Compound BCG vaccines based on different subtypes of Mycobacteria bovis. The recipe has remained unchanged since 1921. Then the Frenchmen Calmette and Guerin, after 13 years of working with cell culture, including various subtypes of mycobacteria, were able to isolate the isolate.
This culture causes tuberculosis in large cattle. The disease caused by it is called “pearl disease” or “bovine tuberculosis.” Bacteria are able to overcome the “species” barrier and cause tuberculosis in humans.
All series of Mycobacteria bovis subtypes still used to produce the BCG vaccine are stored by WHO.
Production technology
The technology for producing the tuberculosis vaccine, which was used to obtain the first doses of the drug, has not changed for almost a hundred years.
The microbial mass of the BCG culture is sown and grown on hard potatoes. It contains starch necessary for the nutrition and growth of mycobacteria. Exposure time – 1 week. Afterwards it “ripens” in liquid synthetic media, from where it is:
- remove;
- filtered;
- washed with a drying medium;
- passed through a shuttel apparatus, where the resulting mass is ground to a homogeneous powder;
- The powder is diluted with a stabilizer. The goal is to obtain a suspension containing 50 mg of the substance per 1 ml;
- the solution is centrifuged for 15-20 minutes at a speed of 2,000 rpm;
- the powder is diluted again with the same stabilizer to obtain a supernatant suspension with a concentration of 0.5 mg of Mycobacteria bovis in 1 ml;
- the drug is poured into ampoules and lyophilized.
All operations are carried out to obtain a BCG vaccine with increased viability.
Features of the components of the drug
Active substance
The drug contains both live and dead bacteria. The number of Mycobacteria bovis cells in 1 dose of BCG vaccine varies and depends on the subtype of mycobacteria and characteristics technological process obtaining the substance.
90% of the BCG vaccine used in the world contains one of the following strains of mycobacteria:
- Danish 1331;
- Tokyo 172;
- French "Pasteur" 1173 P2;
- Strain "Glaxo" 1077.
Each vaccination given with a preparation containing any of the specified strains will be equally effective.
The fundamental difference between the BCG-M vaccine, used for gentle immunization, and the usual one is that the specific gravity of Mycobacteria bovis in the standard dose of the substance is halved.
Tip: If you have concerns about possible reaction If a newborn is affected by the effect of the vaccine, a more gentle version of the drug, BCG-M, should be administered.
In Russia, mycobacteria are placed in a solution of monosodium glutamate, which is a salt of glutamic acid. The latter is present in free form in living organisms and is part of some low-molecular substances and a number of proteins.
Monosodium glutamate is added to foods. Its marking is E621, and its formula is C5H8NO4Na*H2O. This substance actively used in Food Industry, sold as an independent seasoning, is a flavor enhancer.
Solvent
In Russia, the composition of the drug used for BCG vaccination, immediately before use, add a solvent - 0.9% solution of Natrii chloridum (sodium chloride). It is also called saline solution.
The formula of the substance is NaCl. This is normal table salt. It is used when the body loses fluid, is used to wash eyes and wounds, and in the preparation of medicinal solutions.
Other components
Some publications report the presence of formalin, merthiolate, Tween-80 and even aluminum hydroxide in the preparation. All of the compounds listed are strong poisons. But official research tests that would have revealed or refuted their presence in the preparation for anti-tuberculosis vaccination have not been carried out.
Mechanism of action
Anti-tuberculosis vaccination is administered to newborns at 3-4 days of life. This is necessary to protect the baby from infection spreading by airborne droplets. That is, for infection, a short-term presence of a sick person next to a child is sufficient.
Immunity, the development of which should be facilitated by BCG vaccination, is finally formed only after 6 weeks after administration of the serum and persists for 5-7 years. Afterwards, repeated revaccination is carried out.
The vaccination site at the site of its administration becomes a hotbed for the spread of infection. The body begins to fight infection, for which it produces special immune cells. They will persist for several years and protect a person from infection.
The mechanism of action of Mycobacteria bovis on the body is not fully understood: it is unknown how immunity is formed and how long it lasts. The effectiveness of vaccination is also questionable, especially given the complications that arise every year. In medicine, a special term has even been introduced - BCGit.
Drug safety requirements
The anti-tuberculosis drug contains a culture of Mycobacteria bovis, some of the cells of which are already dead, i.e. they are already harmless, and the other part contains living, potentially dangerous cells.
