Rules for administering BCG vaccination to newborns. BCG vaccination: explanation, when it is given to children and why, composition of the BCG vaccine BCG vaccination in newborns how it is done

Throughout the existence of mankind, it has constantly faced a huge number of epidemics that could claim millions of lives. Of course, some diseases remain only memories, but even today there are enough things that can destroy a person. It is for this purpose that a variety of vaccines were invented, which are mandatory and are quite capable of protecting a person from a particular disease.

Tuberculosis and BCG - an excursion into history

One of the most common and oldest diseases is tuberculosis. It was because of him that a huge number of people around the world died in the 19th century. In those days, tuberculosis was called consumption and absolutely everyone suffered from it, regardless of their status in the state or age. Today, nothing has changed and many people still face this serious disease.

Tuberculosis is transmitted by airborne droplets. Initially, the development of the virus in the body remains unnoticeable, but after a short time the disease began to threaten the life and health of the sick person. First of all, the human lungs, bone tissue, joints, and so on suffered. If we talk about newborn children, tuberculosis is accompanied by anemia or dystrophy, in especially severe cases it affects the brain and tuberculous meningitis. It is in such cases that you need to act immediately, because in just a few weeks the disease can kill a weak creature.

Today, modern medicine allows many people to avoid this disease through vaccination, which is done to the child as soon as he is born. The tuberculosis vaccine, or BCG, was invented approximately 100 years ago in France. Initially, the vaccine caused a large number of complications and after many years and attempts at improvement, today we have a completely safe medicine for the prevention of tuberculosis.

BCG vaccination for a newborn baby

The vaccine is given to a newborn baby immediately after birth, while he is still in the maternity hospital - approximately 3-7 days. If for some reason this vaccination was not given in the maternity hospital, then absolutely all doctors without exception recommend having it done in the clinic. This vaccination is mandatory, but according to the legislation of our country, parents can refuse it in writing. When they do this, they must clearly understand that tuberculosis is a very dangerous disease, especially when it comes to newborns and still defenseless children. With the help of vaccination, you can reduce the risk of getting tuberculosis several times.

Of course, doctors say that the vaccine does not provide a 100% guarantee that the child will not get tuberculosis in the future. But you need to understand that the body already has antibodies to this disease, and therefore, in cases of illness, it can quickly begin to fight it. The vaccine is administered exclusively subcutaneously into the child's left shoulder. The vaccine contains weak, semi-live pathogens of tuberculosis. Of course, they are not capable of causing infection, but they help produce antibodies. If the child is completely healthy and full-term, then he is given the BCG vaccine. If he is premature, has health problems and is weakened, then doctors use a weakened BCG-M vaccine. Immunity to tuberculosis will be formed during the first year of life and persists for 5-7 years.

If the child is healthy, then he reacts normally to the vaccine and at about 2-3 months of life a small lump forms at the injection site, which looks like a mosquito bite. By six months, the seal will turn into a small, neat scar, which will be fully formed by the end of the first year of life.

Contraindications for BCG vaccination and possible complications

BCG is a mandatory vaccination that is given to a child immediately after birth and can develop immunity to such a dangerous disease as tuberculosis. Of course, you can get a BCG vaccination, like everyone else, only if the child is completely healthy and does not have certain contraindications. Otherwise, you will not only not get the result expected from the vaccine, but you will also experience serious complications. As a rule, the harm from vaccination if the rules are not followed is insignificant, but still quite often you can encounter a more complex reaction of the body to the vaccine.

Today, there are several contraindications to BCG vaccination, which doctors divide into absolute and relative. Absolute contraindications include the following:

• the child has congenital or acquired diseases of the immune system;
• there is congenital enzymopathy or severe diseases that are inherited, severe damage to the central nervous system;
• You cannot get vaccinated when relatives have had complications after it;
• if the child has been diagnosed with tuberculosis.

Doctors consider these points to be relative contraindications:

• infectious diseases of varying degrees of complexity;
• skin diseases;
• a newborn is diagnosed with hemolytic disease;
• the child has a high degree of prematurity and a very weak body, low weight.

Complications that may occur after BCG vaccination

The most severe complication after this vaccination is the direct infection of the child. Of course, such cases can be found quite rarely, but still they should not be excluded. They can arise due to incorrect diagnosis of contraindications and selection of children for vaccination. Also, the result of improper selection of newborns can be serious problems with the immune system. In some cases, one can observe a very rapid development of the inflammatory process in the child’s bone tissue (osteitis). Of course, such cases can also be considered rare. As a rule, if a newborn develops complications after BCG vaccination, they are minor and disappear fairly quickly without medical intervention. These include:

1. The infiltrate (vaccine injection site) increases significantly in size and may even ulcerate.
2. The infiltrate forms under the skin - if the infiltrate has formed under the skin, then it will feel like a small ball. This occurs when the vaccine is injected too deeply. If you notice the formation of a subcutaneous infiltrate in a child, you should immediately consult a doctor, because it may break through and then the infection will very quickly enter the child’s blood.
3. The infection may spread to the lymph nodes. Then they can increase significantly in size and become very painful. In some cases, the infection breaks out, forming a fistula - a channel through which pus comes out.
4. Very rarely in a newborn, but more often in an older child, a keloid can form: a growth of scar.

Therefore, after your child has been vaccinated with BCG, you need to very carefully monitor his behavior and health. If you notice any changes in your child’s behavior or well-being, you should immediately consult a doctor to clarify the circumstances. As a rule, if complications are detected quite early, then you can get rid of them quickly and this will not affect your child’s health in any way.

Also, if you are thinking about refusing vaccination, then remember how dangerous tuberculosis is, and the BCG vaccination is quite capable of protecting your baby from this disease.

Tuberculosis is a common dangerous infectious disease that can affect any organ of the human body. However, more often the infection develops in the lungs; in this case, infection occurs through airborne droplets. According to statistics, each patient with an open form of tuberculosis is capable of infecting about 15 people annually. And in the absence of timely treatment, the pathology can lead to the death of the patient. Therefore, BCG vaccination is widely used in Russia, which helps protect the child’s body from a fatal disease.

What is BCG?

The BCG vaccination is a vaccination against tuberculosis. Immunization is carried out using a special vaccine, which is created based on strains of live tuberculosis bacillus. The microorganism does not pose a danger to humans because it is previously inactivated. The main purpose of vaccination is to prevent tuberculosis.

Important! After receiving the vaccine, a person can become infected with tuberculosis. However, immunization prevents latent infection from developing into an open disease.

Vaccination helps protect a child from severe forms of the disease: tuberculous meningitis, bone damage, and fatal forms of lung infection. Given the importance of vaccination, BCG vaccination is given to newborn children in the maternity hospital in the absence of contraindications. This helps reduce the incidence of infectious diseases among children.

Description and composition of the vaccine

The abbreviation BCG is a direct reading of the Latin characters BCG, which stands for bacillus Calmette–Guerin. The BCG vaccine was created in 1921 by scientists Kaotmett and Guerin. Doctors were able to isolate an isolate of various subtypes of the causative agent of the disease - Mycobacterium Bovis.

The composition of the drug remains unchanged to this day. The BCG vaccine includes various subtypes of the tuberculosis pathogen. The World Health Organization stores all series of mycobacterial strains that are used to create the drug. The culture of microorganisms for vaccination is obtained by inoculating bacilli on a nutrient medium. Within a week, the bacilli grow and develop, after which the pathogen is isolated, filtered, and concentrated. The result is a BCG vaccine, which contains dead and live weakened mycobacterial cells.

Important! The number of microorganisms in a single dose of the drug is not the same. This parameter depends on the subtype of bacillus used and the characteristics of vaccine production.

Most modern vaccine preparations are based on one of these strains of mycobacteria:

• French subtype “Pasteur” 1173 P2;
• Tokyo strain 172;
• Strain "Glaxo" 1077;
• Danish subtype 1331.

The listed strains are characterized by the same effectiveness.

Types of vaccines

The following types of BCG vaccinations are widely used in Russia:

• BCG directly. Designed for vaccination of full-term newborns in the maternity hospital;
• BCG-m. The drug is administered to children born prematurely and to newborns during vaccination in a district clinic after the child is discharged from the maternity hospital. The vaccine has a reduced content of mycobacteria.

When is immunization carried out?

BCG vaccination is carried out for infants in maternity hospitals in countries with an unfavorable epidemiological situation for tuberculosis. This minimizes the risk of developing an infection. In Russia, universal vaccination of newborns has been carried out since 1962.

According to numerous studies, more than 66% of the world's inhabitants are carriers of the causative agent of tuberculosis - Mycobacterium Bovis. However, doctors were unable to establish the reasons for the transition of pathology from carriage to a pronounced infectious process. It is believed that unsanitary conditions and poor nutrition may be provoking factors.

Vaccination schedule

The first BCG vaccination for children is carried out in the maternity hospital 3-5 days after the child is born. The exception is premature babies. This allows the child to develop reliable immunity within a year.

However, to maintain antibodies to Mycobacterium Bovis at the proper level, children need revaccination throughout their lives. Therefore, the next vaccination is given to children at 7 years old, and the last one at 14 years old. Carrying out more frequent revaccination does not make sense. The introduction of other vaccines is possible only after several months.

