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 the causative agents of mycobacteriosis (eg. Mycobacterium kansasii).

Cases of post-vaccination complications are noted annually. The disease caused by the BCG strain is called BCZhit and has its own characteristics of the development of the tuberculous process.

Indications

BCG - Active specific prevention of tuberculosis:

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

BCG-M - Active specific prophylaxis of tuberculosis (for sparing primary immunization):

• in premature infants weighing 2000 g or more when restoring their original body weight (in the maternity hospital, the day before being discharged to the house);
• in children weighing 2300 g or more (in the nursing departments of premature newborns of medical hospitals (2nd stage of nursing), before leaving the hospital to go home);
• in children who have not received anti-tuberculosis vaccination in the maternity hospital for medical contraindications and who 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 acute manifestations diseases and exacerbations of chronic diseases);
• intrauterine infection;
• purulent-septic diseases;
• hemolytic disease of newborns of moderate and severe form;
• severe lesions nervous system with severe neurological symptoms;
• generalized skin lesions;
• primary immunodeficiency;
• malignant neoplasms;
• simultaneous administration of immunosuppressants;
• radiation therapy (vaccination is carried out no earlier than 6 months after the end of treatment).

History

Public acceptance of the vaccine was difficult, in particular because of the tragedies that happened. In Lubeck, 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 laid on the director of the hospital, who was sentenced to 2 years in prison for negligence, leading to death.

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

A follow-up study in southern India and published in Chingleput Study) showed no protective effect. In terms of thoroughness and coverage, it was perhaps the most serious, controlled, randomized, blinded study. 260 thousand children were randomly divided into 2 groups, the first of which received the BCG vaccine, and the second - a placebo. Observation of the vaccinated in both groups lasted 7 and a half years. As a result, the researchers found that the incidence of tuberculosis in the vaccinated group was slightly higher than in the equal-sized placebo group.

The duration of BCG protection is unclear. Studies showing protective effects have not been consistent. The Medical Research Council of Great Britain (MRC) conducted a test showing that immunity declines by up to 59% after 15 years and to "less than zero" after 20 years. A study conducted on American Indians vaccinated in the 1930s found evidence of protection after 60 years with only slightly diminished effectiveness.

It is believed that the BCG vaccine is most effective against disseminated tuberculosis and brain tuberculosis. For this reason, it is still widely used even in countries where its effectiveness against pulmonary tuberculosis has not been proven, such as India. There is a brief publication in the Indian Pediatric Journal questioning this ability of BCG in Indian settings, showing that even properly vaccinated children develop disseminated tuberculosis in the event of poor nutrition and unsatisfactory social conditions.

Reasons for volatile performance

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

Application

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

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

Methods for introducing BCG

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

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

Other application

Side effects

The anti-tuberculosis vaccine BCG is a preparation from a live culture of BCG-mycobacteria, therefore, post-vaccination complications cannot be avoided. Complications of BCG vaccination have been known for a long time and have been accompanying it since the beginning of its mass use.

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

In the structure of complications developing after vaccination in the clinic and after revaccination, cold abscesses are more often observed (50.8% and 33.0%, respectively), and after vaccination in the maternity hospital - lymphadenitis (71.4%, frequency 0.31-0 , 39 per million vaccinations). The occurrence of lymphadenitis depends on the quality of the vaccine, its dose, the age of the person being vaccinated and the technique of intradermal administration. Cold abscesses are usually the result of a malfunctioning vaccine injection when the drug gets under the skin. However, the influence of the quality of the vaccine on the occurrence of this complication cannot be completely denied. In case of untimely detection of a cold abscess (not to be confused with an abscess), it spontaneously opens, and an ulcer forms in its place. Infiltrates are formed during a vigorous local vaccination reaction.

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

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

It should not be forgotten that confirmed cases are analyzed, however, confirmation occurs by the method of cultural diagnostics, by identifying a specific set of resistance to antibacterial drugs... Sectional material (for example, when a child dies) is not supplied for sowing, and only the general diagnosis of tuberculosis is confirmed by the histological method. [ ]

see also

Notes (edit)

1. Perelman M.I. Physician consultant. Phthisiology. - M.: GEOTAR-Media, 2007 .-- S. (Ch. 32). - ISBN 978-5-9704-1234-3 ..
2. Chistovich A.N. Pathological anatomy and pathogenesis of tuberculosis. - M.: Medicine, 1973. - S. 18-20.
3. Otten T.F., Vasiliev A.V. Mycobacteriosis. - SPb. : Medical Press, 2005. - P. 134.
4. Romanus V., Hallander H. O. Atypical mycobacteria in extrapulmonory disease among children. Incidence in Sweden from 1969 to 1990, related BCG-vaccination coverage // Tuberc. Lung Dis. - 1995 .-- T. 75. - S. 300-310.
5. two tuberculin units. International tuberculin unit- a 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 PD, 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. - S. 349-363.
14. Editorial. BCG: Bad news from India // Lancet: magazine. - 1980. - No. January 12. - S. 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.