During the production process, future grafting is constantly monitored for:
- level of virulence of the strains used;
- absence of foreign microflora, because No preservatives are used in the production of the drug;
- the number of mycobacteria contained in the vaccine dose. It is important to control their quantity and condition. The lack of living culture will not cause the desired reaction body, as a result immune defense will be too weak. Excess can lead to post-vaccination complications.
Dispersity is important in the preparation. It must be at least 1.5, otherwise lymphadenitis and unwanted local reaction. After introducing the solvent into the ampoule, the drug should dissolve within 1 minute.
Important: The drug should not be used after the expiration date. It should be stored at a temperature not exceeding 8ºC. The ampoule must be intact, and there must be a vacuum inside it. Otherwise, the vaccination will be ineffective and complications may occur.
It is important to know
Domestic anti-tuberculosis vaccines are preferable to imported ones. The shelf life of the drug is 1 year, and foreign drugs certainly undergo a long procedure customs control, What:
- increases the travel time of the vaccine;
- increases the risk of non-compliance with storage conditions;
- reduces the effectiveness of vaccination due to the loss of some mycobacteria, i.e. the composition of the substance has changed;
- increases the risk of complications due to loss of quality of the original substance over time.
BCG vaccination is not given if:
- baby weight less than 2 kg;
- he has been diagnosed with neoplasms (both malignant and benign);
- one of the immediate family had complications after the administration of the drug;
- the patient has problems with the immune system (he is taking immunosuppressive medications, is ill, the mother or child has been diagnosed with HIV).
Complications after vaccination occur with a frequency of 2 cases per 10,000 injections given, but they are very severe:
- lymphadenitis;
- disorders thyroid gland, kidneys and the work of other organs;
- cutaneous tuberculosis;
- BCG osteomyelitis;
- general lymphadenopathy.
But vaccination is necessary to prevent the development of:
- open form of tuberculosis;
- the most severe forms of complications in this disease.
BCG M - vaccination to prevent the development of tuberculosis
Mantoux test: why do it to a child, is it dangerous?
If there are no contraindications, mantoux test best test for tuberculosis
Components of the drug used in the Mantoux test
Any vaccination has the function of immunoprophylaxis, the purpose of which is to develop immunity in the human body to the pathogen introduced with the vaccine.
One of the main ones is the BCG vaccination, thanks to which in the child’s body hidden infection the disease does not become obvious, and the occurrence of severe forms of this disease. That is why the first BCG vaccination is administered to children in the first days of life after birth.
In contact with
What does the abbreviation BCG mean?
The generally accepted name for the BCG vaccination comes from the Latin abbreviation Bacillus Calmette-Guérin (BCG), which means Bacillus Calmette-Guérin, named after the scientists who discovered it. It is prepared from a strain of weakened tuberculosis bacillus of domestic cattle - Mycobacteria bovis of various subtypes - grown in a special artificial environment. The vaccine itself contains a certain number of live and dead bacteria.
What does the abbreviation BCG-M mean?
BCG-M - this is the name of dry tuberculosis vaccine against, for primary immunization in a gentle form. It differs from the usual vaccine in its low concentration - if BCG contains 0.05 mg of the drug, then BCG-M 0.025 mg, respectively. This vaccine is intended for primary vaccination:
- Premature newborns (less than 2500g);
- those not vaccinated in the maternity hospital due to weakness or some diseases (vaccinated at the clinic at the place of residence).
The history of the BCG vaccine
The founders of the BCG vaccine are French scientists Camille Guerin (veterinarian) and Albert Calmette (microbiologist).
- 1908 - the beginning of the work of scientists, during which they established that in a certain nutrient medium it is possible to grow tuberculosis bacilli of the least activity. After this, they began to develop a strain to create a vaccine.
- 1919 - scientists obtain a vaccine with non-virulent bacteria, not causing disease in animals.
- 1921 - BCG vaccine was obtained for humans.
- 1925 - the strain was transferred to the scientist L.A. for study in Moscow. Tarasevich, as a result of which the effectiveness of the vaccine was revealed.
- 1928 - BCG adopted by the League of Nations.
- Mid-1950 - vaccination of newborns becomes mandatory.
- 1985 - BCG-M began to be used.
In which countries are they vaccinated against tuberculosis?
