MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

PHARMACOPOEIAL ARTICLE

Tuberculosis vaccine BCGFS.3.3.1.0018.15

liveInstead of GF X, Art. 716,

FS 42-3558-98,

FS 42-3559-98

This pharmacopoeial monograph applies to the live BCG tuberculosis vaccine, which consists of mycobacteria of the vaccine strain Mycobacterium bovis, substrain BCG-1 (Russia), lyophilized in a 1.5% solution of stabilizer - sodium glutamate monohydrate. The cellular immune response that develops in response to vaccination with a tuberculosis vaccine largely depends on the activity of macrophages in which the BCG strain bacteria multiply. The mechanism of protection is to limit the spread of Mycobacterium tuberculosis from the source of infection, which is due to the formation of immunological memory of T-lymphocytes, the production of which is induced by a primary infection due to BCG vaccination.

The drug is intended for specific prevention tuberculosis.

PRODUCTION

All stages of vaccine production must be carried out in compliance with established requirements for production organization and quality control medicinal product, guaranteeing quality and safety for humans, ensuring the specific safety of the drug, excluding contamination by foreign agents. Work must be carried out in rooms equipped with independent supply and exhaust ventilation. Before inoculating mycobacteria, culture media must be tested for sterility. The vaccine at all stages of production is controlled for the absence of foreign microflora.

The technological process at all stages of production and storage must provide protection from direct exposure to light and ultraviolet radiation.

Vaccine production should be carried out by clinically healthy personnel not associated with work with other infectious agents. Personnel should not be at risk of tuberculosis infection and should undergo scheduled periodic examination to ensure the absence of tuberculosis.

The number of microbial cells of BCG and sodium glutamate monohydrate per dose is indicated in the regulatory documentation. The vaccine is produced complete with a solvent - 0.9% sodium chloride solution for injection.

TESTS

Description

The 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 (bottle), is hygroscopic.

Authenticity

Microscopy of Ziehl-Neelsen-stained smears should reveal red-stained (acid-fast) thin, straight or slightly curved rods 1-4 µm long and 0.3-0.5 µm wide, often with small swellings at the ends, not forming spores and capsules. When the vaccine is sown on dense Lowenstein-Jensen medium, after 28-30 days of incubation at a temperature of (37±1) ºС, characteristic rough, dense colonies from 0.5 to 8.0 mm in diameter should grow on the surface of the medium yellowish color with thin uneven edges. Authenticity can be confirmed by a validated molecular biological method.

INdrug recovery time

No more than 1 minute after adding the supplied solvent (0.9% sodium chloride solution) to the ampoule (bottle) to form a coarse homogeneous suspension. The presence of flakes is allowed, which must be broken up by mixing 2-4 times using a syringe or pipette.

Transparency and color of the solution

The dissolved vaccine should look like a coarse suspension of white color with a grayish or yellowish tint, without foreign inclusions. The determination is carried out visually.

Total bacteria content

The optical density should be in the range from 0.30 to 0.40, which corresponds to 1.0 mg/ml of BCG microbial cells. Tests are carried out photometric method at a wavelength of (490 ± 3.0) nm in a cuvette with a layer thickness of 5 mm. A 0.9% sodium chloride solution is used as a control sample.

The vaccine is diluted with a solvent to contain 1 mg/ml BCG cells. Tests are carried out on at least 10 samples in parallel with a standard sample (SS) of the BCG vaccine according to the methodology set out in the regulatory documentation.

Dispersity

The dispersion index must be no lower than 1.5. Tests are carried out using the photometric method (simultaneously with determining general content bacteria) according to the method outlined in the regulatory documentation. If, according to the results of the analysis, no more than 1 sample has a dispersity index below 1.5, the test is carried out on 10 additional samples. During repeated testing, the presence of samples with a dispersion index below 1.5 is not allowed.

Weight loss on drying or Water

No more than 5.0%. The test is carried out by the gravimetric method in accordance with or the titration method with K. Fisher's reagent in accordance with.

Tightness

Ampoules/bottles must be sealed. Determination is carried out only in ampoules/vials sealed under vacuum.

The gas environment in ampoules/vials with the drug should give a pale blue or pink-blue glow (10 Pa - 1000 Pa) when excited gas environment high frequency electric field(20 - 50 kHz at a voltage of 15-20 kV).

No foreign bacteria or fungi

Foreign microflora (bacteria, fungi) should be absent with the exception of mycobacteria BCG. Determination is carried out by direct seeding in accordance with.

Abnormal toxicity

The vaccine must be non-toxic. The determination is carried out in accordance with.

Specific safety

The vaccine must not contain virulent mycobacteria. The test is carried out on guinea pigs same sex weighing from 250 to 350 g, not receiving any treatment or diet with antibiotics that could affect the test results (administered test dose of 5 mg of vaccine in 1 ml of diluent):

1) two guinea pigs are injected with a vaccine under the skin inner surface hips (observe the animals for at least 12 weeks). Animals must remain healthy. After the observation period, the animals were killed. For macroscopic and, if necessary, microscopic examination internal organs there should be no signs of tuberculosis infection. If signs of tuberculosis are detected, the batch is rejected, the release of subsequent batches of the vaccine is stopped, and all available stocks of the vaccine are stored until the causes of the incident are identified.

If one guinea pig dies before the end of the observation period, if it has no signs of tuberculosis infection, the tests are repeated.

2) six guinea pigs are administered the vaccine subcutaneously or intramuscularly (observed for 6 weeks; at least 5 animals must remain alive by the end of the observation period). At the end of the observation period, the animals were killed. Macroscopic and, if necessary, microscopic examination of internal organs should show no signs of tuberculosis infection. If signs of tuberculosis are detected in at least one animal, the batch is rejected, the release of subsequent batches of the vaccine is stopped, and all available stocks of the vaccine are stored until the causes of the incident are identified.

Animals that died before the end of the observation period are opened and examined as described above. If one guinea pig dies without signs of tuberculosis infection, the test is considered completed and the drug is considered specifically safe. If two animals die, the tests are repeated.

Specific activity

Evaluated by the viability indicator - the number of viable BCG cells in 1 mg of vaccine. The upper and lower limits of the indicator are indicated in the regulatory documentation. The method of sowing the vaccine on a dense Levenstein-Jensen nutrient medium is used. Sowing is carried out in parallel with CO or a reference drug.

Thermal stability

When storing the vaccine for 4 weeks at a temperature of (37±1) o C, the number of viable microbial cells in 1.0 mg of the vaccine must be at least 25% of their original number, which is determined in samples stored at temperatures from 2 to 8 o C. Every 5th batch of the drug is subject to testing.