Despite the great medical advances in the prevention of dangerous diseases, about 10 million cases of tuberculosis are recorded annually. The TB vaccine is one of the first to be given right after birth. BCG is a complex vaccine against tuberculosis, which allows you to develop strong immunity to the disease. Its introduction requires examination of newborns and the creation of favorable conditions for vaccination. Unfortunately, there is no absolute guarantee that a vaccinated child will not develop tuberculosis in the future.

The history of breeding the desired strain of mycobacteria has almost a century of history. It was created by two scientists from France, figures of microbiology - Calmette and Guerin - in the second decade of the 20th century. BCG is shorthand. On Latin the decoding of the abbreviation looks like "bacillus Calmette-Guerin" or BCG.

The vaccine is based on the bovine tubercle bacillus. The bacterium that causes "pearl disease" in livestock adapts perfectly in the human body. It is processed in such a way that it is not able to infect, but retains the ability to form protective immunity. The BCG vaccine is not dangerous, but there are rare cases of complications based on the individual's response to the bacterium.

What does BCG vaccine look like, its composition and form of release?

The BCG composition remained the same as it was created and was first used on humans in 1921. The work on the removal of the desired strain lasted more than 10 years. All research data in the course of searching for the desired subtype of mycobacteria are stored in the WHO archives.

The main method for obtaining bacteria of the desired type is sowing in a nutrient medium. The required number grows a week. To obtain the desired homogeneous mass, a lot of manipulations are carried out. The finished vaccine against tuberculosis includes not only live bacteria, but also dead ones.

The modern BCG vaccine contains the same strains:

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

The effectiveness of drugs is manifested in equally... In our country, vaccination against tuberculosis is carried out in two formulations - BCG and BCG-M. It is imperative to take into account the individual indications of the body when using a particular vaccine.

pharmachologic effect

The need for BCG vaccination in newborns is due to the risk of developing the disease. The effectiveness of the development of persistent immunity depends on the timing of the introduction of the vaccine against tuberculosis. The most pronounced resistance immune system in front of the carrier of the disease manifests itself in the case of a child being vaccinated in the first week of life.

The final immunity will form a year after vaccination, and it will last for more than seven years.

A scar at the site of inoculation is a consequence of local skin tuberculosis. If it is clearly visible, it means that the body has developed a strong immune defense. If the scar did not appear or is hardly noticeable, the result suggests otherwise.

Terms of sale, storage and shelf life

The tuberculosis vaccination is free of charge. If for some reason it was not done in the first days of life, you can do it yourself in a specialized institution. The vaccine is freely available in the pharmacy network. It is important to comply with the storage and transportation conditions. No prescription required to purchase. The purchase is accompanied by the issuance of a certificate, which is presented at the place of vaccination.

Storage and transportation of BCG and BCG-M is carried out in special refrigerating chambers with temperatures from +2 to +8 degrees Celsius. Direct sunlight should not be allowed on boxes with ampoules. Violation of these conditions leads to damage to the vaccine.

The shelf life of both types of vaccine is the same and is two years. Tuberculosis vaccine do not apply after the specified period. Ampoules are disposed of physically or chemically. Vessels that have been stored or transported in an improper way are also subject to destruction.

To get the vaccine, the area of ​​skin with the greatest density is selected. BCG is injected intradermally; administration of the vaccine subcutaneously or into muscle tissue is strictly contraindicated. As a result of improper injection, a mass with a large accumulation of pus is formed.

Vaccination can only be performed by a qualified specialist. It is important to quickly and accurately follow the correct sequence of actions, according to the instructions. Only whole ampoules are used, on which the expiration dates are clearly read. The contents of the solvent vial must be free of sediment. The vaccine itself is dry, in the form of a powder from white to cream shade.

Before breaking the ampoule, it must be sterilized with a napkin. The diluent is added to the vaccine with a syringe. A special tuberculin syringe is used for the vaccination.

The BCG vaccination technique must be followed. The injection site is being processed ethyl alcohol... The intradermal route involves an injection at a 15-degree angle with a slow injection of the vaccine. The skin at the site of inoculation is not processed.

Within half an hour from the moment of vaccination, the patient is subject to monitoring for the occurrence of allergic reactions. This time is sufficient for manifestation in most cases. If the drug is well tolerated and there is no allergy, the patient can be free. It is forbidden to wet the vaccine for a day.

Information about the date of vaccination and the series of vaccines is entered into the development chart of the child. Within 6-8 weeks, the formation of immunity occurs. Until the end of the specified period, the child is prohibited from contacting an adult at risk of tuberculosis.

Where to get vaccinated against tuberculosis, where the injection is given and in which arm

An incorrectly given tuberculosis vaccine can backfire. First of all, the injection site and the hand matter.

