How to prepare for vaccination against COVID-19, and to whom is it contraindicated? How to competently refuse vaccination, and what compensation can you expect in case of complications? We asked experts.
The Russian Ministry of Health has registered the Covid vaccine developed at the N.F. Gamaleya Research Center for Epidemiology and Microbiology. This is Gam-COVID-Vac, a vector drug based on an adenovirus. Its trade name is Sputnik V.
In addition, a vaccine developed by Oxford University and the Swedish-British company AstraZeneca, also based on an adenoviral vector, will be produced in Russia.
Registration of another Russian drug is planned for the fall. This is the Epi-Vac-Corona vaccine, created on the basis of peptide antigens (artificially synthesized fragments of the virus) at the State Research Center of Virology and Biotechnology “Vector”.
The head of the Ministry of Health, Mikhail Murashko, said that mass vaccination of the population is planned to begin in October. And Deputy Prime Minister Tatyana Golikova expressed hope that health workers will begin to be vaccinated at the end of August or September.
Is Covid vaccination safe for people with chronic illnesses?
“We tested the Gam-COVID-Vac vaccine on healthy volunteers from 18 to 60 years old and proved its safety,” Vadim Tarasov, director of the Institute of Pharmacy and Translational Medicine of the First Moscow State Medical University named after. I.M. Sechenov. – The drug is very well tolerated.
Only 10%–15% of volunteers had undesirable reactions to it, that is, a temperature of 37-38 degrees and a slight headache. A healthy person can be vaccinated with this vaccine completely calmly.”
(Clinical and preclinical trials of the vaccine developed by the Gamaleya Research Center took place at Sechenov University).
How vaccination affects people with chronic diseases will become known during the third phase of clinical trials, which began on August 12.
“Relatively speaking, several people with kidney disease, several people with heart disease, and so on can take part in the next phase,” explained Vadim Tarasov. – Most likely, they will not have complications after vaccination either. But the final decision on which diseases are a contraindication for vaccination against Covid will be made by the Ministry of Health.”
According to the Instructions for Medical Use of Gam-COVID-Vac, this vaccine cannot be administered to people with a history of severe allergic reactions, acute infectious and non-infectious diseases, during pregnancy and breastfeeding.
The developers recommend using the drug “with caution” for people with chronic diseases of the liver and kidneys, lungs, cardiovascular system, central nervous system, diabetes mellitus, autoimmune diseases, etc.
How is the administered drug tolerated during vaccination?
Each person tolerates the administered covid vaccine differently. Side effects do not affect everyone. Some people may have a very high fever on the same day after the first vaccination. It can also rise in some people only on the second or third day.
For some people, the temperature rises and persists for several days. Some people tolerate the injection very hard and remain in the pastel mode for about a week. There is such a thing that severe tolerance to the vaccine occurs in the first stage. But the main flow of people gets sick after the second.
All this is due to the individuality of the human body:
- state of immunity;
- age;
- infectious experience (have there been any previous infectious diseases).
Is it possible to vaccinate older people against Covid?
The Association of Clinical Research Organizations (AOCO) called on the Ministry of Health to delay the registration of Gam-COVID-Vac the day before the move was made. One of the arguments of opponents of registration was the lack of data on the safety of the vaccine in older people.
The effect of the Covid vaccine on people over 60 years of age will begin to be studied during the third phase of clinical trials, Alexander Gunzburg announced on August 11.
“Now the post-registration phase of research on the vaccine will begin, one of the tasks is to study the possibility of its use in terms of safety and immunogenicity for people over 60 years of age, even for 90-year-olds will be studied,” he told Interfax.
According to AOKI executive director Svetlana Zavidova, the third phase of clinical trials should precede drug registration, and not vice versa. The fourth phase is considered post-registration, she told Miloserdiy.ru.
But the abbreviated clinical trial procedure does comply with the law. It is authorized by Government Decree No. 441 of April 3, 2021 and can be applied until January 1, 2021.
When is it absolutely forbidden to get vaccinated?
“Any inflammation significantly increases the risks associated with vaccination. Regardless of a person’s age, during immunization he should not even have signs of inflammation in his gums, throat, ears, or anywhere.
