person be protected? There are vaccines that form an effective immune system, but then it falls, the pathogen changes, enters the body again, and the person gets sick again — but it is easier to carry the disease, does not die. Such a situation, for example, with the flu. And it happens, as with yellow fever-the immune system rises, then falls to quite low values, but its protective effectiveness remains up to 20 years. And now if there is a person who says that the reduction of antibodies to COVID-19 means that the immune system will not work, it will be a bold, but unsubstantiated and absurd statement.
— In the development of the vaccine, you decided from the very beginning to follow one path and not turn away? And why, let’s say, there are not 13 variants of different vaccines? After all, it happens – you invest entirely in one option, and in the end, suddenly something breaks.
— We were not afraid, we went through this story many times. Again, we have already made a two-vector mers vaccine and administered it to volunteers.
— But there are different options in the world, and now everything is so shared that what kind of science the country has — this is what it will have a vaccine. Your vaccine has analogues-the Oxford vaccine and the Chinese one.
— Moreover, Johnson&Johnson also make an adenovirus vaccine, just a little behind. That is, the three closest analogs.
— Can you name the main differences between your vaccine and the study design?
— The design of the study is about the same everywhere — first a limited group is studied, then full-scale research, which will definitely be done.
— But you have two vectors, and they don’t.
— I will tell you why we have a two-vector vaccine. If you prick one vector and it doesn’t reproduce, you need to prick it a second time. The same vector you can not prick — you have an immune response to it is in the acute phase. And the person did not respond to the first injection, this happens, for example, with elderly people. You do not work with white mice with intact immunity, which react to everything the same way as twins. You have different situations in your population. And very often in this case, you can get a good immune response, but to do this, you need to boost it [strengthen] and give a second injection.
We have tested this story well — both on mice and primates. We had a clinical trial of two-factor administration of the same vector in humans. We know that re-introducing the same vector is not a good story. After the first injection, a response was observed in all volunteers, but when re-administered, significant amplification was achieved only in those who were injected with the second component based on a different vector, and the introduction of the same vector gave extremely weak amplification. That is, if someone introduces the same vector, they risk creating a weak immune system, which can critically decrease within three to six months.
— This is your main difference from the Oxford vaccine?
— You’re looking for a difference, and I’m looking for a similarity. We [all] don’t act on the principle that we want to prick something once, and then suddenly something will work. We need to be sure that different people will respond to the vaccine.
“Both in America and in Russia, it is now possible to cut corners”
— Did the volunteers have unpredictable reactions?
“No, thankfully. Everything is predictable-temperature, pain at the injection site. The rash is small. Everything is standard.
— What is already ready for working with the vaccine, and what is planned?
– Preclinical studies have been conducted on mice, monkeys and hamsters. Safety is additionally tested on rats, rabbits, and two types of monkeys — rhesus macaques and marmosets.
— Is everything all right?”
— Yes, otherwise we would not have been allowed to go to clinical trials with volunteers.
— There are antibodies and no side effects?
— You know, this is not the most problematic part — to get antibodies from rhesus and marmosets.
— And the T-cells?”
— Too. With them, everything is simple, the animals respond quite well.
— And they protect against the virus itself, have you checked it once?
— Yes, there was a study on hamsters and rhesus macaques.
— You haven’t published it yet?”
“Not yet.
– Respectively, then-research on 38 people?
– Twice 38.
— Some are given the usual vaccine, others “dried”?
“It is.
— Is this phase over?
– Ends. Everything has already been entered and tracked.
— And what day is it after the introduction?
– 28th.
— What are the results?”
— We will see the final results, while we have looked at the preliminary ones-safety, immune response. We will announce the full data later.
— You’re testing antibodies, neutralizing antibodies, T-cells, and I guess there’s nothing else you can test?”
— May. We test different antibodies on different test systems-IgG, ELISA for a full-size S-protein and for a fragment of S-protein (RBD domain), the titer of virus-neutralizing antibodies, T — cell immune response in two variants – lymphoproliferation [population increase] of CD4 and CD8 cells and their production of gamma interferon. When there are not many patients, they should be examined from all sides — we do this, first of all, for ourselves — we need to know as much as possible about our vaccine.
