'Nightmarish side effects': a volunteer on the Russian vaccine against COVID-19 - ForumDaily
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'Nightmare side effects': a volunteer talks about the Russian COVID-19 vaccine

The Sputnik V coronavirus vaccine developed by the Gamaleya Institute was registered in Russia before the start of the third stage of clinical trials, which caused sharp criticism from experts. Registration and use of a drug at this stage is a risky experiment with unknown consequences. Vaccines being developed in other countries are still being tested, writes «Radio Svoboda».

Photo: Shutterstock

In cases where volunteers experience side effects, trials are suspended. AstraZeneca has twice suspended trials of its vaccine, which it is developing in partnership with Oxford University, due to neurological symptoms in one of the participants. Pharmaceutical company Johnson & Johnson suspended trials in October due to a volunteer's illness.

And Sputnik V is already being vaccinated in Russia, including officials, representatives of the elite and show business. President Putin announced that his daughter, Katerina Tikhonova, was vaccinated. Tikhonova’s friend and her deputy at the Innopraktika Foundation Natalya Popova is an old acquaintance of the head of the Gamaleya Center, Alexander Ginzburg. Margarita Simonyan and her husband Tigran Keosayan were vaccinated.

“Whether this vaccine is effective or not is no longer so important. The main thing is that we are again ahead of the whole planet. Even if it turns out that Sputnik is bad, it’s okay. By winter, one, or even two more vaccines will appear, one of them will work,” Open Media quotes a source in the pharmaceutical market.

On September 8, the Ministry of Health announced that the first batch of the Russian vaccine was released into civilian circulation. And only the next day the final stage of clinical trials of Sputnik began. About 40 thousand volunteers participate in it. The vaccine involves the introduction of two components of the drug with an interval of three weeks. In the event of a volunteer’s death, his loved ones will be paid two million rubles. If a volunteer becomes disabled in the first group, he will receive one and a half million.

Journalist Svetlana Reiter, who became a volunteer, keeps her diary on the Meduza website. She explains her decision by caring for elderly relatives who are at risk. Media manager, director and producer Andrei Vasilenko had the same motives. His work involves traveling around the world and constant contact with people, and he decided to become a volunteer in order to protect his family, and at the same time test on himself the vaccine that may be used to vaccinate his parents. The Ministry of Health has already authorized a clinical trial of Sputnik with the participation of volunteers over 60 years of age.

In May, 40-year-old Vasilenko suffered from an illness similar to COVID-19. Doctors said that the symptoms of coronavirus were obvious, but the test came first positive, then negative, and the diagnosis was evasive: “suspicious coronavirus.” “I didn’t have a significant level of antibodies, they were on the verge of detection. As I was told, this could be some kind of cross infection.”

On Facebook, Andrei Vasilenko spoke about how his body reacted to Sputnik V. After the first vaccination, approximately 6 hours later, the temperature rose to 38 and a fever occurred with alternating chills and fever.

But Vasilenko suffered the second injection much worse. The temperature jumped to 40,2.

“And it was almost impossible to bring her down. Paracetamol simply flew away into nowhere. 40,2 – and that’s it. Pulse – 140–160. The fever is strong, electric heating pads do not help at all against the chills that accompanied the fever - it is extremely difficult to warm up.”

Vasilenko gave himself an injection of ketonal, the temperature began to drop slowly, but then soared again - 39,2.

“I hit him again with a bunch of paracetamol, nimesil and a new portion of ketonal. Then heart problems began, similar to an attack, difficulty breathing at rest (lack of air), dizziness.”

Andrei Vasilenko tried to tell the vaccine developers at the Gamaleya Institute about his problems, but “received a discouraging answer: “Why are you calling here? We have nothing to do with vaccine research. Don't distract us from our work. If you have questions, go to the Mos.ru website and ask them using a special form!” At the same time, the Moscow Health Department calls what Vasilenko experienced “unpleasant but harmless symptoms.”

As Andrey Vasilenko writes, they refused to diagnose him with a “post-vaccination reaction”, but announced that he had ARVI. He notes the professionalism of emergency doctors and the outrageous behavior of medical officials, as well as the disgraceful organization of Sputnik testing.

On the subject: Those who tested the Russian vaccine against COVID-19 revealed coronavirus

Here is what he told RFE / RL:

- You write that you have developed additional immunity to adenovirus, and at the same time antibodies to coronavirus have disappeared. Why did this happen?

- I dont know. Adenovirus is the carrier in the vaccine. In principle, it is logical if there was some kind of reaction to the adenovirus. I was immune to adenovirus before. But testing for adenovirus cannot be divided by type, it is for all serotypes at once. It is not known what adenovirus I was immune to, maybe by 5, maybe by 26, it is not clear how they interact with each other. The doctors said: everything is understandable, wait for the second vaccination, after which antibodies to coronavirus should be developed.

- And after the second vaccination, the terrible consequences began?

