Vaccination against pneumococcal infection. Vaccination against pneumococcal infection for adults and children: timing of vaccination and contraindications Vaccine against pneumococcal infection instructions

Active substance

Pneumococcal polysaccharide conjugate vaccine (absorbed)

Release form, composition and packaging

Suspension for intramuscular administration white, homogeneous.

	1 dose (0.5 ml)
pneumococcal conjugates (polysaccharide-CRM 197)
polysaccharide serotype 1	2.2 mcg
polysaccharide serotype 3	2.2 mcg
polysaccharide serotype 4	2.2 mcg
polysaccharide serotype 5	2.2 mcg
polysaccharide serotype 6A	2.2 mcg
polysaccharide serotype 6B	4.4 mcg
polysaccharide serotype 7F	2.2 mcg
polysaccharide serotype 9V	2.2 mcg
polysaccharide serotype 14	2.2 mcg
oligosaccharide serotype 18C	2.2 mcg
polysaccharide serotype 19A	2.2 mcg
polysaccharide serotype 19F	2.2 mcg
polysaccharide serotype 23F	2.2 mcg
carrier protein CRM 197	~32 mcg

Excipients: aluminum phosphate - 0.5 mg (in terms of aluminum - 0.125 mg), - 4.25 mg, succinic acid - 0.295 mg, polysorbate 80 - 0.1 mg, water for injection - up to 0.5 ml.

0.5 ml - syringes with a capacity of 1 ml made of transparent colorless glass (1) - plastic packaging (1) complete with a sterile needle - cardboard packs.
0.5 ml - syringes with a capacity of 1 ml made of transparent colorless glass (5) - plastic packaging (2) complete with sterile needles (10 pcs.) - cardboard packs.

pharmachologic effect

Vaccine for prevention pneumococcal infections. The Prevenar13 vaccine is a capsular polysaccharide of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to the diphtheria protein CRM 197 and adsorbed on aluminum phosphate.

Immunological properties

Administration of the Prevenar 13 vaccine causes the production of antibodies to capsular polysaccharides Streptococcus pneumoniae, thereby providing specific protection against infections caused by pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F included in the vaccine.

According to WHO recommendations for new conjugate pneumococcal vaccines, the equivalence of the immune response of vaccine 13 was determined according to three criteria: the percentage of patients who reached the concentration of specific IgG antibodies≥0.35 µg/ml; geometric mean concentrations (GMC) and opsonophagocytic activity (OPA) of bactericidal antibodies (GMA titer ≥1:8 and geometric mean titers (GMT)). Not specified for adults protective level anti-pneumococcal antibodies and serotype-specific SPA (SST) is used.

The Prevenar 13 vaccine includes up to 90% of the serotypes that cause invasive pneumococcal infections (IPI), incl. resistant to antibiotic treatment.

Immune response using three or two doses in a primary vaccination series

After introduction three doses Prevenar 13 vaccine, during primary vaccination of children under 6 months of age, a significant increase in the level of antibodies to all vaccine serotypes was observed.

After introduction two doses during primary vaccination with Prevenar 13 as part of the mass immunization of children of the same age group There is also a significant increase in antibody titers to all components of the vaccine; for serotypes 6B and 23F, an IgG level of ≥0.35 μg/ml was determined in a smaller percentage of children. At the same time, a pronounced booster response to revaccination was noted for all serotypes. The formation of immune memory is indicated for both of the above vaccination regimens. Secondary immune response to a booster dose in children of the second year of life when using three or two doses in the primary vaccination series are comparable for all 13 serotypes.

When vaccinating premature babies (born at gestational age<37 недель), включая глубоко недоношенных детей (родившихся при сроке гестации <28 недель), начиная с возраста 2 месяцев, отмечено, что уровень защитных специфических противопневмококковых антител и их ОФА после законченного курса вакцинации достигали значений выше защитных у 87-100% привитых ко всем 13 включенным в вакцину серотипам.

Immunogenicity in children and adolescents aged 5 to 17 years

Children aged 5 to<10 лет, которые до этого получили как минимум 1 дозу пневмококковой 7-валентной конъюгированной вакцины, а также ранее не вакцинированные дети и подростки в возрасте от 10 до 17 лет, получив по 1 дозе вакцины Превенар 13, продемонстрировали иммунный ответ на все 13 серотипов, эквивалентный таковому у детей 12-15 месяцев, вакцинированных 4 дозами препарата Превенар 13.

A single administration of the Prevenar vaccine to 13 children aged 5-17 years can provide the necessary immune response to all serotypes of the pathogen included in the vaccine.

Efficacy of Prevenar 13 vaccine

Invasive pneumococcal disease (IPI)

After the introduction of the Prevenar vaccine in a 2+1 regimen (2 doses in the first year of life and revaccination once in the second year of life), four years later with 94% vaccination coverage, a 98% (95% CI: 95; 99) reduction in the frequency of IPD caused by vaccines was noted -specific serotypes. After switching to Prevenar 13, there was a further reduction in the incidence of IPD caused by vaccine-specific additional serotypes, from 76% in children under 2 years of age to 91% in children aged 5–14 years.

Serotype-specific efficacy against IPD for additional serotypes of Prevenar 13 in children aged ≤5 years ranged from 68% to 100% (serotypes 3 and 6A, respectively) and was 91% for serotypes 1, 7F and 19A, with There were no cases of IPD caused by serotype 5. Following the introduction of Prevenar 13 into national immunization programmes, the incidence of IPD caused by serotype 3 decreased by 68% (95% CI 6–89%) in children under 5 years of age. A case-control study performed in this age group showed a reduction in the incidence of IPD caused by serotype 3 by 79.5% (95% CI 30.3-94.8).

Otitis media (OM)

After the introduction of Prevenar vaccination with subsequent transition to the drug Prevenar 13 according to the 2+1 scheme, a 95% decrease in the incidence of OM caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A was revealed, as well as an 89% decrease frequencies of OM caused by serotypes 1, 3, 5, 7F and 19A.

Pneumonia

When switching from Prevenar to Prevenar 13, there was a 16% decrease in the incidence of all cases of community-acquired pneumonia (CAP) in children aged 1 month to 15 years. Cases of PFS with pleural effusion decreased by 53% (p<0.001), пневмококковые ВБП снизились на 63% (р <0.001). Во второй год после внедрения вакцины Превенар 13 отмечено 74% снижение частоты ВБП, вызванных 6 дополнительными серотипами вакцины Превенар 13. У детей в возрасте младше 5 лет после внедрения вакцинации препаратом Превенар 13 по схеме 2+1 отмечено 68% (95% ДИ: 73; 61) снижение числа амбулаторных визитов и 32% (95% ДИ: 39; 22) уменьшение числа госпитализаций по поводу альвеолярной ВБП любой этиологии.

Carriage and population effect

The effectiveness of Prevenar 13 has been demonstrated in reducing the carriage of vaccine-specific serotypes in the nasopharynx, both common with the Prevenar vaccine (4, 6B, 9V, 14, 18C, 19F, 23F), and 6 additional (1, 3, 5, 6A, 7A, 19A) and related serotype 6C.

