Characteristics of the BCG vaccine 1 dry. What is the BCG vaccine for?

Tuberculosis is one of the most severe chronic diseases with a high mortality rate. BCG is an anti-tuberculosis vaccine and is used as a prophylaxis for this disease.

The importance and features of vaccination:

• reduces the risk of infection with tubercle bacilli;
• helps to avoid the transition of a latent infection into an open form of the disease;
• prevents the development of severe forms of the disease;
• helps reduce the risk of complications and death from tuberculosis.

The incidence of tuberculosis in Russia is growing every year, so this vaccination is among the mandatory vaccinations.

Vaccine composition

The BCG preparation contains different subtypes of mycobacteria. The current composition of the vaccine is no different from the composition of the drug since its first use in 1927. WHO maintains data on all types of mycobacteria used in the production of BCG.

To obtain the required culture of mycobacteria, which are necessary for the creation of vaccine preparations, the method of inoculating bacilli in a specially created nutrient medium is used. The cell culture grows in a nutrient medium within seven days. After this, the bacilli undergo several processing processes:

• selection;
• filtration;
• concentration;
• bringing the mass to a homogeneous consistency;
• dilution with purified water.

As a result, the finished vaccine contains dead and live bacteria. The number of bacteria in a single dose of the drug may vary. This depends on the subtype of bacteria and the specific production of the vaccine. There are many types of BCG vaccine produced today. However, 90% of all drugs contain one of the strains of mycobacteria:

• Tokyo 172.
• Danish 1331.
• French 1173 P2.
• Glasco 1077.

The effectiveness of the strains used in all preparations is similar.

What vaccine is used

There are 2 types of vaccines: BCG and BCG-M. For revaccination, the second option is extremely rarely used, which is gentle and more suitable for the first vaccination of newborns who have conditional contraindications for immunization. To carry out revaccination, a dry BCG vaccine is used, containing 2 strains of mycobacteria that lack virulence.

Weakened microorganisms cannot cause infection, but contribute to the formation of active immunity.

The vaccine is produced in ampoules sealed under vacuum. 1 container contains 0.5 mg of the drug - this amount is enough for 20 doses. Dilution of the drug is carried out immediately before administration; Once opened, it should be stored for no more than 2 hours.

Contraindications for BCG

Administration of the BCG vaccine is contraindicated in newborns if:

• prematurity (birth weight less than 2.5 kg);
• acute diseases;
• antenatal infection;
• purulent diseases;
• anemia (as a result of blood incompatibility);
• disturbances in the functioning of the nervous system with neurological symptoms;
• skin infections;
• weakened immune system;
• oncological diseases;
• radiation treatment;
• tuberculosis of family members;
• maternal HIV infection.

BCG-M: difference from BCG

If you refer to the instructions for using the BCG-M and BCG vaccinations, you can find out the difference between them. A vaccine with the prefix M is a weakened serum. It contains fewer tuberculosis pathogens. This type of drug is recommended for revaccination.

The BCG vaccine contains 0.05 mg of tuberculosis pathogens. BCG-M serum contains 0.025 mg of pathogens. The weakened vaccine has only been used since 1991 and is prescribed to certain groups of patients.

BCG-M is given to premature or low birth weight babies in the maternity hospital; it is used if the child is prone to allergies. It is recommended to use attenuated serum for patients who are prone to seizures, have a birth injury, or have neurological diseases. In each specific case, the need to replace the standard tuberculosis vaccination with a lighter version is assessed by a pediatrician or immunologist.

Sequence of actions of a medical worker

1. Prepare the necessary materials.
2. Wash your hands, dry them, put on gloves and a mask.
3. Remove the ampoules with the drug and solvent from the box, treat the ampoules with a cotton swab dipped in alcohol, and file.
4. Cover with a sterile napkin and break.
5. Dispose of used materials into a prepared container with a disinfectant solution.
6. Place open ampoules in a beaker.
7. Open the package of the 2 ml syringe. Put the needle on and secure. Remove the cap.
8. From the ampoule with the solvent, draw the liquid into a 2 ml syringe.
9. Introduce the solution into the ampoule with the vaccine carefully along the wall.
10. The vaccine is mixed. The pre-washed syringe is dumped into a container with disinfectant liquid.
11. Open the packaging of the tuberculin syringe, put on the needle and secure it.
12. From the ampoule with the dissolved vaccine, draw 0.2 ml of the prepared solution into a syringe.
13. The ampoule with the remains of the finished drug is placed in a glass, covered with a sterile napkin and a light-protective cone.
14. The sterile napkin is taken with tweezers. Air is released into it from the syringe. The napkin is thrown into a container with a disinfectant solution.
15. There should be 0.1 ml of the drug left in the syringe. The syringe is removed inside the sterile table.

Note: For newborns, 0.1 ml of solution is taken, the administration rate is 0.05 ml. BCG is administered after the child’s mother has been instructed on the rules of caring for the injection site.

Purpose of the Mantoux test performed before BCG

Unlike preventive vaccination, which is done only three times, a test to assess the presence of the tuberculosis pathogen in the body is done many times, including before BCG vaccination. This is necessary to ensure that there are no active mycobacteria in the body and to avoid infection through vaccination.

For the Mantoux reaction, tuberculin is introduced, which is a protein extract from a culture of tuberculosis bacilli. Intradermal administration produces a reaction in the form of redness at the injection site. The size of the spot and the nature of its redness allow doctors to determine the presence of the pathogen in the body and the fact that antibodies to it are being produced.

Where is vaccination carried out?

In the maternity hospital, after birth, all babies are vaccinated with BCG. If the child did not receive the vaccine during his stay in the maternity hospital, immunization is carried out in the clinic where the newborn is observed.

Any children's clinic has a specially equipped vaccination room where the vaccination procedure is carried out. Simultaneous vaccination, blood sampling, and drug injections are unacceptable. If there are two treatment rooms, one is used for daily routine procedures, the second is used only for vaccinations. If there is only one office, a specific day of the week is assigned for vaccinating children with BCG. The office is used exclusively for this procedure.

In addition to the clinic, the BCG vaccine can be given at a tuberculosis clinic. A child at high risk of developing an active reaction is vaccinated exclusively in a hospital setting.

The legislation of the Russian Federation allows immunization to be carried out at home. The visit of a specialized team with the necessary equipment and materials is carried out on a paid basis. This service is not included in the list of mandatory health insurance measures and is paid for by the customer of the service.

BCG vaccination can be carried out at a specialized vaccination center. The center must have a certificate valid at the time of the certificate procedure.

Mantoux after BCG

After immunization against tuberculosis, a child is given a mantoux test every year. Its results make it possible to judge whether infection with Koch's bacillus has occurred. If the mantu reaction is positive, the child is thoroughly examined.

They make mantu without BCG. If the child has not been vaccinated against tuberculosis, then the test is carried out not once a year, but twice. Every 6 months it is necessary to examine the baby to exclude infection with Koch's bacillus.

Due to the fact that previously tuberculosis samples could not be wetted, a stereotype developed that a child should not be bathed with a mantu. Parents also believe that the BCG vaccine should not be wetted until it is completely healed. However, doctors do not give such strict restrictions . It is not recommended to rub the injection site with a washcloth, scratch or open the papule. It is not prohibited to bathe a child and wet the serum injection site. After BCG, you can walk and attend kindergarten or school. There are no strict restrictions on immunization against tuberculosis.

When is the vaccination given?

The first vaccination is carried out in the maternity hospital 3-7 days after birth. Only if no contraindications are found. The first revaccination is carried out at 7 years of age.

Before immunization, a test is required - the Mantoux test. In case of a negative reaction, vaccination is carried out no earlier than three days after the test, no later than two weeks. If the body's reaction to the test is positive, immunization is not carried out.

The second revaccination is carried out at the age of 14 according to similar rules. First, a Mantoux test is performed, then, based on the results, the doctor prescribes vaccination or whether it is not necessary.