The injection point is the border between the upper and middle lobes of the shoulder. If the composition of the BCG vaccine cannot be injected into this place, the vaccine is performed in the left thigh, also choosing the border and the injection site. The tuberculosis vaccine given to the thigh or shoulder has the same immune response.

BCG-M is the same vaccine, only weakened. Differs in BCG-M concentration. One dose contains half the mycobacteria. 0.1 milliliter BCG-M vaccines contains only 0.025 milligrams of active bacteria. Instructions for the use of BCG-M and the grafting technique are the same as for BCG.

Who is the BCG vaccine shown to, what is it for?

• newborns up to 12 months of age in subjects with a large number of cases of tuberculosis;
• newborns, as well as children under 15 years old, in subjects with a small number of cases of tuberculosis;
• adults in contact with tuberculosis patients, especially in its resistant form.

The need for early vaccination childhood justified by the fact that it is in newborn children that tuberculosis develops into severe forms, which almost always lead to death.

Vaccination against tuberculosis does not guarantee complete protection against the disease, but the developed immune protection after vaccination prevents the development of severe forms that lead to death.

When BCG is given, vaccination schedule for newborns and older children

Within the territory of Russian Federation the National Calendar of preventive vaccinations for children has been developed, where the timing of vaccinations is prescribed. Vaccination against tuberculosis is mandatory and is included in the schedule three times:

• before discharge at the hospital, on the 5th ... 7th days;
• at 7 years old (if indicated);
• at the age of 14 (with testimony).

Russia is among the countries where the likelihood of contracting tuberculosis is high. Because of this, BCG is done in the maternity hospital for newborns, for everyone, without exception, who have no contraindications. More developed countries, with a small percentage of cases, vaccinate only those children who are at risk.

All newborns are vaccinated against tuberculosis without contraindications in the period from the 3rd to the 7th days from the moment of birth. Before manipulation, children are examined by a pediatrician. Vaccinations are performed in a specially designated office.

It is mandatory to vaccinate newborns in Russia, because more than half of the country's population in adulthood can be carriers of mycobacteria. Statistics show that over 70 percent of children develop tuberculosis in the first seven years of life. Lack of vaccination during infection leads to the development of meningitis with severe damage to the nervous system or extrapulmonary forms of the disease.

What to do if the vaccine was not given at the hospital

If, for some reason, the BCG vaccination in the hospital was not carried out, it is important to perform it without fail up to a year. When it is possible to get vaccinated, only a doctor can calculate, based on the determination of the necessary parameters and taking into account contraindications. In such cases, the vaccination schedule is drawn up individually.

If the BCG vaccination is not done, then when the child reaches two months, a Mantoux test is put before it. It allows you to detect the presence of antibodies to the causative agent of tuberculosis. You can vaccinate a baby only with a negative reaction. A positive result indicates infection. Accordingly, a thorough examination is required to prevent the development of severe forms of the disease.

Vaccinations against tuberculosis for children

If the child was vaccinated in a timely manner, the Mantoux result may be negative. Then, at the age of seven and fourteen, a mandatory revaccination is carried out. The lack of a reaction indicates that the body has not developed immune defenses, which means that the child may be susceptible to infection.

BCG vaccination is performed two to three days after hepatitis B vaccination. While the body is developing a reaction to the vaccine, it is forbidden to enter other vaccinations (6-8 weeks).

During pregnancy and lactation

The use of BCG vaccine is prohibited during pregnancy and breastfeeding.

BCG: how many times do it in life

Due to the fact that immunity from vaccination lasts for 7 years, it is done three times: in the first week of life - vaccination, at 7 years - BCG revaccination and at 14 years - another revaccination. Statistics show that a sharp increase in the number of patients is associated with the beginning of visits to children's educational institutions... The peak occurs at the age of 14 years. Every year, to prevent mass morbidity in children, the Mantoux test is performed.

Is it worth getting the BCG vaccine?

Vaccination is mandatory, but no one can force parents to do it either. There must be very good reasons for refusal, for example, serious contraindications. The developed countries boast a good epidemiological situation in terms of the spread of tuberculosis. However, do not forget that the main transmission route is airborne. Therefore, a person can become infected simply by being in a public place.

How BCG vaccination heals

Immediately after the administration of the BCG vaccine to the newborn, a white papule forms at the injection site. After 15-20 minutes after vaccination, it disappears. The vaccine takes a long time to heal. The body's immune response is developed due to the formation of a local tuberculous focus at the injection site.

The reaction proceeds in different ways - redness, suppuration, hyperemia. In this regard, the stages of healing are distinguished.