Therefore, before vaccination, you must undergo an examination, at least do a general clinical blood test: an excess of leukocytes and an increased ESR (more than 10) will indicate an inflammatory process,” Alexander Poletaev, professor, doctor of medical sciences, scientific director, said in an interview with Miloserdiy.ru medical research
“There is also a more accurate screening tool called the ELI-Vaccine Test,” the immunologist continued. – It reveals immunochemical signs of inflammation in the body. It doesn’t show where the outbreak is, but it tells you that it exists.”
At least two to three weeks should pass between the history of acute respiratory infections or acute respiratory viral infections and vaccination, he recalled. And between two vaccinations, for example, against influenza and against covid, at least two to three months should pass, added Alexander Poletaev.
A viral or infectious disease is a constant contraindication for any vaccination, Vadim Tarasov emphasized.
Preparing for the study
- It is recommended to donate blood on an empty stomach. This means that at least 3 hours must pass between the last meal and the blood draw. There are no restrictions on water consumption. If you plan to donate blood in the morning, it is advisable to limit yourself to a light dinner the night before (no fatty foods).
- The day before the test, avoid alcohol, intense physical activity and (in consultation with your doctor) taking medications.
- You should not smoke for two hours before the test, and you should not drink juice, tea, or coffee at this time (you can drink still water). Physical stress (running, quickly climbing stairs) and emotional excitement should be excluded. It is recommended that when you arrive at the clinic, sit quietly for 10-15 minutes and only then enter the treatment room.
- You should not donate blood immediately after physiotherapeutic procedures, instrumental examination, X-ray and ultrasound examinations, massage and other medical procedures.
- Study completion time: 2-3 days
What other tests should be done before vaccination?
Volunteers who participated in the vaccine trials, in addition to a general and biochemical blood test, underwent a general urine test, ECG, fluorography, spirometry and ultrasound.
Alexander Poletaev also advises conducting a screening study to assess the general condition and resistance of the body (ELI-Viscero-Test).
“Microbes evolve much faster than humans. Yesterday HIV appeared, today SARS, MERS, COVID, tomorrow there will be something else. You cannot vaccinate against all pathogens.
But there is another way out. In different countries, from 60% to 90% of people who catch coronavirus do not get sick. There is a virus, but there is no disease. This means they have good resistance,” explained the immunologist.
“If a person’s immune system is in order, he will successfully resist infection even without vaccination,” he said. – And if resistance is reduced, then the doctor will have to strictly individually select a method for restoring it.
This may be to compensate for vitamin D deficiency, if any. Maybe the patient has problems with the microbiome. After all, a huge number of microorganisms, our symbionts, live in the body, primarily in the digestive system. When the composition of the microbiome is disrupted, the immune system suffers greatly. Your doctor can recommend appropriate pre- and probiotics.”
“Quantitatively, 85% of the immune system is the part associated with the gastrointestinal tract,” continued Alexander Poletaev. – Therefore, it is very important to understand what we eat. Some foods may not be suitable for a person in terms of antigenic composition; this is called food intolerance (not to be confused with its particular manifestation - allergies). You can also find out what exactly is not suitable with the help of tests prescribed by doctors.”
When is vaccination really necessary? “If a fox suddenly attacked a mushroom picker, he needs to be vaccinated against rabies,” said the immunologist. – If a person is going to a country where the Ebola virus is found, then he needs to be vaccinated, because the mortality rate from the Ebola virus reaches 70%, and not 0.5%, as from covid. If the epidemiological situation for diphtheria is not good in the region, vaccination will also be needed.”
What complications are possible after vaccination?
The developers report only a short-term rise in temperature to 37-38 degrees and a mild headache. This problem can be “resolved with a paracetamol tablet,” said Alexander Ginzburg in an interview with the Rossiya-24 TV channel (quoted by RIA Novosti).
“This drug has no direct toxicity, no damaging effects that are observed for about a month,” said the chief researcher at the National Research Center. Gamaleya Anatoly Altshtein on the radio station “Moscow Speaks”.
Longer-term effects of the vaccine could be studied during the third phase of research, he added.
People who decide to get vaccinated against Covid in August and September will have special applications installed on their phones that will allow them to describe their condition to doctors and promptly contact them if necessary, Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), told Vedomosti. (the foundation partially financed the development of the vaccine at the Gamaleya Research Center).
What symptoms should you report to your doctor after vaccination?