Adults are vaccinated only once after 30 years of age.

When is anti-tuberculosis immunization given?

Nature itself has determined that a healthy child born to a healthy mother, provided there are no pregnancy pathologies, in the first week of his life is protected by her immunity from any infections.

But his own immunity is not yet able to actively respond to the introduction of various pathogenic agents. Therefore, this period - the 3rd, 7th day after birth, is determined for the first anti-tuberculosis immunization of newborns.

During the first vaccination of healthy babies, a “gentle” BCG-M vaccine with a reduced content of infectious pathogens is administered, which does not at all interfere with achieving a sufficient level of activity of the child’s immune system and minimizing the risk of post-vaccination side effects.

The regular vaccine (without the letter M) is used to vaccinate newborns born in regions of high incidence or when the disease is present in the child’s immediate environment.

Babies over 2 months of age who are not vaccinated for any reason are vaccinated against tuberculosis only if they have a negative immunological test for the Mantoux reaction.

To reduce the susceptibility of children to the effects of mycobacteria and tubercle bacilli, repeated BCG vaccination - revaccination is carried out when children reach 7 years of age (if indicated) or can be delayed until 14 years of age.

How to get the BCG vaccine

The technique of administering the BCG vaccine requires compliance with certain mandatory rules. Vaccination is carried out strictly intradermally immediately after drawing the solution into a syringe. The skin area of ​​the left shoulder is treated with 70% ethyl alcohol.

The needle is inserted with the cut edge up into the surface layer of the skin. For ease of insertion, it is slightly stretched. You must first make sure that the needle hits the skin exactly. To do this, a small amount of vaccine is injected. Then the drug is administered completely. As a result of correctly performed vaccination, a whitish papule is formed. Its diameter is 7-9 mm. Usually the primary papule disappears within 20 minutes after administration of the drug.

No preparation is required for the BCG vaccination.

When should the vaccine not be injected?

BCG vaccination is not allowed in the following cases:

• if the child was born premature (weighing less than 2500 kg);
• with intrauterine hypotrophy III-1U degree;
• during exacerbation of chronic diseases;
• during an immunodeficiency state;
• malignant tumors. If immunosuppressants are prescribed, as well as radiation therapy, vaccination is carried out only six months after the end of treatment;
• generalized BCG infection, which was identified in other children in the family;
• if the mother of the newborn is diagnosed with HIV infection.

Children who have contraindications to BCG vaccination are vaccinated with BCG-M vaccine according to the instructions.

Complications after vaccination

A local reaction develops at the injection site. It has several external varieties:

• papule;
• infiltrate;
• pustule;
• ulcer.

In newborns or primary vaccinated children, the vaccine reaction develops at 4-6 weeks. During the revaccination procedure, the reaction appears after 1-2 weeks.

Complications manifest themselves predominantly locally:

• the appearance of pustules;
• inflammation of the lymph nodes;
• appearance of a keloid scar.

What to remember

When prescribing BCG, contraindications cannot be ignored. Due to the fact that the vaccine is administered when it is prohibited, complications of varying severity arise. Complications after BCG vaccination, especially after revaccination, can be caused by the fact that the doctor’s recommendations regarding skin care at the injection site are not followed.

If, after vaccination in a newborn or revaccination in older children, side symptoms appear, parents should take the following steps - show the child to the doctor as soon as possible, and before that do not perform any manipulations with the site of the vaccine. Treatment aimed at eliminating side symptoms can only be prescribed by a doctor.

It is important to remember that any complications from BCG do not occur immediately. The development of the pathological process sometimes takes from several weeks (in newborns) to 12 months (in older children during revaccination). Therefore, parents should periodically examine the skin and consult a doctor if there is the slightest change in its condition or appearance.

What does the reaction to BCG look like?

The BCG vaccine causes an allergic reaction. T-lymphocytes begin to accumulate under the skin, which actively fight the tuberculosis pathogen. A corresponding reaction of the skin develops.

During the first days after vaccination, no visible changes in the skin are observed. There may be slight redness at the injection site. The absence of a visible reaction may last for several days. After this, the injection site should not differ from the surrounding skin.

Within a month after vaccination, a small papule begins to form. Externally, it is a small vial of liquid. This is the development of a normal reaction and we can talk about successful vaccination. Sometimes the appearance of a papule is accompanied by itching. Scratching it is strictly prohibited to avoid subcutaneous infection.

After three months, the papule crusts over and heals. A small whitish scar forms at the site of the healed wound. The size of the scar varies from 7 to 10 mm. A scar of less than 4 mm indicates that the purpose of vaccination has not been achieved. Anti-tuberculosis immunity has not been developed.

Parents need to know that the vaccine does not protect a person from becoming infected with tuberculosis. It can prevent the development of severe forms of tuberculosis diseases that can lead to death. It is imperative to protect a child in the first days of his life. When the child goes out into the world, where 2/3 of the population are carriers of the infection, it may already be too late.

How to check BCG correctly?

The papule that forms at the vaccination site should normally be up to 1 cm in diameter, and the surrounding skin should look without signs of inflammation. Skin color should be white, pinkish, and reddish is also allowed. If the shade is bright red or brown, then this indicates a side effect.

If the papule does not heal within 3-5 months, then you should consult a doctor.

Possible fever should not last more than three days from the moment of injection and be accompanied by additional symptoms.

Instructions for use of BCG

When and who gets the BCG vaccine? First of all, newborn children need vaccination. In an unfavorable epidemiological situation for tuberculosis (and this is exactly what it is in Russia), the risk of infection is high. In addition, according to WHO, about 2/3 of the world's population are carriers of the tuberculosis bacillus. Why and how the transition from carriage to disease occurs has not been sufficiently studied to date. But it is known for sure that sanitation and nutrition factors play a big role.

In young children, tuberculosis occurs in extremely aggressive forms:

• disseminated tuberculosis;
• meningitis;
• tuberculosis of bone tissue.

Vaccination significantly reduces the likelihood of developing such forms of the disease and facilitates its course.

In Russia, universal vaccination of newborns has been introduced since 1962. According to the instructions for use, BCG is administered to newborns in regions with a tuberculosis incidence rate of 80 people per 100 thousand population. Under some conditions, a milder BCG-M vaccine, containing half the vaccination dose, is used for primary vaccination.

How is vaccination carried out?

BCG vaccination is given to a newborn at 3–7 days of life. Before this, the child must be examined to identify contraindications to vaccination. The injection is made intradermally into the outer surface of the shoulder just below its upper third. Use a special tuberculin syringe with a capacity of 0.2 ml. The vaccine is administered in an amount of 0.1 ml - one dose of the drug. If the BCG vaccination technique is followed, a small whitish ball with a diameter of 7–9 mm appears at the injection site in newborns, which disappears after 15–20 minutes.

Reactions to BCG in newborns can occur for several months and even years after the injection. We'll talk about this in more detail below.

Contraindications for BCG vaccination

Let's consider contraindications to BCG vaccination.

For newborn babies, the contraindications to BCG vaccination are as follows:

• the weight of the newborn is less than 2000 grams;
• intrauterine infection, sepsis;
• HIV infection in the mother;
• immunodeficiency states;
• perinatal brain lesions;
• congenital enzymopathies;
• hemolytic disease;
• purulent-inflammatory diseases of the skin;
• generalized BCG infection in other family members.

Contraindications to vaccination for children during the revaccination period and for adults:

• Mantoux reaction is positive or doubtful;
• keloid scar, other complications from previous vaccination;
• disease or infection with tuberculosis;
• acute diseases;
• oncology;
• chronic diseases in the acute stage;
• allergies in the acute stage;
• immunosuppressive conditions;
• pregnancy.

Where do they put it?

In medical practice, it is customary to give an injection in the left shoulder. If for some reason this is not possible, the vaccine can be injected into the thigh.