Healing stages

Immunity is formed within 45 days from the date of vaccination. A month after vaccination, redness or a bump may develop at the injection site. A bubble of fluid or even pus may appear. This is a completely normal reaction to the injected vaccine. The formation that has appeared may begin to boil, therefore, itching will appear. Scratching of the wound, as well as pressure on the injection site, should not be allowed.

When the reaction is over, a crust forms at the site of the abscess. When it falls away, you can see the scar from BCG - the one that adorns left hand all children and adults.

The more active the reaction and the larger the scar, the longer the immunity to tuberculosis is formed in the body.

What to do after BCG vaccination. Care features

It is important to follow some rules after vaccination. On the first day, you cannot wet the injection site. During the period of inflammation and abscess in the injection area, treatment should not be carried out disinfectants as well as iodine. When pus flows out, do not wash the wound or apply bandages. To avoid infection, do not scratch the site of inflammation. For the same reason, you cannot tear off the formed crust on your own.

BCG vaccination - reactions and complications

There are often different reactions to the BCG vaccine. Their complexity and nature is also influenced by the quality of the vaccine itself. Some newborns may experience an allergic reaction within half an hour after BCG vaccination. If it is not there, then everything is fine.

The next reaction, as a rule, appears after a month, when there is a habituation to the introduced strain of bacteria. The reaction occurs according to the scheme:

• inflammation with the formation of a small tubercle;
• sore at the injection site with the formation of a crust;
• scar formation.

If the vaccine is not given correctly, a cold abscess can form. Required medical treatment... As complications, general malaise associated with an abscess abscess and the manifestation of severe soreness can also appear.

No trace of BCG injection

The effect of the vaccine after the vaccination can be assessed after 1, 3, 6 and 12 months. As a rule, a scar is formed. But its absence is also possible. In such cases, there is a mandatory re-vaccination of BCG children by age. The absence of a scar indicates the ineffectiveness of the vaccination performed and the lack of formation of immunity to tuberculosis.

Formation of immunity after vaccination

The final formation of immunity after vaccination occurs after 2 months. If there is a risk of infection from others, the child should be isolated from them until the end of this period. The maximum duration of immune protection after BCG vaccination is 7, and in some cases even more, years.

How long can you get other vaccinations

No other vaccine injections should be given for 45 days after the BCG vaccination.

Where to get the BCG vaccine

Vaccination against tuberculosis is done at the hospital. If it was not completed in a timely manner, then it can be done in the TB dispensary. Medical institutions also have the right to carry out this manipulation, but only in cases where there is a special permit, equipped premises and qualified personnel. It is possible to perform the injection of the strain by a specialist with a visit to the house for a set fee.

Revaccination of BCG

Revaccination against tuberculosis is required. It is carried out at the age of 7 due to the end of the immune protection from the first vaccination. At this age, the child enters school, which means that he is surrounded by new people who may be carriers of the bacteria.

At the age of 14, BCG revaccination is carried out only if there is a negative Mantoux reaction, which indicates a lack of immunity to tuberculosis.

Which countries are vaccinated against tuberculosis

Vaccination against tuberculosis is carried out in all newborns in most countries of the world with an increased epidemiological risk of contracting this disease, including India, China, Japan, Brazil, Mexico. Russia is one of them. In some developed countries, vaccinations are given only to children at risk.

Price where to buy

You can buy the vaccine at most pharmacies. However, when transporting it, certain temperature conditions must be observed. You can order through specialized pharmacy points with delivery to the points of issue. All the conditions will be met there. The price for the vaccine varies within 400 rubles per package.

Analogs

Today you can find analogues of the Russian vaccine for vaccination against tuberculosis. These are imported medicines, which may not differ in the quality of the developed immunity. It should be borne in mind that from abroad, these drugs travel a long way, in which the necessary conditions of transportation and storage cannot always be observed.

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

What is BCG?

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

Important! After the vaccine is administered, a person can become infected with tuberculosis. However, immunization prevents latent infection from spilling over into overt disease.

Vaccination helps to protect the child from the onset of severe forms of the disease: tuberculous meningitis, bone damage, fatal forms of lung infection. Given the importance of vaccination, BCG vaccination is given to newborns in the hospital in the absence of contraindications. It helps to reduce the incidence rate. infectious disease among children.

Decoding and composition of the vaccine

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

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

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

Most modern vaccine preparations are based on one of the following mycobacterial strains:

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

The listed strains are characterized by the same efficiency.

Types of vaccines

On the territory of Russia, the following types of BCG vaccinations are widely used:

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

When is immunization done?

BCG vaccination is carried out for infants in a maternity hospital on the territory of states with an unfavorable epidemiological situation for tuberculosis. This minimizes the risk of infection. On the territory of Russia, universal vaccination of newborns has been carried out since 1962.

According to numerous studies, more than 66% of the world's inhabitants are carriers of the causative agent of tuberculosis - mycobacterium Bovis. However, doctors failed to establish the reasons for the transition of pathology from a carrier to a pronounced infectious process. It is believed that unsanitary conditions and poor nutrition can act as provoking factors.