Production strain

Vaccine production is based on a seed-based system. Seed material (batch) - lyophilisate of substrain M. bovis BCG-1 (Russia) from the State Collection pathogenic microorganisms, Russia (GKPM No. 700001). The next seed batch of the BCG-1 vaccine strain must be made from the earliest batch (primary or secondary seed batch). The seed batch is prepared in a volume that ensures the production of the vaccine for at least 10 years, and is stored at a temperature not exceeding minus 18 o C. Total number passages for preparing seed and commercial series should not exceed 12.

The seed material (batch) must be identified as M. bovis, substrain BCG-1 (Russia) by microbiological methods and suitable molecular biological methods.

Contains at least 10 million viable BCG cells per 1 mg; must not contain virulent Mycobacterium tuberculosis. The determination is made according to the section “Specific Safety”. Control is carried out on 10 guinea pigs for 12 weeks, by the end of this period at least 90% of the animals should remain alive. Should not contain foreign microflora; have a high protective effect, which must be confirmed in experiments on guinea pigs by comparison with the previous series of inoculum; call minimum number adverse reactions in vaccinated children (but not more than 0.06% of lymphadenitis after vaccination). Determined during annual monitoring of post-vaccination complications.

The issue of combating tuberculosis occupies a lot of time among the luminaries of medical science around the world. Insidious disease spreads quickly, the number of cases increases every year, and treatment is long and requires significant material costs. In addition, many forms of tuberculosis leave behind complications, and, unfortunately, deaths occur. No matter how much medical scientists rack their brains, so far the most effective measure Vaccination (vaccination) has been and remains a protection against tuberculosis.

Local pediatrician

The BCG vaccine is mandatory vaccination in our country. But it turns out that not all parents know what this vaccine is and why it is given.

The vaccine against tuberculosis is called the BCG vaccine. After numerous efforts, it was obtained for the first time in 1921 by scientists from France, microbiologist Calmette and his scientific partner, veterinarian Guerin. The BCG vaccine is made from live, but significantly weakened bovine tuberculosis bacillus. This vaccine meets all the requirements for vaccines.

It is harmless because the weakened bacterium has almost lost its ability to infect, but retains the ability to induce the formation of immunity against tuberculosis in the vaccinated body. However, despite the harmlessness of the vaccine, complications that occur after vaccination are rare (but still occur).

Many people wonder why the tuberculosis vaccine has such a strange name. It turns out that everything is very simple. BCG is the first letters of the French words Bacillus Calmette Guerin (Celmette-Guerin bacterium) reinterpreted into Russian.

Why do you get the BCG vaccine?

The main purpose of the BCG vaccination is to prevent the disease of tuberculosis, which is well known and widespread among all segments of the population.

BCG vaccination allows you to:

• protect the baby’s body not from encountering an infection, but from passing unnoticed, hidden form infection into an open form of the disease. Even a vaccinated child can become infected with tuberculosis, but vaccination will not allow the disease to develop in a severe form, there will be no complications or deaths;
• prevent the development of extremely severe and dangerous, especially in childhood, forms of tuberculosis. These forms include tuberculous meningitis, affecting the membranes of the brain, tuberculosis affecting bones and joints, as well as some dangerous forms lung lesions;
• reduce the incidence of morbidity in children.

In our country, the BCG vaccine has been given to newborns since 1926, and at first it was administered through the mouth, then they used the cutaneous method of administration, and only since 1963 they have used the intradermal method of administering the BCG vaccine to everyone age groups population, from newborns to adults.

BCG is the second vaccination that a newborn child receives while in the maternity hospital. First, the newborn is vaccinated against hepatitis B.

The main task of parents is not to listen to gossip and stories about dire consequences after vaccination, but ask the doctor in detail to find out about the vaccination and weigh the pros and cons. After all, it is you who give your consent to all vaccinations for your child, which means that his health is primarily in your hands, you are responsible for him more than anyone. Listen to what the doctor tells you, think it over carefully, try to understand why it is needed, and only then make a decision.

Types of vaccines and features of vaccination

There are two types of tuberculosis vaccines available..

1. BCG vaccine.

The tuberculosis vaccine is traditionally given in the upper third of the left shoulder. The BCG vaccine is administered only intradermally. The dose of one vaccination is 0.05 mg, it contains 0.1 ml of vaccine. Although it is very small, it is necessary to strictly follow the dosage, because the vaccine is a strong microbial agent, violation of the administration technique and dosage can cause complications after vaccination.

The injection technique for BCG-M is exactly the same, only the dosage is different: 0.1 ml of this vaccine contains only 0.025 mg of the active drug.

For vaccination and revaccination, both types of vaccine are used: BCG and BCG-M.

Everyone born is vaccinated healthy children before discharge from the maternity hospital, for whom there are no contraindications. This usually happens on the 3-7th day after the baby is born. The vaccination is done in the morning, in a room specially designed for this purpose, only after examination by a pediatrician and in the absence of contraindications.

A note is made in the developmental history of the newborn, indicating the date of vaccination, as well as the vaccine series. This data, together with an extract in mandatory are transferred to the clinic where the baby will be observed, and the local pediatrician enters them into the child’s record.

On the day of vaccination, you should not bathe your child. Usually the day of vaccination coincides with the day the mother and child are discharged from the maternity hospital, so the mother is warned about this in advance before vaccinating the baby. The day after vaccination, you can safely bathe your baby.

If in the family where the child was born there is a relative with tuberculosis, then the vaccinated newborn must be isolated for a while until immunity is developed. On average it takes 6-8 weeks. All pregnant women living next to a sick relative are registered with a TB doctor. They are monitored more closely as there is a risk of infection.

The gynecologist and pediatrician must be aware in advance, because the newborn must be isolated; the baby can be discharged only if the sick relative is hospitalized in specialized hospital or after sending him to a sanatorium for 2-3 months and disinfecting the house.

If all conditions are met, the mother and child are allowed to be discharged from the maternity hospital.

After vaccination

After vaccination you cannot:

• bathe the baby. This prohibition only applies to the day the vaccination was given. The next day, swimming is allowed;
• treat the vaccination site with various antiseptics. The healing of the vaccination is peculiar, the vaccination can fester and become covered with a crust, and many mothers ask whether it needs to be treated. There is no need to process anything, and it is very convenient, the graft heals on its own;
• rub the vaccination site;
• squeeze out the pus or tear off the crust at the injection site.

The BCG vaccination undergoes healing in several stages. This natural process, and it does not require any parental intervention. In 90-95% of vaccinated children, 5-6 months after vaccination, a small scar measuring from 3 to 10 mm forms at the injection site. This indicates successful vaccination and means that the vaccine worked and the child has developed immunity.