The population effect (serotype-specific reduction in disease incidence in unvaccinated individuals) has been observed in countries where Prevenar 13 has been used as part of mass immunization for more than 3 years with high vaccination coverage and compliance with the immunization schedule. In 13 persons 65 years of age and older not vaccinated with Prevenar, a 25% reduction in IPI was demonstrated, while IPI caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F decreased by 89% and IPI caused by 6 decreased by 64%. additional serotypes (1, 3, 5, 6A, 7A, 19A). The frequency of infections caused by serotype 3 decreased by 44%, serotype 6A by 95%, and serotype 19A by 65%.

Immunogenicity of the Prevenar 13 vaccine in adults

Clinical studies of Prevenar 13 provide immunogenicity data in adults aged 18 years and older, including persons aged 65 years and older and those previously vaccinated with 1 or more doses of polysaccharide pneumococcal 23-valent vaccine (PPV23) within 5 years prior to enrollment into the study. Each study included healthy adults and immunocompetent patients with chronic diseases in the compensation stage, including comorbidities that create increased susceptibility to pneumococcal infection (chronic cardiovascular diseases, chronic lung diseases, including asthma; kidney diseases and diabetes mellitus, chronic liver diseases, including alcohol injuries), and adults with social risk factors – smoking and alcohol abuse. The immunogenicity and safety of Prevenar 13 has been demonstrated in adults aged 18 years and older, including patients previously vaccinated with PPV23. Immunological equivalence was established for 12 serotypes common to PPV23. In addition, for 8 serotypes common to PPV23 and for serotype 6A, unique to the Prevenar 13 vaccine, a statistically significantly higher immune response to the drug Prevenar 13 was demonstrated. In adults aged 18-59 years, opsonophagocytic activity SHT (OPA SHT) to all 13 Prevenar 13 vaccine serotypes were no lower than those in adults aged 60–64 years. Moreover, individuals aged 50-59 years had a statistically higher immune response to 9 of 13 serotypes compared to individuals aged 60-64 years.

Demonstrated clinical efficacy of Prevenar 13 in the randomized, double-blind, placebo-controlled CAPITA trial (more than 84,000 patients) against community-acquired pneumococcal pneumonia (CAP) in adults aged 65 years and older: 45% for a first episode of CAP caused by overlapping serotypes Prevenar 13 (invasive and non-invasive); 75% against invasive infections caused by serotypes covered by Prevenar 13.

Immune response in adults previously vaccinated with PPV23

In adults aged 70 years and older vaccinated with a single dose of PPV23 ≥5 years ago, Prevenar 13 demonstrated immunological equivalence for 12 common serotypes compared with the response to PPV23, with 10 common serotypes and serotype 6A responding to Prevenar 13 was statistically significantly higher compared to the response to PPV23. Prevenar 13 gives a more pronounced immune response compared to revaccination with PPV23.

Immune response in special patient groups

Patients with the conditions described below are at increased risk of pneumococcal infection.

Sickle cell anemia

In an open-label, non-comparative study of 158 children and adolescents aged ≥6 and<18 лет с серповидно-клеточной анемией, ранее вакцинированных одной или более дозами ППВ23 как минимум за 6 месяцев до включения в исследование показало, что введение первой дозы вакцины Превенар 13 при двукратной иммунизации с интервалом 6 месяцев приводило к статистически значимо высокому иммунному ответу (СГК IgG к каждому серотипу, определяемые методом иммуноферментного анализа (ИФА), и ОФА СГТ к каждому серотипу). После ведения второй дозы иммунный ответ был сопоставим с таковыми после первой дозы препарата.

HIV infection

HIV-infected children and adults with CD4 count ≥200 cells/μl (mean 717.0 cells/μl), viral load<50 000 копий/мл (в среднем 2090.0 копий/мл), с отсутствием активных СПИД-ассоциированных заболеваний и ранее не получавшие вакцинации пневмококковой вакциной, получали 3 дозы вакцины Превенар 13. Показатели IgG СГК и ОФА были достоверно выше после первой вакцинации препаратом Превенар 13 по сравнению с довакцинальным уровнем. На вторую и третью дозы (через 6 и 12 месяцев) развивался более высокий иммунный ответ, чем после однократной вакцинации препаратом Превенар 13.

Hematopoietic stem cell transplantation

Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT) aged ≥2 years with complete hematologic remission of the underlying disease or satisfactory partial remission for lymphoma and myeloma received three doses of Prevenar 13 vaccine at least 1 month apart between doses. The first dose of the drug was administered 3-6 months after HSCT. The fourth (booster) dose of Prevenar 13 was administered 6 months after the third dose. In accordance with general recommendations, a single dose of PPV23 was administered 1 month after the fourth dose of Prevenar 13. Functionally active antibody titers (FAA FAT) were not determined in this study. Administration of the Prevenar 13 vaccine caused an increase in SGC serotype-specific antibodies after each dose. The immune response to the booster dose of Prevenar 13 was significantly higher for all serotypes compared to the response to the primary immunization series.

Indications

• prevention of pneumococcal infections, including invasive (including meningitis, bacteremia, sepsis, severe pneumonia) and non-invasive (community-acquired pneumonia and otitis media) forms of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F from 2 months of life onwards without age restrictions:
• within the framework of the national calendar of preventive vaccinations;
• in individuals at increased risk of developing pneumococcal infection.

Vaccination is carried out within the framework of the national calendar of preventive vaccinations according to the approved dates, as well as for persons at risk for the development of pneumococcal infection: with immunodeficiency conditions, incl. HIV infection, cancer, receiving immunosuppressive therapy; with anatomical/functional asplenia; with a cochlear implant installed or planning to have this operation; patients with cerebrospinal fluid leakage; with chronic diseases of the lungs, cardiovascular system, liver, kidneys and diabetes; patients with bronchial asthma; premature babies; persons in organized groups (orphanages, boarding schools, army groups); convalescents of acute otitis media, meningitis, pneumonia; long-term and frequently ill children; patients infected with Mycobacterium tuberculosis; all persons over 50 years of age; Tobacco smokers.

Contraindications

• hypersensitivity to previous administration of the drug Prevenar 13 or Prevenar (including anaphylactic shock, severe generalized allergic reactions);
• hypersensitivity to diphtheria toxoid and/or excipients;
• acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccination is carried out after recovery or during remission.

Dosage

The vaccine is administered in a single dose of 0.5 ml intramuscularly. For children of the first years of life, the vaccine is injected into the upper-outer surface of the middle third of the thigh, for persons over 2 years of age - into the deltoid muscle of the shoulder.

Before use, the syringe with the Prevenar 13 vaccine must be shaken well until a homogeneous suspension is obtained. Do not use if inspection of the contents of the syringe reveals foreign particles, or the contents look different than in the “Dosage form, composition and packaging” section.

Prevenar 13 should not be administered intravascularly or intramuscularly into the gluteal region!

If vaccination with Prevenar 13 is started, it is recommended to complete it with the Prevenar 13 vaccine. If the interval between injections of any of the above vaccination courses is forced to increase, the administration of additional doses of the Prevenar 13 vaccine is not required.