— Will this vaccine be mandatory?
— That’s not a question for me. I can say my opinion: obliging people is not quite right, they are able to make a decision themselves. The Ministry of health is likely to identify some risk groups that may be recommended for vaccination due to the large number of contacts. Doctors, teachers. Recommendations are likely to be adopted for these specialties.
[…]
— Understand, this is an objective study — we do not decide whether the vaccine will be registered or not, we do not influence this decision. From a regulatory point of view, it is arranged as follows: the developer, who is also the sponsor, gives the vaccine to the clinical base [where the study is conducted] and then it will do everything. We won’t be asked anything. The clinical database will prepare documents: observations, diaries of volunteers, etc. All this will be collected in a data package — for analyses, for immunogenicity. All this will be submitted to the center of expertise of the Ministry of health, and it will make a decision — based on a package of data from preclinical and clinical studies — whether this vaccine is suitable, whether it is effective enough, how good the ratio of safety and effectiveness parameters is, and whether it is possible to release such a vaccine on limited terms in circulation.
What do you mean “limited circumstances”? This means that if we don’t repeat [the results] on a large sample, registration will end. Therefore, there will definitely be an expanded study (the third phase, as is customary in the international classification) and all observations of volunteers (both these 76 and those who will only participate) will not be conducted for 42 days-they will be conducted for six months. And only when this happens, when it is proven effective and safe, will we get a permanent registration certificate, if the expert body decides that this is enough. And now [what we are talking about] is only registration on “limited terms”, which will allow you to get, for example, to vaccinate at-risk groups. And all.
“I have no desire to be the first in the world. The first task is to protect your inner circle”
— Are you saying that the tests on these two groups of 38 people are enough to get registered? But this is very little!
— They are enough to get registered under “limited conditions” — for example, it does not allow you to vaccinate children and the elderly, but it will allow you to do research on a larger sample. You will have risk groups, they will receive a drug that will pass the quality examination in Roszdravnadzor. Then you will still need to vaccinate a thousand people in order to pass the third phase. In this sense, almost nothing will change-except that it will be possible to use it in a slightly wider range of people, not only in healthy volunteers, but also in people from risk groups. We don’t want to protect volunteers with a vaccine, do we?
— Do you think it is right to issue a vaccine under this registration scheme?
— America has now come to exactly the same thing — their vaccines have gone according to a simplified scheme. If we are talking about precedents, then more or less everyone has followed the same path. And the British, including-now after the first phase, they will still go to the simplified registration, you will see.
— But they have 1000 people in the study, not 78, and they will come out after a thousand volunteers?
— They won’t be exploring a thousand for long anyway. There will be no full investigation in America or anywhere else.
— Can I give you this very rough arithmetic: if the mortality rate of the disease is about 1%, then in order to prove that the vaccine is safe enough, that it really gives a win when used, you need to observe at least 100 people to be able to see some serious, but rare side effect-I don’t know, the ADE reaction or something else. Just to claim that the risks of vaccination are lower than the risks of the disease itself. Isn’t that right?
— Of course, we’re going to do. The Protocol for the large third phase of the study involving two thousand volunteers has already been developed, but has not yet been approved, so nothing has been published about it. But there is one. We are not just not shying away from this big study, we are doing everything to make it happen right now, in the very near future — in August.
— And if you imagine such a fantastic situation: you put the drug on the market, and then, God forbid, something very bad happens, just like in the movies. What happens then — everything is called back?
— For any medicine — it doesn’t matter whether it is our medicine or any other-there is a special procedure for this: the trial begins, all the steps are prescribed. In General, we must submit a report to the Ministry of health about all things that happen to volunteers. We actually have a fairly strict regulatory system.
— In connection with media reports about hackers who were going to steal the secrets of vaccine production, I would like to ask — and what part of the information in the development of a vaccine is super secret? What should be protected especially well? Such a “Kashcheev’s death” that you will never willingly give to anyone?
