Vaccination against hepatitis B in additional education. Method of administering the hepatitis B vaccine. Contraindications to the use of the vaccine

The HBV vaccine is a vaccination against viral hepatitis B. It reliably protects a child or adult from this dangerous disease. The first drug for vaccination was created back in 1982, but in Russia wide application this remedy started in 2002. Currently, HBV is included in the vaccination schedule. administered to newborns. Many mothers have a question: “Why vaccinate a baby in such a early age? Let's find the answer to it together.

What is hepatitis B?

Hepatitis B is a viral disease that leads to inflammation of the liver. There is jaundice, fever, pain in the right hypochondrium. The disease can provoke severe consequences such as cirrhosis and liver cancer.

The virus itself does not have a harmful effect on liver cells. But it disrupts the functioning of the immune system. As a result, your own lymphocytes begin to destroy the liver. We can say that the virus triggers an autoimmune process.

The disease is extremely common. According to the World Health Organization, about 300 million people are asymptomatic carriers of the virus. And about 1 million people die every year from complications of hepatitis. These are mainly children, teenagers and young people under 20 years of age.

The insidiousness of the virus lies in the fact that in young children hepatitis most often occurs without severe symptoms. And the younger the child, the more likely it is that the disease will not have any symptoms. If a baby has become infected with hepatitis B and has obvious manifestations of jaundice, then this course of the pathology is considered more favorable. This suggests that the baby’s immunity is resisting infection. Conversely, asymptomatic hepatitis means that the body is not fighting the virus.

Where can a child become infected?

Sometimes mothers do not want to vaccinate their newborns with HBV. Women mistakenly believe that if they were tested for hepatitis during pregnancy, then their baby cannot be sick.

There are the following routes of transmission of the hepatitis virus:

• through blood;
• household contact;
• from the mother during childbirth or in utero;
• sexual tract.

It is impossible to get hepatitis by airborne droplets, as well as through water and food. If we talk about infants, they most often get the infection from their mother. And even if a woman was tested for hepatitis during pregnancy, this does not exclude the possibility of infection of the baby. After all expectant mother could, after the examination, visit hospitals and undergo cosmetic procedures or dental treatment, and this increases the risk of infection. Children are usually infected intrauterinely due to pregnancy pathologies. A healthy placenta protects the fetus from infection. Therefore, more often newborns become infected with hepatitis while passing through birth canal infected mother.

An unvaccinated baby can get the virus when medical procedures: blood transfusions, surgeries, tooth extractions. This is the most frequent path infection of children. A child can become infected through everyday contact with sick family members or peers. The hepatitis B (HBV) vaccine protects children from this danger.

Can hepatitis be cured?

Hepatitis B is quite difficult to diagnose in children. Often the disease is disguised as other pathologies and occurs with symptoms of respiratory diseases. Eat the only way Detection of the virus is a blood test from a vein for the “Australian” antigen. But often the doctor assumes that the child has ARVI rather than hepatitis, and the diagnosis is not carried out in a timely manner.

Treatment for hepatitis B is very expensive. Only special treatments help achieve stable, long-term remission. antiviral drugs“But even these expensive drugs do not completely get rid of the virus, but only stop the process of liver destruction. In addition, such medications have many side effects. Such a serious and complex disease is easier to prevent than to treat. For the purpose of prevention, they are vaccinated with HBV.

How does the vaccine work?

The virus is not taken from the surface a large number of protein containing antigen. It is placed in a yeast nutrient medium, which ensures enhanced cell division. As a result, a substance necessary for the drug is formed. It is separated from the yeast solution, aluminum hydroxide and a preservative are added.

After the vaccine is introduced into the human body, the protein comes out under the influence of aluminum hydroxide. The body begins to produce antibodies to the antigen. As a result, lasting immunity against the hepatitis B virus is formed.

What does the name "HBV vaccination" mean? The abbreviation is explained as follows: HBV is the hepatitis B virus.

Preparations for vaccination

Currently, clinics administer vaccinations with the following types of drugs for mass vaccination:

• "Recombinant yeast vaccine against hepatitis B."
• "Engerix".
• "Eberbiovak".
• H-B-VAX II.
• "Regevac V".
• "Biovac".
• "Euvax."
• "Boobo-cock."

The Russian drug "Recombinant yeast vaccine against hepatitis B" does not contain preservatives. It is recommended to vaccinate children using these means.

You should pay attention to the drug "Bubo-kok DTP + HBV". It can be attributed to combined means. At the same time they put DPT vaccine and vaccinate children with HBV. The deciphering of the name of the drug means - and viral hepatitis B (HBV). Thus, this vaccination protects the child from several diseases at once.

There is another variety of this remedy called “Bubo-M ADS-M+HBV”. In addition to hepatitis, this vaccine works against diphtheria and tetanus, but does not prevent whooping cough.

All hepatitis B vaccinations contain only antigen. There are no microorganisms in them, since

How is the vaccine administered?

The HBV vaccine is given by injection. It is usually administered intramuscularly, since subcutaneous administration reduces the effect of vaccination and causes compaction. Aluminum hydroxide may cause subcutaneous inflammation. The injection is never given in the buttock, since the muscles in this area are located very deep. The HBV vaccine is given in the thigh for children and in the shoulder for adults.

How are newborns vaccinated?

For complete protection against hepatitis B, several injections of the vaccine are required. Vaccinations for newborns are given according to the following scheme:

1. The drug is first administered within 12 hours after birth. It is important to vaccinate against hepatitis before BCG vaccinations(for tuberculosis), since they cannot be done on the same day.
2. The second and third injections are given at 3 and 6 months.

After the first vaccination, 50% of children develop immunity against hepatitis, after the second - 75%, and the third vaccination provides 100% protection against the disease.

This schedule is suitable for healthy infants who are not at risk. But there are newborns with increased likelihood infection. These are children whose mothers suffer from hepatitis, are virus carriers, or were not examined for this disease during pregnancy. In such cases it applies quick scheme vaccinations against HBV. What does it mean? Vaccination is carried out not 3, but 4 times according to the following schedule:

1. The first injection is given within 12 hours after birth.
2. The second and third injections are given at 1 and 2 months, and then repeated at the age of 1 year.