Vaccination schedule

The first BCG vaccination for children is carried out in the hospital 3-5 days after the birth of the child. Premature babies are an exception. This allows the child to form reliable immunity during the year.

However, to maintain antibodies to mycobacterium Bovis at the proper level, children need revaccination throughout their lives. Therefore, the next vaccination is given to children at the age of 7, and the last one at the age of 14. More frequent booster vaccinations do not make sense. The introduction of other vaccines is possible only after a few months.

Between vaccinations against tuberculosis, the Mantoux test should be carried out annually, which allows you to determine the body's response to a set of mycobacteria. If the reaction is negative, then the child needs a revaccination. If the reaction is positive, it is necessary to exclude the development of tuberculosis. In such cases, children are referred to a phthisiatrician.

The main contraindications

• The weight of a newborn baby is below 2.5 kg;
• The child was born to a woman infected with HIV;
• Development of intrauterine infections;
• The infant was born to a woman with a history of primary or secondary immunodeficiency;
• Having a severe hemolytic disease in a newborn;
• If during childbirth the child received an injury that provoked brain damage;
• If the child is surrounded by persons infected with tuberculosis;
• In the presence of a widespread pustular lesion of the skin;
• Upon detection of genetic pathologies: Down syndrome, fermentopathies;
• If close relatives of children have various complications after BCG vaccination in history;
• Acute infectious diseases;
• In the presence of malignant neoplasms.

Revaccination should be abandoned in such cases:

• Acute course of infectious diseases;
• Allergic reactions;
• Signs of exacerbation of chronic pathologies;
• Immunodeficiency states;
• Conducted Mantoux test has a dubious or positive reaction;
• History of various oncopathologies;
• While taking immunosuppressants and radiation therapy;
• The presence of tuberculosis;
• Complicated reaction to previous BCG vaccination;
• Contact with people infected with tuberculosis.

Before the BCG vaccination, the doctor must ask the parents and examine the child to make sure there are no contraindications. After all, complications after the administration of the drug arise exclusively if contraindications are not observed.

Features of vaccination of a child in a maternity hospital

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

Usually BCG vaccination is carried out before the discharge of newborns from the hospital (3-6 days). The injection is made into the outer part of the left shoulder. BCG vaccine should be administered intradermally with one or more punctures. During vaccination, a disposable syringe should be used, the corner of which has a short cut.

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

The existing injection technique must be followed precisely to prevent complications in newborns. Before inserting the needle, you should slightly tighten the skin area. Next, a little BCA vaccine is injected. This helps to assess the correct insertion of the needle. In case of intradermal placement, the injection of the drug is continued. After BCG inoculation, the norm is the occurrence of a flat papule (whitish tubercle), the size of which does not exceed 10 mm. Such formation lasts no more than 2 hours, after which it disappears on its own.

Normal reaction to BCG

After vaccination in the maternity hospital, a slight increase in body temperature to subfebrile condition is possible. Such a reaction is associated with the imperfection of the mechanisms of thermoregulation in the child, it develops quite rarely. At the injection site, a slight redness is noted for several days after vaccination, suppuration is possible, which disappears on days 6-8.

Normally, the reaction to the BCG vaccine develops at 28-32 days. At the injection site in newborns, there is a small abscess, swelling, induration and a crust of scab. And also a change in skin color is possible. Such manifestations are the norm, so they should not frighten parents. This is how the child's body reacts to the intake of pathogenic microorganisms, developing immunity.

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

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

Features of a normal reaction

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

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

Complications after BCG

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

Important! Complications - serious conditions that lead to a disorder in the child's health require medical intervention.

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

• The development of lymphadenitis - a disease that leads to inflammation lymph nodes... After vaccination, this reaction occurs in only 1 out of 1,000 vaccinated newborns. In 90% of cases, complications occur in children with severe immunodeficiency. If the size of the lymph node exceeds 1 cm in diameter, then surgical treatment is performed in such cases;
• Osteomyelitis. The reason for the development of the complication is the use of a low quality vaccine;
• The onset of a cold abscess. The reaction appears after vaccination, which was carried out intradermally. Pathological formation is formed up to 1.5 months after the introduction of the vaccine. Treatment of an abscess involves its removal by surgery;
• The development of an extensive ulcer at the injection site, the diameter of which can reach 1 cm. This reaction develops in children who are hypersensitive to the ingredients of the vaccine. In such cases, the child needs local treatment. V medical records information on the development of the complication should be entered;
• Keloid scar. The mass is a red and swollen patch of skin at the injection site. In such cases, you should refuse to carry out revaccination throughout life;
• Development of generalized BCG infection. This reaction belongs to severe pathologies, develops against the background of severe immunodeficiency in a child. The complication rate is 1 child in 1 million vaccinated children;
• The onset of bone tuberculosis. The first signs of the disease develop 2 years after vaccination. The development of this complication indicates serious violations in the child's immunity.