Between vaccinations against tuberculosis, a Mantoux test should be performed annually, which allows you to determine the body's response to a set of mycobacteria. If the reaction is negative, then the child needs revaccination. If the reaction is positive, the development of tuberculosis must be excluded. In such cases, children are referred to a TB specialist.

Main contraindications

• The weight of the newborn baby is below 2.5 kg;
• The child was born to a woman infected with HIV;
• Development of intrauterine infections;
• The infant was born to a woman who has a history of immunodeficiency of primary or secondary origin;
• The presence of severe hemolytic disease in the newborn;
• If during childbirth the child received an injury that caused brain damage;
• If there are people infected with tuberculosis in the child’s environment;
• In the presence of widespread pustular lesions of the skin;
• When genetic pathologies are detected: Down syndrome, enzymopathies;
• If close relatives of children have a history of various complications after BCG vaccination;
• Acute infectious diseases;
• In the presence of malignant neoplasms.

Revaccination should be abandoned in the following cases:

• Acute course of infectious diseases;
• Allergic reactions;
• Signs of exacerbation of chronic pathologies;
• Immunodeficiency conditions;
• The Mantoux test performed has a questionable or positive reaction;
• Various oncopathologies in the anamnesis;
• While taking immunosuppressants and radiation therapy;
• Presence of tuberculosis;
• Complicated reaction to previous BCG vaccination;
• Contact with people infected with tuberculosis.

Before vaccination with BCG, the doctor is obliged to ask the parents and examine the child to make sure there are no contraindications. After all, complications after administration of the drug arise only when contraindications are not observed.

Features of vaccination of a child in the maternity hospital

In Russia, BCG in newborns is carried out after vaccination against hepatitis. This is due to the characteristics of the vaccine preparation - the body develops immunity against tuberculosis over the course of 2-4 months. Therefore, it is not recommended to load the child with other vaccines during this period.

Typically, BCG vaccination is carried out before newborns are discharged from the hospital (3-6 days). The injection is made into the outer part of the left shoulder. The BCG vaccine should be administered intradermally through one or more punctures. During vaccination, you should use a disposable syringe with a short corner.

Important! If the BCG vaccine is mistakenly administered under the skin or inside a muscle, complications inevitably develop.

Existing insertion techniques must be followed accurately to prevent complications in newborns. The area of ​​skin should be slightly stretched before inserting the needle. Next, a small amount of BLC vaccine is injected. This helps assess whether the needle has been inserted correctly. If the drug is placed intradermally, continue injection of the drug. After BCG vaccination, the appearance of a flat papule (whitish lump), the size of which does not exceed 10 mm, is considered normal. This formation lasts no more than 2 hours, after which it disappears on its own.

Normal reaction to BCG

After vaccination in the maternity hospital, a slight increase in body temperature to low-grade fever is possible. This reaction is associated with imperfections in the child’s thermoregulation mechanisms and develops quite rarely. At the injection site for several days after vaccination, there is slight redness and possibly suppuration, which disappears on days 6-8.

Normally, the reaction to the BCG vaccine develops on days 28-32. At the injection site in newborns, a small abscess, swelling, thickening and scabs appear. There may also be a change in skin color. Such manifestations are the norm, so they should not frighten parents. This is how the child’s body reacts to the arrival of pathogenic microorganisms by developing immunity.

Important! Some people have an innate immunity to mycobacteria. In such cases, there is no local reaction at the injection site.

The scab may periodically fall off and appear again, for example, during water procedures. Within 2-3 months, the wound heals, leaving a small scar on the skin (no more than 1 cm). A child's final immunity against tuberculosis is formed by the age of 1 year. If medical documentation is lost, the doctor will be able to assess whether the child is vaccinated against tuberculosis by the presence of a scar.

Features of normal reaction

And also normally, newborn children develop such a reaction to BCG within 1-1.5 months:

• The child's BCG turned red. Redness and slight suppuration are normal. Hyperemia at the injection site may persist even after a scar has formed. However, the redness should not spread to surrounding tissues;
• Suppuration after BCG vaccination. The area where the vaccine was injected should be a small pustule that has a crust in the middle. In this case, the surrounding tissues should not undergo changes. If your child develops redness and swelling around the BCG, you should consult your doctor. This may indicate the addition of a secondary infection;
• Itching at the vaccination site in newborns. This symptom is a normal post-vaccination reaction after BCG. Usually develops against the background of swelling at the injection site. Older children note the sensation that something is moving inside the abscess. Such a reaction is the norm, the degree of its severity is determined by the individual characteristics of the child;
• The BCG vaccine may cause fever in newborns. However, normally hyperthermia does not exceed subfebrile values. If an increase in temperature after the administration of the BCG vaccine is observed in a patient aged 7 or 14 years, then you should consult a phthisiatrician.

Complications after BCG

A normal vaccination reaction at the vaccination site is an abscess and a scar at the injection site. However, if the BCG vaccine was administered incorrectly, the doctor did not take into account the existing contraindications, then complications may develop after vaccination.

Important! Complications are serious conditions that lead to disruption of the child’s health and require medical intervention.

In rare cases, the following complications develop after administration of the vaccine:

• The development of lymphadenitis is a disease that leads to inflammation of the lymph nodes. After vaccination, such a reaction occurs in only 1 child out of 1 thousand vaccinated newborns. In 90% of cases, complications occur in children with severe immunodeficiency. If the size of the lymph node exceeds 1 cm in diameter, then surgical treatment is performed in such cases;
• Osteomyelitis. The reason for the development of complications is the use of a low-quality vaccine;
• The appearance of a cold abscess. The reaction appears after vaccination, which was carried out intradermally. The pathological formation forms up to 1.5 months after the vaccine is administered. Treatment of an abscess involves surgical removal;
• The development of an extensive ulcer at the injection site, the diameter of which can reach 1 cm. This reaction develops in children who are hypersensitive to the ingredients of the vaccine. In such cases, the child needs local treatment. The medical documentation should include information about the development of complications;
• Keloid scar. The lesion is a red and swollen area of ​​skin at the injection site. In such cases, revaccination should be avoided throughout life;
• Development of generalized BCG infection. This reaction is a severe pathology and develops against the background of severe immunodeficiency in a child. The incidence of complications is 1 child per 1 million vaccinated children;
• The occurrence of bone tuberculosis. The first signs of the disease develop 2 years after vaccination. The development of this complication indicates serious disorders in the child’s immunity.

How to prevent the development of complications?

BCG vaccination is usually well tolerated and leads to the formation of stable immunity against tuberculosis. However, if contraindications are not taken into account, the technique of administering the drug is violated, and the conditions for storing and transporting the vaccine are not met, then complications develop. To avoid the development of dangerous reactions, you should adhere to the following recommendations:

• Before vaccination, conduct an allergy test to determine the compatibility of the vaccine with the body. This will prevent complications such as an allergic reaction;
• After vaccination, you should not use antiseptic solutions to treat the skin at the injection site, because they can disrupt the normal post-vaccination process;
• There is no need to squeeze out the pus or apply an iodine mesh to the abscess. If discharge appears at the site of vaccine administration, it is enough to blot it with a sterile napkin;
• Parents should be careful to ensure that the child does not scratch the vaccine injection site. This will help prevent the addition of a secondary infection;
• A few days before vaccination or revaccination at 7 and 14 years old, new foods should not be introduced into the child’s diet. New foods can provoke an allergic reaction, which can be mistaken for a complication after BCG.

Should I do BCG: pros and cons

Many people are wondering whether it is worth getting the BCG vaccine. What is more in vaccination against tuberculosis: benefit or harm to the child’s health? BCG vaccination has the following advantages:

• In rare cases, it causes severe consequences and complications;
• No special care is required for the area where the vaccine was administered;
• After vaccination, immunity against tuberculosis occurs, which helps reduce the risk of infection with Mycobacterium Bovis;
• When infected with tuberculosis, the disease is mild;
• Helps reduce the risk of death.

However, the BCG vaccine also has a number of disadvantages:

• If the conditions of storage and administration of the vaccine are violated, or existing contraindications are not observed, dangerous complications develop;
• Slow scar formation, which is observed in rare cases.

Important! Rumors about the presence of dangerous substances in the vaccine (mercury, formaldehyde, phenol, polysorbate) have no scientific basis.

Parents should decide whether to vaccinate with BCG or not, after weighing the available advantages and disadvantages of the vaccine. Before revaccination, the child needs a comprehensive examination to determine the presence of contraindications to the administration of the vaccine drug. And you also need a Mantoux test, which allows you to exclude infection with tuberculosis. These actions will help reduce the risk of developing severe post-vaccination reactions.

Thank you

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!

Graft BCG is one of the very first that a newborn baby receives in the maternity hospital. Vaccine BCG intended for the prevention and prevention of severe, deadly type of tuberculosis. In Russia, a decision has been made on universal vaccinations all newborns, since the prevalence of tuberculosis is very high, the epidemiological situation is unfavorable, and measures taken for treatment and early detection of cases of infection have not been able to reduce the incidence.

Tuberculosis is considered a social disease, since people are constantly in contact with its causative agent, mycobacterium. Moreover, at least a third of the population of the entire planet are carriers of mycobacteria, but tuberculosis, as a clinical disease, develops only in 5–10% of all infected people. The transition from asymptomatic carriage to the active form - tuberculosis - occurs when exposed to unfavorable factors, such as poor nutrition, bad habits, poor living conditions, unsatisfactory sanitary conditions, etc. The number of Mycobacterium tuberculosis carriers also has a huge impact, since these people are sources of infection.