The injection is given strictly intradermally; incorrect administration can lead to adverse consequences, including severe complications and the formation of a keloid scar in this place, which can only be gotten rid of with the help of a surgeon.

At what age do you get vaccinated against tuberculosis: timing of vaccination and revaccination

Pharmacists offer two drugs to protect against tuberculosis: BCG (they are used to immunize ordinary children) and BCG-M (premature babies are revaccinated with this drug). The first time the vaccination is done in the maternity hospital on the 3-5th day of the child’s life.

Thus, doctors try to protect the baby from birth. There are a number of reasons for this:

• In some countries of the post-Soviet space, tuberculosis epidemics periodically occur.
• In Russia, about 60 citizens out of 1000 are carriers of Koch's bacillus.
• A third of the world's population is infected with tuberculosis infection.
• Koch's bacillus is easily transmitted by aerosol and is highly resistant to environmental influences.
• On average, it takes about three months to recover from tuberculosis.
• The pathology affects all people, regardless of gender, race and age. The baby’s immunity is not yet formed, so the disease is more difficult to tolerate. It is important to protect the baby as much as possible from possible infection.
• Effective modern drugs are used to treat infectious pathologies, but resistance and addiction to them quickly develop.
• Tuberculosis kills about 3 million people worldwide every year.
• Sometimes a previous illness returns.

Vaccination does not provide a 100% guarantee that a child will not get sick. But, even if a person develops an infectious pathology, it will pass faster and without complications. After the first vaccination, specific immunity is developed for 6-7 years. Every year the body's defenses against tuberculosis weaken. Therefore, doctors insist on revaccination.

BCG is given for the second time at the age of 7, the third at 14. At the age of seven, children go to school, where the risk of infection with Koch’s bacillus increases.

Children, unlike adults, do not undergo fluorography every year. Therefore, identifying tuberculosis at the initial stage is extremely difficult. And neglected disease often ends in death. The third peak incidence occurs at 13-14 years of age.

The vaccine made at this time protects for 10-15 years. Therefore, it is necessary to be vaccinated again.

Adults are also revaccinated regardless of whether they were vaccinated in childhood (adolescence) or not. Until the age of 35, you need to administer BCG once (this is quite enough for reliable protection against infection).

BCG is a mandatory type of vaccination. The timing of prophylaxis is given in the National Immunization Calendar of the Russian Federation. Revaccination may be postponed in the following cases:

• The person is sick (cold, acute respiratory infection, exacerbation of chronic pathology, measles, flu). The vaccine can be given after at least two weeks from the moment of recovery.
• An urgent business trip is planned. For some time before and after BCG, it is advisable not to be in crowded places: immunity after the administration of this drug weakens and there is a risk of contracting an infectious viral disease.
• Taking a course of immunosuppressant therapy.

For health reasons, a child may receive a medical exemption from the BCG vaccination. Although vaccination against tuberculosis is mandatory, parents have the right to write a refusal to undergo immunization.

Should I revaccinate?

BCG revaccination is included in the mandatory vaccination schedule. It is carried out strictly according to schedule.

Parents have the right to refuse vaccination, but they should take into account all the risks to which the baby is exposed.

The administration of the drug is a real opportunity to resist the disease. Even if its development is observed, the pathology is mild and responds well to therapy.

Unvaccinated children suffer from tuberculosis with difficulty. There is a high risk of complications.

Reviews from parents

Conclusions about the tolerability of BCG vaccination among parents vary. Most children undergo vaccination without any problems. But some babies develop severe complications. As a rule, negative consequences are associated with improper care of the abscess and wound. Sometimes adverse reactions occur due to physicians’ violation of injection technology and hygiene rules.
Reviews from parents about BCG:

• Valentina. I am seven months pregnant. Therefore, the question of vaccinating the baby is relevant for me. BCG was done for me and my mother. We tolerated the vaccination well. Therefore, I see no reason to refuse immunoprophylaxis for my baby in the maternity hospital. I have not heard from any of my friends that BCG causes side effects and complications;
• Victoria. My daughter was given BCG at the maternity hospital. The day after the injection, the girl began to have a fever and convulsions. It turned out that she does not tolerate this vaccine well. The pediatrician gave a lifelong exemption from BCG;
• Tatiana. I have a four-year-old son. Until a certain time, I was against vaccinations. In the maternity hospital I wrote a refusal to accept BCG and hepatitis B. I always carefully monitor hygiene and try not to walk with my baby in crowded places during the epidemic. Despite all the precautions, my son fell ill with tuberculosis at the age of three. The disease was very difficult, but thanks to the efforts of the doctors, serious complications were avoided. Therefore, I do not recommend that mothers refuse vaccination. BCG is the only reliable measure to prevent infection;
• Nina. I always vaccinate my child according to schedule; in the maternity hospital they also did all the required vaccinations. Due to my inexperience, I didn’t even consider the importance of vaccinating a newborn at first; everything happens so quickly in the maternity hospital. As a result, I didn’t notice any changes in my condition, only then I started reading about negative reviews on the Internet and started thinking about whether I should continue getting vaccinated. But such doubts arise from illiteracy, so after analyzing everything, I did not attach any importance to these horror stories and always vaccinate my child on time and believe that immunization is a great achievement of humanity.

Complications

The consequences of BCG vaccination can be very serious and often develop during the initial administration of the drug. Perhaps BCG is one of the most “scandalous” vaccines; controversy around it has not subsided since its creation. Unfortunately, nothing more effective and safe for the prevention and control of tuberculosis has yet been invented.

In Russia, complicated reactions to BCG are more often of a local nature and are observed in no more than 0.06% of vaccinated children. Complications are recorded mainly in the first six months after vaccination - up to 70% of the total. In the period from 6 to 12 months, about 10% are detected, for the remaining period - a year or later after vaccination - 20% of cases occur.

More often than others, cold abscesses and lymphadenitis develop. They are determined by the quality of the vaccine, the technique of its administration, the dose and age of the vaccinee.

Other complications may include:

• keloid scar;
• extensive ulcers at the site of vaccine administration;
• BCG infection without fatal outcome - osteitis, lupus;
• generalized BCG infection;
• post-BCG syndrome: skin rashes, erythema, granuloma annulare.

Often, in case of complications, a diagnosis of BCG-itis is made. What is it and how does it threaten your child? Any disease caused by the BCG strain of mycobacteria is classified in this category. This can be inflammation of the lymph nodes, osteitis, or non-healing ulcers on the skin that require treatment.

How long after you can get other vaccinations?

After the baby is given a BCG injection, a period of immunological rest begins, which is necessary for the correct formation of the child’s specific immunity. After you have been vaccinated against tuberculosis, you cannot do any other vaccinations for two months.

By doing a Mantoux test before BCG, you can promptly identify the disease in the body and prevent the possibility of serious harm from preventive vaccination given to an already infected person. Doctors recommend doing BCG and Mantoux within the time limits established by the vaccination calendar, if there are no contraindications due to the baby’s health. Timely diagnosis and prevention can significantly reduce the likelihood of contracting tuberculosis, especially in childhood.

What happens if the vaccine is administered incorrectly?

As a rule, the appearance of specific reactions on the part of the child’s body may be associated with the individual characteristics of the child. In some cases, this effect is the reason for improper vaccination, which is due to the lack of proper experience of the health worker. Therefore, during grafting, maintaining technique is important because it will minimize the likelihood of complications. It is equally important to inform the patient about the possible risks, both during vaccination and when refusing it. The child and his parents should know that it is not recommended to scratch or wet the vaccine injection site, and that administration is contraindicated in the following cases:

• the newborn had an intrauterine infection;
• the presence of hemolytic diseases;
• purulent-septic problems;
• diagnosis of malignant neoplasm;
• the child is prescribed immunosuppressants;
• damage to the child’s nervous system of particular severity;
• there are people in the family with tuberculosis;
• prescription of radiation therapy;
• the child's mother has HIV infection.

