Information on vaccination against COVID-19 infection

For reference: Coronavirus infection COVID-19 is an acute respiratory viral infection, the complications may include viral pneumonia leading to life-threatening inflammatory lung disease or respiratory failure with the risk of death.

The transmission of infection from one person to another occurs through airborne droplets when sneezing or coughing. Contact-household transmission is also possible.

The main symptoms of the disease are an increased body temperature (usually 38-39°C), cough (dry or with a small amount of sputum), a feeling of tightness in the chest, shortness of breath, muscle pain and headache. The disease can also begin with the appearance of loose stools, nausea, vomiting, loss of appetite.

Epidemiological situation on the incidence of coronavirus infections COVID-19 (causative agent – the SARS-CoV-2 virus) in the world (as on 15.03.2021)

The number of cases in the world (as on 15.03.2021)

In February 2021, the National Action Plan for Vaccination against COVID-19 Infection in the Republic of Belarus for 2021-2022 was approved.

This plan defines the tactics of vaccination against COVID-19 infection with the gradual inclusion of specific contingents in the vaccination campaign in accordance with the following stages:

Stage 1. Medical and pharmaceutical workers (including students of medical educational institutions involved in providing medical care to the population). Workers of educational institutions. Persons over 18 years old living in institutions with a round-the-clock stay (if they can be vaccinated according to the instructions for vaccines) – February–March 2021.

Stage 2. Persons aged 61 and over, persons with chronic diseases, other persons at risk of a severe course of the disease – as vaccines become available.

Stage 3. Persons with a higher risk of contracting COVID-19 infection compared to the rest of the population due to their professional activities (workers of trade, catering, consumer services, transport, cultural institutions, sports facilities, etc.), workers of government agencies who ensure the security of the state and the vital activity of the population, workers of diplomatic missions and members of their families, others – as vaccines become available.

Stage 4. The rest of the population (taking into account the provision of vaccination coverage of at least 60 percent of the population) – during 2021.

The Ministry of Health of the Republic of Belarus is developing a platform for online registration for vaccination against COVID-19 infection with the possibility of its subsequent integration into the e-health system of the Republic of Belarus.                                                             

The Gam-COVID-Vac "Sputnik V" vaccine is approved by the Ministry of Health of Belarus for use in people over 60 years old.

For today, there is no vaccine for the prevention of SARS-CoV-2 infection registered in the Republic of Belarus for use in patients over 60 years old. Therefore, registration of the drug for  this age group is extremely relevant for the country's healthcare system.

The developer of the vaccine FSBI "The National Research Center for Epidemiology and Microbiology named after N.Gamaleya" of the Ministry of Health of Russia, Russian Federation, made the necessary changes and additions to the instructions for use in order to expand the age limits for the use of the drug for the prevention of coronavirus infection.

Preparations for mass vaccination of the population have begun in Belarusian healthcare institutions, the specialized training sessions are being held. Older people will be asked to undergo a comprehensive medical examination in compliance with the necessary anti-epidemic measures in preparation for vaccination.

Dzmitryj Hryńko, director of the RUE "Center for Expertise and Testing in Healthcare" of the Ministry of Health of the Republic of Belarus:

"Combined vector vaccine for the prevention of coronavirus infection "Sputnik V" is developed by FSBI "The National Research Center for Epidemiology and Microbiology named after N.Gamaleya" of the Ministry of Health of Russia and approved by the Ministry of Health of the Republic of Belarus for use in people over 60 years old. This conclusion was made based on the results of the registration dossier materials assessment made by the specialists of our center and leading scientific experts – infectious disease specialists, epidemiologists, geneticists of Belarus. The decision was made based on the permission to use the vaccine in people over 60 years old, adopted in December 2020 by the regulator of the producing country – the Ministry of Health of Russia."

Clinical studies that investigated the efficiency and safety of the "Sputnik V" vaccine in the elderly.

Vaccines Gam-COVID-Vac "Sputnik V" in persons over 60 years old were studied in Russia in two clinical studies.