It is important to understand that the BCG vaccine does not protect a person from infection with Mycobacterium tuberculosis, since under existing conditions this is simply impossible. However, it has proven to be effective in significantly reducing the severity of tuberculosis in children under 2 years of age. In this category of children, BCG vaccination eliminates the possibility of developing meningitis and disseminated forms of tuberculosis, which are almost always fatal.

Explanation of BCG vaccination

The abbreviation BCG, written in Russian letters, is a tracing paper of the Latin letters BCG as read according to the rules of the Romance languages ​​(Latin, Italian, Romanian, French, Spanish, Portuguese). The letters of the Latin alphabet BCG stand for bacillus Calmette–Guerin, that is, “Bacillus Calmette-Guérin.” In Russian, it is not the translation abbreviation BCG (bacillus Calmette-Guerin) that is used, but the direct reading of the Latin abbreviation BCG, written in Russian letters - BCG.

Vaccine composition

The BCG vaccine consists of different subtypes Mycobacteria bovis. Today, the composition of the vaccine has remained unchanged since 1921. Over the course of 13 years, Calmette and Guerin isolated and repeatedly subcultured a cell culture consisting of various subtypes of Mycobacterium Bovis, ultimately isolating an isolate. The World Health Organization maintains all series of mycobacterial subtypes used to produce BCG.

To obtain a culture of mycobacteria intended for the production of vaccine preparations, a technique is used to inoculate bacilli on a nutrient medium. The cell culture grows on the medium for a week, after which it is isolated, filtered, concentrated, then turned into a homogeneous mass, which is diluted with clean water. As a result, the finished vaccine contains both dead and live bacteria. But the number of bacterial cells in one single dose is not the same; it is determined by the subtype of mycobacteria and the peculiarities of the production method of the vaccine preparation.

Today, a huge number of different types of BCG vaccine are produced in the world, but 90% of all drugs contain one of the following three strains of mycobacteria:

• French "Pasteur" 1173 P2;
• Danish 1331;
• Strain "Glaxo" 1077;
• Tokyo 172.

The effectiveness of all strains used in the BCG vaccine is the same.

Should I get the BCG vaccine?

Today in the world, tuberculosis takes the lives of a huge number of people under the age of 50. Moreover, mortality from tuberculosis is in first place, ahead of both cardiovascular diseases and oncological processes. In countries where tuberculosis is widespread, more women die from this severe infection than from complications of pregnancy and childbirth. Thus, tuberculosis is a very serious problem causing high mortality in the population. In Russia, the problem of tuberculosis is also very acute, the prevalence of the disease is incredibly high, and the mortality rate from the infection is almost equal to that in the countries of Asia and Africa.

For children, the danger of tuberculosis lies in the rapid development of extremely severe forms, such as meningitis and the disseminated form. In the absence of intensive therapy for tuberculous meningitis and the disseminated form of infection, absolutely all patients die. The BCG vaccine makes it possible to create protection against tuberculous meningitis and the disseminated form for 85% of vaccinated children, who, even if infected, have a good chance of recovery without negative consequences and complications.

The World Health Organization recommends that children in countries with a high prevalence of tuberculosis be given the BCG vaccine as early as possible. That is why in Russia the BCG vaccination is the first one on the national calendar; it is given to all babies in the maternity hospital. Unfortunately, the BCG vaccination provides protection against tuberculosis and its severe forms (meningitis and disseminated) only for 15 to 20 years, after which the effect of the vaccine ceases. Repeated administration of the vaccine does not lead to increased protection against the disease, so revaccination is considered inappropriate.

Unfortunately, the BCG vaccine does not in any way reduce the spread of tuberculosis, but it effectively protects against the development of severe forms that are highly lethal. The development of severe forms of tuberculosis is especially dangerous in children, who, as a rule, do not survive. Due to these circumstances, the epidemiological situation in Russia and the mechanism of action of the vaccine, it seems that vaccination is still necessary to protect the newborn from the high risk of developing severe and almost always fatal forms of tuberculosis.

According to the findings and recommendations of the World Health Organization, the BCG vaccine is recommended for the following categories of people:
1. Children of the first year of life who are constantly in regions with an extremely high prevalence of tuberculosis.
2. Children of the first year of life and school-age children who have a high risk of infection with tuberculosis, provided they live in regions with a low prevalence of the disease.
3. People in contact with patients who have been diagnosed with a form of tuberculosis that is resistant to many drugs.

Vaccination of newborns in the maternity hospital

The BCG vaccine has existed and been used since 1921. To date, vaccination of all newborns is used only in countries where the tuberculosis situation is unfavorable. In developed countries, cases of tuberculosis are relatively rare and are detected mainly among risk groups - the poorest segments of the population, consisting mainly of migrants. Due to this state of affairs, developed countries use BCG only in infants at risk, and not in all newborns.

Since the situation with tuberculosis in Russia is unfavorable, BCG vaccination is given to all newborns on the 3rd - 4th day in the maternity hospital. This vaccine has been used for almost 100 years, so its effect has been studied very well. It is well tolerated by all newborns, so it is not only possible, but also should be given as early as possible after the birth of the child. Remember that BCG is given to protect the child from severe forms of tuberculosis, which almost always inevitably lead to death. Vaccination also helps prevent the transition of asymptomatic carriage to acute disease.

The opinion that a newborn has no place to “meet” Mycobacterium tuberculosis in order to get sick is wrong. In Russia, approximately 2/3 of the adult population of the country are carriers of this mycobacterium, but do not get sick. Why many people never get sick with tuberculosis, although they are carriers, is currently unknown, although the interaction of the microbe with the human body has been studied for many years.

Mycobacterium carriers are sources of microorganisms that enter the environment when coughing and sneezing. Since even with a small child it is necessary to walk on the street, where there are always a lot of people, the likelihood of the baby becoming infected with mycobacteria is very high. In Russia, 2/3 of children are already infected with Mycobacterium tuberculosis by the age of 7 years. If the child is not vaccinated with the BCG vaccine, then there is a high risk of developing tuberculous meningitis, a disseminated form of the disease, extrapulmonary tuberculosis and other very dangerous conditions, the mortality rate of children is very high.

Newborns in the maternity hospital are vaccinated with the BCG or BCG-m vaccine, which is a gentle option because it contains exactly half the concentration of microorganisms. BCG-m is used for weakened children, for example, low birth weight or premature babies, who cannot be given a dose intended for ordinary babies.

BCG vaccinations for children

Usually, children are vaccinated with BCG in the maternity hospital on the 3rd to 7th day after birth, if the child has no contraindications. Otherwise, the BCG vaccine is administered as soon as the child’s condition allows it. The drug is injected into the shoulder intradermally, at the border between its upper and middle third. The reaction to the vaccine is delayed and occurs 4 to 6 weeks after the injection. An abscess develops at the injection site, which becomes covered with a scab and heals. After the scab has healed and fallen off, a spot remains at the injection site, indicating that this vaccination has been given.

If the child does not have a medical card and vaccination certificate, and there is also no way to obtain objective data on the presence of vaccinations, then the issue of BCG placement is decided based on the presence or absence of a scar on the shoulder. If there is no scar, then the graft must be administered.

In our country, it is customary to carry out another BCG revaccination, in addition to the vaccination the child receives in the maternity hospital, at the age of 7 years. Revaccination at 7 years of age is carried out only if the tuberculin test (Mantoux test) is negative. This strategy was adopted due to the extremely widespread prevalence of the disease and the high risk of infection. Vaccination is also carried out by injecting the drug intradermally into the shoulder.

Usually the entire dose is administered in one place, but some medical institutions have adopted the technique of multiple injections, when the drug is administered at several points located in close proximity to each other. Both methods are good, and the advantages of one over the other have not been proven - in other words, their effectiveness is the same.

Children are administered only certified and proven BCG vaccines, which are the same throughout the world. Therefore, there is no difference between domestic and imported drugs in relation to this vaccine.

Vaccination after BCG vaccination

No more vaccinations should be administered at the same time as BCG! Those. on the day of BCG placement, only this drug is administered, and no others are added. Since reactions to BCG develop only 4 to 6 weeks after the injection, no other vaccinations should be given during this entire period of time. After vaccination, at least 30–45 days must pass before any other vaccination.

In the maternity hospital, it is precisely because of these features that BCG is given after vaccination against hepatitis B. Since the hepatitis B vaccine gives reactions immediately, lasting within 3 to 5 days, it can be administered before BCG. That is why, on the first day after birth, the child is given the hepatitis B vaccine, and 3–4 days later, before discharge, they are given BCG. Then the child enters a period of immunological rest - that is, no vaccines are administered until the age of 3 months. At this point, immunity to tuberculosis has already been formed, and all vaccination reactions have passed.

BCG vaccination calendar

In Russia, it is customary to administer the BCG vaccine twice during life:
1. 3 – 7 days after birth.
2. 7 years.