What does the vaccine consist of?

The BCG vaccine includes various subtypes of mycobacteria. They are deprived of pathogenic effects by processing and cultivation on certain nutrient media.

How do you get it? The selected type of mycobacteria is inoculated on special media. There it grows at a given temperature for a week. Then the rod culture is isolated, subjected to filtration, followed by concentration and further special processing. The result is a homogeneous mass presented in solution.

Thus, the drug contains a live culture that is not capable of causing disease in a healthy child. The vaccine contains weakened MBT strain BCG-1 in a lyophilisate of 1.5% sodium glutamate.

Today, many companies are producing this vaccine. It has shown its effectiveness. But some progressive states, such as Germany, Denmark, Sweden, abandoned universal immunization, which led to a negative reaction - a two- to four-fold surge in incidence and the development of complications.

Technique and algorithm

The person administering the vaccine should draw a double dose into the syringe, then release part by moving the piston to the 0.1 ml mark before the injection is given in the left shoulder area. This area is pre-treated with an alcohol solution.

In some cases, it is impossible to administer the drug to the shoulder area, which is associated with skin damage in the form of a burn. In this situation, the injection is given in the thigh or other area with thick skin.

Correct administration of the drug

Is it necessary to get a vaccine at birth in the maternity hospital?

Tuberculosis is considered a dangerous infectious pathology. Koch's bacillus affects the lungs and bones.
Complications of the disease are amyloidosis, lung cancer, pneumothorax, pulmonary hemorrhage, atelectasis, fistulas, renal and pulmonary heart failure.

Children have a hard time suffering from tuberculosis. Often their pathology ends in death. Therefore, it is important to protect the newborn from infection with the tuberculosis bacillus.

The only reliable preventative measure is vaccination. BCG vaccination is included in the National Calendar of Russia and is considered mandatory. However, parents have the right to refuse vaccination. Sometimes immunoprophylaxis is postponed for medical reasons.

Children are not vaccinated in the maternity hospital in the following cases:

• prematurity;
• congenital immunodeficiency (HIV, psoriasis);
• malignant blood diseases;
• intrauterine infection;
• increased body temperature;
• jaundice;
• pathologies of purulent-septic type;
• intrauterine malnutrition of 3-4 degrees;
• tuberculin intolerance.

In such cases, the child is given a temporary or lifelong medical exemption. If the newborn is completely healthy, then you should not refuse vaccination. The likelihood of developing severe consequences of tuberculosis is much higher than the risk of complications from vaccination.

It is especially important to vaccinate children living in regions with a poor epidemiological situation. It has been mandatory to vaccinate children against tuberculosis in Russia since 1962. During this time, it was possible to significantly reduce the number of deaths from this pathology among children.

If parents are afraid of the consequences of the BCG vaccine, then BCG-M can be given. This drug is much easier to tolerate.

Do's and Don'ts

Within a day after vaccination, you can wash the injection site. However, you should not rub it with a washcloth or use products containing aggressive substances for cleansing.

A full reaction to the introduction of the tuberculosis vaccine occurs after 1-1.5 months.

During this period, a red papule appears first. It is often very itchy. You should not scratch the injection site. Subsequently, an abscess forms, protruding above the skin. This is a normal reaction to the administered vaccine, so you should not treat it with antiseptics or try to squeeze out pus. When bathing, it is advisable not to use a washcloth to clean the injection site, so as not to injure the abscess. It should heal on its own and form a scar.

Revaccination with BCG

It is believed that vaccination in the maternity hospital provides long-term immunity. Repeated administration of the vaccine is called revaccination and is carried out at different times according to the epidemiological situation. As a rule, in Russia, BCG revaccination is carried out at 7 and 14 years of age.

Before vaccination, a Mantoux test must be done. It shows how actively the body reacts to tuberculosis agents. A complete lack of reaction indicates that the first vaccination did not produce results, and too strong a reaction indicates either an allergization of the body with tuberculin, or the presence of the causative agent of human tuberculosis (field strain).

Features of preparation for the procedure

• clinical blood test;
• blood test for the presence of antibodies to tuberculosis;
• immunogram;
• fecal analysis for helminth eggs;
• urine test;
• identification of an allergic reaction to the components of the drug.

In addition, the child should be examined by a pediatrician. Only after this the decision about vaccination is made.

The vaccine contains live mycobacteria of the BCG-1 strain, which, when entering the human body, lead to the formation of long-term immunity to.

The decoding of BCG is a tracing of the Latin abbreviation (BCG), it stands for bacillus Calmette-Guerin, which means “bacillus Calmette-Guerin”.

The BCG vaccine can accommodate a variety of Mycobacteria bovis subtypes. The composition of this vaccine has remained the same since 1921.

The culture of mycobacteria that are used to make the vaccine is obtained by inoculating bacilli on a special nutrient medium. For one week, this culture grows on the medium, then it is isolated and filtered. After this, it is concentrated and made into a mass of homogeneous consistency.

As a result, the vaccine contains a certain amount of both dead and live bacteria. In this case, a single dose of the vaccine can contain a different number of bacterial cells, this depends on the subtype of mycobacteria, as well as on what technique was used in the process of manufacturing the vaccine preparation.

Release form

The BCG vaccine is produced in the form lyophilisate , which is subsequently used to prepare a suspension that is administered intradermally.

Available in the form of a porous powdery hygroscopic mass, also produced in the form of white or cream-colored tablets.

The vaccination dose contains 0.05 mg of bacteria in 0.1 ml of solvent (sodium chloride 0.9%).

5 ampoules of vaccine complete with solvent (also 5 ampoules) are packed in a cardboard box.

Pharmacological action

Tuberculosis is one of the most dangerous infections, and it can develop in a child from the first days of his life. Its effectiveness depends on when the BCG vaccination is given. The earlier vaccination is carried out (as a rule, it is done on the third to seventh day), the more pronounced its effectiveness will be under the condition of contact with infection.

In the process of reproduction of live mycobacteria of the BCG-1 strain in the body of a person who has been vaccinated, a long-term form of tuberculosis gradually develops. The formation of full immunity against tuberculosis occurs over the course of about one year.

The response to BCG vaccination in newborns determines whether immunity has developed. Vaccination has been carried out successfully if a scar appears on the shoulder, and in the place where the BCG vaccine was administered, the consequences of locally suffered skin tuberculosis are visible. Accordingly, if the scar is very small and invisible, then insufficient immunization is noted.

When weighing the pros and cons of vaccination, it should be noted that the use of the vaccine does not help reduce the spread of tuberculosis. However, vaccination provides protection against severe forms of the disease, which are especially dangerous for children's health.

Pharmacokinetics and pharmacodynamics

The duration of immunity after vaccination is unknown.

Indications for use

• children of the first year of life staying in places where there is a very high level of tuberculosis;
• children in the first year of life, as well as children of school age who have an increased risk of contracting tuberculosis;
• those who have a lot of contact with people who have been diagnosed with tuberculosis in a form resistant to many medications.

Contraindications for BCG

The following contraindications for BCG vaccination have been noted:

• birth of a child prematurely (provided that the birth weight is less than 2500 g);
• intrauterine infection;
• development of acute diseases (it is necessary to postpone the introduction of vaccination until the exacerbation is over);
• purulent-septic diseases;
• severe and moderate forms of hemolytic disease in newborns;
• primary ;
• the presence of neurological symptoms in severe damage to the nervous system;
• generalized skin lesions;
• the presence of malignant tumors;
• simultaneous use of immunosuppressants;
• carrying out radiation therapy (vaccination can be practiced only 6 months after completion of treatment);
• the presence of generalized tuberculosis in other family members;
• diagnosed in the mother.

The same contraindications are noted for the administration of the BCG-M vaccine.