One study involved volunteers aged 18 or older. Almost 40 thousand people took part in this study. The number of volunteers among them that are over 60 years old and received the Sputnik V vaccine amounted to 1 thousand 029 people, 588 of volunteers over 60 are men and 441 participants are women. The oldest participant of the study was 87 years old.

110 volunteers took part in the second study of the vaccine that was used only in people over 60 years old. The name of this study is "The open study of the safety, tolerability and immunogenicity of the medical product "Gam-COVID-Vac", the solution for intramuscular administration with the participation of volunteers in the age group over 60 years old."

So, today there is documented data on the efficiency and safety of the "Sputnik V" vaccine obtained from more than 1000 volunteers over 60 years old which served as a sufficient basis for amending the instructions for medical use.

About the results obtained in the course of "The open study of the safety, tolerability and immunogenicity of the medical product "Sputnik" in volunteers of the age group over 60 years old".

The obtained  data demonstrated that the vaccine administration induces the formation of an intense immune response to the SARS-CoV-2 virus. The vaccine helps to involve in the process both the humoral immune response – specific blood proteins-antibodies that can prevent the development of covid infection – and the cellular link of immunity – blood cells that provide antiviral protection.

The humoral immune response is provided by specific blood proteins – antibodies that can prevent the development of covid infection. Specific antibodies are formed in response to the introduction of the vaccine in almost 100% of the vaccinated people (this is called seroconversion). The maximum level of titer-specific antibodies in time is observed on the 42nd day after vaccination.

The cellular link of immunity is blood cells that provide protection against viral and bacterial infections. Double immunization of volunteers with the drug "Gam-COVID-Vac" forms the both CD4 + and CD8+ antigen-specific T-lymphocytes on the 28th day after the introduction of the first component of the vaccine (T-lymphocytes are cells that provide antiviral protection). The obtained indicators show a pronounced formation of the cellular link in immunity of volunteers of the age group over 60 years after immunization with the drug "Gam-COVID-Vac".

Studies of the immunogenicity, efficiency and safety of the drug in volunteers aged 60 years and older are ongoing.

In addition to the main report on a separate study, the results of evaluating the safety and efficiency in a group of patients over 60 years old were supplemented with data from the interim report on the clinical study “Randomized double-blind placebo-controlled multicenter clinical study of the efficiency, immunogenicity and safety of the combined vector vaccine Gam-COVID-Vac ("Sputnik V") in parallel groups in the prevention of coronavirus infection caused by the SARS-CoV-2 virus".

Thus, the conducted clinical studies allow us to make the next conclusions about Gam-COVID-Vac vaccine ("Sputnik V"):

1. it is effective in a group of patients over 60 years old.

2. it has a favorable safety profile.

3. the safety profile in this group does not differ from the general population of patients.

4. no unexpected serious adverse events were identified.

5. adverse events noted in the course of studies are generally characteristic of vaccine preparations.

Efficiency of vaccination with one or two components of the Gam-COVID-Vac ("Sputnik V") vaccine.

The single immunization with component I or II of the drug "Gam-COVID-Vac" and double immunization in the "prime-boost" mode with the drug "Gam-COVID-Vac" can lead to the formation of antigen-specific IgG antibodies in 100% of volunteers on 21st day after immunization. The maximum antibody titers with double immunization in the "prime-boost" mode with the drug "Gam-COVID-Vac" are shown on the 42nd day after the start of immunization. Double immunization in the "prime-boost" mode with the drug "Gam-COVID-Vac" leads to significantly higher titers of antigen-specific IgG antibodies compared with the single immunization with component I or II of the drug "Gam-COVID-Vac". This shows the advantages of the booster vaccination scheme and allows to recommend it for further clinical practice.

How does the acquired specific immunity differ in those who have been ill and vaccinated?