The BCG vaccine is used in many countries. In the USSR in 1962, it was customary to vaccinate all newborns en masse in the maternity hospital, which continues to this day. Currently, this approach to vaccination has been preserved in Ireland, Belarus, Romania, Portugal, Hungary, Latvia, Estonia, Lithuania, Moldova, Poland, Bulgaria, Brazil, Azerbaijan, India and Slovakia. In Germany, the vaccine was abolished in 1998. 
In Singapore and Malaysia, BCG has been administered only at birth since 2001. Mass vaccination has never been used only in the USA and the Netherlands.
Vaccine composition
Main component of the vaccine different subtypes tubercle bacilli Mycobacteria bovis. The bacilli are grown in a special artificial environment for a week. After this, they are filtered, isolated and concentrated. It is then lyophilized in a solution of monosodium glutamate (frozen and dried in a vacuum chamber). This produces a dry powder that is placed in an ampoule, which contains approximately 20 doses of the vaccine. The strain is dissolved in a 0.9% sodium chloride solution, which is usually immediately included with the vaccine.
Vaccination of newborns in the maternity hospital
If the newborn has a body weight of 2500 or more, and also does not have such contraindications to vaccination as:
- Damage to the central nervous system;
- intrauterine infections;
- skin diseases;
- hemolytic disease;
- HIV infection;
- malignant formations;
- generalized infection for vaccination,
then on days 3–7 the child is vaccinated with BCG. In other cases, he is vaccinated with BCG-M in the maternity hospital (if he is underweight) or in the clinic after complete recovery. Children older than 2 months who were not vaccinated in the maternity hospital must be checked before vaccination - tests are taken and the Mantoux test is performed. BCG is possible with a negative Mantoux test and good test results. A normal reaction to vaccination in newborns appears after about 4-6 weeks in the form of an abscess measuring 5-10 mm. This scar should not be treated or disturbed.
The process of vaccination of infants is particularly careful - it is carried out separately from other vaccinations, with a special needle and syringe. The child’s card must indicate the date of vaccination, series and expiration date of the vaccine. Children from 0 to 2 months should be observed by a pediatrician on the day of vaccination.
In Russia and some other countries, it is customary to revaccinate with BCG. This occurs at 7 and 14 years of age. Revaccination differs from the first vaccination in that it is done only after checking the Mantoux reaction - it must be negative. 
In the absence of data on the first vaccination, the decision on revaccination is made based on the presence or absence of a scar on the shoulder - in its absence, it is necessary to administer the vaccine. A local reaction to revaccination appears within 2 to 3 weeks.
Possible complications
Percent possible complications after BCG vaccination is not high - from 0.004 to 2.5% cases. The most common complications can occur through 2 — 18
months of vaccination, as a result of which mainly the lymph nodes (subclavian, cervical, axillary and supraclavicular) are affected. Sometimes BCG osteitis occurs, which affects bone tissue. According to statistics, from 2005 to 2010, the number of operated children with BCG abscesses increased from 7 to 68 per year. Frequent complication- increase in temperature for 2 days. The main causes of complications are errors and non-compliance with basic rules when administering the drug, individual intolerance to the drug, and failure to take into account contraindications to vaccination. Lethal outcome is possible in 1 case in 1 million (0.0001%). 
Thus,
Tuberculosis vaccine (BCG), lyophilisate for preparing a suspension for intradermal injection, is a live mycobacteria of the vaccine strain BCC-1, lyophilized in a 1.5% solution of monosodium glutamate stabilizer.
One ampoule of BCG vaccine (10 doses) contains 0.5 mg of BCG microbial cells and 3 ± 0.02 mg of monosodium glutamate; BCG vaccine (20 doses) contains 1.0 mg of BCG microbial cells and 3±0.02 mg of monosodium glutamate. The drug does not contain preservatives or antibiotics.
The vaccination dose contains 0.05 mg of BCG microbial cells in 0.1 ml of solvent
The porous mass is powdery or in the form of a thin openwork tablet of white or cream color. Hygroscopic.
BIOLOGICAL AND IMMUNOLOGICAL PROPERTIES
Live mycobacteria of the BCG-1 strain, multiplying in the body of the vaccinated person, lead to the development of long-term immunity to tuberculosis.
PURPOSE
Active specific prevention tuberculosis.