For children aged 7 years, revaccination with BCG is carried out only with a negative Mantoux test. This strategy allows you to increase immunity to tuberculosis and increase the percentage of the body’s resistance to the effects of mycobacteria. In those regions of the country where the prevalence of the disease is relatively low, revaccination at 7 years of age may not be necessary. And where the epidemiological situation is unfavorable, repeated administration of BCG is mandatory. The epidemiological situation is considered unfavorable if more than 80 cases per 100,000 people are detected in a region. This data can be obtained from the tuberculosis clinic or from epidemiologists in the region. Also, revaccination of children at 7 years of age is mandatory if among relatives there are patients with tuberculosis who are in contact with the child.

When is the BCG vaccination given?

If there are no contraindications, then the BCG vaccination is given according to the national calendar - that is, on the 3rd - 7th day after birth, then at 7 years. If there were contraindications and a medical exemption from BCG vaccination for a certain period, then the vaccine is given after the child’s condition has normalized. In this case, before immunization, you must first perform a Mantoux test. If the Mantoux test is negative, then BCG vaccination should be completed as soon as possible. In this case, the vaccine after a negative Mantoux test is given no earlier than three days later, but no later than two weeks. If the Mantoux test is positive (that is, the child has already had contact with mycobacteria), then the vaccination is useless - in this situation, immunization is not carried out.

Vaccine injection site

The World Health Organization recommends placing the BCG vaccine on the outer side of the left shoulder, on the border between its upper and middle third. In Russia, BCG is administered in exactly this way - into the shoulder. The vaccine preparation is administered strictly intradermally; subcutaneous or intramuscular injection is not allowed.

If there are any reasons why the vaccine cannot be injected into the shoulder, then another place with sufficiently thick skin is selected where the injection is placed. As a rule, if it is impossible to place BCG in the shoulder, it is injected into the thigh.

Where can I get the BCG vaccination?

Newborns are vaccinated with BCG in the maternity hospital. If the child did not receive the vaccine in the maternity hospital, then immunization is carried out in the clinic where the baby is being observed. The clinic has a special vaccination room, and sometimes two, where vaccinations are given. If there are two vaccination rooms, then in one of them they carry out BCG vaccination exclusively, and in the second they give all other vaccines. When there is only one vaccination room in the clinic, then, according to sanitary rules, a special day of the week is allocated for vaccinating children with BCG, on which only this manipulation is carried out. It is strictly forbidden to administer this vaccine in a treatment room where a nurse draws blood, performs intramuscular and intravenous injections, etc.

In addition to the local clinic, the BCG vaccine can be delivered at the tuberculosis dispensary. Children who are at high risk of developing a severe reaction to vaccination are vaccinated exclusively in a hospital setting. Russian legislation allows immunization to be carried out at home, when a specialized team arrives with all the necessary equipment and materials. The visit of a vaccination team to your home is paid separately, since this service is not included in the list of mandatory services provided under the compulsory health insurance policy.

In addition to the above options, BCG can be delivered in specialized vaccination centers that are certified to carry out this type of medical procedure.

What does the BCG vaccine look like?

Firstly, the BCG vaccine must be administered strictly with a disposable syringe, with a short-cut needle. It is very important to adhere to the correct injection technique to avoid possible complications. The correctness of the injection can be assessed by the appearance of the BCG vaccination.

So, before the needle is inserted, the skin area is stretched. A small amount of the drug is then injected to see if the needle goes in correctly. If the needle is intradermal, then the entire BCG vaccine is injected. After such correct administration of the vaccine, a flat papule measuring 5–10 mm in diameter, painted white, should form at the injection site. The papule lasts for 15 - 20 minutes, after which it disappears. Such a papule is called a specific reaction to the administration of the BCG vaccine, which is absolutely normal.

In newborn children, 1 - 1.5 months after BCG vaccination, a normal vaccination reaction develops, which lasts for 2 - 3 months. In children who are repeatedly injected with BCG (at 7 years of age), the vaccine reaction develops 1 to 2 weeks after the injection. The injection site with a vaccination reaction should be protected, and strong mechanical effects such as friction, scratching, etc. should be avoided. You should be especially careful when bathing your child; under no circumstances rub the site of the vaccination reaction with a washcloth.

The vaccination reaction is characterized by the formation of a papule, pustule or slight suppuration at the site of BCG injection. Then this formation undergoes reverse involution for 2 - 3 months, during which the wound becomes covered with scabs and gradually heals. After complete healing of the wound, the scab disappears, and in its place remains a small scar, up to 10 mm in diameter. The absence of a scar is evidence of improper administration of the vaccine, which means the complete ineffectiveness of the BCG vaccination.

Many parents are very scared when a child at 1 - 1.5 months develops an abscess at the injection site, which they mistake for a complication. However, this is a completely normal course of the vaccination reaction; you should not be afraid of a local abscess. Remember that the duration of its complete healing can reach up to 3 – 4 months. During this period, the child must maintain a normal routine of life. But you should not smear the abscess or scab with iodine or treat it with antiseptic solutions - the wound should heal on its own. Also, you should not tear off the scab until it falls off on its own.

How does the BCG vaccine heal?

The vaccination reaction to the BCG vaccine begins to develop 1 - 1.5 months after the injection, and can last up to 4.5 months. At the very beginning of the reaction, the vaccination site may turn red or dark (blue, purple, black, etc.), which is normal. Do not be afraid of this type of vaccination. Then, instead of redness, an abscess forms in this place, which protrudes above the surface of the skin. A scab forms in the center of the abscess. In other children, BCG heals without suppuration; only a red blister with liquid contents forms at the injection site, which becomes covered with a scab and tightens, forming a scar.

The abscess can burst with the flow of inflammatory contents - pus. However, after this, pus can still form for some time, flow freely from the wound, or form a new abscess. Both options represent a normal process of the vaccination reaction to the BCG vaccine, which does not need to be feared.

Remember that the healing process of this abscess can take up to 4.5 months. During this period, you should not lubricate the wound with any antiseptic solutions, apply an iodine net, or sprinkle it with antibiotic powders. If pus flows freely from the wound, then it should simply be covered with clean gauze, periodically changing the contaminated napkin. Pus should not be squeezed out of the wound.

After local suppuration ends, a small red pimple will form at the injection site, which after some time will take on the appearance of a characteristic scar on the shoulder. The diameter of the scar can vary, and normally ranges from 2 to 10 mm.

No trace of BCG injection

The absence of a vaccination reaction and a trace (scar) from the BCG vaccination is evidence that immunity to tuberculosis has not been formed and the vaccine turned out to be ineffective. However, there is no need to panic or take any immediate action. In this case, it is necessary to give BCG again if the Mantoux test is negative, or wait for revaccination at 7 years. In this case, in a child under 7 years of age, the Mantoux test should only represent an injection mark.

Lack of body response to the first BCG vaccination occurs in 5–10% of children. In addition, about 2% of people have congenital genetically determined resistance to mycobacteria, that is, in principle, they are not at risk of developing tuberculosis. In such people there will also be no trace of the BCG vaccination.

Reaction to the vaccine

The BCG vaccination is well tolerated by the child, and reactions to the vaccine are of the delayed type, that is, they develop some time after administration. Many adults consider these reactions to be negative consequences of BCG, which is incorrect, since these changes are normal. Let's look at the most common consequences of BCG vaccination.

BCG blushed. Redness and slight suppuration of the injection site is a normal vaccination reaction. Redness can persist even after suppuration; during this period, a scar forms on the skin. Redness of the injection site is normally observed only during the period of vaccination reactions. Redness should not spread to surrounding tissues.

Sometimes a keloid scar forms at the site of injection of the drug - then the skin becomes red and swells slightly. This is not a pathology - the skin reacted to BCG in this way.
BCG festers or breaks out. BCG suppuration during the development of the reaction is normal. The graft should look like a small pustule with a crust in the middle. Moreover, the surrounding tissue (skin around the abscess) should be absolutely normal, that is, there should be no redness or swelling around the festering BCG. If there is redness and swelling around the festering BCG, then you should consult a doctor, since the wound may become infected, which should be treated. In severe cases, when the graft wound suppurates several times, a diagnosis is made BCJit, and the treatment tactics are determined by the doctor. In such a situation, the child should be carefully examined, since other routine vaccinations may be contraindicated, until the baby’s condition normalizes.

BCG is swollen. Immediately after the vaccine is administered, the injection site may swell slightly. This swelling does not last long - a maximum of two to three days, after which it goes away on its own. After such an initial reaction, the site of BCG injection should be absolutely normal, indistinguishable from neighboring areas of the skin. Only after an average of 1.5 months does the development of a vaccination reaction begin, which is characterized by a pimple and suppuration with a crust, ending with the formation of a scar. During the period of the vaccination reaction, BCG should not normally swell or rise. The abscess and subsequent red pimple with a scab in its place should not be swollen. If there is swelling around the vaccination, you should consult a phthisiatrician who will determine further tactics.

BCG is inflamed. Normally, the site of BCG vaccination is characterized by a vaccine reaction, which appears after some time and looks like inflammation. If BCG looks like an abscess or a red pimple, or a vesicle with liquid, and the tissue around this place is normal, then there is no need to worry, there are simply different options for the course of the vaccine reaction. A cause for concern is the spread of swelling or inflammation beyond the BCG to the skin of the shoulder. In this case, you need to consult a doctor.

