Contraindications for BCG vaccination for a newborn. Methods and techniques for administering the BCG vaccine. What to do after BCG vaccination

Hello, dear readers of the blog site. Many young parents are interested in what kind of vaccination they want to give their newborn baby, and even with such an incomprehensible name - BCG.

Today we will talk about what it is, how it is deciphered, why it is done and to whom this vaccine may be contraindicated.

BCG - decoding and what it is

BCG is a literal copy of the abbreviation BCG, which is named tuberculosis vaccine, created at the beginning of the last century by French scientists - microbiologist Albert Calmette and veterinarian Charles Guerin, and named in their honor.

In the original it sounds like Bacillus Calmette-Gurin ( Bacillus Calmette-Guerin). A drug was prepared based on substrains of live, weakened bovine tuberculosis bacilli, which are practically not infectious to humans, as they were grown under artificial conditions.

For decades, scientists have been refining the vaccine using various genetic strains of the pathogen, differing in protective and reactogenic properties.

Today in the Russian Federation two vaccines are used for immunization against tuberculosis - BCG and a weakened vaccine containing half as many bacteria - BCG-M.

The main objective of the BCG vaccination is to trigger immune responses and form the body's immune defense against tuberculosis.

According to experts, vaccinating children with BCG from a very early age is the most effective way secure child from infection with tuberculosis, and in cases of infection, to alleviate the clinical course and reduce risk development of aggressive forms of complications, in the form of:

disseminated tuberculosis;
tuberculous lesions of bone tissue.

When is anti-tuberculosis immunization given?

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

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

At the first vaccination healthy babies are given a “gentle” BCG-M a vaccine with a reduced content of infectious pathogens, which does not at all interfere with achieving a sufficient level of activity of children's immunity and minimizing the risk of post-vaccination side effects.

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

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

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

Features of BCG vaccination

Before vaccination of newborns, the child’s condition is assessed taking into account all indicators on the Apgar scale. The drug is administered by a subcutaneous puncture in the area of the superficial (deltoid) muscle of the left shoulder.

For 2, 4 months in the child’s body immunity is formed to infection. During this period, any other vaccination is contraindicated. It is advisable to protect your baby from the influence of colds.

Immune response to the vaccine is manifested by a local reaction in the injection area after 1-2 months, in the form of:

slight swelling and redness;
change in skin color at the site of vaccination (even black);
the appearance of a purulent vesicle covered with a crust.

These signs should not cause concern, as they are a normal reaction of the body to the vaccine.

Wound healing at the vaccination site can be long-term (up to 4 months). Normally, the diameter of the scar formation after healing should not exceed 10 mm, and there should be no swelling or redness. A slight increase in temperature is possible.

Which newborns are this vaccination contraindicated for?

Contraindications to vaccination are due to many factors. Do not vaccinate:

low birth weight newborn babies (weighing less than 2.5 kg);
children with congenital complex diseases;
when a child comes into contact with an infection before vaccination;
children born to mothers with HIV infection;
in the presence of adverse consequences after BCG.

Such children, if not vaccinated in the future, can easily become carriers of the infection. There is a high risk of infection with complex forms of tuberculosis before the age of 2, which is very difficult to treat and often ends in death.

Possible adverse reactions to BCG

The anti-tuberculosis vaccine contains live strains of mycobacteria.

Therefore, post-vaccination complications, according to statistics, develop in 1.5% of children vaccinated for the first time, and in 0.005% of children after revaccination, manifesting themselves as serious health disorders.

It could be:

All this may be a consequence of the individual characteristics of the baby’s body, vaccination with a low-quality vaccine, or manifest itself as a result of non-compliance with the technique of administering the drug.

Complications after BCG vaccination develop rarely - in 1 out of 1000 vaccinated children.

In most cases, in children with congenital weakened immunity.

Conclusion

Despite the possible manifestation of post-vaccination complications, it should be remembered that this vaccine prevention is one of the key achievements in the field of medicine.

BCG vaccination is a kind of human safety system, from birth to the end of life.

Good luck to you! See you soon on the pages of the blog site

Compound

The suspension contains weakened bacteria that provoke the body to produce antibodies to tuberculosis. After the injection, the risk of illness and severe manifestations of the disease in case of infection is reduced. For vaccination, an active substance and a dissolving liquid are used. Release form of the drug: vacuum ampoule with dry anthophyllite in the form of powder or tablets and solvent. The active substance in the BCG vaccine is live mycobacterium bovine tuberculosis.

The auxiliary component is the stabilizer monosodium salt of glutamic acid - food additive E621.