Revaccination is not carried out in the following cases:

• during acute diseases, both infectious and non-infectious;
• for acute manifestations;
• with immunodeficiency;
• in the event of the appearance of neoplasms and malignant blood diseases;
• when undergoing radiation therapy or taking immunosuppressants (booster vaccination can be carried out only six months after completion of such therapy);
• tuberculosis (also a history of illness or infection with mycobacteria);
• with a positive or questionable Mantoux reaction;
• in case of contact with patients who have infectious diseases;
• when complicated reactions to the vaccine administration occur (in particular, if complications of BCG vaccination were noted in the form of a keloid scar).

Side effects

The occurrence of side effects is determined by the ingredients of the BCG vaccine, what it is, and how it acts on the body. It should be noted that the drug contains live BCG mycobacteria, therefore, a reaction to BCG vaccination invariably occurs. What such manifestations may look like is clearly demonstrated by photographs of the reaction to the BCG vaccination.

During the normal course of the process, a specific reaction appears at the site where the vaccine is injected intradermally; a papule with a diameter of 5-10 mm develops. If vaccination was carried out on newborns, a normal reaction will appear after 4-6 weeks. Reverse development of the reaction occurs within 2-3 months, sometimes it is a longer process. With revaccination, the development of a local reaction is observed 1-2 weeks after administration of the drug.

Complications after vaccination may occur at different times after administration of the drug. Symptoms of the consequences of BCG complications are most often observed in the first six months after administration of the vaccine.

In general, complications in newborns and older children can be severe or mild. Heavy complications after vaccination in newborns are associated with generalization of infection. Lungs arise due to non-compliance with the technique of administering the drug or its poor quality.

The most common manifestation after vaccination and revaccination is cold abscesses, and also lymphadenitis . The manifestation of lymphadenitis is often associated with the quality of the drug, dosage, and administration technique.

The development of cold abscesses is noted if the vaccine gets under the skin during administration. The quality of the drug also influences the development of such negative manifestations. If a cold abscess was discovered untimely, then it opens spontaneously after the graft has festered. As a result, an ulcer appears at this place. A photo of a cold abscess after BCG clearly demonstrates the features of this complication.

If local reactions after vaccination occur very violently, a infiltrate. Subcutaneous infiltration occurs due to too deep administration of the vaccine. It is important to consult a specialist in a timely manner so that the infection does not have time to move into the bloodstream.

It is also possible that keloid scar , as consequences of chronic inflammation in the proliferation stage. This complication occurs relatively rarely, but it should be taken into account that this complication more often occurs in newborns.

Very rarely appears as a complication osteitis , that is, bone tuberculosis. This disease can appear 0.5 - 2 years after immunization; it, as a rule, indicates serious disturbances in the functions of the child’s immune system.

In rare cases, a child may experience a slight increase in body temperature after an injection, most often this is a small, short-term increase.

If these and other side effects develop, it is important to immediately contact a specialist.

Instructions for use (Method and dosage)

The instructions for the vaccine stipulate that the drug is administered to a person three times in his life. The first vaccination is carried out 3-7 days after the child is born, followed by BCG vaccination at 7 years of age. After this, the vaccine is given at 14 years of age.

In this case, the connection between BCG and Mantoux should be taken into account: revaccination at 7 years of age and at 14 years of age is carried out only if the Mantoux test is negative. Also, revaccination is not carried out in areas where there is a relatively low prevalence of the disease.

If a child has contraindications, the vaccine can be administered to him if his condition returns to normal. Before administering the drug, the child must undergo a Mantoux test. If the test is negative, vaccination should be carried out as soon as possible. If the test is positive, the vaccine is not administered.

Do not use syringes whose expiration date has expired. After the injection, the syringe, needle and used cotton swabs should be soaked in a disinfectant solution, after which all this should be destroyed. Before use, the ampoules must be carefully inspected and determined whether they have been damaged or whether the expiration date has expired.

The vaccine, which has already been dissolved, must be protected from exposure to sunlight; it can be stored after dilution for one hour. Unused vaccine is destroyed at a temperature of 126 degrees by autoclaving.

The drug should be injected into the outer side of the left shoulder. The location is determined so that the vaccine is administered at the border between the upper and middle third of the arm. It is very important to administer the medicine intradermally; other methods of administration are unacceptable. Provided that for certain reasons it is not possible to administer the vaccine into the shoulder, you can choose another place with thick skin. Most often in this case it is injected into the thigh.

BCG should only be administered using a disposable syringe, and the needle should have a short bevel. To prevent complications, you need to administer the drug correctly. Before inserting it, the skin needs to be stretched, and then a little solution is injected. If the needle was inserted intradermally, then the entire solution is injected. Next, a white papule appears at the injection site, which is from 5 to 10 mm in diameter. It disappears after 15-20 minutes.

As a rule, BCG and BCG-M vaccines are administered in the maternity hospital or in the clinic where the child is observed. After vaccination, you should carefully care for the area where the drug was administered. Under no circumstances should you lubricate this area of ​​skin with antiseptics.

Please note that there are normal reactions after a child is given a vaccine. So, if the vaccine in a newborn turns red, this indicates the normal course of the process.

After a newborn has been vaccinated, a normal reaction in an infant appears after 1-1.5 months. After repeated administration of the vaccine to children aged 7 and 14 years, the reaction develops earlier, after 1 or 2 weeks. After the reaction develops, you should not rub or scratch the area; you should wash the child very carefully.

The vaccination reaction is as follows: a pustule or papule is formed, and slight suppuration is noted in the place where the vaccine was administered. Gradually, after 2-3 months, the wound heals. A small scar should remain at the site of this wound. If there is none, it means the vaccine was administered incorrectly. The wound can take up to 4 months to heal.

Overdose

When an excessive amount of vaccine is administered, the likelihood of developing purulent lymphadenitis increases. Subsequently, too large a scar may also form.

Interaction

Other preventive vaccinations can be given only at intervals of one month before or after the administration of the tuberculosis vaccine. The only exception is vaccination against viral hepatitis B .

Terms of sale

You can get vaccinated in the maternity hospital after the birth of the child or in the clinic.

Storage conditions

The drug should be stored or transported at a temperature not exceeding 8 degrees.

Best before date

Can be stored for 2 years. After this, the vaccine is unusable.

Special instructions

When deciding whether or not to vaccinate their child with BCG, parents should carefully read the recommendations given by experienced pediatricians (for example, Evgeny Komarovsky and others).

All arguments should be taken into account, clearly understanding what the BCG vaccination is for and what the risk will be if parents deliberately refuse to have it.

After vaccination, a child’s immunity can last for about 5 years. To maintain immunity, revaccination is carried out.

The Mantoux test is performed on a vaccinated child according to a schedule and allows you to determine what the child’s anti-tuberculosis immunity is at the moment.

Vaccination and revaccination should be carried out only by specially trained physicians working in specialized medical institutions. It is prohibited to administer the vaccine at home.

Before vaccination in the clinic, the child must first be examined by a specialist.

Analogues

There are TB vaccine options. The difference between BCG and BCG-M is the content of microbial bodies in the composition. The BCG-M vaccination contains a smaller amount of them; it is also used for specific prevention of tuberculosis, but it is used when gentle immunization is necessary - for premature babies, weakened children, etc.

For children

It is used for vaccination of patients in childhood - on the 3rd - 7th day after birth, at 7 and 14 years of age.

It is important to adhere to the vaccination calendar and all rules for administering the drug.

Newborns

Newborns, depending on their condition, receive BCG or BCG-M vaccines in the maternity hospital.

Among unvaccinated children it was 6 times higher than among vaccinated children, and amounted to 26.8 cases per 100,000.

At the moment, the effectiveness of vaccine prophylaxis against mycobacteriosis pathogens (eg. Mycobacterium kansasii).

Every year there are cases of post-vaccination complications. The disease caused by the BCG strain is called BCJit and has its own characteristics of the development of the tuberculosis process.