Stages of healing of BCG vaccination

1. A papule, swelling or redness initially forms at the site of vaccine administration.

It's completely ordinary normal reaction. It develops in everyone at their own time and can occur after a week, after two months, or maybe after six months. Therefore, do not be afraid, and when you go to your next scheduled appointment, tell your pediatrician about it. But even if you forget to report a reaction, the pediatrician himself will examine the vaccination site and note the result in the child’s record.

1. A pustule (abscess) forms in place of the papule.

This reaction often frightens parents, and they are at a loss, not knowing what to do about it. It turns out that you don't need to do anything. The abscess resembles a pimple with purulent contents in the center; there is a desire to squeeze out the contents and treat it with something disinfectant. This cannot be done. If you see that the vaccination site has festered, do not panic and control yourself. This is a normal reaction and the graft heals as expected.

1. The abscess opens, the wound becomes covered with a crust.

This is the next stage of healing, which requires parents to be patient and not interfere. The crust should also not be processed or torn off. Everything will heal well without it.

1. After the crust falls off, a scar remains at the grafting site.

This is the final healing process.

The healing process does not always go through all stages. There may not be an abscess. It happens that an abscess forms several times. Both the first and second development options are considered normal if a scar is formed as a result.

It is quite rare, but it still happens that even a year after the BCG vaccination, the scar has not appeared. This may be the result of improper administration of the vaccine, the individual reactivity of the child’s body, and if immunity against the tuberculosis bacterium has not been formed. Therefore, if the baby still does not develop a scar, he will be further examined, and then the doctor will decide whether the vaccination needs to be repeated.

One more unpleasant consequence is an increase in temperature that can occur immediately after vaccination and last for several days.

Do not be alarmed if the temperature is not very high and decreases after 2-3 days. This is normal defensive reaction body against foreign bacteria. But when high temperature more than three days, you should immediately consult a doctor.

What to do if the vaccination was not given at the maternity hospital?

There are cases when the administration of the BCG vaccine to a newborn is contraindicated.

10 situations in which vaccination should not be done.

1. If the baby was born premature at less than 36 weeks and weighing less than 2500 grams.
2. If the child was born with 2-4 degrees (delay in fetal development by two weeks or more).
3. For moderate and severe forms of newborns.
4. In case of severe damage to the nervous system with bright severe symptoms defeats.
5. For extensive skin lesions in a newborn.
6. Subject to availability acute diseases. Any disease in acute period is a contraindication to vaccination.
7. Newborn with intrauterine infection.
8. Newborn with purulent-septic diseases.
9. With HIV infection in the mother.
10. If other children living in the family have a BCG infection.

Who is vaccinated with the BCG-M vaccine?

The BCG-M vaccine is a gentle version of the tuberculosis vaccination.

The following categories of children are vaccinated with BCG-M.

1. Premature babies weighing 2000 grams or more, if they gain the weight they were born with the day before discharge.
2. Children who are undergoing rehabilitation in the prematurity care unit and have gained weight of 2300 g or more just before discharge.
3. In clinics for those children who were not vaccinated in the maternity hospital due to contraindications, if all contraindications are removed.

Children who were not vaccinated during the neonatal period are given BCG-M vaccination during the first six months of life in the clinic where they are observed. If the child is already two months old, then before vaccination against tuberculosis it is necessary to do a Mantoux test.

Vaccination with the BCG-M vaccine is contraindicated:

• premature babies born weighing less than 2000 grams;
• for acute diseases, as well as for exacerbation of any chronic diseases. The vaccination can be done after recovery or removal of an exacerbation;
• if the child has developed an intrauterine infection;
• for purulent-septic diseases;
• at severe defeat nervous system;
• in immunodeficiency conditions;
• for skin diseases with extensive lesions;
• for moderate to severe forms hemolytic disease newborns.

Before any vaccination, an examination and permission from a pediatrician is required.

Formation of immunity after vaccination

The formation of immunity from tuberculosis consists of several periods.

1. Intradermal administration of BCG vaccine.

After the vaccine is administered, tuberculosis bacteria multiply and are captured by macrophages, the body's defender cells. By capturing bacteria, they destroy and neutralize them.

1. Pre-immune period.

Starts immediately after administration of BCG and lasts 4-8 weeks before immunity is formed after vaccination. This period is characterized by the formation of a scar at the site of vaccine administration. At the same time, there are no tuberculosis bacteria in the vaccinated person’s body, there is no damage lymph nodes and other organs and tissues.

1. Immune period.

It is characterized by the appearance of immunity against tuberculosis, which is manifested by a positive Mantoux test.

1. The period of post-vaccination immunity.

It begins from the moment of appearance positive test Mantoux.

In children vaccinated after birth, immunity remains for 7 years, then revaccination is required.

This is a repeated vaccination in order to maintain the formed immunity.

Revaccination is carried out for healthy children, adolescents and adults at a certain age, if they have negative result all previous Mantoux samples. Revaccination with BCG should be carried out no earlier than three days after the Mantoux test and no later than two weeks.

For children vaccinated in the maternity hospital, the first revaccination is carried out when they reach 6-7 years of age (first grade students), the second revaccination is done at the age of 14-15 years (9th grade students).

Revaccination is not carried out:

• persons infected with tuberculosis or who have previously had tuberculosis;
• with a positive or questionable Mantoux test reaction;
• if complications arise from previous BCG vaccinations;
• during acute diseases, as well as during exacerbation of any chronic diseases;
• during exacerbation of allergic diseases;
• at malignant diseases blood and other neoplasms;
• in immunodeficiency conditions and during treatment with immunosuppressants.

Children who are temporarily exempt from vaccination are taken under observation and vaccinated after recovery and removal of all contraindications.

After the BCG vaccination and revaccination, other vaccinations can be done only after a month. During this time, immunity is formed after vaccination.

The reaction to BCG at the injection site during vaccination and revaccination varies. When revaccinating older children and adolescents, the reaction appears earlier than with vaccination, after 1-2 weeks.

Vaccinated children are monitored by local doctors together with clinic nurses. They check the reaction to the vaccine at the injection site 1, 3, 6, 12 months after vaccination and note the results in medical records.

Complications

Rarely, but still there are complications after vaccination. Usually these are complications that arise at the injection site if contraindications are not observed.

The reasons for the development of complications are as follows.

1. Incorrect technique for administering the vaccine.
2. Excess permissible dose vaccines.
3. Increased allergic background of the body.
4. State of immunodeficiency (decreased protective forces organism).

To prevent complications from developing, two rules must be followed.