To dilute the dry substance, a 0.9% sodium chloride solution is used.

For vaccination, disposable tuberculin syringes with short thin needles with a cut end are used. It is prohibited to use needleless injectors. After the injection, the syringe with the needle, as well as cotton swabs, are disinfected and destroyed.

The dry vaccine is diluted with NaCl solution immediately before administration. To completely dissolve the substance, the sterile syringe must be shaken several times.

Properties and purpose

The lightweight BCG-M vaccination contains mycobacterium bovine tuberculosis in an amount of 0.025 mg per single dose. A reduced amount of 0.1 ml of monosodium glutamate is also used as an excipient. A gentle vaccination is prescribed as an alternative to the main preventive vaccine.

Prescriptions of the drug include all cases in which the administration of a standard type of medication is contraindicated. The main indications include prematurity and weakness of newborns whose bodies are not adapted to intrauterine life.

What is the difference from BCG

The difference between BCG and BCG-M is the quantitative composition of the drugs. A weakened vaccine is characterized by a reduced content of live mycobacteria (M.bovis). Unlike BCG, it is used for the prevention of weak children with deviations in physical development, and for vaccination of the population of areas with a favorable tuberculosis situation.

BCG is not used in children if there are contraindications. A weakened vaccine can be used to vaccinate children with acute and severe forms of certain diseases. The gentle drug can also be used for mild neurological pathologies.

At what age is the vaccine given?

Primary vaccination is carried out for newborn children in the maternity hospital on days 3-7 of life. If for some reason the child was not given the BCG-M vaccine in the first week of life, he will be vaccinated at any time during the first 2 months from birth.

Immunization is not carried out at home.

All vaccinations are given in a clinic or other medical facility.

If the lack of vaccination was due to contraindications for health reasons, the child is vaccinated after recovery. Revaccination is carried out for children aged 7 and 14-16 years. The interval between the test and vaccination is 3-14 days.

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Instructions for use

Tuberculosis is a serious disease, against which no vaccine provides a 100% guarantee. However, an effective vaccine can provide a high level of protection against specific pathologies. Immunization takes place in the first days of a child’s life, thanks to which the body has time to quickly adapt to the viral agent.

Instructions for use:

The solution is stored in a place protected from sunlight at a temperature of +2...+8°C for at least 60 minutes before administration.
Before vaccination, the injection site is treated with 70% alcohol.
The medicine is injected into the skin at the insertion site of the deltoid muscle of the left shoulder.

Vaccines that have expired should not be used for vaccination. Do not use medicine that has not been properly prepared or stored under inappropriate conditions.

Precautions:

After vaccination, the injection site should be protected from mechanical damage, but without applying a bandage. Particular attention should be paid to this during water procedures. Do not treat the injection site with iodine or other disinfectant solutions.
Vaccination is carried out by a medical professional only after the child has been examined by a pediatrician. It is imperative to measure the patient’s body temperature and check for other contraindications. If necessary, the child is prescribed laboratory tests of urine and blood.

After vaccination, information about the vaccination is entered into the medical record. The expiration date, number and series of the drug, and the name of the manufacturer are indicated.

Contraindications

The following factors are contraindications for BCG-M:

weight up to 2 kg;
exacerbation of chronic diseases;
ARVI;
immunodeficiency;
allergic reaction to the components of the drug;
severe forms of neurological diseases;
tumors and neoplasms.

In addition, children born from a mother with HIV infection or who have blood relatives who have had BCG infection are not vaccinated.

Complications

Most patients tolerate the lightweight vaccine well without exhibiting any unusual reactions. Sometimes there may be a temporary change in behavior that goes away within the first 24 hours after immunization.

The gentle composition of the drug rarely causes side effects or complications. Most often, they can be caused by a violation of the technique of administering the drug or the use of a low-quality vaccine. For example, a negative reaction may occur due to violation of disinfection rules. If this happens, you should immediately consult your doctor.

A negative reaction of the body to the administration of the BCG-M vaccine is an enlargement of the lymph nodes. The papule nodule that remains at the injection site heals for quite a long time. A scar at the injection site appears 2-3 months after vaccination - such a reaction is normal and does not require parental concern.

Doctors identify 4 types of side effects:

Ulcers, cold abscesses, regional BCG lymphadenitis.
BCG infection is not fatal. It is an active tuberculosis process developing in the body.
BCG infection that ends in death. May occur in immunocompromised children.
Post-BCG syndrome. Manifests itself in the form of skin rashes, redness, and hives.

If there are obvious symptoms of negative consequences, you should immediately contact the pediatrician observing the child, and if necessary, call an ambulance.