“Any vaccination is a small disease,” emphasized Alexander Poletaev. – The antigen of the causative agent of the disease – virus, bacteria – is introduced into the body. It doesn’t matter whether the antigen is synthetic (in a recombinant vaccine) or natural (in an inactivated vaccine), we still cannot predict safety 100%.
After all, the immune response begins with molecules of the major histocompatibility complex (a complex of genes encoding MHC proteins responsible for presenting antigens and triggering the immune response). And there are more than a million options for MNS!
And in each person, these molecules will present different fragments of the antigen to the cells of the immune system, accordingly, the immune response they induced will also be different.
It is very rare, but it happens that someone is presented with a piece of antigen for an immune response, which begins, for example, the development of lymphoproliferative diseases, that is, blood cancer, or diabetes, or multiple sclerosis, etc.
The risk of serious, disabling complications from vaccinations is approximately 1 in 10,000. We have not yet, in principle, learned to predict how a person will respond to a particular vaccine, depending on his individual MHC.
Even a successful vaccination is a serious intervention that permanently changes the parameters of the human body. Professor Yehuda Schoenfeld, a world-renowned immunologist, examined American Rangers who were vaccinated before Operation Desert Storm in Iraq. He assessed their immune status for three years at intervals of several months. In three years, not one of them returned to the original state of the immune system.”
According to Alexander Poletaev, any symptoms that appear after vaccination must be reported to the doctor in order to prevent the development of severe complications.
Immune response to coronavirus
When a vaccine is administered, the human body begins to produce specific proteins called immunoglobulins or otherwise antibodies. These proteins include the nucleocapsid (N) and spike (S) proteins.
A blood test for antibodies to the Covid-19 nucleocapsid protein is highly sensitive at the initial stage of infection with the virus. Therefore, they mainly test for antibodies after the vaccine to the coronavirus spike protein. This helps determine the presence of protective immunity. Immunity may appear after contracting coronavirus or after receiving a vaccine.
Is it possible to avoid vaccination and not lose your job?
Vaccination against Covid should be entirely voluntary, Vladimir Putin noted during an online meeting with government members on August 11.
“The concept of “forced vaccination” is unknown to the legislation. In accordance with the provisions of the law “On Immunoprophylaxis of Infectious Diseases” (Federal Law No. 157), citizens have the right to refuse preventive vaccinations.
But it is necessary to understand that the lack of preventive vaccinations entails refusal to hire citizens or removal of citizens from work, the performance of which is associated with a high risk of contracting infectious diseases, noted Polina Gabay, head of legal affairs, in an interview with Miloserdiy.ru. “The list of such works was approved by government decree No. 825.”
According to this document, employees of educational institutions, medical laboratories, infectious diseases departments of hospitals, etc. must be vaccinated.
The list of preventive vaccinations discussed in the resolution was approved by Order of the Ministry of Health No. 125n, clarified Polina Gabay.
“Vaccination against coronavirus infection has not yet been included in the national calendar and the calendar for epidemiological indications, therefore we believe that refusal to hire or removal from work, the performance of which is associated with a high risk of contracting infectious diseases, of citizens who have not been vaccinated against coronavirus infection is unacceptable (according to at least until appropriate legislative changes are made),” she said.
Whether the presence of medical contraindications to vaccination can be considered a valid reason that does not allow a person to be removed from work associated with the risk of infection is a debatable issue. If you interpret the law literally, then it is impossible. However, a small amount of judicial practice demonstrates that medical indications are still a valid reason for refusing vaccination, said Polina Gabay.
“There are a huge number of people who never get vaccinated because they have a medical exemption. If the employer requires such an employee to get vaccinated, the issue can be resolved in court,” noted Yulia Stibikina, director of legal services, in an interview with Miloserdiy.ru.
Interpretation of the result
Qualitative analysis: the result is given in the form of a digital value - the positivity coefficient (CP). Positive result – more than 1.1.
Quantitative analysis: The result is given in the form of a quantitative indicator - antibody titer. Positive result – more than 0.8 U/ml.
A positive result indicates the presence of antibodies to Covid-19. If there is a history of vaccination against coronavirus infection, a positive result indicates the presence of post-vaccination immunity.
It is necessary to take into account that the analysis will also be positive in people who have had Covid-19, so these antibodies can be considered post-vaccination only if it is reliably known that before vaccination the person was not sick and antibodies to Covid-19 were not detected in the blood.