Indications

BCG - Active specific prevention of tuberculosis:

• primary vaccination of healthy newborns on days 3-5 of life;
• revaccination of children aged 7 years.

BCG-M - Active specific prevention of tuberculosis (for gentle primary immunization):

• in premature newborns weighing 2000 g or more when restoring their original body weight (in the maternity hospital, the day before discharge to home);
• in children with a body weight of 2300 g or more (in the departments for nursing premature newborns in medical hospitals (2nd stage of nursing), before discharge from the hospital home);
• in 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 (in children's clinics);
• in all newborns in territories with a satisfactory epidemiological situation for tuberculosis.

Contraindications

For BCG vaccination

• prematurity (birth weight less than 2500 g);
• acute diseases (vaccination is postponed until the end of the exacerbation);
• intrauterine infection;
• primary immunodeficiency;
• radiation therapy (vaccination is carried out 6 months after the end of treatment);
• generalized tuberculosis in other children in the family;
• HIV infection in the mother.

For revaccination

BCG-M

• prematurity (birth weight less than 2000 g);
• acute diseases (vaccination is postponed until the end of acute manifestations of the disease and exacerbation 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;
• primary immunodeficiency;
• malignant neoplasms;
• simultaneous use of immunosuppressants;
• radiation therapy (vaccination is carried out no earlier than 6 months after the end of treatment).

Story

Public acceptance of the vaccine has been difficult, in part due to tragedies. In Lübeck, 240 newborns were vaccinated at 10 days of age. All of them fell ill with tuberculosis, 77 of them died. An investigation revealed that the vaccine was contaminated with a virulent strain that was stored in the same incubator. The blame was placed on the director of the hospital, who was sentenced to 2 years in prison for negligence resulting in death.

The first large clinical study evaluating the effectiveness of BCG was conducted from 1963 to almost 60,000 BCG-vaccinated schoolchildren aged 14-15 years. This study showed 84 percent effectiveness up to 5 years after immunization. However, a study by US health authorities in Georgia and Alabama, published in, showed an effectiveness of 14% and prompted the US to abandon the implementation of mass immunization with BCG.

A subsequent study conducted in southern India and published in Chingleput showed no protective effect. In terms of rigor and scope, this was perhaps the most rigorous, blinded, controlled randomized trial. 260 thousand children were randomly divided into 2 groups, the first of which received the BCG vaccine, and the second - a placebo. Observation of vaccinated both groups lasted 7 and a half years. As a result, the researchers found that the incidence of tuberculosis in the vaccine group was slightly higher than in the equally sized placebo group.

The duration of BCG protection is unclear. Studies that found a protective effect did not provide consistent data. The UK's Medical Research Council (MRC) conducted a trial which showed that immunity declined to 59% after 15 years and to "less than zero" after 20 years. A study of American Indians vaccinated in the 1930s found evidence of protection after 60 years, with only slightly diminished effectiveness.

The BCG vaccine is considered to be most effective against disseminated tuberculosis and cerebral tuberculosis. For this reason, it is still widely used even in countries where its effectiveness against pulmonary tuberculosis has not been confirmed, such as India. There is a brief publication in the Indian Pediatric Journal questioning this ability of BCG in Indian conditions, showing that even properly vaccinated children develop disseminated tuberculosis in the case of poor nutrition and unsatisfactory social and living conditions.

Reasons for Variable Performance

The reasons for the different effectiveness of BCG in different countries are difficult to understand. The following reasons have been suggested, but none have been scientifically proven:

Application

The main use of BCG is vaccination against tuberculosis. It is recommended to administer intradermally. BCG vaccination can give a false positive reaction to the Mantoux test, but a particularly strong reaction usually indicates a disease, except in cases of allergies. Does not affect the results of the quantiferon test.

The frequency and age of BCG vaccination varies from country to country.

Methods of administering BCG

• Austria Andorra Belgium Germany Greece Denmark Spain Italy Cyprus Luxembourg Malta Netherlands Norway Slovenia France Czech Republic Switzerland Sweden has abandoned mass BCG vaccination since 2006 after an outbreak of BCG infection

Some of them vaccinate all older children or are limited to children at risk.

Other uses

Side effects

The BCG anti-tuberculosis vaccine is a preparation made from a live culture of BCG-mycobacteria, therefore it is not possible to avoid post-vaccination complications. Complications with BCG vaccination have been known for a long time and have accompanied it since the beginning of its mass use.

Complications in children are diagnosed at different times from the moment the vaccine is administered. In the first 6 months after vaccination, 68.7% of complications are detected, from 6 to 12 months - 11.6%, a year or later after vaccination - 19.7%. According to the Order of the Ministry of Health and Medical Industry of Russia dated November 22, 1995 No. 324 and the instructions of the Ministry of Health of Russia dated June 6, 1994 No. 13−01/13−20, a Republican Center was created at the Russian Research Institute of Phthisiopulmonology of the Ministry of Health of Russia (now the Research Institute of Phthisiopulmonology of MMA named after I.M. Sechenov) on complications of tuberculosis vaccination.

In the structure of complications developing after vaccination in the clinic and after revaccination, cold abscesses are more often noted (50.8% and 33.0%, respectively), and after vaccination in the maternity hospital - lymphadenitis (71.4%, frequency 0.31-0 .39 per 1 million vaccinations). The occurrence of lymphadenitis depends on the quality of the vaccine, its dose, the age of the vaccinee and the technique of intradermal administration. Cold abscesses are usually the result of improper vaccine administration technique when the drug gets under the skin. However, the influence of vaccine quality on the occurrence of this complication cannot be completely denied. If a cold abscess (not to be confused with an abscess) is not detected in a timely manner, it spontaneously opens and an ulcer forms in its place. Infiltrates are formed during a rapidly occurring local vaccination reaction.

• Category 1: local lesions (subcutaneous infiltrates, cold abscesses, ulcers) and regional lymphadenitis.
• Category 2: persistent and disseminated BCG infection without death (lupus, osteitis).
• Category 3: disseminated BCG infection, a generalized lesion with a fatal outcome, noted in congenital immunodeficiency.
• Category 4: post-BCG syndrome (erythema nodosum, granuloma annulare, rash).

Traditionally, complications of BCG vaccination are considered to be proven if the vaccine strain has been isolated, however, in practice this is only possible if there is a cold abscess or peripheral lymphadenitis. In this case, direct puncture of the lesion and isolation of the pathogen is possible. However, in most cases it is not possible to do this, therefore, when diagnosing complications of BCG vaccination, it is necessary to focus primarily on anamnesis and clinical data.

We should not forget that confirmed cases are analyzed, but confirmation occurs by cultural diagnostics, by identifying a specific set of resistance to antibacterial drugs. Sectional material (for example, in the case of the death of a child) is not submitted for culture, and only the general diagnosis of tuberculosis is confirmed by the histological method. [ ]