METHOD OF APPLICATION AND DOSAGE
The BCG vaccine is used intradermally at a dose of 0.05 mg in 0.1 ml of the supplied solvent (sodium chloride solution 0.9% for injection).
Vaccination is carried out for healthy newborn children on days 3-7 of life (usually on the day of discharge from the maternity hospital) in areas with a tuberculosis incidence rate of over 80 per 100,000 population. With a lower incidence of tuberculosis, the population is vaccinated with BCG-M.
Children who were not vaccinated during the neonatal period 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 standard breeding and only tuberculin-negative people are vaccinated.
Children aged 7 and 14 years who have negative reaction for Mantoux test with 2 TE PPD-L. The Mantoux reaction is considered negative when complete absence 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 and certified 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, the selection of children for vaccination is preliminarily carried out by a doctor (paramedic) with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history data. If necessary, consultations with medical specialists and blood and urine tests are carried out. When carrying out revaccination at school, 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.
For vaccination (re-vaccination), disposable sterile tuberculin syringes with a capacity of 1 ml with thin short needles with a short bevel 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 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 the refrigerator (locked) in the vaccination room. Persons unrelated to BCG vaccination are not allowed into the premises where vaccinations are carried out (maternity hospital) and into the vaccination room (clinic) on the day of vaccinations. On the day of BCG vaccination (re-vaccination) it is prohibited to carry out other activities in the vaccination room (room). preventive vaccinations.
Vaccine ampoules are carefully inspected before opening.
The drug should not be used if:
- absence of markings on the ampoule or its incorrect filling;
- expired expiration date;
- presence of cracks and notches on the ampoule;
- change physical properties drug (discoloration, wrinkled tablet, etc.).
The vaccine is dissolved immediately before use with a sterile solution of sodium chloride 0.9% for injection, supplied with the vaccine. The solvent must be transparent, colorless and free of foreign inclusions.
The vaccine is vacuum sealed: The neck and head of the ampoule are wiped with alcohol. First, file down and carefully, using tweezers, break off the sealing area. Then they file and break off the neck of the ampoule, wrapping the sawed end in a sterile gauze napkin.
The vaccine is sealed under inert gas: The neck and head of the ampoule are wiped with alcohol. Break off the neck of the ampoule along the ring or break point, wrapping the head in a sterile gauze napkin.
To obtain a dose of 0.05 mg of BCG in 0.1 ml, transfer 2 ml of 0.9% sodium chloride solution for injection into an ampoule containing 20 doses of the vaccine with a sterile syringe, and 1 ml of sodium chloride solution into an ampoule containing 10 doses of the vaccine. 0.9% for injection. The vaccine should dissolve within 1 minute. The presence of flakes is allowed, which must be broken up when mixed 3-4 times using a syringe (air should not enter the syringe). The dissolved vaccine should look like a coarse suspension of white color with a grayish tint. If there are large flakes in the diluted preparation that do not break up when mixed 3-4 times with a syringe, or sediment, this ampoule with the vaccine is destroyed without using it.
The diluted vaccine must be protected from exposure to sunlight and daylight(for example, a cylinder of black paper). The diluted vaccine is suitable for use for no more than 1 hour after dilution 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 of the drug and destruction of the ampoule with the vaccine. Unused vaccine is destroyed by boiling for 30 minutes, autoclaving at 126 ° C for 30 minutes or immersing opened ampoules in disinfectant solution(5% chloramine solution or 3% hydrogen peroxide solution) for 60 minutes.
For each vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn into a tuberculin syringe, then approximately 0.1 ml of 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. 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 outer surface left shoulder after pre-treatment of the skin with 70° alcohol. The needle is inserted with the cut upward into the surface layer of the stretched skin. First enter insignificant amount vaccine to make sure that the needle enters exactly intradermally, and then the entire dose of the drug (only 0.1 ml). At correct technique injection, a whitish papule with a diameter of 7-9 mm should form, usually disappearing within 15-20 minutes.
REACTION TO INTRODUCTION
Normally, at the site of intradermal administration of the BCG vaccine, after 4-6 weeks, vaccinated people consistently develop a local specific reaction in the form of infiltrate, papules, pustules, and ulcers measuring 5-10 mm in diameter. 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 reaction site should be protected from mechanical irritation, especially during water procedures.
In 90-95% of vaccinated people, a superficial scar measuring up to 10 mm is formed at the vaccination site.