1. Before vaccination, the child must be examined by a pediatrician, exclude the presence of contraindications and give permission for vaccination.
2. BCG vaccination is carried out by a nurse who is specially trained and authorized to administer vaccinations. The vaccination is done in a separate room, specially adapted for vaccination against tuberculosis.

The complications that arise after BCG vaccination are as follows.

1. Cold abscesses ( purulent inflammation, arising under the skin). This is the result of improper administration of the vaccine, which forms at the injection site 1-1.5 months after vaccination. This complication is treated by surgeons.
2. Ulcers forming at the injection site. A complication is considered to be ulcers larger than 10 mm in diameter, meaning increased sensitivity baby to the components of the vaccine. The ulcer is treated with local medications.
3. Inflammation of nearby lymph nodes. These include axillary, cervical lymph nodes and lymph nodes located above and below the collarbones. This indicates the penetration of tuberculosis bacteria into the lymph nodes.
4. Keloid scars that form at the site of vaccination after it has healed. If a keloid scar forms, the child should not be vaccinated again with BCG.
5. An extremely rare but serious complication is the development of a generalized BCG infection. It may occur if there are serious immune disorders.
6. Bone tuberculosis or osteitis. Also rare, but dangerous complication, which occurs when the immune system is impaired.

If complications develop after BCG vaccination, all children and adolescents without exception are sent for consultation to an anti-tuberculosis dispensary, where additional examination. A note is made in the child’s card about the development of a particular complication.

Conclusion

In Russia, the main documents regulating vaccinations are Federal Law about immunoprophylaxis, National calendar preventive vaccinations and a document giving consent to vaccination.

You can get all the information about the calendar from your pediatrician or find it on the Internet. The vaccination calendar includes vaccinations against diseases that pose a serious threat and danger to society. Tuberculosis is one of these diseases, so everyone should be vaccinated.

However, none of medical workers cannot vaccinate a child without obtaining the consent of his parents. Parental consent must be obtained before age 15. Moreover, only the parents (the child’s mother and father) must give consent, and not the grandmother or other relatives. Upon reaching 15 years of age, he has the right to give permission for various medical procedures.

Information about BCG vaccination publicly available. Vaccination protects against tuberculosis, preventing the development of especially severe forms and reducing the incidence of illness in children. But despite this, many parents continue to refuse vaccination.

Doubting parents are frightened by the list of complications that the pediatrician must talk about before vaccination. Here a lot depends on the pediatrician. He must clearly explain what the risk of complications is if there are no contraindications, and what the risk of developing severe tuberculosis is. Competent and sensible parents will understand everything and make the right decision, providing their child with protection from tuberculosis.

Once again, I advise all parents to think before deciding whether to vaccinate or not. You are responsible for the health of your children.

Unfortunately, in society there is very, very little knowledge about tuberculosis, especially with regard to the problem of vaccinations against tuberculosis and Mantoux tests (tuberculin diagnostics).

Why is this vaccination needed? And why, despite the fact that everyone is vaccinated, many people get tuberculosis?

BCG vaccination is needed to prevent tuberculosis in children. It does not protect against infection with the causative agent of tuberculosis, but it really protects against the transition of a latent infection into an overt disease (in about 70% of those vaccinated), and almost 100% protects children from severe forms of tuberculosis - from tuberculous meningitis, tuberculosis of bones and joints and severe forms pulmonary tuberculosis. It was the use of the BCG vaccine that made it possible to achieve a significant reduction in the incidence of tuberculosis in children in general, and in particular, for many years, despite the difficult social situation, we have not seen cases of tuberculous meningitis in vaccinated children.

BCG vaccination, as a rule, is done in the maternity hospital on the fourth day of the child’s life, in the left shoulder, at the border of its upper and middle third.

Why so early? The fact is that, unfortunately, the situation with tuberculosis in society is unfavorable, and not all tuberculosis patients who secrete the pathogen know about their disease, accordingly they do not receive treatment and are contagious. Therefore, a child can encounter Mycobacterium tuberculosis very, very early. And phthisiatricians have long known that what earlier child infected, the greater the likelihood of the infection turning into a disease and the more unfavorable the course of the disease will be. That’s why vaccinations are done as early as possible, so that the child has time to develop immunity so as not to get sick. And in this regard, let me remind you of the old rule - you should not show your newborn to any strangers for up to a month.

The BCG vaccine is a weakened vaccine strain that cannot cause tuberculosis, but allows the development of immunity against this disease. Since immunity against tuberculosis is developed only when the pathogen or its vaccine replacement is present in the body, it is impossible to make a killed vaccine, therefore the same BCG vaccine is used in all countries various manufacturers(many parents often ask about imported vaccines because they believe they are better). Moreover, domestic vaccine, it seems to me, is better, because both vaccinators and pediatricians have a lot of experience working with it. In addition, imported vaccines may be held in customs for quite a long time or end up in unsuitable conditions, and since the vaccine is live, its storage conditions must be very strict.

There is a variant of the BCG vaccine - the BCG-M vaccine, which contains half as many microbial bodies as the regular vaccine. BCG-M vaccine weakened and low birth weight premature babies are vaccinated, and usually this vaccine is no longer used in the maternity hospital, but where the child will be transferred from the maternity hospital.

Usually the BCG vaccine, unlike, say, DTP vaccines, is well tolerated, but complications from vaccination are possible, and I will remind you of this here so that parents know what to pay attention to.

But first, a few words about the normal course of the post-vaccination process, since there are surprisingly many questions on this topic.

Normally, 6-8 weeks after vaccination (that is, one and a half to two months) begins post-vaccination reaction– a previously invisible whitish nodule rises on the skin, initially resembling mosquito bite, and then a bubble filled with a light yellow liquid appears at the grafting site, then (usually by 3-4 months) the bubble bursts, the grafting site becomes covered with a crust, which comes off several times and appears again.

All this is a completely normal process, and not a “terrible abscess”, as some parents describe. No special care is needed for the vaccination site; you should not lubricate the abscess with any disinfectants, iodine, brilliant green or ointments - this can kill a rather unstable vaccine strain and disrupt the course of the post-vaccination reaction.

What should parents be wary of? The fact is that it is rare, but it happens that the vaccine gets subcutaneously, and not intradermally, and suppuration forms, but under the skin, while outwardly there is no abscess, there is a pea under the bluish skin. There may also be enlargement of the lymph nodes in the left armpit. All these are signs possible complication BCG vaccination, and this should definitely be brought to the attention of your local doctor.

Immunity after BCG vaccination lasts 6-7 years, so all children with a negative Mantoux reaction at 7 years of age are offered repeated BCG vaccination.