If the vaccine was given in infancy, it will last for about 22 years. Then, as an adult, you can repeat the vaccination or take an antibody test to ensure that you have immunity against hepatitis. For some people, the vaccine may last a lifetime.

Sometimes it happens that the recommended timing of vaccinations is violated due to acute illness child. In this case, we must remember that the minimum interval between injections cannot be less than 1 month. As for the maximum interval, it should not exceed 4 months for the second vaccination and 18 months for the third.

Many parents have heard of the HBV-1 vaccine. What kind of vaccine is this? This is how the calendar indicates the first administration of the hepatitis B vaccine.

How are older children vaccinated?

If for some reason the child was not vaccinated in infancy, then vaccination can be carried out at an older age. An antigen test is not necessary before vaccination. The injections are given three times, and the following scheme is followed:

1. First vaccination.
2. Second injection after 1 month.
3. The third injection six months after the first.

If a child has hepatitis or is a carrier of the infection, then the injections will not harm him, but will not bring any benefit. The vaccine can last from 15 to 20 years. After this period, you should take an antibody test and, if necessary, repeat the vaccination.

Vaccination of adults

The HBV vaccine is given to adults quite often. The vaccine is new, and most people did not receive hepatitis prophylaxis during childhood. Usually 3 injections are given:

• The first injection is administered immediately upon visiting the doctor.
• The second - in 1 month.
• The third - six months after the first.

Immunity can last from 8 to 20 years. After this period, revaccination is done. Medical workers have an increased risk of contracting hepatitis, so vaccinations are required for them every 5 years.

If a person requires revaccination against other infections, you can use combination drugs, for example "Hexavac". This is a convenient option for HBV vaccination in adults. The decoding of the designation of the vaccine “DTP + hepatitis B + inactivated polio vaccine + Act-HIB” indicates that the product provides immunity not only from hepatitis. The drug protects against diphtheria, tetanus, whooping cough, polio, as well as Haemophilus influenzae infection, which causes respiratory inflammation and sepsis.

If a person has had contact with a patient with hepatitis, then an emergency vaccination regimen may help in the first 2 weeks:

1. The first injection is given immediately upon presentation to a medical facility.
2. The second is on the 7th day.
3. The third is on the 21st day.
4. The fourth - 6-12 months after the first.

Along with the vaccine, immunoglobulin with ready-made antibodies against hepatitis B is administered. This regimen can only be used for adults and adolescents; it is not used for small children.

How to prepare for vaccination?

Vaccination against hepatitis B does not require special preparation. You just need to measure your temperature before the procedure. For acute respiratory diseases Vaccination should be postponed. If the body temperature is more than +37 degrees, then you should postpone vaccination.

Sometimes doctors advise taking a pill before vaccination antihistamine to prevent allergies. However, this is not necessary. This recommendation should only be followed if the child or adult has had allergic reactions in the past.

Contraindications to vaccination

This vaccination is quite safe and has few contraindications. It is necessary to refrain from vaccination in the following cases:

• during pregnancy;
• during acute infectious diseases or during exacerbation of chronic ailments;
• if you are intolerant to any component of the drug;
• if you are allergic to yeast or to previous vaccinations.

It should be noted that if the baby has birth injury or hemolytic jaundice due to a conflict regarding the Rh factor, this is not a contraindication to vaccination.

Side effects

Since the vaccine is inactivated and does not contain microorganisms, it side effects occur extremely rarely. There is usually a slight rise in temperature and skin reactions: redness, thickening and slight soreness at the injection site. Allergic reactions possible only in rare cases.

Often mothers are afraid or do not consider it necessary to vaccinate their children against hepatitis B. But their fears are in vain, since the vaccine has a high degree of safety. Parents are mistaken when they believe that a newborn cannot become infected with this virus. Infection can occur at any age. Only timely vaccination can protect a child from a dangerous disease.

• The need for routine vaccination against the hepatitis B virus
• Vaccination schedule
• Contraindications and conditions for urgent vaccination
• Composition and properties of the vaccine

Vaccination against hepatitis B helps protect the body from damage by viruses; once the disease occurs, it goes away much faster and easier. Viral hepatitis B is very complex disease, which affects almost the entire liver and is provoked by a virus.

The need for routine vaccination against the hepatitis B virus

The peculiarity of the course of the hepatitis B virus has long led to the fact that it has become widespread and there is the possibility of significant infection of almost all segments of the population.

The hepatitis B virus is different:

• increased resistance to various factors;
• the ability to be in different habitats;
• increased level of susceptibility to infection.

The hepatitis B vaccine can be different, there are a large number of types, but they are all interchangeable because they are produced using the same technology.

The popular drug Engerix, which is used in almost every country, helps well against hepatitis B. The extent of the effect of each drug used against the hepatitis B virus depends on how quickly the body develops immunity. Basically, you need to give 3 injections of the vaccine to develop immunity against the virus.

When carrying out routine vaccination, a drug is used that is produced using protein particles of the virus. But the vaccine against viral hepatitis B itself does not contain viruses, so it is impossible to become infected with the disease after it is administered.

After introduction similar drug existing antibodies to viruses begin to be produced on their own within just 2 weeks. The vaccine is considered safe and does not cause side effects. Safety makes it possible to use it for protection even in newborn children.

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Vaccination schedule

The hepatitis B vaccine is administered under the skin in the area of ​​the right forearm. The vaccination schedule is simple, because the drug is administered at different intervals. As a rule, the first dose is administered three times with a break of a month; the procedure is carried out for the child from 1 to 5 months.

The drug is first administered to the newborn within a few days after birth. After this, revaccination is carried out at 3 months and at six months. This scheme is used only if the child has no contraindications. If a child was born from an already infected mother, then the vaccination must be done every month during the first three months after birth and repeated when the child is one year old.

If a child has not been vaccinated within 24 hours after birth, then vaccination is given to children after the age of 10 years. Vaccination against hepatitis B is given to adults after 20 years of age.