Vaccination scheme

Age of start of vaccination	Vaccination scheme	Intervals and dosage
2-6 months	3+1 or 2+1	Individual immunization: 3 doses with an interval of at least 4 weeks between administrations. The first dose can be administered from 2 months. Revaccination once every 11-15 months. Mass immunization of children: 2 doses with an interval of at least 8 weeks between administrations. Revaccination once every 11-15 months.
7-11 months	2+1	2 doses with an interval of at least 4 weeks between administrations. Revaccination once in the second year of life
12-23 months	1+1	2 doses with an interval of at least 8 weeks between administrations
2 years and older	1	One time

Children previously vaccinated with Prevenar

Vaccination against pneumococcal disease started with Prevenar 7-valent vaccine can be continued with Prevenar 13 at any stage of the immunization regimen.

Persons aged 18 years and older

Prevenar 13 is administered once. The need for revaccination with Prevenar 13 has not been established. The decision on the interval between the administration of Prevenar 13 and PPV23 vaccines should be made in accordance with official guidelines.

Special patient groups

U patients after hematopoietic stem cell transplantation An immunization series of 4 doses of Prevenar 13, 0.5 ml each, is recommended. The first series of immunization consists of 3 doses of the drug: the first dose is administered from the 3rd to the 6th month after transplantation. The interval between administrations should be 1 month. A booster dose is recommended to be administered 6 months after the third dose.

Premature babies Quadruple vaccination is recommended. The first series of immunization consists of 3 doses. The first dose should be administered at 2 months of age, regardless of the child's body weight, with an interval of 1 month between doses. A fourth (booster) dose is recommended at 12–15 months of age.

The immunogenicity and safety of Prevenar 13 have been confirmed for elderly patients.

Side effects

The safety of the Prevenar 13 vaccine was studied in healthy children (4429 children/14,267 vaccine doses) aged from 6 weeks to 11-16 months and 100 children born prematurely (at term<37 недель гестации). Во всех исследованиях Превенар 13 применялся одновременно с другими вакцинами, рекомендованными для данного возраста.

In addition, the safety of the Prevenar 13 vaccine was assessed in 354 children aged 7 months to 5 years who had not previously been vaccinated with any of the pneumococcal conjugate vaccines. The most common adverse reactions were injection site reactions, fever, irritability, decreased appetite, and sleep disturbances. In older children, during primary vaccination with Prevenar 13, a higher frequency of local reactions was observed than in children of the first year of life.

When 13 premature infants (born at a gestation of ≤37 weeks) were vaccinated with Prevenar, including very premature infants born at a gestational age of less than 28 weeks and children with extremely low body weight (≤500 g), the nature, frequency and severity of post-vaccination reactions did not differ. from those in full-term children.

Individuals aged 18 years and older experienced fewer side effects regardless of previous vaccinations. However, the frequency of reactions was the same as in younger vaccinated people.

In general, the incidence of side effects was similar in patients aged 18–49 years and in patients over 50 years of age, with the exception of vomiting. This side effect was more common in patients aged 18–49 years than in patients over 50 years of age.

Adult patients with HIV infection had the same incidence of adverse reactions as patients aged 50 years and older, with the exception of fever and vomiting, which were very common, and nausea, which was common.

In hematopoietic stem cell transplant patients, the incidence of adverse reactions was the same as in healthy adult patients, with the exception of fever and vomiting, which were very common in transplant patients. Children and adolescents with sickle cell disease, HIV infection, or hematopoietic stem cell transplant had the same incidence of adverse reactions as healthy patients aged 2-17 years, with the exception of headache, vomiting, diarrhea, fever, fatigue , arthralgia and myalgia, which were considered “very common” in such patients.

The adverse reactions listed below are classified according to their frequency in all age groups as follows: very often (≥1/10), often (≥1/100, but<1/10), нечасто (≥1/1000, но <1/100), редко (≥1/10 000, но <1/1000) и очень редко (≤1/10 000).

Adverse reactions identified in clinical studies of the Prevenar 13 vaccine

Often: hyperthermia; irritability; skin redness, pain, thickening or swelling measuring 2.5-7 cm at the injection site (after revaccination and/or in children aged 2-5 years); vomiting (in patients aged 18–49 years), drowsiness, worsening sleep, worsening appetite, headache, generalized new or exacerbation of existing joint and muscle pain, chills, fatigue.

Often: hyperthermia above 39°C; pain at the injection site, leading to short-term limitation of the range of motion of the limb; hyperemia, induration or swelling measuring 2.5-7 cm at the site of vaccine administration (after a series of primary vaccinations in children under 6 months of age), vomiting, diarrhea, rash.

Infrequently: skin redness, thickening or swelling larger than 7 cm at the injection site; tearfulness, convulsions (including febrile convulsions), hypersensitivity reactions at the injection site (urticaria, dermatitis, itching)**, nausea.

Rarely: cases of hypotonic collapse*, facial flushing**, hypersensitivity reaction, including shortness of breath, bronchospasm, angioedema of various locations, including facial swelling**, anaphylactic/anaphylactoid reaction, including shock**, lymphadenopathy at the injection site.

Very rarely: regional lymphadenopathy**, erythema multiforme**.

* were observed only in clinical studies of the Prevenar vaccine, but are also possible for the Prevenar 13 vaccine.
** noted during post-marketing observations of the Prevenar vaccine; they can be considered as quite possible for the Prevenar 13 vaccine.

Adverse events observed in other age groups may also occur in children and adolescents aged 5–17 years. However, they were not noted in clinical studies due to the small number of participants.

There were no significant differences in the incidence of side effects in adults previously vaccinated and not vaccinated with PPV23.

Overdose

An overdose of the Prevenar 13 vaccine is unlikely, because The vaccine is released in a syringe containing only one dose.

Drug interactions

There is no data on the interchangeability of Prevenar 13 with other pneumococcal conjugate vaccines. During simultaneous immunization with Prevenar 13 and other vaccines, injections are made into different parts of the body.

Children aged 2 months-5 years

Prevenar 13 is combined with any other vaccines included in the immunization schedule for children in the first years of life, with the exception of BCG. Simultaneous administration of the Prevenar 13 vaccine with any of the following antigens included in both monovalent and combined vaccines: diphtheria, tetanus, acellular or whole-cell pertussis, Haemophilus influenzae type b, polio, hepatitis A, hepatitis B, measles, mumps, rubella, chickenpox and rotavirus infection - does not affect the immunogenicity of these vaccines. Due to the higher risk of developing febrile reactions in children with seizure disorders, incl. with a history of febrile convulsions, and also receiving Prevenar 13 vaccine simultaneously with whole-cell pertussis vaccines, symptomatic administration of antipyretics is recommended. When the Prevenar 13 vaccines were used together, the frequency of febrile reactions coincided with that for the joint use of the Prevenar (PCV7) and Infanrix-hexa vaccines. An increased incidence of reported seizures (with and without fever) and hypotensive-hyporesponsive episodes (HHE) was observed with the combined use of Prevenar 13 and Infanrix-Hexa vaccines. Antipyretic medications should be initiated in accordance with local treatment guidelines for children with seizure disorders or a history of febrile seizures and in all children receiving Prevenar 13 concomitantly with vaccines containing whole cell pertussis.

Post-marketing data from a post-marketing study of prophylactic antipyretics on the immune response to Prevenar 13 vaccine suggest that prophylactic administration of acetaminophen () may reduce the immune response to a primary vaccination series with Prevenar 13. Immune response to booster vaccination with Prevenar 13 at 12 months with prophylactic use paracetamol does not change. The clinical significance of these data is unknown.