Now, in the wake of the fashionable anti-vaccination craze, some parents believe that vaccinations are harmful, since they contain phenol, mercury and all that stuff. The fact is that the BCG vaccine does contain preservatives, but without it live vaccine not to do, and one more point - in our tap water much more rubbish than in the vaccine. However, if parents decide that their child does not need vaccination, they have every right to refuse it; this point is clearly stated in our legislation. To such parents I sincerely want to say only one thing - this is your child and it is you who take responsibility for refusing vaccinations, in particular BCG. In this case, parents must write in their own hand on the child’s record a refusal to undergo preventive vaccinations and indicate that they had the opportunity to ask all the questions they were interested in and will not have any claims against the medical institution.

Tuberculosis in children

There are the following stages of tuberculosis in children (so, for general information. To know what we are vaccinated against):

Primary infection - local inflammation occurs at the site of infection. From here, the bacteria penetrate the nearest lymph nodes, and the so-called “primary complex” is formed. General health in most cases the violation is insignificant. Possible appearance fatigue, weight loss, loss of appetite, night sweats, dry skin. In most cases infectious focus calcifies and the development of tuberculosis stops at this stage.

Latent (hidden) infection - due to the weakening of the body’s defenses, the pathogen may spread from a fresh or calcified lesion and form numerous lesions in other organs (lungs, spleen, liver, brain, meninges, bones). Tuberculous meningitis (inflammation of meninges) and bone tuberculosis.

Recurrent tuberculosis of the adult type - manifests itself as tuberculous damage to many organs, accompanied by fever and significant loss of strength. Most often, the lungs are affected with the formation of cavities (cavities), which can break into the bronchi, as a result of which pathogens are released out ( open form tuberculosis).

In 90-95% of cases, the primary infection goes unnoticed, leaving only positive tuberculin tests and latent infection, and the latter can develop into active form at any age (it's like a time bomb).

Vaccination against tuberculosis.

The main factor determining the occurrence and course of the disease is the state of the body's defenses. Unfavorable social conditions and previous weakening of the body due to others, primarily chronic diseases, contribute to the occurrence of tuberculosis.

Vaccine effectiveness.

Research results are mixed and vary in different countries. In the UK, studies of 50,000 children showed an 80% reduction in the risk of infection after vaccination. The results in the US are not as impressive. However, recent studies have shown that after vaccination, the risk of pulmonary tuberculosis is reduced by 2 times, and mortality by 71%.

Results Russian studies showed that unvaccinated children get tuberculosis 15 times more often than those vaccinated in a timely manner and according to all the rules.

Anti-tuberculosis vaccination in vaccinated children induces immunity to tuberculosis infection. When entering the body of a child vaccinated with the BCG vaccine, Mycobacterium tuberculosis usually does not cause severe forms of tuberculosis that develop as a result of primary infection (tuberculous meningitis, miliary tuberculosis, caseous pneumonia, extensive infiltrates in the lung with the formation of a primary cavity). However, the BCG vaccine does not protect against tuberculosis infection, i.e. from the penetration of mycobacteria by aerogenic or elementary routes and the development of primary tuberculosis infection, which is accompanied by the occurrence of local forms of primary tuberculosis in 7–10% of those infected. In vaccinated children, primary infection usually occurs unnoticed, and it is often not detected or is diagnosed when the tuberculin reaction develops, which in those who have had primary infection remains positive for life. Such persons are called tuberculosis infected.

In countries where the number infected with tuberculosis is more than 1% (and Russia is included here).

Children whose family has tuberculosis patients.

When is BCG done?

BCG vaccination is given to newborns; if the vaccination was not given in the maternity hospital, then it must be taken care of during the first 6 weeks of the baby’s life. Up to six weeks of age tuberculin test(Mantoux) is not needed. For children over 6 weeks of age, the vaccine is administered only when negative reaction for tuberculin to avoid complications due to possible infection.

The BCG TB vaccine is not effective if it is given to someone who is already infected.

Side effects of BCG vaccination.

Typically worn local character and include subcutaneous “cold” abscesses (ulcers), which occur when vaccination techniques are violated, and inflammation of local lymph nodes. Keloid scars, bone inflammation and widespread BCG infection are very rare, mainly in children with severe immunodeficiency.

During the entire period of use of the vaccine (more than 100 million people were given), only 24 deaths were observed, almost all of the dead suffered from immunodeficiency.

Contraindications to BCG vaccination.

Absolute (constant):

Primary immunodeficiencies
- HIV infection
- malignant diseases blood
- neoplasms
- there were severe reactions to the previous administration of BCG.
- Tuberculosis

Temporary:

Intrauterine infections
- hemolytic disease
- severe prematurity (<2000 гр).
- skin diseases
- treatment with large doses of corticosteroids or immunosuppressants is carried out;

Permitted drugs:

BCG, BCG-M Vaccine against tuberculosis. Production: Russia

Ingredients: live weakened mycobacterium tuberculosis strain BCG-I. One dose contains 0.05 mg of the drug (BCG) or 0.025 mg (BCG-M)

Contraindications to vaccination of newborns:

Prematurity II-IV degree;
- intrauterine hypotrophy III-IV degree;
- intrauterine infection;
- purulent-septic diseases;
- hemolytic disease of newborns (moderate and severe forms);
- generalized skin lesions;
- acute diseases;
- generalized BCG infection detected in other children in the family;

For revaccination of children:

Infected with tuberculosis or tuberculosis in the past;
- positive or questionable Mantoux reaction;
- complicated reactions to the previous administration of the BCG or BCG-M vaccine (keloid scars, lymphadenitis, etc.);
- acute diseases, chronic diseases in the acute stage;
- allergic diseases in the acute stage;
- malignant blood diseases and neoplasms;
- secondary immunodeficiencies, treatment with immunosuppressants (according to the conclusion of a specialist after an immunological study);
- primary immunodeficiencies, HIV infection;
- pregnancy

Adverse reactions: as a rule, a specific reaction develops at the site of vaccine administration in the form of an infiltrate, 5-10 mm in diameter with a small nodule in the center. Sometimes a small necrosis with a slight serous discharge appears in the center of the infiltrate.

complications of BCG vaccination include: subcutaneous abscesses, ulcers measuring 10 mm or more in diameter; lymphadenitis of regional lymph nodes, keloid scars; Extremely rare complications include BCG osteitis and other disseminated forms of BCG infection.

Tuberculosis vaccine

The anti-tuberculosis vaccine was created in 1921 by French scientists Calmette and Guerin, hence its name (Bacille Calmette-Guerin, abbreviated as BCG, and in Russian designation BCG). In the first years of use, the vaccine was used to create artificial immunity in newborns by administering it with expressed mother's milk. Subsequently, a cutaneous vaccination method was developed and introduced. Currently, the vaccine is administered intradermally (i.c.) into the forearm in the maternity hospital. Repeated vaccination (re-vaccination) is carried out at the age of 6–7 years, and, if necessary, at 14–15 years.