Vaccination for adults is carried out according to the same scheme as for all children, that is, with a break of a month.

This type of vaccination is not recommended for pregnant women; it is best to do it before pregnancy occurs. If a pregnant woman is at risk of contracting the virus, then she should get vaccinated, because pregnancy is not a reason or contraindication for the introduction of such a vaccine.

During breastfeeding, vaccination can be carried out if necessary.

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Contraindications and conditions for urgent vaccination

Vaccination against hepatitis B has no serious contraindications. Attention should be paid only to those people who have significant sensitivity to the components of the drug or allergic reactions.

In this case, immediately after the administration of such a vaccine, the person’s condition is monitored for half an hour. Since any vaccine used against hepatitis contains yeast, it should not be given to people who are allergic to it or baked goods.

You should not get vaccinated during illness, especially if there is an increase in temperature. In this case, vaccination is administered approximately a month after full recovery. If a person is constantly on hemodialysis, then he is vaccinated against hepatitis B more than 3 times, the interval between the administration of each vaccine should be about a month.

Emergency immunization is carried out only if a person has been in contact with a carrier of the infection. Urgent vaccination is required to help get rid of even more strong manifestation diseases.

There are several ways to administer the vaccine, depending on how the infection occurred. If infection occurs through sexual contact with a sick person, then you need to administer an additional drug that will help speed up the body’s defense against the virus.

If infection occurs through contact with a sick person by everyday means, then you should first determine whether the virus is in the blood. After this, vaccination is carried out with additional drug, which enhances the effect of the vaccine, or in the usual way.

If a person has previously been vaccinated several times, but has not been fully vaccinated, then he needs to be given an additional dose of the vaccine and subsequently administer the drug, strictly adhering to the schedule.

For urgent prevention The vaccine must be administered on the first day after contact with an infected person.

Hepatitis B is viral disease, the action of which is aimed at destroying liver cells, can lead to fatal outcome

Hepatitis is a complex disease that affects the entire liver. As a result, irreversible processes are launched in the body, the outcome of which is extremely difficult to predict. Therefore, the hepatitis B vaccine is a mandatory planned measure to combat the disease. Its use allows you to do immune system immune to the virus even in close contact with an infected person. Vaccination helps reduce the spread of the disease.

Hepatitis B - what is it and why are vaccinations against the virus so necessary?

Hepatitis B is a viral disease that targets the destruction of liver cells. The development of the disease often leads to death. The danger of the disease is that even after it is cured, there may be severe complications. This is why vaccination against hepatitis B is so relevant and necessary.

Additional dangers are posed by numerous ways of contracting the virus:

• transmission of the disease during pregnancy through the placenta;
• surgical interventions;
• direct contact with blood - transfusions, taking blood for analysis, injections;
• close contact with infected people at the household level;
• during a manicure in beauty salons;
• unprotected sexual intercourse;

during dental procedures. The virus is resistant to various factors, including high and low temperatures, can be found and remain active in different habitats. The disease does not show any symptoms for a long time, which makes diagnosing the disease difficult. Even after successful treatment, the virus can remain in the blood for a long time, making a person a carrier of hepatitis B.

Who should get vaccinated first?

All segments of the population are susceptible to infection with the virus, but children are most susceptible to the disease. Therefore, vaccination against hepatitis B is mandatory in the first days of a child’s life. In addition, the following groups of people should be vaccinated:

1. children whose mothers are infected or carriers of the virus;
2. patients who have received blood transfusions;
3. patients undergoing treatment with program hemodialysis;
4. all medical workers;
5. all members of the family in which there is an infected person;
6. people who are planning to travel to regions and countries with increased risk infection;
7. people with big amount sexual relations.

How long does the vaccination last and how often does it need to be done?

Scientific studies claim that immunity against the virus lasts for 20 years if the hepatitis B vaccine was given in the first days after birth. There have been cases where no antibodies were detected during a blood test. However, this is not a reason for re-vaccination. This is explained by the fact that it is not always possible to take for analysis the part of the blood that contains antibodies.

According to WHO, average term maintaining immunity against the disease is about 7 years if the vaccine was performed in adolescence or adulthood. To determine the need for re-vaccination, doctors recommend undergoing examinations every 7 years after the last vaccination.

Quantity necessary vaccinations life is determined by many factors. Including the person’s type of activity, area of ​​residence, presence or absence of business trips to other countries, etc.

Vaccine composition

The hepatitis B vaccine is a result of genetic engineering. To do this, a specific gene that is responsible for blocking protein generation is cut out from the genome of the disease. Next, using molecular biology methods, the viral protein is placed into the genotype of the cell. During the synthesis of the cell's own proteins, the necessary antigen is produced.

Next, the viral protein is placed on a carrier, which is aluminum hydroxide. It releases the virus in portions, and not all in full. Due to this, the immune system has time to overcome the infection and develop the correct reaction to the foreign agent. Today, vaccination against hepatitis B is carried out in this way. It is safe and always leads to the formation of high-quality immunity against the disease.

What vaccines against hepatitis B exist today?

The modern medical market offers vaccines, both domestic and foreign developed. They all have almost identical composition and properties. Therefore, you can use any of the proposed ones. Types of vaccines:

• recombinant yeast - domestic production, most often used for children;
• Engerix B - Belgian production, has two types that differ in dosage (for adults and children);
• Polyvaccine Bubo-kok is a vaccine of domestic medicine;
• Ebirbiovak - joint production of Russian and Cuban doctors, used for mass vaccination;
• H-B-VAX II - produced in America, has different dosages;
• Shanvak - produced in India;
• Biovac - produced in India;
• Sci-B-Vac – produced in Israel.

Hepatitis vaccination - where is the injection given?

The hepatitis B vaccine is always given in a muscle. Subcutaneous administration is prohibited, since the effectiveness of the drug in this case is significantly reduced and the required level of immunity to the disease will not be developed. In addition, compactions may form. The choice of the area for injection is explained by the fact that during the injection of antibodies into the muscle, the body responds to a threat of adequate strength.