Children and adolescents aged 6-17 years

There are no data on the use of Prevenar 13 simultaneously with the vaccine against human papillomavirus infection, meningococcal conjugate vaccine, tetanus, diphtheria and pertussis vaccine, and tick-borne encephalitis.

Persons aged 18-49 years

There are no data on the simultaneous use of Prevenar 13 with other vaccines.

Persons aged 50 years and older

Prevenar 13 can be used in conjunction with trivalent inactivated seasonal influenza vaccine (DVT). When Prevenar 13 and DVT were used in combination, immune responses to DVT were similar to those obtained with DVT alone, and immune responses to Prevenar 13 were lower than with Prevenar 13 alone. The clinical significance of this finding is unknown. The incidence of local reactions did not increase with simultaneous administration of Prevenar 13 with inactivated influenza vaccine, while the incidence of general reactions (headache, chills, rash, loss of appetite, joint and muscle pain) increased with simultaneous immunization. Concomitant use with other vaccines has not been studied.

special instructions

Given the rare incidence of anaphylactic reactions with any vaccine, the vaccinated patient should be under medical supervision for at least 30 minutes after immunization. Immunization sites must be provided with anti-shock therapy.

Vaccination of premature (as well as full-term) children should begin from the second month of life (passport age). When deciding whether to vaccinate a premature baby (born at term<37 недель беременности), особенно имеющего в анамнезе незрелость дыхательной системы, необходимо учесть, что польза иммунизации против пневмококковой инфекции у данной группы пациентов особенно высока и не следует ни отказываться от вакцинации, ни переносить ее сроки. В связи с потенциальным риском апноэ, имеющимся при применении любых вакцин, первая вакцинация препаратом Превенар 13 недоношенного ребенка возможна под врачебным наблюдением (не менее 48 ч) в стационаре на втором этапе выхаживания.

As with other intramuscular injections, in patients with thrombocytopenia and/or other coagulation disorders and/or in the case of treatment with anticoagulants, vaccination with Prevenar 13 should be administered with caution, provided that the patient's condition is stabilized and hemostasis is controlled. It is possible to administer the Prevenar 13 vaccine subcutaneously to this group of patients.

Prevenar 13 cannot provide prevention of diseases caused by pneumococci of other serotypes, the antigens of which are not included in this vaccine.

High-risk children under 2 years of age should receive an age-appropriate primary vaccination with Prevenar 13. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody formation.

Application of Prevenar 13 and PPV23

To form immune memory, it is preferable to start immunization against pneumococcal infection with the Prevenar 13 vaccine. The need for revaccination has not been determined. For individuals at high risk, PPV23 may be subsequently recommended to expand serotype coverage. There are data from clinical studies of PPV23 vaccination after 1 year, as well as 3.5-4 years after the Prevenar 13 vaccine. With an interval between vaccinations of 3.5-4 years, the immune response to PPV23 was higher without changes in reactogenicity.

For children vaccinated with Prevenar 13 who are at high risk (eg, sickle cell disease, asplenia, HIV infection, chronic disease, or immune dysfunction), PPV23 is administered at least 8 weeks apart. In turn, patients at high risk of pneumococcal disease (patients with sickle cell disease or HIV infection), including patients previously vaccinated with one or more doses of PPV23, can receive at least one dose of Prevenar 13 vaccine.

The decision on the interval between administrations of PPV23 and Prevenar 13 should be made in accordance with official recommendations. In some countries (USA), the recommended interval is at least 8 weeks (up to 12 months). If the patient has previously been vaccinated with PPV23, Prevenar 13 should be administered no earlier than 1 year later. In the Russian Federation, PCV13 vaccination is recommended for all adults over 50 years of age and patients in risk groups, and the PCV13 vaccine is administered first, with possible subsequent revaccination with PPV23 at an interval of at least 8 weeks.

Prevenar 13 contains less than 1 mmol sodium (23 mg) per dose, meaning it is virtually sodium-free.

Within the specified shelf life, Prevenar 13 remains stable for 4 days at temperatures up to 25°C. At the end of this period, the drug should either be used immediately or returned to the refrigerator. These data do not constitute instructions for storage and transportation conditions, but may be the basis for a decision on the use of the vaccine in the event of temporary temperature fluctuations during storage and transportation.

Impact on the ability to drive vehicles and operate machinery

Prevenar 13 has no or negligible effect on the ability to drive a car and use equipment. However, some reactions listed in the "Side Effects" section may temporarily affect the ability to drive a vehicle and operate potentially dangerous machinery.

Pregnancy and lactation

The safety of the vaccine during pregnancy and breastfeeding has not been established.

There are no data on the use of the Prevenar 13 vaccine during pregnancy.

There is no data on the release of vaccine antigens or post-vaccination antibodies into breast milk during lactation.

Conditions for dispensing from pharmacies

A package of 1 syringe is available with a prescription.

A package of 10 syringes is intended for medical institutions.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 2 to 8°C; do not freeze. Shelf life - 3 years. Do not use after the expiration date stated on the packaging.

Transportation conditions

Transport at temperatures between 2°C–25°C. Do not freeze. Transportation at temperatures above 2-8°C is allowed for no more than 5 days.

Vaccination plays an important role in the prevention of diseases caused by pneumococcal infection. Most often, young children and elderly people are susceptible to such diseases. There may be several causes, ranging from a common cold to improper treatment of inflammatory processes.

In Russia, the population is being vaccinated to prevent pneumonia. Initially, it was performed only in private clinics, but later they began to do it in municipal hospitals. The most commonly used vaccine is Pneumo 23.

The causative agent of pneumococcal infection is a subspecies of streptococcus - pneumococcus. The bacteria are transmitted by airborne droplets and are highly resistant to a variety of antibiotics.

Pneumococci cause the following diseases:

• arthritis;
• pleurisy;
• endocarditis;
• bacterial meningitis.

A distinctive feature of pneumococcus is its persistence on human mucous membranes without the formation of severe forms of the disease, but the bacteria are released into the environment during talking or sneezing. More than 60% of adults are diagnosed with pneumococcal infection in a “dormant” form.

To effectively prevent the development of pneumonia, both young children and adults are given injections of the drug Pneumo 23.

Composition and principle of action of the vaccine

The manufacturer of the drug is France, namely the company Sanofi Pasteur. The vaccine can be administered to children over two years of age. Vaccination ensures the formation of immunity in a person and the production of antibodies to pneumococcal serotypes.

Pneumo 23 includes the following components:

• phenol - acts as a preservative;
• water for injections;
• sodium phosphate;
• antigens – polysaccharides of 23 types of pneumococcal infections.

The injection is done subcutaneously or intravenously. If the need arises, revaccination is carried out in a similar dosage (0.5 ml) after three years.

The vaccine is not prescribed to children over 6 years of age unless they are susceptible to frequent colds, since in this case it is ineffective.

Pneumo 23 was synthesized as a means for the prevention of infectious diseases caused by 23 strains of pneumococcal bacteria. After the first administration, the drug promotes the formation of specific immunity. It belongs to drugs of improved action.