— When you live in a certain technology, whether you want it or not, you have a lot of your own developments, which you often do not even take out in the patent. But they are very difficult to steal — you need to live 15-20 years to really master this technology and reproduce it in any conditions. How can this be stolen? Only together with the development team itself. And when the vaccine goes on the market, in any case, everyone will be able to see what is in its composition, there will be no secret.
— Do you want to be the first in the world?
– Me? No. Probably should be, but no. I have always set a different goal for myself: the first task is to protect my inner circle. Because it was all quite scary, actually-and the desire to protect and save loved ones, it is quite strong. And then, you know, winning the Americans, winning the Europeans – these are financial goals to win the market, and I’m not winning markets, I’m developing drugs. And I need my medication to be good and to work. And who and how it will move, this is important, but secondary.
“By the end of this year, we should reach millions of vaccines a year”
— You only look at indirect signs of a protective effect in your research: antibodies and T-cells. But you don’t collect the statistics that vaccinated people get sick less often than unvaccinated people. Is it possible that the vaccine will be ineffective in real life, even when laboratory tests say that everything should work?
— Of course, all this will be observed and we will all see it. Animals after vaccination are protected [from infection] – both ferrets, hamsters, and primates. Therefore, there is no reason to believe that the vaccine will not work. The only concern in this regard — if you ask my personal opinion-is the duration of immunity. Whether it will last a year, two, or three, we do not know. What will a repeat infection look like in a year? Neither we nor anyone else knows this yet, because the disease is only six months old.
— How many doses of vaccines are you going to produce?
— In order to release this, production must be scaled up. And here the Ministry of health is taking all efforts to make the vaccines that will, most broadcast would be on [production] platforms so that these platforms quickly joined the game, quickly went to the market to have the quality that it could be quickly scaled. This is, of course, one of the priority tasks that will also be addressed in parallel.
— Let’s say that today you have a permit and you are told: “All right, go ahead, we need 146 million doses of the vaccine.”
— I can answer [only] what will happen at the Gamalei Institute, what capacity we will reach. We need to ask them what capacity our colleagues will reach — and they will really be our colleagues and assistants, not our enemies — and how quickly they will come out.
“And you?”
— By the end of this year, we should reach millions of vaccines a year. Three to five million doses a year. Our production will be expanded in three stages — equipment and consumables have already been ordered.
— Even with a culture medium for growing cells, there can be problems — everyone needs the same environment. These environments, they are not made here, they are imported. Will there be any problems with this?
— So far, there is no such thing that Russia is cut off and something is not sold to it just because it is Russia. In theory, perhaps, this can happen, but so far I have not encountered it. On the contrary, manufacturers are asked to specify that the environment will be used to create funds against COVID-19 in order to speed up the order.
— Are you not afraid of some kind of unrest if it turns out that officials, for example, will get the opportunity to get vaccinated as a priority?
— Why should I worry about that?” No, I’m not afraid. That’s not my question. My question is to make a good product, and this is the end of my field of activity. State priorities that need to be set — this should be handled by the government and the Ministry of health. If the government sends appropriate orders to our Institute, we will act according to them, and nothing more. There are no other options, we are a subordinate institution. Who to give, which cohorts to protect in the first place-this will be considered and is already considered. I am sure that there will be no such thing — these we will protect, and these we will not.
— What other sites will produce your vaccine?
— “R-Pharm”, “Generium”, “Binnopharm” — the main sites. Companies came out to us and wanted to participate.
– Financially profitable?
“Probably. But for many people, I think it’s also an opportunity to participate in something big.
— This is a strong ambition.
— Of course. Participation in a large case, and not in some kind of nonsense.
— Maybe this is a stupid question, but still: do you feel any special responsibility to the population of Russia for what you are doing?
— Of course. You can’t sit in a trench and watch everything that’s going on. This is a really big challenge for us to meet. It just so happens that this is my specialty, you can’t be a microbiologist, virologist and not participate — this is a challenge and we have to work it out.
— Pardon my ignorance, but you are the closest people were infected with coronavirus?
— Ill my relatives. Those who are older, even went to the hospital.
Original here:
Meduza interview
Posted by: the pessimist | Aug 12 2020 15:41 utc | 23
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