For children under 3 years old, an injection is given in the thigh. For older children and adults, the injection is performed in the shoulder. This choice of location is determined by good muscle development and minimum distance muscles from the skin. It is not recommended to inject into the gluteal area. Since the layer of subcutaneous lipids is too wide, which will make it difficult to enter the muscle. In this case, there is a possibility of damage to the nerves and vascular system.

Vaccination scheme

There are several vaccination schemes. The first is for children and adults who are not part of the group increased risk. It provides for three stages of vaccination. The first occurs in infancy. The second injection is given a month after the first. The third vaccination is carried out 5 months after the last injection was administered. The main principle of the procedure is to maintain the required interval between the injection of antibodies.

If a child or adult is at risk, the hepatitis B vaccination regimen is carried out in a different way: the first injection is given at birth, then after a month, then after two, and after 12 months.

If emergency vaccination is necessary, the following scheme is used: the first vaccination, the second injection is given a week later, then repeated vaccination after 21 days, the final vaccination is prescribed after 12 months. This type of vaccination is used to develop immunity as quickly as possible. This may be needed before upcoming operation or a long business trip to countries with an increased risk of contracting hepatitis.

Several stages of vaccination are necessary to develop stable immunity. With the first injection, the body’s correct reaction occurs in 50% of patients, with the second – in 75%, with the third – in 100%.

Advice: it is necessary to maintain the schedule of injections. If more than 5 months have passed from the moment of the first vaccination to the second, then the scheme for developing immunity will have to be followed again. And the first injection is cancelled. IN as a last resort, you can slightly lengthen the intervals between injections. Shortening the time frame is strictly prohibited, otherwise this will lead to the development of defective immunity.

Contraindications and possible reactions to vaccination

Despite the fact that vaccination is designed to protect the body from external threats, it has its contraindications:

• intolerance to baker's yeast;
• strong reaction of the body to the previous injection;
• autoimmune diseases;
• the presence of skin inflammation;
• meningitis;
• infectious diseases at the acute stage.

In most cases, the injection is tolerated by patients painlessly and quite easily. However, side effects are also possible:

1. compaction and redness in the injection area;
2. temperature increase;
3. malaise and loss of strength;
4. diarrhea;
5. sweating;
6. weakness;
7. itching and skin redness.

Complications may occur after hepatitis B vaccination. They are extremely rare - in 1 patient out of 100,000. They manifest themselves in the form of urticaria, rash, exacerbation of allergies and even anaphylactic shock.

Important points

Before vaccination you must undergo general examination at the doctor's. This will allow you to determine whether you have contraindications to the injection. After vaccination it is not recommended to stay in crowded places. Since immunity is just being formed. The information that the vaccine cannot be wetted is nothing more than a myth. Doctors allow you to swim after the injection. Just don’t rub the injection site with a washcloth. However, it is recommended to refrain from visiting rivers, lakes and other bodies of water. Otherwise you risk getting negative reaction body in the area of ​​the injection.

Latest update of the description by the manufacturer 06.06.2006

Filterable list

Active substance:

ATX

Pharmacological group

Composition and release form

in glass bottles (type 1, USP) or glass ampoules of 0.5 ml (1 pediatric dose) or 5 ml (10 pediatric doses), or 10 ml (20 pediatric doses); in a cardboard box there are 10, 25 and 50 bottles or 50 ampoules.

in glass bottles (type 1, USP) or glass ampoules of 1 ml (1 adult dose) or 5 ml (5 adult doses), or 10 ml (10 adult doses); in a cardboard box there are 10, 25 and 50 bottles or 50 ampoules.

Directions for use and doses

V/m, adults, older children and adolescents - into the deltoid muscle;

newborns and children younger age- into the anterolateral surface of the thigh.

Under no circumstances should the vaccine be administered intravenously.

In patients with thrombocytopenia and hemophilia, the vaccine should be administered subcutaneously.

Before use, the vial or ampoule with the vaccine must be shaken well several times until a homogeneous suspension is obtained. The vaccination procedure must be carried out in strict compliance with the rules of asepsis and antiseptics. The drug from an opened multi-dose vial must be used within one day.

A single dose of the vaccine for children and adolescents under 19 years of age is 0.5 ml (10 mcg HBsAg);

for adults over 19 years old - 1 ml (20 µg HBsAg);

for patients in the hemodialysis department - 2 ml (40 μg HBsAg).

The vaccine can be prescribed simultaneously (on the same day) with vaccines of the National Vaccination Calendar, with the exception of BCG, as well as with the vaccine against yellow fever. In this case, vaccines must be administered using different syringes. different places.

Immunization schedule

To achieve an optimal level of protection against hepatitis B, 3 IM injections are required according to the following regimens:

Vaccination of children within the framework of the National Preventive Vaccination Calendar

Newborn children are vaccinated three times according to the schedule: 0-1-6 months. The first administration of the vaccine is on the child's birthday. For newborns whose mothers are carriers of the hepatitis B virus, a vaccination schedule of 0-1-2-12 months is recommended. Simultaneously with the first vaccination, immunoglobulin against hepatitis B can be injected intramuscularly into the other thigh.

Children, adolescents and adults who have not previously been vaccinated against hepatitis B are vaccinated according to the schedule: 0-1-6 months.

Accelerated

IN in case of emergency accelerated vaccination is carried out according to the following scheme:

1st dose: on the selected day;

2nd dose: 1 month after the 1st dose;

3rd dose: 2 months after the 1st dose;

4th dose: 12 months after the 1st dose.

Such vaccination leads to the rapid development of protection against hepatitis B, but the antibody titer may be at a lower level in some vaccinated people than with standard immunization.

Vaccination for hemodialysis

1st dose 40 mcg (2 ml): on the selected day;

2nd dose 40 mcg (2 ml): 30 days after 1st dose;

3rd dose 40 mcg (2 ml): 60 days after 1st dose;

4th dose 40 mcg (2 ml): 180 days after 1st dose.

Vaccination for known or suspected exposure to hepatitis B virus

Upon contact with the material, infected with a virus hepatitis B (eg, a contaminated needle stick), the first dose of hepatitis B vaccine should be given at the same time as hepatitis B immune globulin (injections at different sites). It is recommended that further vaccinations be carried out according to an accelerated immunization schedule.