BCG itches. The site of BCG vaccination may itch, since the active process of healing and regeneration of skin structures is often accompanied by various similar sensations. In addition to scratching, it may seem that something is moving or tickling inside the abscess or under the scab, etc. Such sensations are normal; their development, as well as the degree of severity, depend on the individual properties and reactions of the human body. However, you should not scratch or rub the injection site - it is best to restrain the child by placing a gauze pad over the injection site or putting on gloves.

Temperature after BCG. After BCG vaccination, a slight fever may occur, but this is a rare occurrence. During the period of development of the vaccination reaction, when an abscess forms, temperature may well accompany this process. Usually in children in this case the temperature does not rise above 37.5 o C. In general, some jumps in the temperature curve are characteristic - from 36.4 to 38.0 o C, over a short period of time. If, after a BCG vaccination, a child’s temperature rises at 7 years old, then you should consult a doctor.

Complications of BCG vaccination

Complications of BCG include conditions in which a serious disorder of the child’s health develops, requiring serious treatment. A vaccination reaction to BCG in the form of an abscess followed by the formation of a scar on the skin is not a complication, but is the norm. Complications of the BCG vaccine are extremely rare, and the majority of such cases occur in children who have a persistent congenital decrease in immunity (for example, at birth from an HIV-infected mother). Complications in the form of local reactions, such as inflammation of the lymph nodes (lymphadenitis) or a large area of ​​suppuration, occur in less than 1 child per 1000 vaccinated people. Moreover, 90% of these complications occur in children with immunodeficiency. A complication such as osteomyelitis is associated exclusively with a low-quality vaccine. In principle, almost all complications of BCG are associated with failure to comply with the technique of administering the drug.

Today, BCG vaccination can lead to the following complications:

• Cold abscess – develops when the drug is administered subcutaneously rather than intradermally. Such an abscess forms 1 - 1.5 months after immunization and requires surgical intervention.
• Extensive ulcer at the injection site more than 10 mm in diameter - in this case the child is highly sensitive to the components of the drug. For such ulcers, local treatment is carried out, and information about sensitivity is recorded in the medical record.
• Inflammation of the lymph node – develops when mycobacteria spread from the skin to the lymph nodes. Inflammation requires surgical treatment if the lymph node increases in size more than 1 cm in diameter.
• Keloid scar– skin reaction to the BCG vaccine. The scar appears as red and bulging skin around the injection site. In this case, BCG cannot be reintroduced at 7 years of age.
• Generalized BCG infection – is a serious complication that develops in the presence of severe immune disorders in a child. This complication occurs in 1 child per 1,000,000 vaccinated people.
• Osteitis– bone tuberculosis, which develops 0.5 – 2 years after immunization, and reflects serious disorders in the child’s immune system. The complication occurs in 1 child per 200,000 vaccinated people.

BCG vaccination: reactions and complications - video

Contraindications to BCG vaccination

Today, the list of contraindications to BCG vaccination in Russia is much wider than that recommended by the World Health Organization, and includes the following conditions:
1. The weight of the newborn is less than 2500 g.
2. Acute pathology or exacerbation of chronic diseases (for example, in the presence of intrauterine infection, hemolytic disease of the newborn, neurological disorders, systemic skin pathologies). If these conditions are present, BCG vaccination is postponed until the child’s condition normalizes.
3. Immunodeficiency.
4. Generalized BCG infection, which was present in other close relatives.
5. Presence of HIV in the mother.
6. The presence of neoplasms of any localization.
7. Positive or questionable Mantoux test.
8. The presence of a keloid scar or lymphadenitis in response to previous administration of the BCG vaccine.

BCG-m vaccine

This vaccine differs from regular BCG only in that it contains a half dose of mycobacteria. BCG-m is used to vaccinate premature babies or those who are vaccinated not in the maternity hospital, but a little later. There are contraindications. Before use, you should consult a specialist.

Instructions for vaccination and revaccination against tuberculosis with BCG and BCG-M vaccines

II. Use of dry tuberculosis vaccine (BCG) for intradermal administration

The drug is a live mycobacteria of the BCG-1 vaccine strain, lyophilized in 1.5%. monosodium glutamate solution. The porous mass, powdery or in the form of a white or cream-colored tablet, is hygroscopic.

The vaccination dose contains 0.05 mg in 0.1 ml of solvent.

Biological and immunological properties.

Purpose.

The drug is intended for specific prevention of tuberculosis.

Methods of application and dosage.

The BCG vaccine is used intradermally at a dose of 0.05 mg in a volume of 0.1 ml. Primary vaccination is carried out on healthy newborn children on days 3-7 of life.

Children aged 7 and 14 years who have a negative reaction to the Mantoux test with 2 TE PPD-L are subject to revaccination. The reaction is considered negative in the complete absence of infiltration, hyperemia, or in the presence of a prick reaction (1 mm). Children infected with tuberculous mycobacteria who have a negative reaction to the Mantoux test are not subject to revaccination. The interval between the Mantoux test and revaccination should be at least 3 days and no more than 2 weeks.

Vaccinations should be carried out by specially trained medical personnel of the maternity hospital (ward), department for nursing premature babies, children's clinics or feldsher-obstetric stations. Vaccination of newborns is carried out in the morning in a specially designated room after the children have been examined by a pediatrician. In clinics, the selection of children to be vaccinated is preliminarily carried out by a doctor (paramedic) with mandatory thermometry on the day of the check, taking into account medical contraindications and medical history. If necessary, consultations with medical specialists and blood and urine tests are carried out. The history of the newborn (medical record) indicates the date of vaccination, series and control number of the vaccine, manufacturer, and expiration date of the drug.

For vaccination (re-vaccination), disposable tuberculin syringes with a capacity of 1.0 ml with tightly fitting pistons and thin needles with a short bevel are used. It is prohibited to use syringes and needles that have expired and needleless injectors. After each injection, a syringe with a needle and cotton swabs are soaked in a disinfectant solution (5% chloramine), then centrally destroyed. It is prohibited to use instruments intended for vaccination against tuberculosis for other purposes. The vaccine is stored in the vaccination room (in the refrigerator, under lock and key) and diluted. Persons unrelated to BCG vaccination are not allowed into the vaccination room. To avoid contamination, it is unacceptable to combine tuberculosis vaccination with other parenteral procedures on the same day.

Vaccine ampoules are carefully inspected before opening.

The drug cannot be used:

If there are foreign inclusions or flakes that do not break when shaken in the diluted preparation.

The dry vaccine is diluted immediately before use with a sterile 0.9% sodium chloride solution attached to the vaccine. The solvent must be transparent, colorless and free of foreign impurities.

The neck and head of the ampoule are wiped with alcohol, the sealing area (head) is filed down and carefully broken off using tweezers. Then they file and break off the neck of the ampoule, wrapping the sawed end in a sterile gauze napkin.

To obtain a dose of 0.05 mg of BCG in 0.1 ml, transfer 2 ml of 0.9% sodium chloride solution into an ampoule with a 20-dose vaccine with a sterile syringe with a capacity of 2.0 ml, with a long needle, and into an ampoule with 10- dose vaccine - 1 ml of 0.9% sodium chloride solution. The vaccine should completely dissolve within 1 minute after shaking 2-3 times. Precipitation or formation of flakes that do not break when shaken is not allowed.

The diluted vaccine must be protected from sunlight and daylight (a black paper cylinder) and used immediately after dilution. Unused vaccine is destroyed by boiling for 30 minutes, autoclaving at 126°C for 30 minutes, or immersing in a disinfectant solution (5% chloramine solution) for 60 minutes.

For one vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn up with a syringe, then 0.1 ml of the vaccine is released through a needle into a sterile cotton swab to displace the air and bring the syringe plunger to the desired graduation - 0.1 ml. Before each kit, the vaccine must be carefully mixed with a syringe 2-3 times. One syringe can only administer the vaccine to one child.

The BCG vaccine is administered strictly intradermally at the border of the upper and middle third of the outer surface of the left shoulder after pre-treatment of the skin with 70° alcohol. The needle is inserted with the cut upward into the surface layer of the stretched skin. First, a small amount of the vaccine is injected to make sure that the needle enters exactly intradermally, and then the entire dose of the drug (only 0.1 ml). With the correct injection technique, a whitish papule with a diameter of 7-9 mm should form, usually disappearing after 15-20 minutes.

It is prohibited to apply a bandage or treat the vaccine injection site with iodine or other disinfectant solutions.

Reaction to introduction

At the site of intradermal injection of the BCG vaccine, a specific reaction develops in the form of a papule measuring 5-10 mm in diameter.

In newborns, a normal vaccination reaction appears after 4-6 weeks. The reaction undergoes reverse development within 2-3 months, sometimes over a longer period. In those revaccinated, a local reaction develops after 1-2 weeks. The site of the reaction should be protected from mechanical irritation, especially during water procedures.

In 90-95% of vaccinated people, a superficial scar up to 10.0 mm in diameter should form at the vaccination site. Complications after vaccination and revaccination are rare and are usually local in nature.

Contraindications

For vaccination:

1) Prematurity 2-4 degrees (with birth weight less than 2500 g).

2) Vaccination is postponed in case of acute diseases and exacerbations of chronic diseases (intrauterine infection, purulent-septic diseases, moderate and severe hemolytic disease of newborns, severe damage to the nervous system with severe neurological symptoms, generalized skin lesions, etc.) until clinical manifestations disappear diseases.