Comparison of the titers of antigen-specific IgG antibodies in vaccinated volunteers on day 28 from the start of vaccination with titers of antigen-specific IgG antibodies in those who recovered after COVID-19 (patients who had mild or moderate disease form one month after complete recovery) showed that with a single administration the titers are comparable, and in case of vaccination in the prime-boost mode the titers in vaccinated volunteers exceed the titers in patients one month after recovery.

The production of a vaccine against COVID-19 was discussed on March 10, 2021 at a meeting with the participation of Prime Minister of Belarus Raman Haloŭčanka.

“The vaccine will be developed – we have no doubts about that. Another question is that the creation of a domestic vaccine has a number of necessary conditions'', said Minister of Health Dzmitryj Pinievič. He explained that we are talking not only about creating a prototype of the vaccine and receiving small batches, but also about industrial production.

“The complex group has been created. The main work is concentrated on the basis of the institutions of the Ministry of Health – in particular, this Republican Scientific and Practical Center. But success is possible in case of joint work with interested colleagues, including colleagues from the Academy of Sciences and universities”, the minister said. ”Quite strict deadlines have been set. It is planned to create a prototype of the vaccine by autumn, and a pilot batch by the end of the year”.

Speaking about the prospects for the appearance of a domestic vaccine, deputy minister, head state sanitary doctor Aliaksandr Tarasienka noted that there are all opportunities for this. The RSPC has experience in creating vaccines – in particular, against rabies. The equipment available in the center makes it possible to implement the first stages of work. Moreover, a list of the necessary high-tech equipment which is planned for purchase has been formed.

As the director of the Republican Scientific and Practical Center, candidate of medical sciences, associate professor Uladzimir Harbunoŭ said, “The Republican Scientific and Practical Center for Epidemiology and Microbiology makes 300-600 studies on COVID-19 daily. The center has developed two drugs for diagnosing coronavirus infection – the PCR kit and the ELISA kit (for detecting antibodies in the blood serum of patients), which complement each other and are used at different stages. We use them successfully and implement them in practical healthcare. In addition, domestic developments are used by five laboratories, which are both engaged in scientific research and carry out research in the interests of individuals and legal entities, including travel companies and other organizations". 

Uladzimir Harbunoŭ noted: the center's specialists are studying post-vaccination and post-infectious immunity. “That is, we are looking at how effective the vaccine used in our country is, and we are also studying immunity after a disease. Our data can form the basis for the development of new vaccine preparations and the choice of the optimal vaccination for the available range of vaccines. We will soon find out how long immunity lasts after illness and after vaccination”, he said.

The Republican Scientific and Practical Center for Epidemiology and Microbiology is a leading institution in Belarus in the field of scientific developments in virology, microbiology, epidemiology, parasitology, immunology and a number of other disciplines. Here they carry out scientific research of a fundamental, but mainly applied nature. Most of the developments are completed with the production of diagnostic kits and methods that are introduced into practice and used in the country. The center has 11 laboratories, nine of which deal with virology.

In accordance with the order of the Ministry of Health of the Republic of Belarus of December 31, 2020 No. 1412 "On Vaccination Against COVID-19 Infection", medical workers are being vaccinated.

2,285 medical workers were vaccinated during the first stage of the vaccination campaign against COVID-19 infection in Minsk with the Gam-COVID-Vak vaccine (manufactured in the Russian Federation), including pharmaceutical workers and students of medical institutions involved in providing medical care to the population.

As a result of the organizational work implemented in outpatient healthcare institutions, lists of workers of education, social service institutions and persons living in institutions with a round-the-clock stay that are need to be vaccinated against COVID-19 infection were compiled.

The vaccination procedure consists of 2 injections with an interval of 3 weeks, which will form a complete protection against the disease.

The conditions for storing vaccines in healthcare institutions in Minsk have been created, additional medical freezing equipment has been purchased.

The information was prepared on the basis of electronic messages published on the websites of the Ministry of Health of the Republic of Belarus, the State Institution "Minsk City Center for Hygiene and Epidemiology", the State Institution "Republican Scientific and Practical Center for Epidemiology and Microbiology".