Revaccination

With primary immunization at 0, 1, 6 months, repeated vaccination may be necessary 5 years after the primary course.

Storage conditions for the drug Hepatitis B vaccine recombinant (rDNA)

Keep out of the reach of children.

Shelf life of the drug Hepatitis B vaccine recombinant (rDNA)

Do not use after the expiration date stated on the package.

Instructions for medical use

Hepatitis B vaccine, recombinant (rDNA)
Instructions for medical use- RU No. LS-001140

date last change: 27.04.2017

Dosage form

Compound

The vaccine does not contain any substrates of human or animal origin. The vaccine meets WHO requirements for recombinant vaccines against hepatitis B

Description of the dosage form

Homogeneous suspension of white gray tint color, without visible foreign inclusions, when settling, it separates into 2 layers: the top one is colorless clear liquid, the bottom is a white precipitate that breaks easily when shaken.

Characteristic

The vaccine is a purified hepatitis B virus surface antigen (HBsAg) adsorbed on an aluminum hydroxide gel.

The surface antigen is obtained by cultivating genetically modified yeast cells Hansenula polymorpha K 3/8-1 ADW 001/4/7/96, into which the surface antigen gene is integrated.

Pharmacological group

MIBP - vaccine

Indications

Specific prevention of infection caused by the hepatitis B virus in children aged 1 year and older and adults.

Contraindications

• period of pregnancy and breastfeeding;
• hypersensitivity to the hepatitis B vaccine and its components - yeast or thiomersal;
• symptoms of hypersensitivity to previous administration of hepatitis B vaccine;
• severe reaction (temperature above 40°C, swelling at the injection site, hyperemia over 8 cm in diameter) or post-vaccination complication on previous administration of the drug;
• acute infectious and non-communicable diseases, exacerbation chronic diseases. Vaccination is carried out 2-4 weeks after recovery (remission);

For mild ARVI and acute intestinal diseases, vaccinations are carried out immediately after the temperature has normalized;

• pronounced and severe immunodeficiency in children with HIV infection.

HIV infection is not a contraindication to hepatitis B vaccination.

Children of the first year of life:

When vaccinating against hepatitis B in children of the first year of life, vaccines that do not contain preservatives are used.

Persons temporarily exempt from vaccinations should be monitored and vaccinated after the contraindications are lifted.

Directions for use and doses

Before use, the vial (ampoule) with the vaccine must be shaken well several times until a homogeneous suspension is obtained.

The vaccine is administered intramuscularly:

• for young children (1-2 years) - in the upper outer surface of the middle part of the thigh;
• adults, teenagers and older children (over 2 years old) - into the deltoid muscle.

For patients with bleeding disorders, the vaccine should be administered subcutaneously.

It is prohibited to administer the vaccine intravenously!

When administering the vaccine, you should make sure that the needle does not enter the vascular bed.

The drug from an opened bottle with 10 doses of the vaccine must be stored at a temperature of 2-8 ºС and used within one day.

A single dose of the vaccine is:

• for children over 1 year of age, adolescents and persons under 19 years of age - 0.5 ml (10 mcg HBsAg),
• for persons over 19 years of age - 1 ml (20 mcg HBsAg).

Vaccination against viral hepatitis B for persons who have not been previously vaccinated and do not belong to risk groups is carried out in accordance with National calendar preventive vaccinations of the Russian Federation and the calendar of preventive vaccinations according to epidemic indications(Order of the Ministry of Health of Russia dated March 21, 2014 No. 125n) according to the 0-1-6 scheme (1st dose at the start of vaccination, 2nd dose - 1 month after the 1st dose, 3rd dose - 6 months after the 1st dose).

Children belonging to risk groups (born from mothers who are carriers of HBsAg, patients with viral hepatitis B or who have had viral hepatitis B in the third semester of pregnancy, who do not have test results for markers of hepatitis B, who consume narcotic drugs or psychotropic substances, from families in which there is a carrier of HBsAg or a patient with acute viral hepatitis B and chronic viral hepatitis), vaccination is carried out according to the 0-1-2-12 scheme (1st dose at the start of vaccination, 2nd dose 1 month after administration of the 1st dose, 3rd dose 2 months after the 1st dose, 4th dose 12 months after the 1st dose).

Contact persons from the outbreaks of the disease who have not been sick, not vaccinated and have no information about preventive vaccinations against viral hepatitis B, are subject to vaccination according to the 0-1-6 scheme.

Vaccinations against hepatitis B according to the 0-1-6 scheme are also subject to:

• children and adults who regularly receive blood and its preparations;
• oncohematological patients;
• medical workers who have contact with the blood of patients;
• persons involved in production immunological drugs from donor and placental blood;
• students medical institutes and students of secondary medical educational institutions(primarily graduates);
• persons who inject drugs.

For patients receiving hemodialysis treatment, the vaccine is administered four times according to the scheme: 0-1-2-6 or 0-1-2-3 at a double age dose.

Unvaccinated persons who have had contact with material infected with the hepatitis B virus are vaccinated according to the 0-1-2 scheme. Simultaneously with the first vaccination, it is recommended to administer intramuscularly (to another place) human immunoglobulin against hepatitis B at a dose of 100 IU (children under 10 years old) or 6-8 IU/kg (other ages).

Unvaccinated patients who are planning to undergo surgical interventions are recommended to undergo vaccination according to the 0-7-21 day schedule one month before surgery.

Side effects

Frequency classification side effects World Organization Health (WHO):

Very common: e1/10

Often: from e1/100 to<1/10

Uncommon: from e1/1000 to<1/100

Rarely: from e1/10000 to<1/1000

Very rare: from<1/10000

During clinical and post-marketing studies of the recombinant hepatitis B vaccine (rDNA), the following adverse reactions were identified:

From the nervous system:

Often: headache.

Rarely: dizziness.

From the respiratory, pulmonary and mediastinal systems:

Common: pneumonia, cough, chills.

From the skin and subcutaneous tissue:

Rarely: rash.