3) Immunodeficiency state (primary).

4) Generalized BCG infection detected in other children in the family.

5) HIV infection in the mother.

Children who were not vaccinated during the neonatal period, after eliminating contraindications, are prescribed the BCG-M vaccine.

For revaccination:

1. Acute infectious and non-infectious diseases, exacerbation of chronic diseases, including allergic ones. The vaccination is carried out 1 month after recovery or remission.

2. Immunodeficiency conditions, malignant neoplasms of any location. When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.

3. Tuberculosis, diagnosis of MBT infection in the anamnesis.

4. Positive and questionable Mantoux reaction with 2 TE PPD-L.

5. Complicated reactions to the previous administration of the BCG vaccine (keloid scar, lymphadenitis, etc.).

In case of contact with infectious patients in the family, child care facility, etc. Vaccinations are carried out after the end of the quarantine period or the maximum incubation period for a given disease.

Persons temporarily exempt from vaccinations should be placed under observation and registration and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.

Children who were not vaccinated during the neonatal period receive the BCG-M vaccine. Children aged 2 months and older are first given the Mantoux test 2 TE PPD-L and only those who are tuberculin negative are vaccinated.

Other preventive vaccinations can be carried out at an interval of at least 1 month before and after BCG revaccination.

Release form

In ampoules containing 0.5 mg (10 doses) or 1.0 mg of the drug (20 doses) complete with a solvent - 0.9% sodium chloride solution - 1 or 2 ml per ampoule, respectively.

One pack contains 5 ampoules of BCG vaccine and 5 ampoules of 0.9% sodium chloride solution (5 sets).

The shelf life of the BCG vaccine is 2 years.

Store the drug at a temperature of 5-8°C.

III. Use of tuberculosis vaccine (BCG-M) dry (for gentle primary immunization)

The drug is a live mycobacteria of the BCG-1 vaccine strain, lyophilized in a 1.5% solution of monosodium glutamate. The porous mass is powdery or in the form of a white or cream-colored tablet. Hygroscopic. The vaccination dose contains 0.025 mg of the drug in 0.1 ml of solvent.

Biological and immunological properties

Live mycobacteria of the BCG-1 strain, multiplying in the body of the vaccinated person, lead to the development of long-term immunity to tuberculosis.

Purpose

The drug is intended for gentle specific prevention of tuberculosis.

Directions for use and dosage

The BCG-M vaccine is used intradermally at a dose of 0.025 mg in 0.1 ml of solvent.

The BCG-M vaccine is vaccinated:

1. In the maternity hospital, premature newborns with a body weight of 2000 g or more, with restoration of the original body weight - the day before discharge.

2. In departments for nursing premature newborns in medical hospitals (2nd stage of nursing) - children weighing 2300 g or more before being discharged from the hospital to home.

3. In children's clinics - children who did not receive an anti-tuberculosis vaccination in the maternity hospital due to medical contraindications and are subject to vaccination in connection with the removal of contraindications.

4. In areas with a satisfactory epidemiological situation for tuberculosis, the BCG-M vaccine is used to vaccinate all newborns.

Children who have not been vaccinated in the first days of life are vaccinated during the first two months in a children's clinic or other medical institution without prior tuberculin diagnostics.

Children over 2 months of age require a preliminary Mantoux test with 2 TU PPD-L before vaccination. Children with a negative reaction to tuberculin are vaccinated. The reaction is considered negative in the complete absence of infiltration (hyperemia) or the presence of a prick reaction (1.0 mm). The interval between the Mantoux test and vaccination should be at least 3 days and no more than 2 weeks.

Vaccinations should be carried out by specially trained medical personnel of the maternity hospital (ward), department for the care of premature babies, children's clinics or medical and obstetric stations. Vaccination of newborns is carried out in the morning in a specially designated room after the children have been examined by a pediatrician. Vaccinations at home are prohibited. The selection of children to be vaccinated is preliminarily carried out by a doctor (paramedic) with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history. If necessary, consultation with medical specialists and blood and urine tests are carried out. The medical history of the newborn (medical record) indicates the date of vaccination, series and control number of the vaccine, manufacturer, and expiration date of the drug.

For vaccination, disposable sterile tuberculin syringes are used, with a capacity of 1.0 ml, with tightly fitting pistons and thin short needles with a short bevel. It is prohibited to use syringes and needles that have expired and needleless injectors. After each injection, a syringe with a needle and cotton swabs are soaked in a disinfectant solution (5% chloramine), then centrally destroyed. It is prohibited to use instruments intended for vaccination against tuberculosis for other purposes. In the vaccination room, the vaccine is stored (in the refrigerator, under lock and key) and diluted. Persons unrelated to BCG vaccination are not allowed into the vaccination room. To avoid contamination, it is unacceptable to combine tuberculosis vaccination with other parenteral procedures on the same day.

Vaccine ampoules are carefully inspected before opening. The drug cannot be used:

If there is no label on the ampoule or it is filled incorrectly;

When the expiration date has expired;

If there are cracks and notches on the ampoule;

When the physical properties of the drug change (wrinkled tablet, change in color, etc.);

If there are foreign inclusions or flakes that do not break in the diluted drug.

The dry vaccine is diluted immediately before use with a sterile 0.9% sodium chloride solution included with the vaccine. The solvent must be transparent, colorless and free of foreign inclusions.

The neck and head of the ampoule are wiped with alcohol, the sealing area (head) is filed down and carefully broken off using tweezers. Then they file and break off the neck of the ampoule, wrapping the sawed end in a sterile gauze napkin.

To obtain a dose of 0.025 mg of BCG-M in 0.1 ml, transfer 2 ml of 0.9% sodium chloride solution into an ampoule with the vaccine using a sterile syringe with a long needle. The vaccine should completely dissolve within 1 minute after shaking 2-3 times.

Precipitation or formation of flakes that do not break when shaken is not allowed.

The diluted vaccine must be protected from sunlight and daylight (a black paper cylinder) and used immediately after dilution. Unused vaccine is destroyed by boiling for 30 minutes, autoclaving at 126°C for 30 minutes or immersing in a disinfectant solution (5% chloramine solution) for 60 minutes.

For one vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn up with a sterile syringe, then 0.1 ml of the vaccine is released through a needle into a sterile cotton swab to displace the air and bring the piston to the desired graduation - 0.1 ml. Before each set of two doses, the vaccine must be carefully mixed using a syringe 2-3 times. One syringe can only administer the vaccine to one child.

The BCG-M vaccine is administered strictly intradermally at the border of the upper and middle third of the outer surface of the left shoulder after pre-treatment of the skin with 70° alcohol. The needle is inserted with the cut upward into the surface layer of the stretched skin. First, a small amount of the vaccine is injected to make sure that the needle enters exactly intradermally, and then the entire dose of the drug (only 0.1 ml). With the correct injection technique, a whitish papule with a diameter of at least 7-9 mm should form, usually disappearing after 15-20 minutes.

Injecting the drug under the skin is unacceptable, as this may result in the formation of a cold abscess.

It is prohibited to apply a bandage or treat the vaccine injection site with iodine or other disinfectant solutions.

Reaction to introduction

At the site of intradermal injection of the BCG-M vaccine, a specific reaction develops in the form of a papule measuring 5-10 mm in diameter.

In newborns, a normal vaccination reaction appears after 4-6 weeks. The reaction undergoes reverse development within 2-3 months, sometimes over a longer period.

The site of the reaction should be protected from mechanical irritation, especially during water procedures.

Complications after vaccination are rare and are usually local in nature.

Contraindications for vaccination with BCG-M vaccine in newborns

1. Prematurity - birth weight less than 2000 g.

2. Vaccination is postponed in case of acute diseases and exacerbations of chronic diseases (intrauterine infection, purulent-septic diseases, moderate and severe hemolytic disease of newborns, severe damage to the nervous system with severe neurological symptoms, generalized skin lesions, etc.) until clinical manifestations disappear. diseases.

3. Immunodeficiency state (primary).

4. Generalized BCG infection detected in other children in the family.

5. HIV infection in the mother.

Persons temporarily exempt from vaccinations must be monitored and registered, and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.

Children who were not vaccinated during the neonatal period receive the BCG-M vaccine after the contraindications are lifted.

Release form

In ampoules containing 0.5 mg of the drug (20 doses) complete with a solvent - 0.9% sodium chloride solution, 2 ml per ampoule.

One pack contains 5 ampoules of BCG-M vaccine and 5 ampoules of 0.9% sodium chloride solution (5 sets).

The shelf life of the BCG-M vaccine is 1 year.

Storage and transportation conditions

The drug is stored at a temperature of 5-8°C.

Transportation by all types of transport at a temperature of 5-8°C.

IV. Complications after administration of BCG and BCG-M vaccines

The causes of complications after immunization with a tuberculosis vaccine, in addition to the biological properties of the strain, may be violations of the technique of intradermal administration of the drug, indications for vaccination, as well as concomitant pathology in the child before vaccination and during the development of a local vaccination reaction.

Complications are divided into four categories:

Taking into account the importance of timely detection and the need to take adequate measures in cases of complications arising after the administration of the BCG or BCG-M vaccine, the following set of organizational actions for the timely detection of the disease, subsequent treatment and dispensary observation of children with this pathology is shown.