The developed gentle composition of the vaccine allows it to be used without side effects for preventive purposes for young children. For this reason, doctors recommend giving injections to children while attending kindergarten, when the risk of infectious diseases increases several times.

Thus, the Pneumo 23 graft:

• is the only injection in Russia designed specifically for the prevention of infectious diseases;
• after a single administration, it protects the body from disease for 5 years;
• the likelihood of contracting pneumonia is reduced by 6 times;
• contains stereotypes resistant to penicillin.

The vaccine can be combined with other antiviral agents to improve immune resistance.

Vaccination schedule and method

The intended purpose of Pneumo 23 is to protect the body from pneumococcal infection. At risk for this disease are mainly children under 6 years of age and adults over 65 years of age.

The main requirement is that the child must be absolutely healthy at the time of the procedure. Two weeks before the expected date of vaccination, preparations for it begin. The immune response to the vaccine will be formed after 2 weeks.

Serious complications can arise if there are problems with the liver, kidneys, respiratory organs, or heart. The incubation period for pneumonia ranges from 1 to 3 days.

Symptoms of infection of the body are:

• body aches;
• fever, chills;
• increased heart rate;
• dyspnea;
• ear pain;
• nausea, vomiting;
• dizziness;
• cough with purulent sputum.

Pneumonia is characterized by damage to various organs. The greatest burden falls on the lungs, the most serious complication is inflammation of the meninges.

Pneumo 23 is given to children to prevent respiratory tract infections. Children under 5 years of age are most susceptible to colds of various origins. Their body is not able to cope with the production of the necessary antibodies, which it previously received along with mother's milk during breastfeeding.

Accordingly, a child usually first becomes ill after the mother stops breastfeeding. And when a baby enters kindergarten, his body is faced with a large number of viruses and infections.

A child’s predisposition to various infectious diseases is greatly influenced by the anatomical features of the body. In the presence of pathologies, vaccination of children with Pneumo 23 is mandatory to build the child’s immunity.

Full resistance of the child's body to pneumococcus is formed only after 3-4 weeks after administration of the drug. Accordingly, you should not send your child to kindergarten immediately after vaccination.

If a child goes to a preschool educational institution for the first time on Knowledge Day, then vaccination should be done no later than August 1. Otherwise, the baby can quickly get sick due to reduced immunity, and the disease will be much more difficult to tolerate.

Contraindications

In the case of Pneumo 23, all contraindications are divided into two groups: absolute and relative. The first include allergic reactions to one of the substances included in the drug.

Relative contraindications are:

• chronic diseases that are in the acute stage. Vaccination is possible only during the period of remission;
• elevated body temperature.

Pneumo 23 during pregnancy is done only after the third trimester and on the recommendation of a doctor. There are no contraindications for a nursing mother; vaccine components do not pass into breast milk.

The opinion that people who have had pneumonia and pneumonia do not need to get such a vaccination is wrong. Pneumo 23 allows you to obtain immunity to 23 strains of pneumococci, while resistance acquired as a result of the disease extends only to 1-2 strains.

Indications for vaccination

Vaccination with this drug protects the body from most strains of pneumococci. The effectiveness of the drug has been scientifically proven. In vaccinated patients, the likelihood of contracting pneumonia and bronchitis is reduced by 90%, while those who became ill experienced a mild form of the disease.

Pneumo 23 is not included in the mandatory vaccination calendar, so it is administered at the request of the patient or according to medical indications. Vaccination is especially recommended for those who are at risk:

• small children;
• adults over 65 years of age;
• people who are in specialized organizations for a long time (workers of kindergartens, schools, medical institutions, etc.);
• patients with diagnosed renal, cardiovascular, bronchopulmonary and chronic diseases;
• suffering from diabetes mellitus;
• people with weakened immune systems after surgery to remove the spleen, chemotherapy for the treatment of oncology, bone marrow or organ transplantation, suppression of the immune system due to HIV and AIDS;
• young children with sickle disease.

Normal and abnormal reactions

According to medical statistics, about 97.5% of children tolerate vaccination without any consequences or side effects. It is extremely rare to see lumps and redness at the injection site, which completely disappear after a few days.

There is a 5% chance of local reactions to the administration of the drug, expressed as a burning sensation or pain at the injection site.

Such symptoms disappear 24 hours after the procedure. General reactions include an increase in body temperature, which is eliminated with the help of antipyretics or goes away on its own.

Abnormal reactions are considered:

• allergic reactions of anaphylactic type;
• joint pain;
• skin rash;
• enlarged lymph nodes.

Such complications are exceptions, since the vaccine is tolerated very well in the vast majority. Before injecting Pneumo 23, the doctor must consult the patient and warn about all possible reactions.

Revaccination

Prophylactic use of the drug Pneumo 23 includes a one-time administration of a drug that provides protection for 5 years. Revaccination is usually prescribed after this period of time.

If prescribed by a doctor, a second injection can be done after 3 years in certain cases:

• patients at risk for renal, cardiac and bronchopulmonary pathologies;
• young children over 10 years of age who have been diagnosed with sickle cell anemia;
• patients with immunodeficiency associated with removal of the spleen or the HIV virus.

Latin name: Prevenar, Prevenar 13
ATX code: J07AL02
Active substance: Pneumococcal
conjugates
Manufacturer: Pfizer, USA
Conditions for dispensing from a pharmacy: On prescription
Price: from 1898 to 2021 rub.

“Prevenar 13” together with “Prevenar” are vaccines that are used against pneumococcal infection (the causative agent of pneumonia, meningitis and other ailments) for vaccination of children from 2 months to 5 years.

Indications for use

Vaccination with Prevenar is carried out to prevent the occurrence of diseases caused by the pathogen - Streptococcus pneumoniae, these include:

• Sepsis
• Otitis media (acute stage)
• Glomerulonephritis
• Erysipelas of the skin
• Pneumonia
• Scarlet fever
• Bacteremia
• Meningitis.

Compound

The drug is based on pneumococcal conjugates, which are represented by polysaccharides of a number of serotypes: 4 (2 μg), 6B (4 μg), 9V (2 μg), 14 (2 μg), 18C (2 μg), 19F (2 μg), 23F (2 µg), as well as carrier protein CRM 197 (20 µg).

Additional components: aluminum phosphate at a dosage of 0.5 mg, sodium chloride at a dose of 4.5 mg, and purified water (0.5 ml).

The new vaccine Prevenar 13 contains 7 serotypes common to Prevenar along with the carrier protein CRM197.

An additional six pneumococcal serotypes of the Prevenar 13 vaccine are presented: 1, 3, 5, 6A, 7F, 19A, which are conjugated together with CRM₁₉₇ (diphtheria protein), adsorbed using aluminum sulfate.

Additional components of the Prevenar 13 vaccine include: sodium chloride, aluminum phosphate, polysorbate, succinic acid, and purified water.

Medicinal properties

The vaccine used to prevent pneumococcal infection includes active components represented by pneumococcal polysaccharides. Such components are obtained during laboratory studies from gram-positive microorganisms - Streptococcus pneumoniae, they are conjugated with the carrier protein of the diphtheria group (CRM197), adsorbed in aluminum phosphate.