SIDE EFFECT
After vaccination and revaccination, complications are rare and are usually local in nature (lymphadenitis with a diameter of more than 1 cm - regional, often axillary, sometimes supra- or subclavian, less often - subcutaneous infiltrates, cold abscesses, ulcers, keloids). Persistent and disseminated BCG infection without fatal outcome(lupus, osteitis, etc.), post-BCG syndrome of an allergic nature, which occurs soon after vaccination ( erythema nodosum, granuloma annulare, rashes, etc.), extremely rarely - generalized BCG damage in congenital immunodeficiency. Complications are detected in different deadlines after vaccination - from several weeks to a year or more.
USE SIMULTANEOUSLY WITH OTHER MEDICINES
Other preventive vaccinations can be carried out at an interval of at least 1 month before and after vaccination (re-vaccination) with BCG (with the exception of the hepatitis B vaccine, which is administered in accordance with the National Calendar of Preventive Vaccinations in the Russian Federation).
CONTRAINDICATIONS
Vaccination
1. Prematurity - birth weight less than 2500 g.
2. Intrauterine malnutritionШ-1У degree.
3. Acute diseases. Vaccination is postponed until completion acute manifestations diseases and exacerbations chronic diseases(intrauterine infection, purulent-septic diseases, moderate and severe hemolytic disease of newborns, severe lesions nervous system with severe neurological symptoms, generalized skin lesions and so on.).
4. Immunodeficiency state (primary), malignant neoplasms.
5. Generalized BCG infection detected in other children in the family.
6. HIV infection in the mother of a newborn.
Children who have contraindications to vaccination with the BCG vaccine are vaccinated with the BCG-M vaccine in compliance with the instructions for this vaccine.
Revaccination
1. Acute infectious and non-communicable 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. Complications from previous administration of the BCG vaccine.
In case of contact with infectious patients in the family, children's institution etc. vaccinations are carried out at the end of the quarantine period or maximum period incubation period for this disease.
Persons temporarily exempt from vaccinations must be monitored and recorded. and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.
PRECAUTIONARY MEASURES
Injecting the drug under the skin is unacceptable, as this will form a cold abscess.
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: infiltration, papules, pustules, ulcers, about which the child’s parents should be warned.
More full information on the implementation of vaccine prevention of tuberculosis is presented in Order of the Ministry of Health of Russia No. 109 “On improving anti-tuberculosis measures in Russian Federation» dated March 21, 2003
RELEASE FORM
In ampoules containing 0.5 mg (10 doses) or 1.0 mg of the drug (20 doses), complete with a solvent - sodium chloride solution 0.9% for injection - 1 or 2 ml per ampoule, respectively.
One pack contains 5 ampoules of BCG vaccine and 5 ampoules of 0.9% sodium chloride solution for injection (5 sets).
VACATION CONDITIONS
The drug is intended for use in medical institutions.
BEST BEFORE DATE
2 years. A drug that has expired cannot be used.
STORAGE AND TRANSPORTATION CONDITIONS
The drug is stored according to SP 3.3.2.1248-03, at a temperature of 0 to 8 °C, out of the reach of children.
Transported according to SP 3.3.2.1248-03 at temperatures from 0 to 8 °C.
Manufacturer:
FSBI "NIIEM named after N.F. Gamaleya" of the Ministry of Health of Russia (Branch "Medgamal" of the FSBI "NIIEM named after N.F. Gamaleya" of the Ministry of Health of Russia).
The BCG anti-tuberculosis vaccine is one of the first vaccines that is administered to a newborn child to prevent tuberculosis in the maternity hospital 3-7 days after birth according to the national calendar of preventive vaccinations.
Vaccination in maternity hospital carried out in the morning. On the day of vaccination, no other parenteral manipulations are performed on the child, including examination of the child for phenylketonuria and congenital hypothyroidism.
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.
Prevention of tuberculosis can be carried out only with drugs registered in the Russian Federation:
- tuberculosis vaccine ( BCG) dry for intradermal administration (BCG vaccine);
- tuberculosis vaccine ( BCG-M) dry (for gentle primary immunization).
It is prohibited to apply a bandage or treat the vaccine injection site with iodine or other disinfectant solutions.