From the musculoskeletal system, connective and bone tissue:

Rarely: pain throughout the whole body.

Adverse reactions, general and at the injection site

Very common: fever, pain at the injection site.

Common: prolonged crying, local induration, local swelling, redness.

Rarely: nodular thickening at the injection site, local pain.

All these symptoms are transient and do not require drug treatment.

Interaction

The vaccine can be prescribed simultaneously (on the same day) with vaccines of the National Preventive Vaccination Calendar, with the exception of vaccines for the prevention of tuberculosis, and with the vaccine against yellow fever. In this case, vaccines must be administered with different syringes to different parts of the body. The interval between vaccinations against different infections when administered separately (not on the same day) should be at least 1 month.

Impact on the ability to drive vehicles

The vaccine does not affect the ability to drive.

Precautionary measures

The vaccination procedure must be carried out in strict compliance with the rules of asepsis and antiseptics. In very rare cases, immediate allergic reactions may develop; therefore, those vaccinated with the vaccine should be under medical supervision for 30 minutes after vaccination.

As with the administration of other parenteral vaccines, vaccination sites should be provided with anti-shock therapy, primarily adrenaline.

Release form

Suspension for intramuscular administration.

Serum Institute of India Ltd., India

0.5 ml or 1 ml in ampoules and vials. 10 ampoules of 0.5 ml or 1 ml in a PVC blister, 5 blisters each along with 5 copies of the Instructions for Medical Use in a cardboard box. 50 bottles of 0.5; 1; 5 ml or 25 bottles of 10 ml along with 5 copies of Instructions for Medical Use in a cardboard box.

Horizontal blue stripes are applied to the ampoule or vial of the vaccine for children.

An ampoule or vial containing 10 doses of vaccine for children is marked with horizontal red stripes.

Horizontal green stripes are applied to the ampoule or vial of the vaccine for adults.

An ampoule or vial containing 10 doses of vaccine for adults is marked with horizontal purple stripes.

Nanolek LLC

10 ampoules of 1 ml in a PVC blister along with instructions for medical use in a cardboard box.

10 bottles of 1 ml along with Instructions for medical use in a cardboard box.

10 bottles of 10 ml each along with 10 copies of Instructions for Medical Use in a cardboard box.

Horizontal green stripes are applied on the label of a cardboard pack of ampoules or vials with 1 dose of vaccine for adults.

The label of a carton of vials containing 10 doses of vaccine for adults has horizontal purple stripes on the label.

Storage conditions

In a place protected from light at a temperature of 2 to 8 ° C. Keep out of the reach of children. Do not freeze.

Transportation conditions:

In containers protected from light at a temperature of 2 to 8 ° C. Do not freeze.

Best before date

The shelf life of the vaccine is 3 years. Do not use after the expiration date stated on the label.

Conditions for dispensing from pharmacies

For medical and preventive institutions.

LS-001140 from 2015-11-20
Recombinant hepatitis B vaccine (rDNA) - instructions for medical use - RU No.

The ignorance of many people about diseases and vaccinations, and sometimes a skeptical attitude towards doctors’ recommendations, become an obstacle to the fight against such dangerous infectious diseases as hepatitis A and B. Long-term debates about the benefits and harms of vaccinations, as well as the tendency of people to take and absorb literally negative information, have sown the seed of mistrust in vaccination.

But why then, despite all the possible complications and consequences, is the hepatitis B vaccine included in the vaccination calendar and administered in the first hours of a child’s life? In this article we will try to figure out: are vaccinations against hepatitis B and A beneficial or harmful? And also what contraindications are there for the use of these vaccines.

Hepatitis A (jaundice, Botkin's disease, “unwashed hands disease”) is an acute liver injury caused by a group A virus. This type of hepatitis is the easiest, as it is highly treatable and does not take chronic forms.

Having a stable outer shell and the ability to adapt to acidic and aqueous environments, the hepatitis A virus easily penetrates the human body and “settles” in it. The infection manifests itself as fever, yellowing of the skin and sclera of the eyes, nausea and vomiting.

Hepatitis B (B, HBV) is a viral infectious disease that affects liver cells. Adaptable to many conditions, the DNA-containing hepatitis B virus is transmitted through the blood and biological fluids of the human body.

The danger of the disease lies in the way it affects liver cells. Once inside, the virus begins to actively divide (multiply), again and again forming viral particles that freely leave the affected cell and begin to attack healthy ones. Hepatitis B is considered a dangerous disease that can progress. It can progress to a chronic stage with a high likelihood of developing liver failure, liver cirrhosis and hepatocarcinoma.

Routes of infection with hepatitis A and B virus

There are several ways to become infected with hepatitis A and B, but the source is always the same – the virus carrier. It is from an infected person that the virus is transmitted.

The hepatitis A virus is spread in the feces of an infected person. It is not difficult to become infected with Botkin's disease, because the routes of transmission are quite simple:

• unwashed or insufficiently heat-treated food products;
• untreated drinking tap water.

Hepatitis B is a very serious disease that leads to changes in liver tissue and often becomes chronic.

The spreader of the disease can be either a sick person with obvious symptoms or a passive carrier of the virus.

This disease is transmitted through blood and some other body fluids. Most often, you can become infected during invasive medical procedures and unprotected sexual intercourse.

Medical manipulations

Many diseases are spread through blood. And in medical institutions they work with her directly. Infection with the virus can occur when the integrity of the skin is damaged and infected blood enters the wound. Basic manipulations that pose a risk of infection:

• Blood transfusion from donor to recipient. Today, the donor route of infection is no longer dangerous and does not carry any risks. Before the blood enters the recipient’s body, it undergoes thorough testing, which reveals the presence of certain viral markers in it, including hepatitis B. If, for some unknown reason, the blood was not tested or the virus was not detected, then the likelihood of becoming infected increases several times.
• Through poorly disinfected medical supplies. To become infected with hepatitis, a microscopically small amount of infected blood (0.001 ml) is sufficient. Approximately this volume remains on the medical needle after the injection.
• Sterile disposable gloves, which nurses wear when drawing blood, are not always changed with each new patient and are sometimes simply wiped with alcohol. When working with blood, gloves should be used individually for each patient.
• There is also a risk of contracting a virus during dental treatment when the instruments have not been properly disinfected.