Some time after the vaccine is administered, the process of producing antibodies directly to the capsular polysaccharides of Streptococcus pneumoniae of a number of serotypes is launched, as a result of which it is possible to provide a specific immune response to infections provoked by them.

The use of the drug "Prevenar 13" for the purpose of vaccinating children two months of age allows stimulating the child's immune system, as a result of which it is possible to form an immune reaction after the first vaccination procedure, as well as revaccination. After the first three vaccinations, as well as the next revaccination procedure, a significant increase in antibody levels is observed. Prevenar 13 stimulates the production of functional antibody cells to the serotypes included in this drug.

In patients aged 2-5 years, the formation of cells - antibodies to serotypes of this drug occurs after the first vaccination. The immune reaction in this group of children is practically the same as in those children who have completed the first stage of immunization.

Vaccination with Prevenar 13 can be carried out for prophylactic purposes to prevent diseases of infectious origin, as well as otitis media in the acute stage. Can be combined with IPV (poliomyelitis), DTP.

Vaccines have the same safety indicator and level of immunogenicity, so switching from one drug to another is possible at any stage of the vaccination procedure. In addition, Prevenar 13, in addition to 6 other serotypes, allows you to strengthen the protection of the child’s body from IPD.

Release form

Price: from 1898 to 2021 rubles.

The vaccine against pneumococcal infection is produced in the form of a suspension of a rich whitish hue, intended for intramuscular injection, homogeneous. The presence of a slight cloudy sediment is allowed in the suspension. The vaccine is supplied in syringes for single use; a cardboard package can contain 1 or 5 pieces.

Mode of application

The vaccine is given intramuscularly directly into the lateral area in the upper thigh (recommended for children under 2 years of age). For children from 2 years of age, the vaccine is given in the deltoid muscle (shoulder region). A single dose for vaccination is 0.5 ml.

Immediately before vaccinating, the syringe with the solution must be shaken until a homogeneous suspension is formed.

The Prevenar 13 vaccine, along with Prevenar, is not intended for intravenous administration.

Children aged 2 months. – It is recommended to get vaccinated for 5 years, taking into account the vaccination schedule. The pediatrician determines at what month the child should be vaccinated.

For children from 2 to 6 months

Children under six months old are vaccinated three times during primary vaccination, the interval between vaccinations is at least 1 month. It is also possible to carry out double vaccination during primary immunization with a break of 2 months. Pediatricians usually recommend that a child's first vaccination be given at 2 months. Next, the second stage of vaccination (re-vaccination) is carried out once at 11-15 months. The scheme is recommended for immunization of children against infections caused by pneumococci. It is better to agree with your pediatrician at what month to get revaccination.

For children from six months of age in case of the first vaccination

Babies are 7 months old. - 11 months They are vaccinated twice with a 1 month interval. A one-time revaccination is carried out in the second year of a child’s life.

Preschool children from 2 to 5 years old are vaccinated once.

For pneumococcal infection

If vaccination is carried out primarily using Prevenar, during subsequent vaccination a drug with similar characteristics, Prevenar 13, can be used. It is worth considering that vaccination can only be completed with Prevenar 13. If the recommended interval between administration of the drug is forced to be extended, additional vaccination against pneumococcal infection is not necessary.

During pregnancy and pregnancy

The drug is not intended for immunization of adults. There is no information on the safety of using this vaccine during pregnancy or breastfeeding.

Contraindications

Children should not be vaccinated in the following cases:

• Excessive sensitivity to the components of the drug, as well as diphtheria toxoid
• Viral infections and non-infectious diseases
• Acute course of chronic diseases.

Precautionary measures

The reaction to vaccination may vary, so in order to avoid complications after vaccination, you should remain under the supervision of a pediatrician for half an hour. Further monitoring of the child’s condition is carried out by parents at home.

It is worth considering that the children's pneumococcal vaccine does not stimulate the child's body to protect against streptococcal serotypes.

The vaccine is not prescribed for vaccination in children who have serious blood clotting disorders, and intramuscular administration is not indicated. The possibility of vaccination in a particular case is determined by the attending physician when the expected benefit significantly exceeds the possible risks to the child’s health that are caused by the administration of the drug.

Impaired immunoreactivity, as observed during immunosuppressive therapy for HIV, can provoke a decrease in the production of antibodies to vaccine components. The issue of vaccinating a child at high risk is decided during a consultation with a pediatrician.

The contents of the syringe for injection should not be mixed with other vaccines (for example, polio, DPT) or placed in other containers.

Cross-drug interactions

The vaccine against pneumococcal infection can be administered on the same day with other types of vaccines (except BCG). The list includes Hemophilus influenzae, live DTP, polio (drops), Infanrix, vaccination takes place taking into account the established immunization calendar. It is better to administer the drug to different areas of the skin.

Side effects

Usually the vaccine is well tolerated by children, but after the child has been vaccinated, both local and general reactions may be observed:

• Redness
• Local swelling of the skin, thickening
• Painful sensations (local reaction)
• Hyperthermia (temperature rises above 38°C and lasts for a long time)
• Lethargy
• Impaired sleep quality
• Nervous excitability

Along with such signs, complications may be observed, namely disturbances in the hematopoietic system, central nervous system, lymphatic system, functioning of the gastrointestinal tract: lymphadenopathy, loss of appetite, increased sensitivity, changes in stool, convulsions, vomiting.

If a high body temperature rises after the vaccination, it is necessary to give the child an antipyretic drug. The child's body temperature may rise the first few days after vaccination.

Overdose

The likelihood of an overdose with Prevenar is very low, complications are unlikely, since the drug is produced in a syringe containing a dosage for one use.

Conditions and shelf life

The shelf life of Prevenar is 3 years.

Analogues

Sanofi Pasteur, France
average price– 1322 rub.

"Pneumo 23" is used to prevent the occurrence of illnesses caused by pneumococci. The main active ingredient of the drug is Vaccinum antipneumococcum. One dose of the vaccine (0.5 ml) is dispensed in a syringe placed in a cardboard package.

Pros:

• A good remedy for preventing the development of pneumococcal infection
• Vaccination can be carried out with polio vaccine, DTP
• Vaccination is indicated for children diagnosed with diabetes.

Minuses:

• High price
• Vaccination with the drug “Pneumo 23” is carried out from the third year of a child’s life
• Local allergic reactions after vaccination and increased body temperature during the first few days cannot be ruled out.

"Synflorix"

GlaxoSmithKline, Belgium
Price from 1500 to 1680 rub.

Synflorix is ​​indicated for vaccination of infants from 6 weeks of age to 5 years of age to prevent invasive diseases caused by streptococcal serotypes. "Synflorix" is combined with IPV (poliomyelitis), DTP. Available in the form of a suspension for intramuscular injections, each package contains a syringe with a dose for one use.

Pros:

• "Synflorix" is indicated for vaccination of babies from two months of age
• Complications and local allergic reactions occur quite rarely.

Minuses:

• After vaccination, body temperature may rise slightly
• Vaccination is carried out up to 2 years
• It is quite difficult to find in the pharmacy chain.

Manufacturer: NPO Petrovax Pharm Russia

PBX code: J07AL02

Farm group:

Release form: Liquid dosage forms. Suspension for injection.