See also

Notes

1. Perelman M. I. Doctor's consultant. Phthisiology. - M.: GEOTAR-Media, 2007. - S. (Chapter 32). - ISBN 978-5-9704-1234-3 ..
2. Chistovich A. N. Pathological anatomy and pathogenesis of tuberculosis. - M.: Medicine, 1973. - P. 18−20.
3. Otten T. F., Vasiliev A. V. Mycobacteriosis. - St. Petersburg. : Medical press, 2005. - P. 134.
4. Romanus V., Hallander H. O. Atypical mycobacteria in extrapulmonary disease among children. Incidence in Sweden from 1969 to 1990, related BCG-vaccination coverage // Tuberc. Lung Dis. - 1995. - T. 75. - P. 300−310.
5. two tuberculin units. International tuberculin unit- unit of tuberculin activity corresponding to the activity of 0.028 μg of a standard preparation of dry purified tuberculin.
6. Fine PEM, Carneiro IAM, Milstein JB, Clements CJ. Issues relating to the use of BCG in immunization programs. - Geneva: WHO, 1999.
7. Rosenthal SR. BCG vaccination against tuberculosis. - Boston: Litte, Brown & Co., 1957.
8. P. E. M. Fine PhD, Prof. (1995). “Variation in protection by BCG: implications of and for heterologous immunity.” The LANCET. 346 : 1339-1345.
9. Colditz GA, Brewer TF, Berkey CS; et al. (1994). “Efficacy of BCG Vaccine in the Prevention of Tuberculosis.” J Am Med Assoc.. 271 : 698-702.
10. Hart P. D., Sutherland I. (1977). “BCG and vole bacillus vaccines in the prevention of tuberculosis in adolescence and early adult life. Final Report of the Medical Research Council.” Brit Med J. 2 : 293-95.
11. Comstock GW, Palmer CE. (1966). “Long-term results of BCG in the southern United States.” Am Rev Resp Dis. 93 (2): 171-83.
12. https://www.ncbi.nlm.nih.gov/pubmed/10573656
13. Indian Council of Medical Research in collaboration with WHO. Trial of BCG vaccines in South India for tuberculosis prevention // Indian J Med Res. - 1979. - No. 70. - pp. 349-363.
14. Editorial. BCG: Bad news from India // Lancet: magazine. - 1980. - No. January 12. - pp. 73-74.
15. Aronson NE, Santosham M, Comstock GW; et al. (2004). “Long-term efficacy of BCG vaccine in American Indians and Alaska Natives: A 60-year follow-up study.” JAMA. 291 (17): 2086-91. PMID 15126436 .

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Active ingredient:

Instructions for medical use

Instructions for medical use - RU No.

Last modified date: 27.04.2017

Dosage form

Lyophilisate for preparing a suspension for intradermal administration.

Compound

One dose of the drug contains:

Active ingredient: microbial cells BCG - 0.05 mg.

Excipient: sodium glutamate monohydrate (stabilizer) - no more than 0.3 mg.

The drug does not contain preservatives or antibiotics.

Produced complete with a solvent - sodium chloride solvent for the preparation of dosage forms for injection 0.9%.

Description of the dosage form

A porous mass, powdery or in the form of a thin openwork tablet of white or light yellow color, easily separated from the bottom of the ampoule when shaken. Hygroscopic.

Pharmacological group

MIBP vaccine.

Pharmacological (immunobiological) properties

Live mycobacteria vaccine strain Mycobacterium bovis, substrain BCG-I multiplying in the body of the vaccinated person, leading to the development of long-term immunity to tuberculosis.

Indications

Active specific prevention of tuberculosis in children in areas with tuberculosis incidence rates exceeding 80 per 100 thousand population, as well as in the presence of tuberculosis patients in the newborn’s environment.

Contraindications

Vaccination:

1. Prematurity, birth weight less than 2500 g.

2. Intrauterine malnutrition of III-IV degree.

3. Acute diseases and exacerbation of chronic diseases. Vaccination is postponed until the end of acute manifestations of the disease and exacerbation 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.).

4. Children born to mothers who were not tested for HIV during pregnancy and childbirth, as well as children born to HIV-infected mothers who did not receive three-stage chemoprophylaxis for mother-to-child transmission of HIV, are not vaccinated until the child’s HIV status is established at the age of 18 months.

5. Immunodeficiency state (primary), malignant neoplasms.

When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.

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

Vaccination against tuberculosis of children born to mothers with HIV infection and who received three-stage chemoprophylaxis for mother-to-child transmission of HIV (during pregnancy, childbirth and the neonatal period) is carried out in the maternity hospital with the tuberculosis vaccine for gentle primary immunization (BCG-M).

Children who have contraindications to immunization with the BCG tuberculosis vaccine are vaccinated with the BCG-M vaccine in accordance with the instructions for this vaccine.

Revaccination:

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

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

3. Patients with tuberculosis, persons who have had tuberculosis and are infected with mycobacteria.

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

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

6. HIV infection, detection of HIV nucleic acids by molecular methods.

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

Use during pregnancy and breastfeeding

Directions for use and doses

The BCG vaccine is used intradermally at a dose of 0.05 mg in a volume of 0.1 ml of solvent (sodium chloride solvent for the preparation of dosage forms for injection 0.9%).

Primary vaccination is carried out on healthy newborn children on days 3-7 of life (usually on the day of discharge from the maternity hospital).

Children who were not vaccinated during the neonatal period due to illness receive the BCG-M vaccine after recovery. Children aged 2 months and older are first given a Mantoux test with 2 TE of purified tuberculin in a standard dilution and only those who are tuberculin-negative are vaccinated.

Children aged 7 years who have a negative reaction to the Mantoux test with 2 TE PPD-L are subject to revaccination. The Mantoux test is considered negative in the complete absence of infiltration, hyperemia, or in the presence of a prick reaction (1 mm). Children infected with Mycobacterium tuberculosis 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 maternity hospitals (departments), departments for the care of 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, children are pre-selected for vaccination by a doctor (paramedic) with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history. If necessary, consultations with medical specialists and blood and urine tests are carried out. When carrying out revaccination in schools, all of the above requirements must be met. To avoid contamination with live mycobacteria BCG, it is unacceptable to combine vaccination against tuberculosis with other parenteral procedures on the same day.

The fact of vaccination (re-vaccination) is recorded in established registration forms indicating the date of vaccination, name of the vaccine, manufacturer, batch number and expiration date of the drug.

The vaccine is dissolved immediately before use with the sterile diluent 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 vaccine is sealed under vacuum, so first cut it down and carefully, using tweezers, break off the sealing area. 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 of solvent, 1 ml of sodium chloride of solvent for the preparation of dosage forms for injections of 0.9% is transferred into an ampoule containing 10 doses of the vaccine with a sterile syringe. The vaccine should dissolve within 1 minute. The presence of flakes is allowed, which should be broken by gently shaking 3-4 times and mixing the contents by withdrawing them back into the syringe. The dissolved vaccine has the appearance of a coarse suspension of white color with a grayish or yellowish tint, without foreign inclusions. If there are large flakes in the diluted preparation that do not break up when mixed 4 times with a syringe, or sediment, the vaccine is not used and the ampoule is destroyed.

The diluted vaccine must be protected from sunlight and daylight (for example, with a cylinder of black paper) and used immediately after dilution. The diluted vaccine is suitable for use for no more than 1 hour when stored under aseptic conditions at a temperature of 2 to 8 °C. It is mandatory to maintain a protocol indicating the time of dilution and destruction of the vaccine ampoule.

For one vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn up with a tuberculin syringe, then about 0.1 ml of the vaccine is released through a needle into a sterile cotton swab in order to displace the air and bring the syringe piston to the desired graduation - 0.1 ml. Before each set, the vaccine should be carefully mixed 2-3 times using a syringe. Vaccination is carried out immediately after drawing the vaccination dose into the syringe. 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% ethyl alcohol. The needle is inserted with the cut upward into the superficial area 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.

Side effects

At the site of intradermal administration of the BCG vaccine, a local specific reaction consistently develops in the form of infiltrate, papules, pustules, and ulcers measuring 5-10 mm in diameter. In primary vaccinated people, 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 mm in diameter forms at the vaccination site.

Complications after vaccination they are rare and usually have a local character (lymphadenitis - regional, often axillary, sometimes supra- or subclavian, less often - ulcers, keloid scar, “cold” abscesses, subcutaneous infiltrates). Persistent and disseminated BCG infection without a fatal outcome (lupus, osteitis, osteomyelitis, etc.), post-BCG syndrome of an allergic nature, which occurs soon after vaccination (erythema nodosum, granuloma annulare, rashes, anaphylactic shock), are very rare. cases - generalized BCG infection with congenital immunodeficiency. Complications are detected at various times after vaccination - from several weeks to a year or more.

Overdose

Cases of overdose have not been established.