How can complications be prevented?

BCG vaccination is usually well tolerated, leading to the formation of strong immunity against tuberculosis. However, if contraindications were not taken into account, the technique of drug administration was violated, the conditions for storage and transportation of the vaccine were not met, then complications develop. To avoid the development of hazardous reactions, you should adhere to the following recommendations:

• Before vaccination, carry out an allergy test for the compatibility of the vaccine with the body. This will prevent complications in the form of an allergic reaction;
• After vaccination, antiseptic solutions should not be used to treat the skin at the injection site, because they can disrupt the normal post-vaccination process;
• No need to squeeze out pus, apply an iodine mesh to the abscess. If a discharge appears at the injection site, it is enough to blot it with a sterile napkin;
• Parents should be careful not to scratch the vaccine site with their child. This will help prevent the addition of a secondary infection;
• A few days before the vaccination or revaccination at the age of 7 and 14, new foods should not be introduced into the child's diet. New dishes can provoke an allergic reaction, which can be mistaken for a complication after BCG.

Whether to do BCG: pros and cons

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

• In rare cases, it causes serious consequences and complications;
• No special care is required for the area where the vaccine has been injected;
• After vaccination, immunity against tuberculosis develops, which helps to reduce the risk of infection with mycobacterium Bovis;
• When infected with tuberculosis, the disease is mild;
• Helps reduce the risk of death.

However, the BCG vaccine also has several disadvantages:

• If the conditions for storage and administration of the vaccine are violated, if the existing contraindications are not observed, dangerous complications develop;
• Slow scar formation rarely seen.

Important! Rumors about the presence of a vaccine hazardous substances(mercury, formalin, phenol, polysorbate) have no scientific basis.

Parents should decide whether to vaccinate with BCG or not, having weighed the existing advantages and disadvantages of the vaccine. Before the revaccination, the child needs a comprehensive examination to determine if there are any contraindications to the administration of the vaccine. And you also need a Mantoux test, which allows you to exclude infection with tuberculosis. These actions will help reduce the risk of severe post-vaccination reactions.

Any parent knows the word "BCG". It is one of the oldest and most widely used vaccines in the world - a drug against tuberculosis. In many countries, the vaccine is included in the national immunization schedule, and almost 80% of people in these countries receive it at birth. July 18 is a significant date in the history of this vaccine. It was on this day in 1921 that the first BCG vaccination was given. Since then, for almost 100 years, the vaccine has been serving humanity, which regularly asks the question: what, in fact, is BCG and is it really necessary? MedAboutMe understood the specifics of BCG vaccination and its new medical applications.

The history of the BCG vaccine Koch's bacillus, a mycobacterium that causes tuberculosis, was discovered in 1882. To this day, it remains the bacterium that has killed more people in the world than any other microorganism.

In 1900, the French A. Calmette and C. Guerin from the Pasteur Institute in Lille began to develop an anti-tuberculosis vaccine. A strain of bovine mycobacterium tuberculosis, which caused the disease when infected, was taken as a basis. Scientists have found that if a culture of bacteria is sequentially inoculated from one medium to another for a long, long time, the strain weakens. After 4 years of subcultures (passages), the bacterium became safe for guinea pigs and cattle... In 1919 - after 230 passages - it stopped causing tuberculosis in monkeys and rabbits. At the same time, the immune system of the experimental animals regularly learned to fight unweakened mycobacteria. The new strain received a name that forever imprinted the names of its creators: Bacielle Calmette-Guerin (BCG), which in the Russian version was transliterated in BCG.

In 1921, on July 18, the vaccine was first administered to a newborn whose mother died of tuberculosis a few hours after his birth. The vaccine was administered orally, since, according to pediatrician Benjamin Weill-Allé, who experimented with the drug, infection with live mycobacteria also occurs through gastrointestinal tract... It should be noted that later he tried to inject the vaccine subcutaneously and dermally, but met resistance from the parents of the children, as local reactions developed.

By 1924, there had been 664 vaccinations with proven efficacy, and the Pasteur Institute began mass production of the vaccine. Over the next 4 years, more than 114 thousand children were vaccinated. During this time, no serious complications were recorded. But doctors and scientists were still wary of the vaccine - and then a tragedy happened in a hospital in the city of Lubeck (Germany).

In 1930, as a result of a tragic mistake, 252 children received a vaccine mixed with a virulent (that is, infectious) culture of mycobacteria. The mistake was made at the preparation stage. After 4-6 weeks, most babies developed severe tuberculosis. In the first year, the disease claimed the lives of 73 children, and 135 more small patients subsequently recovered. A months-long trial ruled that the doctors from Lübeck's laboratory were guilty. Two of them were sentenced to prison terms. But the vaccine suffered huge reputational losses - until now, people who oppose vaccines cite this case as an example of their danger.