General characteristics. Compound:

Composition per dose (0.5 ml):
Active substances:
Pneumococcal conjugates (polysaccharide - CRM197):

• Polysaccharide serotype 1 2.2 μg
• Polysaccharide serotype 3 2.2 μg
• Polysaccharide serotype 4 2.2 μg
• Polysaccharide serotype 5 2.2 μg
• Polysaccharide serotype 6A 2.2 μg
• Polysaccharide serotype 6B 4.4 μg
• Polysaccharide serotype 7F 2.2 μg
• Polysaccharide serotype 9V 2.2 μg
• Polysaccharide serotype 14 2.2 μg
• Oligosaccharide serotype 18C 2.2 μg
• Polysaccharide serotype 19A 2.2 μg
• Polysaccharide serotype 19F 2.2 μg
• Polysaccharide serotype 23F 2.2 μg
• Carrier protein CRM197 ~32 μg

Excipients:
aluminum phosphate - 0.5 mg (in terms of aluminum 0.125 mg), sodium chloride - 4.25 mg, succinic acid - 0.295 mg, Polysorbate 80 - 0.1 mg, water for injection - up to 0.5 ml.

PREVENAR® 13 is manufactured in accordance with WHO recommendations for the production and quality control of pneumococcal conjugate vaccines.

Pharmacological properties:

Administration of the Prevenar® 13 vaccine causes the production of antibodies to capsular polysaccharides of Streptococcus pneumoniae, thereby providing specific protection against infections caused by 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and included in the vaccine 23F pneumococcal serotypes.

According to WHO recommendations for new conjugate anti-pneumococcal vaccines, the equivalence of the immune response when using the Prevenar® 13 and Prevenar® vaccines was assessed using a combination of three independent criteria: the percentage of patients who reached a concentration of specific IgG antibodies of 0.35 μg/ml; geometric mean concentrations of immunoglobulins (IgG GMC) and opsonophagocytic activity of bactericidal antibodies (OPA titer 1:8). Administration Prevenar® 13 causes the development of an immune response to all 13 vaccine serotypes, equivalent to the Prevenar® vaccine according to the above criteria. For adults, the protective level of antipneumococcal antibodies has not been determined and a serotype-specific OPA is used.

The Prevenar® 13 vaccine covers up to 90% of all serotypes that cause invasive pneumococcal infections (IPI), including those resistant to antibiotic treatment. Observations in the United States since the introduction of the 7-valent conjugate vaccine Prevenar® suggest that the most severe cases of invasive disease are associated with the serotypes included in Prevenar® 13 (1, 3, 7F and 19A), in particular serotype 3 itself associated with necrotizing pneumonia.

Immune response using three or two doses in a primary vaccination series

After three doses of Prevenar® 13 were administered during the primary vaccination of children under 6 months of age, a significant increase in the level of antibodies to all serotypes of the vaccine was observed.

After the administration of two doses during the primary vaccination of Prevenar® 13 as part of mass immunization of children of the same age group, a significant increase in antibody titers to all components of the vaccine was also observed, but the IgG level of 0.35 μg/ml for serotypes 6B and 23F was determined in a smaller percentage of children. At the same time, the concentration of antibodies after the administration of a booster dose of Prevenar® 13 compared with the concentration of antibodies before the introduction of a booster dose increased for all 13 serotypes. The formation of immune memory is indicated for both of the above vaccination regimens. The secondary immune response to a booster dose in children of the second year of life using three or two doses in the primary vaccination series is comparable for all 13 serotypes. Prevenar® 13 contains seven serotypes and the carrier protein CRM197 common to the Prevenar® vaccine. The comparative identity of both vaccines in terms of immunogenicity and safety profile makes it possible to switch from Prevenar® to Prevenar® 13 at any stage of child vaccination, and the additional 6 serotypes in Prevenar® 13 provide broader protection against IPD.

Indications for use:

Prevention of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (including bacteremia, pneumonia and acute) in children aged 2 months - 5 years.
prevention of pneumococcal diseases (including pneumonia and invasive diseases) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, in adults aged 50 years and older.

Important! Get to know the treatment

Directions for use and dosage:

The vaccine is administered intramuscularly - into the anterolateral surface of the thigh (children under 2 years old) or into the deltoid muscle of the shoulder (persons over 2 years old), in a single dose of 0.5 ml.
Before use, the syringe with the Prevenar® 13 vaccine must be shaken well until a homogeneous suspension is obtained. Do not use if inspection of the contents of the syringe reveals foreign particles, or the contents look different than those described in the “Description” section of these instructions.
Do not administer Prevenar® 13 intravenously, intradermally or intramuscularly into the gluteal region!:

Vaccination schedule:
Age from 2 to 6 months::
A series of three-time primary vaccination: 3 doses of Prevenar® 13 are administered with intervals between doses of at least 1 month. The first dose can be administered to children from the age of 2 months. Revaccination is carried out once at 11-15 months. The scheme is used for individual immunization of children against pneumococcal infection.

A series of two-time primary vaccination: 2 doses of Prevenar® 13 are administered with an interval between doses of at least 2 months. The first dose can be administered to children from the age of 2 months. Revaccination is carried out once at 11-15 months. The scheme is used for mass immunization of children against pneumococcal infection.

For children for whom vaccination was not started in the first 6 months of life, Prevenar® 13 is administered according to the following schemes:
Ages 7 to 11 months: two doses with an interval of at least 1 month between doses. Revaccination is carried out once in the second year of life.
Ages 12 to 23 months: two doses with an interval of at least 2 months between doses.
Ages from 2 to 5 years (inclusive): once If vaccination is started with Prevenar® 13, it is recommended to complete it with the Prevenar® 13 vaccine.

If there is a forced increase in the interval between injections of any of the above vaccination courses, the administration of additional doses of Prevenar® 13 is not required.
Children previously vaccinated with Prevenar®
Vaccination against pneumococcal disease started with the 7-valent Prevenar® vaccine can be continued with Prevenar® 13 at any stage of the immunization regimen.

Persons over 50 years of age
For adults, including patients previously vaccinated with polysaccharide pneumococcal vaccine, Prevenar® 13 is administered once.
The need for revaccination has not been established.

Features of application:

Given the rare cases of anaphylactic reactions, the vaccinated patient should be under medical supervision for at least 30 minutes after vaccination. Immunization sites must be provided with anti-shock therapy.

When deciding to vaccinate a child with severe prematurity (28 weeks of pregnancy), especially one with a history of immaturity of the respiratory system, it is necessary to take into account that the benefits of immunization against pneumococcal infection in this group of patients are especially high and one should neither refuse nor postpone vaccination deadlines. However, due to the potential risk of apnea associated with the use of any vaccines, the first vaccination with Prevenar® 13 is recommended in a hospital setting under medical supervision (at least 48 hours).

As with other intramuscular injections, in patients with thrombocytopenia and/or other coagulation disorders and/or in the case of treatment with anticoagulants, Prevenar® 13 vaccination should be administered with caution, provided that the patient's condition is stabilized and hemostasis is controlled. Subcutaneous administration of Prevenar® 13 to this group of patients is possible.

Prevenar® 13 provides protection only against those serotypes of Streptococcus pneumoniae that it contains and does not protect against other microorganisms that cause invasive disease, pneumonia or otitis media. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody formation.