You may also be interested in:

One of the mandatory vaccines is the BCG vaccination for children, which is given for the first time immediately in infancy - still in the maternity hospital, 3-4 days after the birth of the baby. There are many myths, various gossip and stories about terrible consequences and complications about it. After listening to them, many parents take responsibility and refuse this vaccination without thoroughly understanding it. Although their first duty is to find out in detail from doctors what BCG is and evaluate the pros and cons of this vaccination.

What is BCG - a foreign abbreviation that stands for BCG - Bacillus Calmette, i.e. Calmette-Guerin bacillus. Despite its obligatory nature and relevance in the modern world, not everyone has an idea of what BCG is and what this vaccination is for. This is a vaccine against tuberculosis, it is prepared from a strain of live but weakened cow tuberculosis bacillus. It is not dangerous to humans, as it is specially grown in an artificial environment. Its main features: the goal is the prevention of tuberculosis; protects not from infection, but from the spillover of a latent infection into an open disease; prevents the development of severe forms of the disease - tuberculous meningitis, infection of joints and bones, dangerous forms of infection of the lungs; allows us to achieve a significant reduction in the incidence rate among children.

Since the importance of such vaccination is taken into account, BCG vaccination in newborns is given as early as possible: in the absence of contraindications, even in the maternity hospital. Then, if necessary, it is carried out twice more - this process is called revaccination. The more information parents know about why, where and when children are vaccinated with BCG, the calmer they will be. Vaccination One of the most exciting questions about vaccination is how many times children are vaccinated with BCG. According to the generally accepted calendar, three times: on days 3–7 immediately after the baby is born; at 7 years old; c 14. Sometimes in the maternity hospital, for some reason, vaccination against tuberculosis is not carried out (for example, the baby has some contraindications). If at 2 months the doctor still suggests getting a vaccination, there won’t be any special problems. But after this period has passed (for example, 3 months), before that you will have to do a Mantoux test. And if only the result is negative, it will be possible to vaccinate. They do the same at 7 and 14 years old. This technique makes it possible to strengthen the immunity of a small organism to tuberculosis and increase the percentage of resistance to the effects of mycobacteria. Moreover, revaccination at 7 and 14 years of age is mandatory if the child comes into contact with a patient with tuberculosis (for example, someone among relatives is infected).

The second question that worries parents is where newborns are vaccinated with BCG and whether it is dangerous. The usual injection site is the outer side of the left shoulder, the border between the upper and middle 1/3 of the shoulder is selected. The vaccine is administered intradermally: subcutaneous and intramuscular injections are excluded. If there are any reasons that prevent the vaccine from being administered into the shoulder, another place is chosen where there is thick skin into which the injection can be easily placed - most often this is the thigh.

Despite the fact that all the information about BCG vaccination for newborns is open and available to parents today, there are still many refusals. A very relevant question today is what is more in the BCG vaccination: benefit or harm to the baby’s health? Among the advantages, the following can be noted: minimum consequences; complications are very rare; no hassle when caring for the injection site: parents often ask whether it is possible to wet the BCG vaccine - yes, but do not scratch it or smear it with anything; reduces the risk of infection with tubercle bacilli; when infected, allows the disease to proceed in a milder form; prevents death from tuberculosis. If this vaccination has so many positive aspects, then why does it collect so many negative reviews? There are reasons for this: a number of dangerous complications if contraindications are not followed or the vaccine is administered incorrectly; in rare cases - slow tightening of the injection site: all parents are interested in knowing how long the BCG vaccination takes to heal, since this process occurs for a whole year after vaccination; widespread and persistent rumors that the BCG vaccine contains components such as formaldehyde, mercury salts, phenol, polysorbate and even aluminum hydroxide - this information has no scientific basis.

The decision to vaccinate the baby is made by parents, having first weighed the pros and cons, after a comprehensive examination is carried out to determine the presence of contraindications for BCG vaccination. After all, in most cases they become the cause of the development of further complications after vaccination. Contraindications The following contraindications exist for vaccination: prematurity (if the child weighs no more than 2,500 grams); diseases during an exacerbation (vaccination is given after recovery); intrauterine infection; hemolytic disease; purulent-septic diseases; neurological symptoms in severe lesions of the nervous system; large-scale skin lesions; malignant neoplasms; primary immunodeficiency; taking immunosuppressants; tuberculosis in other family members; radiation therapy; HIV infection in the mother. For revaccination (after 2 months) there is a slightly different list of contraindications: acute diseases; allergic reactions; immunodeficiency; doubtful or positive Mantoux reaction; malignant neoplasms; radiation therapy; taking immunosuppressants; tuberculosis; complicated reaction to a previous vaccination; contact with a tuberculosis patient.