Unprotected sexual contact

In this case, hepatitis infection occurs through the biological fluids of one of the partners who has this disease. The probability of infection in this way is almost 40%.

Condoms do not provide an absolute guarantee, but they significantly reduce the risk of infection.

The greatest danger of infection through sexual contact will be in homosexual couples or during anal sex due to increased trauma to the mucous membranes.

Household way

Close household contacts in a family where a person with this disease lives puts everyone in the household at risk. Razor blades, manicure sets, reusable syringes and other accessories that can damage the surface of the skin are hidden carriers of the virus.

From mother to child

If the mother is a carrier of hepatitis B, then during childbirth there is a high probability of giving birth to an infected child. When the fetus passes through the birth canal, the integrity of its skin may be compromised and the virus will enter the baby’s body through micro-wounds.

In developed countries, infected mothers undergo elective caesarean section and are advised to completely avoid breastfeeding.

Manicures, piercings, tattoos and other invasive cosmetic procedures

The hepatitis virus is often transmitted when visiting beauty salons, tattoos, etc. Special tools for manicures, tattoos, and piercings are not always treated with disinfectants. Many salons neglect instructions and safety rules. With their negligence, they automatically put visitors at risk of hepatitis B.

Addiction

In injection drug addiction, one Spitz is used for several people. Methods of administration and consequences fade into the background. Hence the large number of people infected with incurable diseases transmitted through blood.

Hepatitis A vaccination

Although the hepatitis A vaccine is not included in the vaccination calendar, doctors recommend that everyone get it. Everyone should understand that the hepatitis A vaccine reduces the risk of contracting the virus and is highly desirable under certain conditions when the risk of infection is particularly high. So, vaccinations against hepatitis A are given:

• Before going on vacation, especially to countries with low social conditions. Vaccination against hepatitis A is done 2 weeks before departure so that immunity has time to develop.
• If there is someone in the family who is infected with this virus. The hepatitis A vaccine is administered within 10 days of contact with the patient.
• In case of serious liver pathology. In this case, vaccination against hepatitis A is mandatory.

Before vaccination, the blood is tested for the presence of antibodies to the disease. If there are any, then they do not get vaccinated against hepatitis A. The presence of antibodies in the blood indicates that a person has already had jaundice and will not be able to become infected with hepatitis A again, so someone who has had this disease once provides themselves with immunity for life.

Who should get the hepatitis B vaccine?

The most correct answer is – everyone. According to the vaccination schedule, newborns should be vaccinated against hepatitis within the first 12 hours of life. Subsequent vaccinations must be completed according to the current schedule (see paragraph Vaccination schedules for hepatitis A and B).

Not everyone understands the importance of this vaccine and refuses to take it. People have every right to do this, since vaccination against hepatitis B is not a mandatory measure in the modern world.

The decision to vaccinate is made by the patient himself, and parents make this decision for minor children.

Taking into account the ways the virus spreads, it is possible to determine the categories of people who are at risk and the hepatitis B vaccine is mandatory for them:

• those in need of blood transfusion;
• persons who are promiscuous;
• people with non-traditional sexual orientation;
• doctors working with blood;
• relatives of patients with hepatitis B;
• drug addicts;
• beauty salon workers, tattoo artists, piercers, etc.

What vaccines are used nowadays?

At the moment, recombinant genetically engineered vaccines are approved for use. Each vaccine contains the immunogenic envelope component of the hepatitis B virus (HBsAg). It is to this that the vaccinated person develops immunity.

There is no need to worry that vaccination may cause hepatitis infection. This is absolutely impossible, since an inferior viral agent is introduced into the body, but only one of its antigens.

Several antigens are required for hepatitis B infection.

Currently, 2 types of vaccines are approved for use:

• A monovaccine is a vaccine against hepatitis B only.
• Combined – a vaccine containing the immunogenic component of hepatitis B and additional components of other diseases.

The names of the vaccines are summarized in the table:

Their main difference is the manufacturing company, but in terms of dose, regimen and effectiveness, they are absolutely identical. Therefore, vaccination against hepatitis B can be done with any vaccine available at the medical center, since they are all interchangeable.

Engerix vaccine

Today in Russia the Engerix vaccine is the most popular. The experience of its practical use has gone beyond the mark of 15 years. Numerous studies demonstrate a high degree of effectiveness of immunoprophylaxis in both newborns and adults, and rates of seroprotection (immunological protection) after vaccination with Engerix reach almost 100%.

In addition, the Engerix vaccine has proven itself to be effective in immunizing low birth weight infants, those with blood disorders, and those living with HIV.

Side effects associated with the vaccine are usually mild and resolve quickly. Approximately a third of people vaccinated with Engerix do not report any complications or adverse reactions.

Vaccination schedules for hepatitis A and B

There is no vaccination schedule for hepatitis A. There are recommendations for how to carry it out. Vaccination is allowed for young children from 1 year of age. It is injected intramuscularly into the shoulder or thigh. A single vaccination against hepatitis A is sufficient to develop lasting immunity. After 6–18 months, vaccination can be repeated according to indications.

All hepatitis B vaccines contain artificial antigens. They are not as effective as live virus vaccines (hepatitis A vaccine). In this regard, specialists have developed a set of vaccinations, the implementation of which lies within a strict time frame to achieve maximum effectiveness. There are 3 types of regimens by which hepatitis B vaccination is administered:

1. Standard (basic) scheme: 0-1-6 months. The first vaccination against hepatitis B is given to newborns, the second injection is carried out at 1 month, the third at 6 months. This algorithm is used if there are no contraindications.
2. Fast (alternative) scheme: 0-1–6–12 months. It is used to vaccinate children at increased risk of contracting the virus.
3. Emergency: 0–7–21 days. and 12 months It is used to quickly increase immunity, for example, before surgery.