Since 1991, the BCG-M vaccine has also been used, in which the dose of the bacterial mass is halved, which makes it possible to use it for immunization of premature newborns and weakened children.

I will give some regulatory documents on this vaccination.

Appendix No. 5 to the order of the Ministry of Health of Russia dated March 21, 2003 No. 109 (extract)

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

Federal Law of September 17, 1998 No. 157-FZ “On Immunoprophylaxis of Infectious Diseases” provides for mandatory preventive vaccinations against nine infectious diseases, including tuberculosis.
Specific prevention of tuberculosis can be carried out only with drugs registered in the Russian Federation - dry tuberculosis vaccine (BCG) for intradermal administration and dry tuberculosis vaccine (BCG-M) (for gentle primary immunization). In constituent entities of the Russian Federation with a satisfactory epidemic situation for tuberculosis, one BCG revaccination is possible. Increasing or decreasing the interval between BCG vaccinations in a constituent entity of the Russian Federation is agreed with the Russian Ministry of Health.
Vaccinations are administered by a specially trained nurse.

In the medical record, the doctor on the day of vaccination (re-vaccination) must make a detailed entry indicating the results of thermometry, a detailed diary, the appointment of administration of the BCG vaccine (BCG-M) indicating the method of administration (i.c.), dose of the vaccine (0.05 or 0.025 ), series, number, expiration date and vaccine manufacturer. The passport data of the drug must be personally read by the doctor on the packaging and on the ampoule with the vaccine (usually, if it is given in a maternity hospital, all the data about the vaccination is written in the discharge summary, you can look it up).

Before vaccination (re-vaccination), the doctor and nurse must read the instructions for using the vaccine, and also inform the parents of the child (teenager) in advance about immunization and the local reaction to the vaccine. And you must sign informed consent to perform BCG.

Vaccinations at home are allowed in exceptional cases by the decision of the commission, which must be recorded in the medical record, and are carried out in the presence of a doctor.
Vaccination of newborns in a maternity hospital (pathology department) is allowed in the children's ward in the presence of a doctor. In these cases, the formation of the vaccination setup is carried out in a special room.

All items necessary for BCG vaccination (re-vaccination) (tables, bins, trays, cabinets, etc.) must be labeled. Vaccination in the maternity hospital is carried out in the morning.

In connection with early discharge from obstetric hospitals, in the absence of contraindications, vaccination of newborns against tuberculosis can be carried out from the third day of life; discharge is possible an hour after vaccination if there is no reaction to it.
Monitoring of vaccinated and revaccinated children, adolescents and adults is carried out by doctors and nurses of the general medical network. 1, 3, 6, 12 months after vaccination or revaccination, they must check the vaccination reaction, recording the size and nature of the local reaction (papule, pustule with crust formation, with or without discharge, scar, pigmentation, etc.).

These details must be recorded:

For children and adolescents attending children's institutions in registration forms No. 063/u (child's card in the clinic) and No. 026/u (child's card in the kindergarten or school);
- for unorganized children - in registration form No. 063/u and in the history of the child’s development (form No. 112).

Information about the nature and extent of complications after the administration of the BCG and BCG-M vaccines is recorded in accounting forms No. 063/u; 026/у (for example, “lymphadenitis 2.0, 2.0 cm with fistula”). If the cause of complications turns out to be a violation of the vaccine administration technique, measures are taken to eliminate them.

Treatment and prevention institutions refer children and adolescents with complications to an anti-tuberculosis clinic, they are observed and treated.

For all cases of complications, a card is drawn up with an exact indication of the series, expiration date of the BCG or BCG-M vaccine and the manufacturer, which is sent to the center of state sanitary and epidemiological surveillance (district, city, region), which controls the quality of vaccinations. Copies of the cards are sent 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 I.M. Sechenov Medical Academy of the Ministry of Health of Russia. Information about the nature of complications is also recorded in accounting forms No. 063/u; No. 112/у.

Vaccinations against tuberculosis must be carried out strictly according to the instructions for the use of BCG and BCG-M vaccines.

Organization of vaccination of newborns.

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

When sending an exchange card (registration form No. 0113/u) 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.

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.

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 No. 840 for diluting the vaccine - 2–3 pcs.
- Ethyl alcohol (70%) registration No. 74\614\11(12).
- Chloramine (5%). registration number 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 instruments for checking the Mantoux tuberculin test.

Organization of revaccination against tuberculosis

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.

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

Nurses who are part of the team must be proficient in the technique 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.

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, employees of the State Sanitary and Epidemiological Supervision Service and TB specialists monitor the work on the ground. 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.

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.

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.

BCG vaccination: questions and answers. V.K. Tatochenko, Scientific Center for Children's Health of the Russian Academy of Medical Sciences

What degree of protection does BCG vaccination provide?

The BCG vaccine provides 80-85% protection, primarily against generalized forms of primary tuberculosis, including meningitis. The protection period begins after 2 months. after vaccination and can last 10 years or more. However, a massive tuberculosis infection can “break through” the immune system and cause a manifest disease.

On what day is it preferable to vaccinate a newborn?

Vaccinations are optimal for children aged 3-7 days, as prescribed by the new Russian Vaccination Calendar since 2002. In addition, children who did not receive BCG in the first days of life (premature, sick) should be vaccinated before being discharged from the 2nd stage department nursing This scheme is preferable to vaccinations on any fixed day of the child’s life, since it allows vaccination of several children in the maternity hospital during one vaccination day.

How to vaccinate a child who has had contact with a person with tuberculosis at home with the BCG vaccine?

If a child had contact with a bacillary patient before vaccination, he should undergo preventive treatment and be given a p. Mantoux, if the result is negative, administer BCG followed by isolation for 8 weeks. If the result is positive, Mantoux continues chemotherapy.

If there is no scar after BCG vaccination, should such a child be revaccinated?

A scar is formed in 90% of children after BCG vaccination. If there is no scar, and p. Mantoux is positive, BCG is not re-administered. If r. Mantoux is negative, it is logical to introduce BCG again, but a clear judgment can be obtained using a more sensitive tuberculin test, for example, with 5 TE or by determining antibodies to mycobacteria.

How effective is BCG revaccination?