The doctor’s algorithm (sequence) of action includes the following stages of examining a child after administering the anti-tuberculosis vaccine:

Stage 1. When examined by a pediatrician in a children's clinic, it is necessary to remember that each child vaccinated intradermally with the tuberculosis vaccine is examined by a pediatrician at the age of 1, 3, 6, 12 months before the local vaccination reaction heals. During the examination, the pediatrician pays attention to the site of vaccine administration and the condition of the regional (cervical, axillary, supraclavicular and subclavian) lymph nodes.

Ulceration at the site of vaccine administration of more than 10 mm or an increase of more than 10 mm in one of the specified peripheral lymph nodes, or long-term, over 6 months, failure to heal the local vaccination reaction is an indication for referring the child for consultation to a pediatric TB specialist. An additional examination by a pediatric phthisiatrician is also indicated for children with axillary (axillary), supra-, subclavian lymphadenitis, detected by chance during an X-ray examination of the chest organs due to a slight enlargement of the lymph node, a “bend” of tuberculin reactions, hypersensitivity to tuberculin, symptoms of tuberculosis intoxication, frequent colds, the presence of a bone lesion regarded as osteomyelitis, chronic synovitis and arthritis.

Stage 2. In a children's clinic, a TB specialist, based on the clinical manifestations of the disease, determines the scope of diagnostic measures to confirm the diagnosis. Clinical criteria for post-vaccination complications, allowing to distinguish them from nonspecific lesions, are given below.

Lymphadenitis (regional, often axillary (axillary), sometimes supra- or subclavian, found mainly in young children):

Enlargement of the lymph nodes to IV (“bean”), V (“hazelnut”) and later VI (“walnut”) sizes;

The consistency of the lymph nodes at first is soft, elastic, later - dense;

Palpation of the lymph nodes is painless;

The skin over them is unchanged or pinkish in color;

It may be accompanied by caseification with the breakthrough of caseous masses outward and the formation of a fistula with moderate or profuse purulent discharge.

Infiltration develops at the site of vaccine administration:

There may be ulceration in the center,

Size from 15 to 30 mm - or more;

Accompanied by an increase in regional lymph nodes.

Cold abscess (scrofuloderma):

Tumor-like formation without changes in the skin above it;

Palpation is painless, fluctuation is determined in the center;

Often accompanied by reactive enlargement of the axillary lymph nodes;

Ulceration (in case of untimely diagnosis of a cold abscess and its spontaneous opening).

Ulcer (defect of the skin and subcutaneous fat at the site of vaccine administration):

The size of the ulcer is from 10 to 20-30 mm in diameter (its edges are undermined, the infiltration around is weak, the bottom is covered with copious purulent discharge).

Keloid scar (tumor-like formation at the site of vaccine administration of various sizes, rising above the skin level). Unlike a scar that forms during the normal course of the vaccine process, a keloid:

It has a dense, sometimes cartilaginous consistency;

In the thickness of the keloid there are capillaries that are clearly visible upon examination;

The shape of the scar is round, elliptical, sometimes star-shaped;

The surface is smooth, glossy;

Color ranges from pale pink, intense pink with a bluish tint to brownish;

Accompanied by a feeling of itching in its area, the itching is accompanied by pain.

Osteitis is a lesion of the skeletal system (the clinical picture corresponds to the lesion). The criterion for suggesting a post-vaccination etiology of the process is the age of the child from 6 months. up to 1 year and limited lesion area

The following additional studies are carried out in a children's clinic:

Laboratory methods: general blood and urine tests,

Tuberculin diagnostics: Mantoux test with 2 TE PPD-L (if the complication is diagnosed 12 months or later after immunization with the tuberculosis vaccine),

Plain X-ray of the chest organs.

Stage 3. After a clinical and x-ray examination, a child with a suspected complication is sent to a specialized anti-tuberculosis department to verify the diagnosis and prescribe treatment.

In the conditions of an anti-tuberculosis dispensary, additional X-ray tomographic examination and verification of the diagnosis are carried out.

Tomographic examination of the chest organs shows:

If there are pathological changes on a plain X-ray of the chest organs, requiring tomography of the mediastinum to verify the diagnosis;

When identifying osteoarticular pathology.

If BCG osteitis is suspected, additional radiography of the affected area is performed in two projections, which allows identifying characteristic signs of pathology, regional osteoporosis, bone atrophy, foci of destruction in the epimetaphyseal sections of long tubular bones with shadows of dense inclusions, sequestration, contact destruction of articular surfaces, narrowing joint space, compaction of the shadows of the soft tissues of the joints.

To verify the diagnosis of BCGitis, predominantly bacteriological methods are used (isolation of a pathogen culture with proof of its belonging to M.bovis BCG by determining its biological properties: growth rate, morphology, tinctorial properties, nitrate reductase test, catalase activity, drug resistance, with special treatment attention to drug sensitivity to cycloserine). If possible, molecular biological methods for identifying the pathogen are also used.

If it is impossible to verify that the pathogen belongs to Mbovis BCG, the diagnosis of a post-vaccination complication is established on the basis of a comprehensive examination (clinical, radiological, laboratory). After making a diagnosis, the TB specialist, based on the clinical manifestations of the disease, determines the scope of measures for treating the child and prescribes anti-tuberculosis therapy.

Treatment of post-vaccination complications is carried out by a phthisiatrician, in the conditions of an anti-tuberculosis dispensary, according to the general principles of treating a child with extrapulmonary tuberculosis, with individualization depending on the type of complication and the prevalence of the process. Hospitalization in a specialized hospital is indicated if it is impossible to adequately conduct therapy on an outpatient basis. Carrying out any other preventive vaccinations during treatment of a child (adolescent) for a complication is strictly prohibited.

The final 4th stage of the algorithm of medical measures after diagnosing a post-vaccination complication at the site of administration of the BCG vaccine is to inform medical institutions dealing with these problems about the identified complication, namely:

Immediately notify the head of the medical institution and send an emergency notification to the center of state sanitary and epidemiological surveillance;

They compile a “Registration Card for a patient with complications after immunization with a tuberculosis vaccine” (Appendix 1) and send it to the Republican Center for Complications of the Anti-TB Vaccine of the Ministry of Health of Russia at the Research Institute of Phthisiopulmonology of the Ministry of Health of Russia;

All cases of complications and unusual reactions or inconsistencies in the physical properties of the tuberculosis vaccine are reported to the GISC named after. L.A. Tarasovich Ministry of Health of Russia.

V. Organization of vaccination of newborns

1. The chief physician of the maternity hospital (head of the department) organizes vaccination of newborns.

2. The chief physician of the maternity hospital (department) allocates at least two nurses to undergo special training in the technique of administering the vaccine.

3. When sending an exchange card (registration form N 0113/у) to the children's clinic, the maternity hospital (department) notes on it the date of intradermal vaccination, the series of the vaccine, its expiration date and the name of the manufacturing institute.

4. The maternity hospital (department) informs parents that 4-6 weeks after intradermal vaccination, the child should develop a local vaccination reaction, upon the appearance of which the child must be shown to the local pediatrician. It is strictly forbidden to treat the reaction site with any solutions or lubricate it with various ointments.

5. Children born outside the maternity hospital, as well as newborns who for some reason were not vaccinated, are vaccinated in a children's clinic (in the children's department of a hospital, at a medical and obstetric station) by a nurse (paramedic) specially trained in the intradermal vaccination technique ).

To vaccinate newborns using the intradermal method in the children's room of the maternity hospital (ward), you must have:

Refrigerator for storing BCG and BCG-M vaccines at a temperature not exceeding +8°C.

2-5 gram disposable syringes for diluting the vaccine - 2-3 pcs.

Disposable tuberculin syringes with a well-fitting piston and a thin short needle with a short oblique cut - at least 10-15 pcs. for one day of work.

Injection needles N 840 for diluting the vaccine - 2-3 pcs.

Ethyl alcohol (70%) registration N 74\614\11(12).

Chloramine (5%), registration No. 67\554\250. Prepared on the day of vaccination.

All items necessary for intradermal vaccination should be stored under lock and key in a separate locker. Their use for any other purposes is strictly prohibited.

When vaccinating children who were not vaccinated during the neonatal period, the clinic must additionally have equipment for conducting the Mantoux tuberculin test.

VI. Organization of revaccination against tuberculosis

1. The Mantoux test with 2 TE PPD-L and anti-tuberculosis revaccination are carried out by the same team of specially trained paramedical workers in children's city, district and central district clinics, united in teams of 2 people.

2. The composition of the team and their work schedules are annually drawn up by order of the chief physician of the relevant medical institution.

3. Nurses who are members of the team must be proficient in the methods of setting up, assessing Mantoux tests and administering vaccinations. Samples are administered by one nurse, sample assessment should be carried out by both team members, and vaccinations, depending on the number of subjects, may be carried out by one or both nurses. During the work, a medical worker from the institution where mass tuberculin diagnostics and revaccination are carried out is connected to the team.

4. Local medical workers carry out sampling and vaccination, organize a flow, select and refer to a phthisiatrician persons who need further examination for tuberculosis; draw up documentation and prepare a report on the work done. Doctors from children's and adolescent institutions, state sanitary and epidemiological inspectors and TB specialists monitor the work on the ground.

