“Vaccine is not a drug of despair that is used when there is no other way out”

So it is worth waiting for the moment when there will be confidence in its harmlessness, says Mark Goloviznin

“Pulmonologist of the ministry of healthcare for the Central Federal District, Professor Andrey Malyavin said that he will not be vaccinated before 2021. The vaccine must pass all the necessary clinical trials, then it will be harmless. Over the hundred-year history of vaccination, the algorithm has been developed: first it is laboratory tests, then repeated tests on animals to determine the necessary dose of the vaccine, and then tests on volunteers and in the clinic. It usually takes 2-3 years from the laboratory stage and the design of the vaccine to its introduction into practice," says Candidate of Medical Sciences, Associate Professor of the Moscow State University of Medicine and Dentistry Mark Goloviznin. In the column written for Realnoe Vremya, he discusses whether the COVID-19 vaccine should be used universally and how to avoid a repeat of the dengue vaccine story in the Philippines.

The question is not “what complications vaccines gives” but “what people give pathological reactions to vaccines”

What is vaccine? This is a weakened disease-causing agent or parts of it that are intentionally introduced into a healthy body to prevent a more severe course of the disease. Vaccines have been used in the world for more than a hundred years, and all this time there are some complications after vaccination. Nevertheless, it is important to ask the question not “what complications vaccines give” but “what people give pathological reactions to vaccines”. If the vaccine is made with full compliance with technology, the causes of complications are not in it, but in a particular person. There are people who, due to inherited or acquired factors, may have severe complications from vaccination. Light, harmless reactions can occur in a significant part of the vaccinated.

Complications occur primarily due to allergies. Since the pre-war times of the twentieth century, the world has known the term “serum disease”. A number of patients who were given the vaccine developed this severe complication. It is expressed in damage to the kidneys, lungs, and joints and is due to the fact that the protein components of the vaccine are not removed in time by phagocyte cells. Another cause of complications is congenital immunodeficiency. These children should not be given live BCG-type vaccines. The BCG vaccine is a live attenuated pathogenic strain of the tuberculosis bacterium. But if the child has an immunodeficiency, even this harmless strain can cause a disease like tuberculosis. But both immunodeficiency and allergic predisposition can be predicted in advance. Now the question is that vaccination should have a personalised approach.

The vaccine itself is not absolutely evil, otherwise we would not use them. The world has realised that, despite a number of complications from vaccines, if the vaccination is cancelled, the consequences will be much more severe for public health, and for the state budget, which will have to support many new patients and disabled people.

Often patients, having read the instructions, flatly refuse to use the drug

In October 2019, the Internet was full of ads on various portals that the ministry of healthcare published a list of deadly vaccines. In fact, it was an internal methodological development for doctors that fell into the hands of journalists. It simply analysed all possible complications from traditional vaccines, which have been used for almost 100 years. It included well-known vaccines against pertussis, tetanus and diphtheria (DDS), BCG, and measles. This manual stated that a number of people may have complications from vaccination, either mild or severe. And the doctor must determine for each person the indications for vaccination. The same information is contained in the huge instructions that are attached to modern drugs sold in pharmacies. It is designed to prevent people from self-medicating.

Now it is accepted that if one in 100,000 people has a serious complication during clinical trials of a drug, then you need to write about it in the instructions. And already the doctor must correlate the degree of risk and benefit. But we've been using self-medication for a long time. And often patients, having read such instructions, flatly refuse to use the drug, because it says that there may be a myocardial infarction. And it is almost impossible to explain that one in 100,000 had it. Nevertheless, it is necessary to explain — this is also the task of the doctor, as in relation to vaccination.

In Soviet times, we had universal vaccination. This had its great positive consequences, but at the same time, medicine in our country, and in the world, too, was largely authoritarian: if the doctor said something, then it was necessary to do so. Now medicine is a partnership: the patient has the right to ask questions, choose who will treat him, refuse treatment or give informed consent to it.

The vaccine is not a cure for despair

The most dangerous vaccine is the one that has not passed the established clinical trials. This is worth talking about in connection with the current situation. Over the hundred-year history of vaccination, an algorithm for testing the vaccine has been developed. First it is laboratory tests, then repeated tests on animals to determine the necessary dose of the vaccine, and then tests on volunteers and in the clinic. It usually takes 2-3 years from the laboratory stage and the design of the vaccine to its introduction into practice. As the history of vaccination shows, outbreaks of complications not related to individual intolerance were associated with violations of vaccine technology. This was the case in Germany in 1930, when a pathogenic strain was mistakenly introduced to children instead of BCG. Then 70 people died of tuberculosis.