– Horrible side effects! And these effects weren’t even so scary as it was extremely unpleasant to find out that no one cared about what was happening. The “Informed Consent” states that if I have a side effect, I can contact either my attending physician, or the research physician, or the insurance company, or the department’s ethics committee hotline, and so on, a million phone numbers. Then it turned out that there is a volunteer hotline, there is “Telemedicine” and, of course, an ambulance. It’s not clear where exactly to go. At first I tried to contact Telemedicine, they called an ambulance, but the ambulance did not know where to take me. Go to the hospital just like that, not understanding how they will help me there, and at the same time contract coronavirus? Naturally, I said no. The next day, after a temperature of 40, I felt better, but in the evening it skyrocketed again. It was October 27th. I tried to contact Telemedicine, no one answered. Nobody called me back all day. I was forced to go to a private clinic to see a cardiologist.

- And how do you feel now?

- I continue to feel bad, my temperature jumps, yesterday it was 37,5, at night it fell to 36,6. At the same time, there was a strong chill, sticky cold sweat. Now the temperature is going in the opposite direction, already 35,8. Heart problems persist.

- At the same time, doctors refuse to write that this is a post-vaccination reaction.

- This is not available anywhere at all. The cardiologist didn’t even write that I had pain in the heart area, her wording was “discomfort in the heart area.” Pain and discomfort are different conditions, to put it mildly. They are now convincing me that my symptoms have nothing to do with the vaccine, they say: your chronic diseases have worsened. I say: “Please tell me, what chronic diseases do I have?” “We don’t know, but it’s definitely not related to the vaccine.” I say: “How did you find out? By what method? You didn’t invite me to any research, I donated blood for my own money, I did tests for my own money. On what basis is this conclusion?” No one showed any interest, no one really examined me, no one took any tests. The only chronic disease I have is pharyngitis associated with professional activities. I ask them about C-reactive protein, they say: “You apparently have some kind of hidden chronic disease that produces such C-reactive protein.” I say: “61?! Even when I had manifestations of coronavirus, my protein level was less than 10, within the normal range.”

- You write that your friends, who became volunteers, have unexpected consequences.

- Yes, my friend Max Popov, he also works in the field of television, had side effects. He runs professionally, now he says that it has become difficult to run, pulse 150-160. Many volunteers responded to my notes, and everyone says that they have a fever. Therefore, the statement by the health department that only 15% of people experience side effects looks strange. Plus, I don’t understand how they came to this conclusion if the vaccine research ends only in May. How do they know now that 15% show up if they have not yet received the second vaccination?

 

- If antibodies appear, but at the same time the temperature rises to 40,2 or complications arise in the heart, how to recommend such a vaccine?

- I agree with you. And I still don’t understand how people with chronic diseases will be vaccinated and how mass vaccination will take place. You know how they give flu shots: there’s a trailer, people come in, they get the shot, and they leave. It was us, the volunteers, who carried out some kind of examinations, we at least donated blood for drugs and alcohol. Although they didn’t take anything from me before the second vaccination. I went to the doctor, he gave me an electronic thermometer, it showed a temperature of 34,2. I tell the doctor: “We probably need to re-measure.” He says: “No, don’t.” I took my temperature at the entrance and it was 36,4. He says: “Well, screw him, there’s no need to try on anything.” And he entered 34,2 into the electronic card. This is also the approach. The entire study was poorly organized. I don't understand why it is at all. I have had side effects, I need to be examined to determine whether or not there is a relationship with the vaccine. Maybe the vaccination started some processes, maybe it didn’t. This is why research is being done. And here everyone gives a damn. There is no unified control system, a bunch of different services, it is unclear who is responsible for what. The Gamaleya Institute doesn’t care, and the private research organization doesn’t care either. So why are we doing all this? They would start vaccinating everyone right away and sign everyone up as volunteers. I have a feeling that this is purely for show.

On the subject: 'Not everyone knows why they came': how the Russian vaccine against COVID-19 is tested in humans

- Let's not forget that the vaccine is going to be sold to India, Venezuela and other countries.

- These are the countries where if someone dies from the vaccine, no one will notice. A couple of dozen people will die, and okay. Collateral losses, as they say in the army. Why is such research needed? They would have collected people for show, knocked down statistics, would not do it so publicly, they would have said that they had injected 20 thousand people, everyone is fine, 15% of side effects, the vaccine is running.

- Now, if you knew about the consequences, you probably wouldn't volunteer?

“I can now say unequivocally: I will in no way recommend this vaccine to my parents. Now I can only recommend it if you know doctors or some clinic where you are being treated, and you are firmly convinced that if you have any complications, they will immediately take you there and begin treatment. Then maybe you can try. And I won’t even recommend this until I see results. If I see that I have antibodies, I can advise taking this vaccine with a very serious reservation. If you have someone to provide emergency medical care in case of side effects, do so. If there is no one and you are ready to die from vaccination, then you can do it too. Because no one will help if they don’t even care about the volunteers. They are somehow messing with me thanks to the public outcry. But cheating still occurs. It’s completely beyond the bounds that I’m recovering after the vaccine. Manufacturers of flu vaccines contacted me, they are also at a loss: how can clinical trials be carried out like this? They say: if we had done this, we would have been closed a long time ago. As Chernomyrdin said, “we wanted the best, it turned out as always.” That is, a vaccine is a good idea, we were the first to come up with it, it’s great. This means that it needs to be tested, proven to be safe and effective, and modified if necessary. But all this is extinguished at the next stage: we don’t care about everything, let’s promote it as it is. We need to overtake everyone, be the first, report back, receive an order. But no one is interested in what it really is.

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