Revaccination provides a certain degree of protection to children who have not responded to the first dose of BCG, or whose immunity has decreased, as judged by the decline of the tuberculin test. WHO does not recommend BCG revaccination as part of EPI. For countries that practice revaccination, WHO recommends that it be carried out without prior p. Mantoux. In Russia, revaccination is provided for children who are not infected with Mycobacterium tuberculosis and who are negative. Mantoux at 7 years old or at 14 years old (for children who did not receive the vaccine at 7 years old). In some regions, it is considered advisable to give 2 revaccinations to tuberculin-negative children - at 7 and 14 years old, although there is no evidence of the effectiveness of this scheme.

What to do in case of overdose of BCG or subcutaneous injection?

Systemic chemotherapy has been used and local injection of aminoglycosides has been proposed, but the effectiveness of these methods is difficult to assess.

What are the features of the BCG vaccination technique?

To administer BCG, one-gram or tuberculin disposable syringes and thin needles (No. 0415) with a short cut are used; if they are not available, insulin syringes are used, which are then destroyed. BCG is administered strictly intradermally at the border of the upper and middle third of the outer surface of the left shoulder; subcutaneous administration is unacceptable due to the danger of a “cold” abscess. The needle is inserted with the cut upward into the surface layer of the skin; with the correct technique, a white papule (“lemon peel”) is formed, which disappears after 15-20 minutes. Applying a bandage and treating the injection site with disinfectant solutions is unacceptable.

Can BCG vaccine be administered together with other vaccines?

Yes, the vaccination process after BCG lasts many weeks, so there is no competition, if any, with other vaccines. In turn, BCG is not affected by interferon, which can be produced in response to the administration of other live vaccines. According to the new Russian calendar, from 2002 all newborns will be vaccinated against hepatitis B and BCG. As studies have shown, there is no mutual influence of these vaccines.

What is the reason for the requirement for BCG vaccination to be carried out separately from other vaccinations?

Accidental penetration of even a tiny amount of BCG vaccine under the skin or into a muscle can cause a serious complication. Therefore, in order to avoid contamination of the vaccination material or instruments, the BCG vaccine is used only separately from other vaccines (vaccinations are carried out on a different day).

How is a child not vaccinated in the maternity hospital vaccinated?

The child is vaccinated in the clinic over the age of 3 months with a preliminary diagnosis. Mantoux (to diagnose possible tuberculosis infection); children under 3 months of age. Mantoux is not used because... during this period it can be negative even in case of infection.

Is a negative p an indication of the ineffectiveness of vaccination? Mantoux with 2 TE at the age of 1 year in a child with a good scar after BCG?

No, it’s just that the achieved level of skin reaction to tuberculin after vaccination is small and a test with 2 TE is not detected (2 TE is a very small dose of tuberculin, it may not detect a post-vaccination immune response). But it is hardly worth putting a reaction with 5 or 10 TE, since the presence of a scar at the site of vaccination is a good indication of the effectiveness of the vaccination.

For what diseases is BCG vaccination contraindicated?

For immunodeficiency states: primary cellular (chronic granulomatous disease and combined - Swiss type of immunodeficiency), drug immunosuppression, as well as HIV infection with signs of impaired immune reactions. In Russia, BCG is not administered to children from mothers who are HIV carriers until it is confirmed that they do not have HIV infection (WHO recommends that in developing countries, BCG be administered to all children from HIV-infected mothers, since their risk of complications is much lower than the risk of tuberculosis). Screening of newborns for primary immunodeficiency is not possible, but you should refrain from vaccinating children whose family has had diseases similar to immunodeficiency.

Mycobacterium, or Koch's bacillus, in the human body leads to the development of tuberculosis. This is a serious disease that has many complications and often ends in death.

Full name, composition and release form of BCG vaccine

To prevent the development of tuberculosis, the tuberculosis vaccine, or BCG, is used. The abbreviation BCG is a translation of the abbreviation BCG, which stands for bacillus Calmette-Guerin (bacillus Calmette-Guerin).

The BCG vaccination consists of live, weakened mycobacteria. Available in the form of a lyophilisate for the preparation of a suspension complete with a solvent - 0.9% sodium chloride solution. It looks like a creamy or white powdery mass. One ampoule contains 0.05 mg of live bacteria and 0.3 mg of stabilizer (monosodium glutamate).

Characteristics of the BCG vaccine

The BCG vaccine is made from live bovine tuberculosis bacillus. This strain of mycobacteria is not dangerous to humans and does not cause disease. Weakened bacteria, after entering the body, multiply and form stable anti-tuberculosis immunity.

Koch's wand is widespread in nature, and humans come into contact with it every day. But not everyone develops tuberculosis. It is worth understanding that vaccination does not protect a person from infection with Koch’s bacillus. BCG prevents the development of severe and open forms of tuberculosis. Immunity after such a vaccine is non-sterile (infectious). This means that antibodies against mycobacteria persist as long as it circulates in the human blood.

Indications for vaccine administration

Active prevention of tuberculosis is indicated:

• to all healthy newborns on days 3-5 in the absence of contraindications;
• children older than 2 months after the mantoux test, if BCG was not done earlier;
• for children aged 7 and 14 years as revaccination;
• children and adults who come into contact with tuberculosis patients;
• children, after eliminating temporary contraindications;

Vaccine administration method

Vaccination against tuberculosis is done in a maternity hospital, children's clinic or tuberculosis. dispensary. According to sanitary standards, the clinic must have two vaccination rooms: in one only BCG is administered, in the other - all other vaccines. If there is only one such office, then the clinic selects a day for vaccination only against tuberculosis. On the remaining days, other vaccinations will be carried out. It is prohibited to place BCG in manipulation rooms.

The vaccine is administered with a disposable syringe at a dose of 0.05 mg intradermally. If the injection is done correctly, a white papule about 1 cm in diameter is formed. The BCG vaccination is given on the outer side of the upper third of the left shoulder. If for some reason it is impossible to vaccinate in the shoulder, then choose another place with a thick area of ​​skin. Most often in such cases the vaccine is injected into the thigh.

Important! The vaccine cannot be administered subcutaneously or intramuscularly! This type of vaccination leads to the development of complications and does not form immunity.

How does the injection site heal?

A BCG scar normally begins to form within 1-2 months. Initially, redness appears at the injection site, which over time may change color to blue or black. Further, in the center of the redness, an abscess gradually develops, which becomes covered with a crust. Sometimes the abscess opens up on its own, and pus flows out of it for a while. After this, the wound heals and a scar of up to 10 mm is formed. The period of scar development lasts about 5 months.

In some children, scar formation occurs without the formation of an abscess. In such cases, a red vesicle with liquid appears at the injection site. After a while, a crust appears in this place, and then a scar. Both options represent the body's normal response to vaccination against tuberculosis.