The second World War, which significantly contributed to the spread of tuberculosis throughout the world and the increase in the incidence, put everything in its place. By the end of the 1940s, several studies were published one after another, proving the effectiveness of BCG vaccination against tuberculosis. Developed countries have begun to actively introduce the procedure for the universal vaccination of children.

Today, about 40 types of BCG vaccines are produced in the world. They all have a common ancestor - the same strain that A. Calmette and K. Guerin once received. But over the years of its breeding in laboratories around the world, over the years, new strains of BCG have been obtained, which differ from each other. Since 1956, WHO has kept the original vaccine strain batch. But with the production of new batches, deviations still accumulate, so that depending on the place of manufacture of the vaccine, BCG can vary significantly.

Today, drugs from four suppliers are considered the best in the world:

BCG-SSI, manufactured by the Danish Serum Institute in Copenhagen (SSI); BCG and BCG-M (Russia, manufacturer of FSUE NPO Microgen of the Ministry of Health of Russia, Gamaleya NIIEM State Institution of the Russian Academy of Medical Sciences) - BCG-M contains a half dose of mycobacteria and is used to vaccinate weakened and premature babies; BCG Inoculum Merier (Sanofi-Aventis Group, France); Freeze-dried vaccine glutamate (Japan BCG Laboratory, Japan). Vaccination against tuberculosis in Russia

So, BCG does not prevent the penetration of infection into the body, that is, the primary infection occurs either without a vaccine or after its administration. BCG prevents infection from developing, but is unable to limit the reactivation of latent (latent) pulmonary infection.

Today in Russia 2/3 of the adult population are carriers of the tubercle bacillus. That is, according to the WHO definition, our country is one of the countries with a high burden of tuberculosis. Therefore, children born in Russia are vaccinated immediately after birth, so that the body has time to learn how to deal with Koch's bacillus even before the first meeting with it. And the risk of such a meeting in our society is extremely high.

When infected with Koch's bacillus, unvaccinated children most often die from tuberculous meningitis or from the disseminated form of the disease, when multiple foci of infection form in the lungs. Given the growing number of cases of multidrug-resistant tuberculosis (MDR-tuberculosis), the issue of vaccination of newborn babies is especially acute.

In Russia, due to the high prevalence of mycobacterium among the population, children aged 7 years are re-vaccinated with BCG - subject to a negative Mantoux test. The second inoculation is also done in the shoulder, intradermally.

Several years ago, information spread across Russian and Ukrainian social networks that the Danish vaccine is dangerous, as it causes lymphadenitis (inflammation of the lymph nodes). However, upon closer examination of the issue, the following became clear. Ukraine has decided to switch to the Danish vaccine, as studies have shown that it is less reactogenic (that is, less likely to cause complications). But when the technique of administering the vaccine was violated, that is, with a low quality of vaccination, lymphadenitis developed. According to doctors, this meant that the drug was injected not intradermally, but subcutaneously, which is strictly prohibited. Thus, the vaccine itself turned out to be “not to blame” - problems arose due to its incorrect administration.

What is important to know when vaccinating with BCG? BCG is never given at the same time as other vaccines. Even in the maternity hospital, there is an interval of 3-4 days between the first vaccination against hepatitis B and BCG. With the introduction of the vaccine, the reaction develops 4-6 weeks after vaccination. In the area of ​​the injection, as a result, redness (or blue discoloration and even blackening of tissues) develops, an abscess and later a crust. According to the results of inoculation, a characteristic scar of 2 to 10 mm in size should form on the skin. Its absence means that the child was not vaccinated. You can not squeeze the vial at the vaccination site, lubricate with something, fill it with antibiotics, fill it with iodine (or make an iodine grid), etc. it is necessary to contact a phthisiatrician - a specialist in the field of tuberculosis treatment. BCG vaccine and other diseases

BCG is an amazing vaccine with a number of properties that give hope for a much wider application than protection against tuberculosis. It is known that human body possesses the so-called innate immunity. Research shows BCG stimulates it.

BCG and infections

After some time, after observing children who received the BCG vaccine, it was noticed that they not only get sick with tuberculosis much less often, but they also die less often from other infections. For example, it has long been known that vaccination with BCG protects against leprosy (and even better than against tuberculosis), as well as against Buruli ulcer.

In 2015, scientists discovered that the introduction of BCG leads to an increase in the synthesis of cytokines - these are proteins that control the work of immune cells. It also increases the number of receptors required to recognize foreign proteins. This effect is observed for about three months after vaccination. Scientists have come to the conclusion that BCG must activate certain sections of DNA in order to start the process of producing the necessary proteins. Experiments on animals have confirmed that BCG protects the body not only against tuberculosis. Today, the effects of the vaccine on the innate immune system are being actively studied. Perhaps, in the near future, people whose immunity is weakened for various reasons, for example, elderly patients who are discharged from the hospital home, will receive additional vaccinations.