It often happens that one or another vaccination cannot be done on time, for example, a cold, flu or other contraindications. In such cases, there is an acceptable interval within which vaccination can be performed without violating the instructions for use of the drug. For the standard schedule – 0–1 (+4) and 6 (+4–18) months. This means that the second vaccination can be done “late” by 4 months, no more. The third vaccine can be administered a minimum of 4 months and a maximum of 18 months after the second. It is worth noting that it is not recommended to violate the scheme unless absolutely necessary.

If you still have questions about how many times you need to be vaccinated and at what intervals, then do not be embarrassed, you need to carefully ask your doctor.

Method of vaccination

The hepatitis B vaccine is administered strictly intramuscularly. Another method of administration (subcutaneous, intradermal, intravenous) reduces the effectiveness of the vaccine to zero and can lead to unwanted complications (compaction or formation of infiltrate). In some countries, an incorrectly performed vaccination is considered an error and is canceled. After some time it is duly repeated.

The choice of the intramuscular route of administration is simply explained. When the vaccine enters the muscle, it enters the blood in full, providing complete immune protection.

In accordance with the instructions for vaccination against hepatitis B, the vaccine is administered to young children (under 3 years old) in the anterolateral area of ​​the thigh, for children over 3 years old and adults - in the shoulder. Injections into such areas are most effective, since the muscles in these areas are well developed and are closest to the surface of the skin. Vaccination in the buttock is highly not recommended, because the muscle needed for vaccination is located under the fat layer. If the vaccine is injected into the fatty layer, the absorption of the drug is significantly deteriorated and complications may occur.

Duration of action of the vaccine

Research by scientists has shown that vaccinations given in infancy can remain effective for up to 22 years. Even if a blood test does not reveal the presence of antibodies to hepatitis B, this does not provide grounds for asserting that they are absent in the body. After all, it is not always possible to take exactly the “fragment” of blood in which they are present.

WHO recommends testing 5 years after vaccination against hepatitis B.

This is explained by the fact that in 80% of vaccinated people, antibodies retain their protective ability for an average period of time. If contact with the hepatitis B virus occurs later, and there are no symptoms or laboratory confirmation of the disease, then revaccination may not be carried out, since a single vaccination according to the schedule is sufficient for lifelong immunity.

Mandatory revaccination every 5 years is indicated for people at risk and patients with immunodeficiency.

Contraindications

Vaccination against hepatitis A and B is contraindicated in several cases:

• If at the time of vaccination a person has a deterioration in their general condition (fever, weakness), then vaccination should be postponed until complete recovery.
• If there was a strong reaction to the first injection.
• An allergy to nutritional yeast or vaccine components is a serious contraindication to vaccination. This must be reported to the attending physician who prescribes vaccination.
• If there are complex progressive diseases of the nervous system (epilepsy, hydrocephalus).
• If the weight of the newborn baby does not reach 2 kg. Vaccination is prescribed only when the child reaches a normal weight.
• Bronchial asthma.

Before vaccination, the health worker must find out information on each contraindication that the patient has. Failure to take precautions can lead to serious complications.

What to expect after vaccination

Any vaccination triggers a complex set of immunological reactions in the human body. It is difficult to predict in advance how the body will react to a vaccine. This depends on a number of internal and external factors. But, based on many years of experience in using immunization drugs, we can identify the main symptoms characteristic of these vaccinations.

Side effects of the hepatitis A vaccine

As practice has shown, the reaction to each hepatitis A vaccine is different. For example, imported Havrix most often does not cause any reactions, while domestic GEP-A-in-VAKV (and similar drugs) can cause a number of negative, but quickly passing reactions:

• gastrointestinal disorders;
• headache;
• weakness and malaise;
• skin allergic manifestations;
• nervousness, irritability;
• irritation of the injection site (itching, redness, rash, compaction, etc.);
• increase in body temperature.

If such symptoms continue for more than a week, you should immediately consult a doctor.

Side effects of the hepatitis B vaccine

Vaccination against hepatitis B is usually tolerated easily and without complications. But still, there are a number of accompanying reactions that you need to be prepared for. In 10–20% of people, a red spot, a lump, a nodule, or an unpleasant sensation upon palpation at the injection site may appear at the injection site.

1–5% of people may notice more serious side effects:

• weakness and malaise;
• increased body temperature;
• diarrhea;
• increased sweating;
• redness and itching at the injection site;
• headache.

A similar behavior of the body is observed in the first 1–2 days after the injection. Then all the unpleasant side effects disappear.

In very rare cases, a reaction to the vaccine may include anaphylactic shock, apnea (stopping breathing) or an aggressive skin rash.

How to behave after receiving the vaccine

All doctors strongly recommend not to wet the injection site for the first 3 days in order to minimize the occurrence of unpleasant side reactions of the body. But this does not mean that water procedures should be completely abolished. If water gets on the graft, wipe it carefully with a clean towel and try not to wet it again.

Otherwise, stick to your normal routine. If you feel unwell, you should devote more time to proper rest.

Additional Information

In addition to contraindications, you need to pay attention to the points that are described in the instructions for vaccination against hepatitis B (for example, Engerix) or A:

• The hepatitis B vaccine given during the incubation period cannot prevent infection with the disease. The same applies to vaccination against hepatitis of other groups.
• The hepatitis A vaccine (as well as the hepatitis B vaccine) given to children or adults does not provide immunity against another type of virus.
• Due to possible complications after vaccination (for example, anaphylactic shock), vaccinated persons must be under the supervision of medical staff for half an hour. In addition, manipulation rooms must be provided with anti-shock agents. If the patient has a history of allergic reactions to such vaccinations, then vaccination is a contraindication until the circumstances are fully clarified.

Conclusion

Absolutely all medications have contraindications, adverse reactions or consequences, even those that do not cause any concern and are used in everyday life. The main thing is to know the individual characteristics of the body and its reaction to one or another component of the drug. Don’t be afraid to get vaccinated, because they can protect against dangerous infections and save lives.

After vaccination, the risk of infection is minimal and even if infection occurs, it will be much easier to tolerate than without prior immunization.

If you take vaccination seriously and take into account all factors and contraindications, then this process will bring an extremely positive effect and provide reliable protection for the body.