The doctor is obliged to identify the presence of these contraindications in the child before vaccinating him, since it is their non-compliance that leads to violations of the norm and complications. It is based on the reaction after the BCG vaccination that it is deciphered: whether the vaccination was successful, that is, whether the baby has developed immunity against tuberculosis. Over the course of a whole year, doctors observe what happens to the injection site: parents are also interested in learning how the BCG vaccination in children is interpreted.

Small organisms all react very differently to tuberculosis vaccination, so the consequences after BCG vaccination in children can be very different. It is useful for parents to know which of them develop within the normal range and should not cause unnecessary worries, and which ones should be treated more carefully and promptly report them to the doctor. If the BCG vaccination turns red, this reaction is considered completely normal for a whole year after the vaccination. For some this happens within a week, for some by the end of the second month, and for others only by six months. In this case, you should not immediately rush to consult a doctor, but during a routine examination you should inform your local pediatrician that the vaccine has turned red. Parents are especially frightened by the abscess that forms at the injection site. Panic sets in, as many have no idea what to do if the BCG vaccination festers some time after vaccination. Indeed, within a few months, an abscess with a white head in the middle forms at the puncture site. It gradually becomes covered with a crust, which cannot be picked off or smeared with anything, and then it flies off on its own, and the grafting site becomes scarred. So don’t be alarmed if the BCG vaccination has festered - this does not mean that you didn’t care for it correctly or that the baby has some health problems. Everything is as it should be. In rare cases, parents turn to doctors with such a problem that, after a whole year after vaccination, their child does not have a scar after the BCG vaccination, like most children. There may be several reasons for this phenomenon: the vaccine was administered incorrectly (i.e. too deeply, so no traces may remain on the surface), the individual characteristics of the child’s body, immunity to the bacillus was not formed. The most dangerous factor that can provoke such a consequence is the last reason. So, if after the BCG vaccination there is no mark on the baby’s arm, additional examination will be required. Next, you will need to follow the doctor’s recommendations to determine whether it is worth repeating the vaccination again. One of the consequences may be elevated temperature for several days after the BCG vaccination. If it is not critical and goes away in 2-3 days, there is no need to be afraid: the body actively reacts in this way to the bacteria introduced into it. If the temperature is too high and lasts longer than 3 days, you should immediately seek medical help. Related to this consequence is the question of when can a child be bathed after a BCG vaccination: there are no contraindications for this (not to be confused with the Mantoux test). However, with elevated body temperature, it is better to wait with water procedures so as not to aggravate the baby’s condition. Such consequences of BCG vaccination in children are usually not dangerous and should not cause fear in parents. For complete peace of mind, you can always consult a doctor about those reactions that cause concern. Throughout the first year of a child’s life, regular, fairly frequent examinations are carried out by a pediatrician, with whom you can always consult about how the child’s body is reacting to vaccination.

Sometimes serious complications occur after BCG vaccination if the necessary contraindications are not observed. So they can be dangerous to the health of the child.

Before vaccinating, doctors are required to advise parents about the dangers of BCG vaccination if contraindications are not followed. Complications can be so serious that they leave their mark on the little person’s entire life. However, prudent and competent parents should understand that this only happens if contraindications are not observed. The most common side effects that are life-threatening for children include: lymphadenitis - inflammation of the lymph nodes means that mycobacteria have penetrated from the skin into the lymph nodes, which is unacceptable: if the diameter of the inflammation is more than 1 cm, surgical treatment will be required; too extensive, large-scale, and not local, as expected, the area of suppuration - this is usually associated with immunodeficiency; osteomyelitis can begin when using a low-quality vaccine; a cold abscess develops after 1–1.5 months. after vaccination, if the drug was administered subcutaneously instead of intradermally, it will require surgical intervention; an extensive ulcer with a diameter of more than 10 mm means that the child is highly sensitive to the components of the drug - therapy is limited to local treatment, but information about such a complication must be entered into the personal medical record; a keloid scar in the form of red, swollen skin at the injection site: it will signal to doctors that BCG cannot be administered to this child again; generalized BCG infection is a very rare but serious complication in children with immune disorders; Osteitis (so-called bone tuberculosis) develops 0.5–2 years after vaccination; it is also a rare, but very dangerous reflection of serious disorders in the immune system of children.