Interaction

Other preventive vaccinations can be carried out at an interval of at least 1 month before and after BCG vaccination. An exception is vaccination for the prevention of viral hepatitis B in the case of primary immunization.

Precautions

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

For vaccination (re-vaccination), disposable sterile tuberculin syringes with a capacity of 1 ml with thin needles with a short cut are used. To add the solvent into the ampoule with the vaccine, use a disposable sterile syringe with a capacity of 2 ml with a long needle. It is prohibited to use syringes and needles that have expired and insulin syringes that do not have ml graduations. It is prohibited to vaccinate with a needleless injector. After each injection, a syringe with a needle and cotton swabs are soaked in a disinfectant solution (5% chloramine B solution or 3% hydrogen peroxide solution) and then centrally destroyed. It is prohibited to use instruments intended for vaccination against tuberculosis for other purposes. The vaccine is stored in a refrigerator (locked) in the vaccination room. Persons unrelated to BCG vaccination are not allowed into the vaccination room.

Vaccine ampoules are carefully inspected before opening.

The drug should not be used if:

• absence of a label on the ampoule or markings that do not allow identification of the drug;
• expired;
• the presence of cracks and notches on the ampoule;
• changing the physical properties of the drug (change in color, etc.).

It is prohibited to apply a bandage and treat the site of vaccine administration with iodine and other disinfectant solutions during the development of a local vaccination reaction: infiltrate, papules, pustules, ulcers.

Vaccine prevention of tuberculosis is carried out in accordance with Order of the Ministry of Health of Russia No. 109 “On improving anti-tuberculosis measures in the Russian Federation” dated March 21, 2003.

Special instructions

Unused vaccine is destroyed by boiling for 30 minutes, autoclaving at a temperature of 126 ºC for 30 minutes, or immersing opened ampoules in a disinfectant solution (5% chloramine B solution or 3% hydrogen peroxide solution) for 60 minutes.

Information about the possible effect of the drug on the ability to drive vehicles and machinery.

Not applicable. The drug is used to vaccinate children.

Release form

Lyophilisate for the preparation of a suspension for intradermal administration, 0.05 mg/dose - 10 doses per ampoule. Produced complete with a solvent - sodium chloride solvent for the preparation of dosage forms for injection 0.9%. Solvent - 1 ml per ampoule.

The kit consists of 1 ampoule of vaccine and 1 ampoule of solvent.

5 sets in a cardboard pack. The pack contains instructions for use and an ampoule knife or ampoule scarifier.

Storage conditions

Storage conditions.

In accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 °C out of the reach of children.

Transportation conditions.

In accordance with SP 3.3.2.3332-16 at temperatures from 2 to 8 °C.

Best before date

2 years. A drug that has expired cannot be used.

Conditions for dispensing from pharmacies

For medical and preventive institutions.

R N001969/01 dated 2018-07-25
Tuberculosis vaccine (BCG) - instructions for medical use - RU No. LS-000574 dated 2017-01-25
Tuberculosis vaccine (BCG) - instructions for medical use - RU No. LS-000574 dated 2017-01-25
Tuberculosis vaccine (BCG) - instructions for medical use - RU No.

Tuberculosis is a dangerous disease, protection against which is necessary from childhood. That is why parents should make sure that their child receives everything while still in the hospital. Awareness of the effect and contraindications is the knowledge necessary to maintain the baby’s health.

Indications for vaccination against tuberculosis

There are several categories of citizens who are allowed. These include:

1. infants without congenital pathologies and identified contraindications. The first injection is given on the third to fifth day of life;
2. children and teenagers. The standard time for revaccination is 7 years;
3. healthy adults under 30 years of age.

It is worth noting that vaccination is not carried out if a person is sick with tuberculosis. The approximate period for the formation of immunity is 2 months.

Preparing for vaccination

An important part of preventive actions is proper preparation for vaccination. The main preparatory steps are to identify contraindications and check the baby’s well-being. Make sure the baby is not constipated, is not sick, or has direct contact with infected people.

Contraindications to BCG for newborns

Before vaccination, pathologies and contraindications are identified in newborns, which may cause them.

BCG vaccination is contraindicated if:

1. the baby's weight at birth is less than 2 kilograms;
2. . If the disease does not cause any complications, then the vaccination is given after its completion;
3. jaundice;
4. the mother has a newborn;
5. intrauterine infections;
6. skin lesions in an infant;
7. manifestation of symptoms of tuberculosis in other family members;
8. hemolytic disease. Vaccination is permitted if the disease is mild;
9. radiation therapy. The vaccination is given at the end of the treatment period (six months after cessation of therapy);
10. damage to the nervous system;
11. malignant formations.

There is one more, most important contraindication that can make life difficult for a baby – vaccination.

Contraindications for revaccination

Revaccination is a standard procedure that is most often carried out in schools for children aged seven.

Before revaccination, it is necessary to identify the presence of dangerous contraindications in the child:

1. immunodeficiency;
2. the presence of allergic reactions;
3. presence of infected people around;
4. various blood diseases;
5. acute diseases. Including seasonal flu;
6. If the child has received another vaccination, the recommended waiting interval of one month must be observed.

If a child has at least one of the contraindications, BCG vaccination should be excluded.

Post-vaccination period

The successful course of the post-vaccination period largely depends on compliance with the necessary safety measures, such as refusal to vaccinate during periods of illness or contact with infected people.

How can you find out if your baby is allergic to a vaccine?

Identifying allergic reactions to vaccines has become a very simple process. To do this, doctors inject the microbacterium tuberculin into the blood in advance to identify specific reactions of the body. This procedure is also called.

The main signs related to the manifestation of allergies include:

1. severe redness of the skin around the injection site. It is also possible for rashes to appear on other parts of the body;
2. sleep and appetite disturbances, general weakness.

However, the Mantoux reaction does not give an absolute result. Other components contained in the vaccine may cause unpleasant symptoms. If an allergic reaction is detected, additional tests are performed.

Complications due to non-compliance with contraindications to immunization

The most dangerous thing that can happen to a child is complications after vaccination. In this case, there is a risk of serious consequences.

The most serious complications can be:

1. increase in body temperature up to 40 degrees;
2. serious allergic reactions, including swelling that makes it difficult for the baby to breathe;
3. anaphylactic shock;
4. infections that cause blood damage;
5. skin diseases, including seborrhea;
6. damage to mucous membranes and skin.

If the prescribed instructions are not followed, the baby may find himself in a difficult situation and appears. A similar situation may arise if the conditions for the post-vaccination period are not met.

Medical advice from BCG vaccination in the maternity hospital

If parents are not sure about the safety of the measures being taken, they should discuss this issue with their pediatrician. You can postpone vaccination for a while so that parents can make the final decision without harm to the child’s health.

However, you can refuse vaccination only after talking with your doctor. It is he who assesses the situation in which refusal to vaccinate will not be dangerous for the newborn in the future.

The reason for medical withdrawal may be contraindications, which include:

1. the presence of a tumor, regardless of its location;
2. tuberculosis infection. For this they are used. Suspicion of the presence of infection can be caused by a papule size of more than ten millimeters. But such a result may also indicate recent contact with a person with tuberculosis;
3. blood diseases;
4. HIV infection.

The reason for refusing vaccination is given to the newborn. At the same time, parents need to remember the consequences of refusal.

Consequences of refusing the BCG vaccination

Refusal to vaccinate entails certain consequences that may affect the future of the family and the child.

The most dangerous consequence may be a serious illness resulting from the lack of developed immunity.

Also, a child whose medical record does not contain a vaccination label has restrictions related to admission to a kindergarten or educational institution.

In addition, parents will not be able to travel abroad with their child until a compelling reason for refusing vaccination is identified.

Video on the topic

About contraindications to BCG vaccination in the video:

Remember that vaccinations are necessary to keep your child healthy. This option allows the baby to develop its own immunity and receive protection from viruses in the future.