Revaccinations Children aged 7 and 14 years who have a negative reaction to the Mantoux test are subject to treatment (the reaction is considered negative in the complete absence of infiltration, redness or in the presence of a prick reaction (1 mm). Children infected with tuberculous mycobacteria who have a negative reaction to the Mantoux test are not subject to revaccination The interval between the Mantoux test and revaccination should be at least 3 days and no more than 2 weeks.
Reaction to the BCG vaccine
At the site of intradermal administration of the BCG vaccine, a specific reaction develops in the form of a papule measuring 5 - 10 mm in diameter.
In newborns, a normal vaccination reaction appears after 4 - 6 weeks. The reaction undergoes reverse development within 2 - 3 months, sometimes over a longer period. In those revaccinated, a local reaction develops after 1 to 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 should form at the vaccination site. Complications after vaccination and revaccination are rare and are usually local in nature.
Contraindications to BCG vaccination
- Prematurity 2 - 4 degrees (with body weight at birth less than 2500 g).
- Vaccination is postponed in case of acute diseases and exacerbations of chronic diseases (intrauterine infection, purulent-septic diseases, moderate and severe hemolytic disease of newborns, severe damage to the nervous system with severe neurological symptoms, generalized skin lesions, etc.) until disappearance clinical manifestations diseases.
- Immunodeficiency condition (primary, i.e. congenital).
- HIV infection in the mother.
Children who were not vaccinated during the neonatal period, after eliminating contraindications, the vaccine is prescribed BCG-M. Children aged 2 months and older are first given the Mantoux test 2 TE PPD-L and only those who are tuberculin negative are vaccinated.
Contraindications to revaccination
- Acute infectious and non-infectious diseases, exacerbation of chronic diseases, including allergic ones. The vaccination is carried out 1 month after recovery or remission.
- Immunodeficiency conditions, malignant neoplasms of any location. When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.
- Infected with tuberculosis and persons who have had tuberculosis previously.
- Positive and questionable Mantoux reaction with 2 TE PPD-L.
- Complicated reactions to previous administration of the BCG vaccine ( keloid scar, lymphadenitis, etc.).
Persons temporarily exempt from vaccinations should be placed under observation and registration and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.
Other preventive vaccinations can be carried out at intervals of at least 1 month before and after BCG revaccination.
Monitoring of vaccinated and revaccinated children and adolescents is carried out by pediatricians. 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.).
BCG-M vaccine (for gentle primary immunization)
The vaccination dose of the BCG-M vaccine contains 0.025 mg of the drug in 0.1 ml of solvent (which is 2 times “weaker” than the BCG vaccine) and is intended for gentle specific prevention of tuberculosis.
The BCG-M vaccine is vaccinated:
- In the maternity hospital for premature newborns weighing 2000 g or more, when restoring their original body weight - the day before discharge.
- In departments for nursing premature newborns in medical hospitals (2nd stage of nursing) - children weighing 2300 g or more before being discharged from the hospital to home.
- In children's clinics - children who did not receive anti-tuberculosis vaccination in the maternity hospital due to medical contraindications and are subject to vaccination in connection with the removal of contraindications.
- In areas with a satisfactory epidemiological situation for tuberculosis, the BCG-M vaccine is used to vaccinate all newborns.
Children who have not been vaccinated in the first days of life are vaccinated during the first two months in a children's clinic or other medical institution without prior tuberculin diagnostics.
Children over 2 months of age require a preliminary Mantoux test with 2 TU PPD-L before vaccination. Children with a negative reaction to tuberculin are vaccinated. The reaction is considered negative in the complete absence of infiltration (hyperemia) or the presence of a prick reaction (1.0 mm). The interval between the Mantoux test and vaccination should be at least 3 days and no more than 2 weeks.
Vaccinations should be carried out by specially trained medical personnel of the maternity hospital (ward), department for nursing premature babies, children's clinics or feldsher-obstetric stations. Vaccination of newborns is carried out in the morning in a specially designated room after the children have been examined by a pediatrician. Vaccinations at home are prohibited. The selection of children to be vaccinated is preliminarily carried out by a doctor with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history. If necessary, consultation with medical specialists and blood and urine tests are carried out. In the medical history of the newborn ( medical card) indicate the date of vaccination, series and control number of the vaccine, manufacturer, and expiration date of the drug.
The BCG-M vaccine is administered in the same way as BCG - strictly intradermally into the outer surface of the left shoulder.