Those parents who doubt whether or not to vaccinate their children with BCG usually become even more frightened after such an impressive list of complications and refuse vaccination. Here, a lot depends on the doctors, who must give parents all the necessary explanations. There are no contraindications - no dangerous consequences. But there will be confidence that the child’s body is protected from such a terrible disease as tuberculosis, if not 100%, then at least only a mild form of the disease is guaranteed. You need to weigh the pros and cons before making such a responsible decision, on which the health of your baby will depend.

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

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

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

Indications

BCG - Active specific prevention of tuberculosis:

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

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

in premature newborns weighing 2000 g or more when restoring their original body weight (in the maternity hospital, the day before discharge to home);
in children with a body weight of 2300 g or more (in the departments for nursing premature newborns in medical hospitals (2nd stage of nursing), before discharge from the hospital home);
in children who did not receive an anti-tuberculosis vaccination in the maternity hospital due to medical contraindications and are subject to vaccination in connection with the removal of contraindications (in children's clinics);
in all newborns in territories with a satisfactory epidemiological situation for tuberculosis.

Contraindications

For BCG vaccination

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

For revaccination

BCG-M

prematurity (birth weight less than 2000 g);
acute diseases (vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases);
intrauterine infection;
purulent-septic diseases;
moderate and severe hemolytic disease of newborns;
severe damage to the nervous system with severe neurological symptoms;
generalized skin lesions;
primary immunodeficiency;
malignant neoplasms;
simultaneous use of immunosuppressants;
radiation therapy (vaccination is carried out no earlier than 6 months after the end of treatment).

Story

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

The first large clinical study evaluating the effectiveness of BCG was conducted from 1963 to almost 60,000 BCG-vaccinated schoolchildren aged 14-15 years. This study showed 84 percent effectiveness up to 5 years after immunization. However, a study by US health authorities in Georgia and Alabama, published in 2009, showed an effectiveness of 14% and prompted the US to abandon the implementation of mass immunization with BCG.

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

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

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

Reasons for Variable Performance

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

Application

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

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

Methods of administering BCG

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

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

Other uses

Side effects

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

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

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

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

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

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

Notes

Perelman M. I. Doctor's consultant. Phthisiology. - M.: GEOTAR-Media, 2007. - S. (Chapter 32). - ISBN 978-5-9704-1234-3 ..
Chistovich A. N. Pathological anatomy and pathogenesis of tuberculosis. - M.: Medicine, 1973. - P. 18−20.
Otten T. F., Vasiliev A. V. Mycobacteriosis. - St. Petersburg. : Medical press, 2005. - P. 134.
Romanus V., Hallander H. O. Atypical mycobacteria in extrapulmonary disease among children. Incidence in Sweden from 1969 to 1990, related BCG-vaccination coverage // Tuberc. Lung Dis. - 1995. - T. 75. - P. 300−310.
two tuberculin units. International tuberculin unit- unit of tuberculin activity corresponding to the activity of 0.028 μg of a standard preparation of dry purified tuberculin.
Fine PEM, Carneiro IAM, Milstein JB, Clements CJ. Issues relating to the use of BCG in immunization programs. - Geneva: WHO, 1999.
Rosenthal SR. BCG vaccination against tuberculosis. - Boston: Litte, Brown & Co., 1957.
P. E. M. Fine PhD, Prof. (1995). “Variation in protection by BCG: implications of and for heterologous immunity.” The LANCET. 346 : 1339-1345.
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.
Hart P. D., Sutherland I. (1977). “BCG and vole bacillus vaccines in the prevention of tuberculosis in adolescence and early adult life. Final Report of the Medical Research Council.” Brit Med J. 2 : 293-95.
Comstock GW, Palmer CE. (1966). “Long-term results of BCG in the southern United States.” Am Rev Resp Dis. 93 (2): 171-83.
https://www.ncbi.nlm.nih.gov/pubmed/10573656
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. - P. 349-363.
Editorial. BCG: Bad news from India // Lancet: magazine. - 1980. - No. January 12. - pp. 73-74.
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 .

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

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

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

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

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

Release form

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

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

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

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

Pharmacological action

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

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

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

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

Pharmacokinetics and pharmacodynamics

The duration of immunity after vaccination is unknown.

Indications for use

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

Contraindications for BCG

The following contraindications for BCG vaccination have been noted:

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

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

Revaccination is not carried out in the following cases:

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

Side effects

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

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

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

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

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

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

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

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

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

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

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

Instructions for use (Method and dosage)

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

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

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

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

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

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

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

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

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

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

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

Overdose

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

Interaction

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

Terms of sale

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

Storage conditions

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

Best before date

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

Special instructions

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

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

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

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

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

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

Analogues

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