Doctor's advice. Do not treat the wound with antiseptics or apply a bandage to the injection site. You should also not squeeze pus out of the wound yourself. Such actions will not speed up healing, but will only cause complications.

Contraindications for administering the vaccine

Contraindications are divided into temporary and permanent. Temporary contraindications include:

• Prematurity of the child, weight less than 2.5 kg. Once the child reaches a weight of more than 2.5 kg, vaccination can be carried out;
• intrauterine infection;
• purulent-septic skin diseases;
• hemolytic disease of newborns;
• HIV infection in the mother. Vaccination is carried out at 18 months after establishing a negative HIV status in a child;
• acute diseases or exacerbation of chronic ones. Vaccination is done a month after recovery or remission;
• taking immunosuppressants, chemotherapy or radiation therapy. Vaccination is possible six months after the end of treatment;
• anemia;
• allergic and autoimmune diseases. Vaccination is carried out after recovery;
• contact with tuberculosis patients. Vaccination is carried out after completion of quarantine.

Absolute contraindications to BCG vaccination:

• primary immunodeficiencies;
• generalized BCG infection in other children in the family;
• malignant blood diseases and neoplasms;
• history of tuberculosis;
• neurological disorders with clear symptoms;
• complication of previous vaccination against tuberculosis;
• positive or questionable results of the Mantoux test, Mantoux test;
• HIV infection.

Possible complications and reactions

Usually, the body reacts normally to the administration of BCG. But sometimes, after a few hours or even days, specific reactions to the vaccine occur that should not be alarmed. Such reactions include:

• redness;
• suppuration;
• swelling;
• temperature rise to 37.5-38°C;
• itching at the injection site.

These reactions are normal and usually go away within a few days. If the temperature rises above 38°C or lasts more than 3 days, you should immediately consult a doctor.

In rare cases, complications occur after BCG administration:

• cold abscess. It develops when the vaccine is given subcutaneously rather than intradermally. It appears after 1-2 months and requires mandatory surgical treatment;
• ulcer at the injection site. This reaction occurs if the child has an immunodeficiency or sensitivity to the components of the vaccine. Treatment is carried out locally;
• lymphadenitis. The development of this complication means that bacteria have entered the lymph nodes. Enlarged lymph nodes up to 10 mm or more require surgical intervention;
• osteomyelitis. This disease most often means that a low-quality vaccine was used or it was stored incorrectly. Requires mandatory treatment depending on the stage of the disease;
• keloid scar. A red and protruding scar means that such a child cannot be revaccinated with BCG. If the scar does not cause discomfort, there is no need to treat it. The treatment of such scars is surgical;
• generalized BCG infection. The most serious complication of vaccination against tuberculosis. Develops in children with severe immunodeficiencies. This disease occurs as disseminated tuberculosis with severe intoxication and damage to other human organs. This complication occurs extremely rarely and requires urgent treatment.

If complications occur in a child, you should urgently contact your pediatrician for further treatment.

Application of the vaccine

According to the vaccination calendar, children are vaccinated against tuberculosis three times:

• 2-5 days after birth;
• 7 years old;
• 14 years old.

If vaccination was not carried out on days 2-5 after birth, it is done until the child reaches 2 months. After 2 months, the BCG vaccine can be administered only after the Mantoux test has been performed and a negative result has been obtained. Revaccination at 7 and 14 years of age is also carried out only if the Mantoux test is negative. According to the standards, at least 3 days and no more than 2 weeks should pass between the Mantoux test and the BCG vaccination.

Adults can receive the tuberculosis vaccine after a Mantoux test if they wish. The vaccine is given only if there are no contraindications to it.

When should adults be vaccinated with the BCG vaccine:

• negative Mantoux tests;
• constant contact with tuberculosis patients, socially disadvantaged people (medical workers, teachers, social service workers);
• lack of vaccination data and lack of a characteristic scar.

This vaccine should not be administered to pregnant women.

Pros and cons of using a vaccine

Koch's wand can be found anywhere on the planet. Patients with open forms of tuberculosis calmly walk the streets, ride in public transport and go to shops, releasing millions of mycobacteria into the external environment. Healthy people encounter bacteria every day. Therefore, the question of vaccination against tuberculosis remains open. Unfortunately, vaccination does not reduce the spread of mycobacteria and does not protect against infection with it. But BCG creates reliable protection against the development of disseminated forms of tuberculosis and tuberculous meningitis. These complications are often fatal. In vaccinated people, tuberculosis usually occurs in mild forms that respond well to treatment. But like any vaccination, BCG has both pros and cons.

Benefits of the vaccine:

• reduces the risk of developing severe forms of tuberculosis, which lead to death;
• with correct administration there are no complications;
• does not require special care;
• stable immunity is formed.

The disadvantages include:

• a large number of contraindications;
• severe complications if administered incorrectly;
• does not protect against mycobacterial infection.

The BCG vaccination has no more disadvantages than any other. The decision to vaccinate a child must be made carefully, weighing the pros and cons. Given the mortality rate from tuberculosis and the prevalence of the bacterium, it is better to get vaccinated. But before this, the child should be thoroughly examined for any contraindications to this vaccine.

Interaction with other drugs for immunoprophylaxis

It is prohibited to give other vaccinations together with BCG. Immunity is formed within 4-6 weeks from the moment of vaccination, and all possible reactions also occur during this period. Therefore, it is permissible to administer the next vaccinations no earlier than a month after the BCG vaccination.

Vaccine storage conditions

Vaccine ampoules are stored in the refrigerator under strict temperature conditions. Storage temperature in the range +2+4°C. The vaccine is transported at the same temperature. The shelves on which the vaccine is stored must be labeled. Refrigerators are equipped with two thermometers, top and bottom, to control the temperature. Temperature monitoring is carried out twice a day, and all data is entered into a log. The BCG vaccination is sensitive to light, so it is necessary to prevent sunlight from entering the vaccine ampoules. The shelf life of BCG is 2 years.

One ampoule contains 10 doses of vaccination. The diluted vaccine is stored for an hour at a temperature of +2 to +8°C. The drug is also protected from direct rays of the sun. A protocol is kept in the office, which indicates the time of opening the ampoule and its disposal. Unused vaccine must be disposed of. If the integrity of the packaging is compromised, the expiration date, lack of labeling or improper storage of the vaccine ampoules must be destroyed.

Important! The BCG vaccine has no analogues.

Filterable list

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 the 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 the neck of the ampoule is filed and broken off, 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. Available 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.

LS-000574 dated 2015-02-10
Tuberculosis vaccine (BCG) - instructions for medical use - RU No. LS-000574 dated 2015-02-10
Tuberculosis vaccine (BCG) - instructions for medical use - RU No.