A vaccine against COVID-19 has been developed and registered in Russia. It is planned to release it into civilian circulation on January 1, 2021. However, mass vaccinations with it can be started in a month. Many doctors, as polls show, do not want to be vaccinated. They believe that there is no reliable data on the Sputnik V vaccine, RBC reported. We spoke with people who are still willing to take risks.
The controversy over the vaccine developed by the Gamaleya Center continues unabated. Cons are the following: the 3rd phase of the research has not been carried out, there are no publications in authoritative international scientific journals based on the results of the two previous phases, the vaccine was tested on volunteers from among the so-called “dependent groups” (military), which contradicts modern bioethics standards, Pravmir wrote.
Pros are as follows: the vaccine is registered “under limited conditions”. This means that the Ministry of Health is confident in its safety, but its effectiveness will be checked during the starting phase 3. People who, due to their profession, age or other parameters, are at risk of more often encountering the infection or tolerating it more difficult will take part in it. Participation will be voluntary, which is confirmed by the newsletter of the Gamalea Research Center, which teachers of Moscow schools receive (there are the screenshots in the editorial office).
“I have to see for myself what it is”
Valery Beznosenko, infectious disease specialist at the Medical Center in Kolomenskoye, says:
– As a person who is directly involved in the vaccination of employees and patients, I have to inform about the benefits of vaccination and possible post-vaccination reactions. And to be ready to answer the question whether I was vaccinated or not. To do this, I should experience for myself what a vaccination against coronavirus is. From a moral and ethical point of view, this will be absolutely correct. Someone has to start. Why not me?
I do not know yet how the participation in the third phase of clinical trials will be technically organized. Will this be some kind of order from the chief sanitary doctor or the Ministry of Health? There should be a guidance document that outlines the procedure.
We are now striving to implement the principles of evidence-based medicine. If we talk about the coronavirus vaccine, then it does not yet correspond to them, since it has not passed all the stages of clinical trials. Therefore, getting vaccinated is exclusively my personal decision, I do not urge anyone to do it.
In a situation where there is no data on the efficacy and safety of the Sputnik V vaccine, a medical professional has no right to convince or persuade anyone to do so. The main argument against is the lack of information about the long-term safety of the vaccine.
There is a risk of a so-called antibody-dependent enhancement of infection. When a vaccinated person encounters the virus, it is more difficult to tolerate the disease. But this risk, from my point of view, is no higher than the likelihood of an unwanted outcome with natural infection. As for me, this likelihood is slightly higher for me than that of my younger colleagues, because I am 57 years old.
Today, about 630 medical workers have passed away after getting infected. If we focus on the official data of the deceased, then this is about 4-5%. The average age is about 52 years. I am sure that even if there are some serious adverse events, vaccination will not have such a high degree of risk.
In general, vaccination is good, it helps to form population immunity. How effective a drug is in natural infection conditions is a question that should be investigated in the third phase of clinical trials when evaluating the protective properties of this vaccine. At the same time, vaccination does not exclude the preservation of personal prevention measures, social distancing and wearing masks.
“The more volunteers there are now, the lower the likelihood of coercion is.”
Semyon Galperin, neurophysiologist, President of the League for the Defense of Doctors, says:
– Now, through the fault of the organization conducting clinical trials, in my opinion, there are some doubts about the quality of this drug. So it will probably be difficult to recruit enough volunteers. We need to somehow save the situation.
Without continued clinical trials, this vaccine, like any drug, will never be able to get into practice. Discouraging people from participating in clinical trials means to close the topic and say that a vaccine should not appear at all.
To be honest, I think that the fuss is a little bit excessive, since all vaccines are tested according to the same rules. Currently, several dozen vaccines against coronavirus are being tested in the world, some trials have entered the third phase. The problem is not that our vaccine is different from others, but that we have no data on it.
The talk that it is effective and that it can already be put into practice is as unfounded as the fear that it is harmful. Therefore, volunteers are needed who will participate in its tests.
I do not insist that anyone be pushed. On the contrary, the appearance of volunteers will give a reason to not put pressure on teachers, on pensioners or on those doctors who do not want to be vaccinated. The more volunteers there are now, the lower the likelihood of coercion will be.
Moreover, all requirements for clinical trials must be met. This means that the results of all stages must be published. It’s one thing if they force doctors and teachers to take part in the upcoming vaccination, without giving them full information, without signing a consent to participate in the clinical trials. Another thing is if it is a competent clinical trial going according to all the rules, with the publication of previous results.
For this, the topic needs to be widely covered, including in the media. This is the only way to force the manufacturer to conduct full clinical trials of the drug. Then we can be sure that an untested vaccine will not go on sale and clinical practice without the publication of research results.
“We, doctors, should protect people”
Olga Demicheva, endocrinologist, says:
– At the moment, we only have information that in a short time after giving this vaccine, there was not a large number of significant adverse events observed. And those volunteers who participated in the clinical trials showed an increase in immunoglobulin G titers, that is, presumably, immunity to the new coronavirus was obtained, as a result of this vaccination.
Nevertheless, from October, mass vaccinations of doctors and teachers will start, as we are informed. In fact, the third phase of clinical trials will be conducted on specific categories of the population who (especially teachers, this is not their specialty) do not fully realize all the potential risks.
In our country it happens so that the leaders of some institutions can make their employees choose either to be vaccinated or to leave.
In order to avoid such unacceptable situations, I speak about my own readiness to take part in clinical trials, and invite volunteers, especially my colleagues, to take part in the third phase.
So that people who agree to this were aware of the potential risks, so that there is no compulsory – not legally compulsory, when we cannot prove that people were forced to be vaccinated – but actually compulsory use of this vaccine.
We, doctors, should protect people. As soon as the Ministry of Health approves the protocol of the 3rd phase of clinical trials and the list of medical institutions participating in it is published, I will choose the center closest to my home and go there as a volunteer.
Thus, my proposal to participate in the third phase of clinical trials was not dictated by the desire to receive an experimental drug, but to emphasize the need for this research and my willingness to participate as a volunteer in order to prevent mass vaccination, which, from the standpoint of medical ethics, would be premature.
“If you don’t try it, you won’t know it”
Irina Gonchar, teacher-defectologist, says:
– I know from my colleagues that in Moscow there was no such thing as forcing one of the teachers to be vaccinated. This is not even included in our medical book, where there are mandatory vaccinations, which means that no one has the right to force us by law. All this is voluntary.
I live with an elderly mother-in-law and a child with autism. I would not want him to get sick, because treating children with mental disabilities is very problematic. My son has a difficult psychotic state, I can’t imagine what will happen if he goes to the hospital. He cannot be there alone.
Therefore, my position is the following: I will get vaccinated in order to protect everyone.
Perhaps this is unreasonable, but, on the other hand, if you don’t try, you won’t know.
Besides me, one more person is definitely going to be vaccinated. We are waiting for the mailing with the indication of the place and time. Perhaps there will be more interested people by that time. But I know that many people do not want to be vaccinated, because the vaccine is not yet very well known.
Translated by Alyona Malafeeva