Reaction to BCG-M administration
At the site of intradermal injection of the BCG-M vaccine, a specific reaction develops in the form of a papule measuring 5 - 10 mm in diameter.
In newborns, a normal vaccination reaction appears after 4 - 6 weeks. The reaction undergoes reverse development within 2 - 3 months, sometimes over a longer period.
The site of the reaction should be protected from mechanical irritation, especially during water procedures.
Complications after vaccination are rare and are usually local in nature.
Contraindications for vaccination with BCG-M vaccine in newborns
- Prematurity - birth weight less than 2000 g.
- Vaccination is postponed in case of acute diseases and exacerbations of chronic diseases (intrauterine infection, purulent-septic diseases, moderate and severe hemolytic disease of newborns (hemolytic pronounced jaundice), severe damage to the nervous system with severe neurological symptoms, generalized skin lesions, etc.) until the clinical manifestations of the disease disappear.
- Immunodeficiency state (primary).
- Generalized BCG infection detected in other children in the family.
- HIV infection in the mother.
Persons temporarily exempt from vaccinations should be placed under observation and registration and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.
Children who were not vaccinated during the neonatal period receive the BCG-M vaccine after the contraindications are lifted.
Filterable list
Active substance:
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.
Available complete with a solvent - sodium chloride solvent for preparation dosage forms for injection 0.9%.
Description of the dosage form
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 nursing premature babies, children's clinics or feldsher-obstetric stations. Vaccination of newborns is carried out in the morning in a specially designated room after the children have been examined by a pediatrician. In clinics, the selection of children for vaccination is preliminarily carried out by a doctor (paramedic) with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history. If necessary, 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 and carefully, using tweezers, break off the sealing area. Then they file and break off the neck of the ampoule, wrapping the sawed end in a sterile gauze napkin.
To obtain a dose of 0.05 mg of BCG in 0.1 ml of solvent, 1 ml of sodium chloride of solvent for the preparation of dosage forms for injections of 0.9% is transferred into an ampoule containing 10 doses of the vaccine with a sterile syringe. The vaccine should dissolve within 1 minute. The presence of flakes is allowed, which should be broken by gently shaking 3-4 times and mixing the contents by withdrawing them back into the syringe. The dissolved vaccine has the appearance of a coarse suspension of white color with a grayish or yellowish tint, without foreign inclusions. If there are large flakes in the diluted preparation that do not break up when mixed 4 times with a syringe, or sediment, the vaccine is not used and the ampoule is destroyed.
The diluted vaccine must be protected from sunlight and daylight (for example, with a cylinder of black paper) and used immediately after dilution. The diluted vaccine is suitable for use for no more than 1 hour when stored under aseptic conditions at a temperature of 2 to 8 °C. It is mandatory to maintain a protocol indicating the time of dilution and destruction of the vaccine ampoule.
For one vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn up with a tuberculin syringe, then about 0.1 ml of the vaccine is released through a needle into a sterile cotton swab in order to displace the air and bring the syringe piston to the desired graduation - 0.1 ml. Before each set, the vaccine should be carefully mixed 2-3 times using a syringe. Vaccination is carried out immediately after drawing the vaccination dose into the syringe. One syringe can only administer the vaccine to one child.
The BCG vaccine is administered strictly intradermally at the border of the upper and middle third of the outer surface of the left shoulder after pre-treatment of the skin 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). Very rare are 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), in some 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. The exception is vaccination for prevention viral hepatitis In case of primary immunization.
Precautionary measures
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: infiltration, 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 possible influence medicinal product on the ability to manage vehicles, mechanisms.
Not applicable. The drug is used to vaccinate children.
Release form
Lyophilisate for the preparation of a suspension for intradermal administration, 0.05 mg/dose - 10 doses per ampoule. Produced complete with a solvent - sodium chloride solvent for the preparation of dosage forms for injection 0.9%. Solvent - 1 ml per ampoule.
The kit consists of 1 ampoule of vaccine and 1 ampoule of solvent.
5 sets in a cardboard pack. The pack contains instructions for use and an ampoule knife or ampoule scarifier.
Storage conditions
Storage conditions.
In accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 °C out of the reach of children.
Transportation conditions.
In accordance with SP 3.3.2.3332-16 at temperatures from 2 to 8 °C.
Best before date
2 years. A drug that has expired cannot be used.
Conditions for dispensing from pharmacies
For medical and preventive institutions.
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.