5. In the work schedule of the teams, it is necessary to provide for their re-entry during the year to cover children and adolescents who were absent due to illness or had temporary medical exemptions during the first mass examination of the team.

6. In each anti-tuberculosis dispensary (department) there is a person responsible for anti-tuberculosis vaccinations, who is entrusted with monitoring the work of district teams, methodological assistance and revaccination of uninfected persons.

7. Full coverage of the populations subject to anti-tuberculosis vaccinations, as well as the quality of intradermal revaccination, is ensured by the chief physician of the clinic, central and regional hospital, outpatient clinic, district pediatrician, chief physician of the anti-tuberculosis dispensary, chief physician of the state center for sanitary and epidemiological surveillance and persons directly performing this work .

The chief doctors of the anti-tuberculosis dispensary (regional, district subordination) must organize a doctor’s appointment in the children’s department to treat children (early, school-age) with post-vaccination complications. Treatment should be carried out by a trained phthisiopediatrician, and children should be seen on certain days.

VII. Tools for performing the Mantoux test before revaccination and for revaccination

When using tuberculin one-gram disposable syringes, 150 syringes with well-fitting pistons with a short oblique cut are required for one day of work by the team; 3-5 pieces of 2-5 gram syringes with needles for diluting the vaccine. For the year, the number of syringes and needles is planned based on the number of persons subject to revaccination: for 1st grade schoolchildren - 50%; 9th grade - 30% of students.

List of reusable instruments:

Bix 18 x 14 cm for cotton wool - 1 pc.

Sterilizers - storage for syringes with a capacity of 5.0; 2.0 gr. - 2 pcs.

2-5 ml syringes - 3-5 pcs.

Injection needles N 804 for extracting tuberculin from the vial and for diluting the vaccine - 3-5 pcs.

Anatomical tweezers, 15 cm long - 2 pcs.

File for opening ampoules - 1 pc.

Millimeter rulers 100 mm long (plastic) - 6 pcs. or special calipers.

Bottles for medicines with a capacity of 10 ml - 2 pcs.

Bottle with a capacity of 0.25-0.5 l. for disinfectant solutions - 1 pc.

To carry out tuberculin diagnostics and revaccination in large groups using a team method, when 2 nurses work simultaneously, in conditions of a continuous flow of subjects, a set of instruments should be used in accordance with the “Instructions for the use of tuberculin tests.”

Instruments for producing a tuberculin test and revaccination must be separate and appropriately labeled. One sterile syringe can only administer tuberculin or BCG vaccine to one person.

VIII. Drawing up a vaccination plan and monitoring its implementation

1. Drawing up a plan for anti-tuberculosis vaccinations is entrusted to the chief doctors of the center of state sanitary and epidemiological surveillance, maternity hospital, children's and general clinics, anti-tuberculosis dispensary (within the region and scope of activity of each institution).

2. The consolidated vaccination plan against tuberculosis for the district, city, region is drawn up by the center of state sanitary and epidemiological surveillance together with the chief pediatricians and anti-tuberculosis dispensaries.

3. In terms of revaccination for the district, city, region, the following is provided:

recording the number of children and adolescents subject to tuberculosis vaccinations;

calendar plan for examining contingents and conducting BCG revaccination, taking into account the timing of other vaccinations;

preparation of medical personnel for vaccinations and their instructions.

4. Registration of persons subject to vaccination in children's and adolescent groups is carried out by doctors of the general pediatric network serving these groups and institutions.

5. When drawing up a vaccination plan, the birth rate in a given area or city is taken as a basis; the revaccination plan is the number of children, adolescents and adults subject to revaccination, taking into account the percentage of people who react negatively to the Mantoux test with 2 TE PPD-L.

6. Monitoring the implementation of the anti-tuberculosis vaccination plan on site is carried out by the center of state sanitary and epidemiological surveillance, to which a monthly report is submitted in form N 086/to the institutions conducting vaccinations.

7. The need for tuberculin is calculated at the rate of two doses of 0.1 ml for each person examined. It is necessary to take into account that in 3 ml ampoules - 30 doses - for examination of 15 people. One liter of tuberculin contains 10,000 doses, which are used to examine 5,000 people.

8. The need for BCG and BCG-M vaccine for vaccination of newborns is calculated at the rate of 20-30 ampoules of dry tuberculosis vaccine for intradermal administration and solvent (included) per month for one maternity ward, where 5-10 children are born per day. In this case, it is also necessary to take into account the presence of a 10- or 20-dose BCG vaccine.

BCG is the very first vaccination in a person’s life. It is given to a newborn right in the maternity hospital on the third to fifth day after birth. Today, according to current legislation, the mother is asked for written permission for vaccination. They bring the paper for signature, and more than half of the women have no idea what they are signing or what they are refusing. The famous pediatrician and authoritative favorite of millions of modern mothers, Evgeniy Komarovsky, often talks about the BCG vaccination in his articles and television programs.

What it is

BCG is a vaccine against tuberculosis, a disease that kills about 3 million people worldwide every year. Vaccination is mandatory in 19 countries. The vaccine contains a weakened bovine tuberculosis bacillus. The drug exists in two versions: BCG - for ordinary children and BCG-M - for babies born prematurely.

The first administration of the BCG vaccine is carried out in the maternity hospital (if the mother agrees, if the child has no contraindications), revaccination - at 7 years, 12 years, 16 years.

The first vaccination is done without a preliminary Mantoux test; for revaccination, a preliminary “button” is required. The fact is that it makes sense to get vaccinated only if infection has not yet occurred. If the child’s body has already encountered Koch’s bacillus, then there is no need to vaccinate. The Mantoux test just shows the advisability of revaccination.

The vaccine is administered subcutaneously into the shoulder. The injection site sometimes festers, although this is an individual reaction, but everyone, with a few exceptions, remains with a characteristic scar, confirming the fact of vaccination.

If there is no scar or it is too small, experts say that the child’s immunity to tuberculosis has not developed or is weak.

Komarovsky about BCG

When asked by mothers whether BCG should be done, Evgeniy Komarovsky answers unequivocally - it is necessary. After all, it will be much better for a child’s body if it encounters a small number of weakened pathogens of a serious illness than if the child receives an infectious dose of strong and aggressive microbes. But the reality in Russia is that getting sick is as easy as shelling pears - people with infectious tuberculosis move freely, travel in public transport, go to stores, sneeze and cough on the street. There is no shortage of aggressive sticks.

The video where Dr. Komarovsky will tell you everything about the BCG vaccination can be seen below.

This first vaccination is not done at the whim of Ministry of Health officials, but for a completely objective reason - the causative agent of tuberculosis is very likely to be the first pathogenic microbe that a newborn will encounter almost immediately after being discharged from the hospital.

Komarovsky especially emphasizes that the Mantoux test, which many mothers mistakenly also call vaccination, is a very informative way to find out whether a child is infected. The test must be done annually. If it suddenly turns out to be positive, this does not mean that the child will have a comfortable government bed in a tuberculosis dispensary. If an active live bacillus enters a child’s body, then usually the immune defense and the efforts of antibodies are sufficient to prevent tuberculosis from developing. In the absence of proper attention from doctors and parents, without special treatment, a serious illness develops in only 10-15% of children.

In general, the BCG vaccine protects quite effectively against fatal forms of tuberculosis, but, Evgeniy Komarovsky emphasizes, even a timely vaccination and subsequent timely revaccination do not provide an absolute guarantee that a child will not get tuberculosis, although they significantly reduce this risk.

Dr. Komarovsky will tell you why the Mantoux test is needed for children in the next video.

To minimize the risk of infection with the tuberculosis bacillus, the doctor advises strengthening the child’s immunity from the very moment he is born. It is mandatory to get the BCG vaccine, but do not shift all responsibility only to doctors. Parents themselves must try. First of all, Komarovsky says, they must understand that the fight against vaccinations is a fight against future generations of the Earth’s inhabitants.

At the everyday level, mothers need to ventilate the premises more often, walk more and longer with the child, and provide the baby with adequate nutrition.

Preparation for BCG vaccination has no special features. Evgeniy Olegovich reminds that the child should go to the clinic on an empty stomach, with bowels emptied several hours before the visit. Two days before vaccination, mothers should not introduce new foods to the toddler’s diet; everything should be familiar to him. The less stress on the baby’s digestive system, the easier it will tolerate the vaccination, the doctor reminds.

Before administering the vaccine, the pediatrician is required to examine the child to identify contraindications. If you have viral infections, immunodeficiency, an allergic reaction to anything, elevated body temperature, or any disease in the acute stage, you cannot vaccinate a child. In this situation, vaccination is postponed to a later date until the little patient has fully recovered.

Some vaccinations cause complications, Dr. Komarovsky will talk about this in the next video.

After the BCG vaccination, Komarovsky advises giving the child more to drink, providing fresh air, and if the temperature rises, giving an antipyretic, preferably Paracetamol. In all other unclear situations, it is better to call a doctor. When asked by parents whether it is possible to bathe a child after BCG, Komarovsky answers in the affirmative. You can, but be careful; it is better not to rub the injection site with a washcloth or steam it. And if the injection mark festers, there is no need to treat it with antiseptics, because this is a natural process.