The COVID-19 vaccine has been talked about throughout the pandemic. The further we go through the quarantine, the more claims that we will get the vaccine in the autumn of this year. On may 30, the media published information that a vaccine will be introduced through the nose very soon.

But the virus only appeared in 2019. It should take some time to decipher its genetic apparatus, its protein structure, and the clinical symptoms of the disease. This raises the question: how soon should we get a vaccine that will pass all the stages of testing? There are several disturbing statements made by authoritative figures in medicine on this subject. In particular, academician Vitaly Zverev said that without thorough confirmation of the safety of the vaccine, the threat of its use can be fatal. Academician Valery Chereshnev, the president of the Russian Society of Immunologists, said the same thing — that the vaccine must pass all the necessary clinical trials, then it will be harmless. Here we cannot bite off more than we can chew. It takes time. Yes, we can now simulate some stages on a computer, but this does not eliminate the need for experimental verification.

Pulmonologist of the ministry of healthcare for the Central Federal District, Professor Andrey Malyavin has recently said recently that he will not be vaccinated before 2021, based on the fact that the vaccine is not a medicine of despair, which is necessary when there is no other way out.

The vaccine is a “weakened disease” that is administered to healthy people, and you need to be sure of its safety.

People who received the vaccination became ill with a severe form of dengue fever with a mortality rate of 50%

Here it is appropriate to recall the recent tragic situation related to the dengue vaccine. This was in 2017. Dengue fever is a serious disease that affects millions of people. You can get infected with it several times, there is no lifetime immunity, there is no specific treatment. A significant number of people suffer from this disease, but they recover. But there is a severe form of dengue fever, when massive hemorrhages develop in the internal organs, vascular thrombosis, which we see in the severe course of Covid infection.

Pharmaceutical giant Sanofi has spent 10 years developing a live dengue vaccine. The work was completed in 2015, and in 2016, the WHO raised concerns about possible complications. Nevertheless, the government of the Philippines, ignoring the WHO's warning, purchased the vaccine for $60 million. Approximately 700,000 children and adolescents were vaccinated. It turned out that those vaccinated with this vaccine received a high level of antibodies, this was a formal sign that the vaccine works.

Now they also think that if there are antibodies to COVID-19 in the blood, it means that a person has acquired immunity, but in fact everything is more complicated.

With the dengue vaccine, the following happened: yes, the level of antibodies increased, but only those who had already had the infection did not get sick. But those people who had not been ill before, after receiving the vaccination, fell ill with a severe form of dengue fever with a mortality rate of 50%. And they started dying in the Philippines. First, there were reports of deaths among vaccinated children — from 14 to 200 deaths according to various data. Most importantly, in 2019, a new dengue fever epidemic broke out in the Philippines, with many more people infected than before the use of the vaccine. The use of the vaccine has been stopped, but $60 million had already been spent. At the same time, the government and judicial authorities of the Philippines initiated a number of criminal cases against both officials and employees of the pharmaceutical company.

Will the COVID vaccine be harmless?

As a result, there was a kind of experiment on people. Its data is taken into account, and recent scientific articles say that the dengue vaccine must be improved: it should not only raise the level of antibodies in the blood, but also stimulate cellular immunity. The vaccine is modified by injecting proteins that would activate cellular receptors to prevent cytokine storm. But it is already clear that a new vaccination is not a matter of the immediate future. By the way, the epidemic in the Philippines also had social consequences in the form of mass refusal of other vaccinations. As a result — a new epidemic of measles in adults with two hundred deaths last year.

Nowadays, the question is: does everyone need a COVID-19 vaccine? And most importantly, will it be harmless? Will it repeat the story of the dengue vaccine? And is it only with a high level of antibodies that we can talk about acquired immunity? There is evidence that a high level of antibodies in infected COVID-19 is an unreliable indicator of cure from the virus. It does not mean that a person will never get COVID-19 infection again.

There is already news that fines will be imposed for refusing to vaccinate. In anticipation of the release of the COVID-19 vaccine, the case in the Philippines requires the most detailed analysis in Russia.

The COVID-19 vaccine itself is necessary, but it must pass all the necessary stages of testing on animals, on volunteers, and in clinics. This should take the necessary time, it is dangerous to act in any other way.

You need to remember the first principle of the doctor, who says: “Do no harm.” And the statements of highly respected medical figures of the Russian Academy of Sciences, which I have cited above, should not be ignored.

By Mark Goloviznin