BCG and Cancer The ability of BCG to activate the cytokine production process has led scientists to believe that the drug could be an effective adjunct to cancer therapy. It is known that cancer cells can disguise themselves as healthy cells. The cells of the immune system cannot recognize them, as a result of which the disease spreads throughout the body. Experiments have shown that BCG increases the likelihood of cell detection malignant tumors the immune system. The vaccine sets off a chain of events, as a result of which the tumor cells "turn off camouflage" and become visible to the white blood cells responsible for the destruction of foreign tissue.

According to research results, the introduction of BCG leads to an increase in the "visibility" of malignant cells in lung, breast and colon cancer. The effectiveness of the use of BCG in cancer has been proven Bladder, and its effect is enhanced with the additional introduction of vitamin D.

It should be emphasized that BCG is not a cure for cancer; it cannot be used without chemotherapy to fight tumor cells. Moreover, in 30-40% of cases, it does not work and does not enhance the effect of anti-cancer drugs. But, according to scientists, this medicine contains a still unexplored potential for the fight against cancer.

In 2011, a group of American researchers launched the BCG World Atlas, a website that collects information on past and present vaccine policy in 180 countries. The resource is intended for doctors and scientists.

BCG and diabetes

The vaccine also increases levels of an immune modulating protein called tumor necrosis factor (TNF). And this protein, in the course of experiments in mice, lowered the activity of abnormal white blood cells, which are responsible for the attack of the immune system on the tissue of the pancreas - which, in fact, causes type 1 diabetes. In addition, TNF activates the processes of T-lymphocyte production, which reduce the risks of autoimmune disruptions in the body. Human studies have shown that two BCG injections per month given to patients with diabetes mellitus Type 1, lead to a temporary restoration of insulin production - albeit not in full. Today, scientists are trying to achieve full production of insulin using BCG injections.

It should be added that research is also underway on the use of BCG to combat other autoimmune diseases, for example, with multiple sclerosis.

Conclusions BCG is not a panacea for tuberculosis. It does not protect against infection with the tubercle bacillus. But it prevents infections from developing. The BCG vaccine also works against a number of various diseases: infectious, oncological, autoimmune. Despite its long history, BCG vaccine is not only a drug of the past, but also of the future. It is full of surprises - and will certainly surprise scientists more than once.

Tuberculosis - dangerous disease, protection from which is necessary from childhood. This is why parents should make sure that their child gets still in the hospital. Awareness of the effect and contraindications is the knowledge necessary to maintain the health of the baby.

Indications for vaccination against tuberculosis

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

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

It should be noted that the vaccination is not carried out if the person is sick with tuberculosis. The approximate term for the formation of immunity is 2 months.

Preparation for vaccination

An important part of preventive action is correct preparation to get vaccinated. The main preparatory steps are to identify contraindications and check the baby's well-being. Make sure the baby is not constipated, sick, or has direct contact with infected people.

Contraindications to BCG in newborns

Before vaccination in newborns, pathologies and contraindications are identified, which can become a reason for.

BCG vaccination is contraindicated if:

1. the weight of the child at birth is less than 2 kilograms;
2. ... If the disease has not caused any complications, then the vaccination is given at the end of it;
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 allowed if the disease is mild;
9. radiation therapy. Vaccination is done at the end of the treatment period (six months after stopping therapy);
10. damage to the nervous system;
11. malignant formations.

There is one more thing, the most important contraindication, which can make life difficult for the baby - for the vaccine.

Contraindications for revaccination

Revaccination is a standard procedure most often performed in schools for children of seven years old.

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

If the 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 adherence to necessary measures safety, such as refusal to vaccinate during periods of illness or contact with infected people.

How do I know if my baby is allergic to the vaccine?

Identifying allergic reactions to a vaccine 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 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 that rashes 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 in the vaccine can cause unpleasant symptoms. If an allergic reaction is detected, additional tests are performed.

Complications of non-compliance with contraindications to immunization

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

The most serious complications can be:

1. an 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 itself in a difficult position, appears. A similar situation can arise if the conditions for the post-vaccination period are not met.

Medical withdrawal from BCG vaccination in the maternity hospital

If parents are not sure about the safety of the measures being taken, this issue should be discussed with the pediatrician. Vaccinations can be postponed for some time so that the 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.

Contraindications may become the reason for the medical withdrawal, including:

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

The reason for the refusal of vaccination is indicated to the newborn. At the same time, parents need to be aware of the consequences of refusal.

Consequences of refusing BCG vaccination

The most dangerous consequence can be serious illness, resulting from the lack of developed immunity.

Also, a child whose medical record does not contain a label about the vaccination carried out has restrictions associated with admission to 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.

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