There is limited evidence that Prevenar® 13's predecessor, the seven-valent Prevenar® vaccine, induces an adequate immune response in children under 6 months of age with sickle cell disease, with a safety profile similar to that of Prevenar® in non-vaccine recipients. high risk groups.

Currently, there is no data on the safety and immunogenicity of the vaccine in patients at high risk for invasive pneumococcal infections (for example, in patients with congenital or acquired splenic dysfunction, HIV infection, malignant tumors, after transplantation of a hematopoietic stem cell strain, nephrotic syndrome). The decision to vaccinate high-risk patients should be made individually.

High-risk children under 2 years of age should receive an age-appropriate primary vaccination with Prevenar® 13. In cases where children aged 2 years and older who are at high risk (for example, with sickle cell disease, asplenia, HIV infection, chronic disease or immunological dysfunction) and have previously received courses of Prevenar® 13 vaccination, 23 -valent pneumococcal polysaccharide vaccine, the interval between vaccine administrations should be at least 8 weeks.

It is advisable to start immunization against pneumococcal infection in adults with Prevenar® 13.

Due to the fact that the development of otitis media can be caused by a variety of pathogens (viruses, bacteria, fungi, mixed infections), and not just pneumococci of the 13 serotypes included in Prevenar®, the estimated preventive effectiveness of Prevenar® 13 against otitis may be less expressed relative to effectiveness for invasive diseases.

Due to the higher risk of developing febrile reactions in children with seizure disorders, including a history of febrile seizures, and those receiving Prevenar® 13 concomitantly with whole-cell pertussis vaccines, prophylactic administration of antipyretics is recommended.

There is no information on the effect of the drug on the ability to drive a car and use equipment.

Side effects:

The safety of the Prevenar® 13 vaccine was studied in healthy children (4429 children/14267 vaccine doses) aged from 6 weeks to 11-16 months. In all studies, Prevenar® 13 was administered concomitantly with other vaccines recommended for a given age.
In addition, the safety of the Prevenar® 13 vaccine was assessed in 354 children aged 7 months and older. up to 5 years of age who have not previously been vaccinated with any of the pneumococcal conjugate vaccines.
The most common adverse reactions were injection site reactions, fever, irritability, decreased appetite, and sleep disturbances.
In older children, during primary vaccination with Prevenar® 13, a higher frequency of local reactions was observed than in children of the first year of life.

People aged 65 years and older had fewer side effects, regardless of previous vaccinations. However, the incidence of reactions was the same as in the younger population.

The undesirable reactions listed below are classified by organs and systems, as well as in accordance with the frequency of their occurrence in all age groups.

The frequency of adverse reactions was determined as follows:
Very common (≥ 1/10), common (≥ 1/100, but< 1/10), нечастые (≥ 1/1000, но < 1/100), редкие (≥ 1/10000, но < 1/1000) и очень редкие (≤ 1/10000).

Adverse reactions identified in clinical studies of Prevenar® 13 in children
General and local reactions:

Very common:	hyperthermia up to 39° C; irritability; skin hyperemia, pain, thickening or swelling measuring 2.5-7.0 cm at the injection site; drowsiness, worsening sleep.
Frequent:	hyperthermia above 39° C; pain at the injection site, leading to short-term limitation of the range of motion of the limb.
Uncommon:	skin hyperemia, thickening or swelling larger than 7.0 cm at the injection site; tearfulness.
Rare:	cases of hypotonic, hypersensitivity reactions at the injection site (urticaria, itching)*; flushes of blood to the face*.

Blood and lymphatic system:

Nervous system:

Gastrointestinal tract:

* - noted during post-marketing observations of the Prevenar® vaccine; can be considered as possible for Prevenar® 13.
Adverse reactions identified in clinical studies of Prevenar® 13 in adults

Gastrointestinal tract:

The immune system:

Skin and subcutaneous tissue:

General and local reactions:

Overall, there were no significant differences in the incidence of side effects between adults previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine and those not vaccinated with this vaccine.

The incidence of local adverse reactions was the same for persons aged 50-59 years and persons over 65 years of age when vaccinated with Prevenar® 13, and the number of local adverse reactions did not increase when vaccinated simultaneously with inactivated influenza vaccine.

The incidence of common vaccine systemic reactions was higher with concomitant administration of Prevenar® 13 and inactivated influenza vaccine compared with the use of inactivated influenza vaccine alone (headache, rash, decreased appetite, joint and muscle pain) or Prevenar® 13 alone (headache, fatigue , chills, loss of appetite and joint pain).

Interaction with other drugs:

There is no data on the interchangeability of Prevenar® and Prevenar® 13 with non-CRM197-based pneumococcal conjugate vaccines.

When vaccinated simultaneously with Prevenar® 13 and other vaccines, injections are made into different parts of the body.

Children aged 2 months to 5 years
Prevenar® 13 is combined with any other vaccines included in the immunization schedule for children in the first years of life. Prevenar® 13 can be administered to children simultaneously (on the same day) with any of the following antigens included in both monovalent and combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated polio, hepatitis B, measles, mumps, rubella and chickenpox - without changing reactogenicity and immunological parameters.

Persons aged 50 years and older
Prevenar® 13 can be administered simultaneously with trivalent inactivated influenza vaccine.
Concomitant use with other vaccines has not been studied.

Contraindications:

Hypersensitivity to previous administration of Prevenar® 13 or Prevenar® (including severe generalized allergic reactions);
- hypersensitivity to diphtheria toxoid and/or excipients;
-acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccination is carried out after recovery or during remission.

PREGNANCY AND BREASTFEEDING
There are no data on the use of Prevenar 13 during pregnancy. It is not known whether Prevenar 13 is excreted in breast milk.

Overdose:

An overdose of Prevenar® 13 is unlikely because the vaccine is dispensed in a syringe containing only one dose.

Storage conditions:

At temperatures from 2 to 8 °C. Do not freeze.
Keep out of the reach of children.

Vacation conditions:

On prescription

Package:

Suspension for intramuscular administration 0.5 ml/dose. 0.5 ml per 1 ml syringe made of transparent, colorless glass (type I).

5 syringes in a plastic package, sealed with plastic film. 2 plastic packages and 10 sterile needles along with instructions for use in a cardboard box.

When packaging NPO Petrovax Pharm LLC, Russian Federation:
1 syringe and 1 sterile needle in a plastic package sealed with plastic film. 1 plastic package together with instructions for use in a cardboard box.

Vaccine against pneumococcal infection

Pneumococcal disease includes a group of severe diseases such as meningitis, bacteremia and pneumonia, as well as milder but more common diseases such as sinusitis and otitis media. The pathogen that causes the infection, Streptococcus pneumoniae, is often present as colonies in the human nasopharynx, from where it is usually spread by airborne droplets. Infants and young children are believed to be the main reservoir of this pathogen, with varying rates of nasopharyngeal carriage ranging from 27% in economically developed countries to 85% in developing countries.

There are more than 90 serotypes of S. pneumoniae. The distribution of serotypes causing the disease varies depending on age, clinical manifestations of the disease, severity, geographic location and time. Before the introduction of pneumococcal conjugate vaccines, serotypes 6–11 were associated with 70% or more of invasive pneumococcal disease (IPI) occurring among children worldwide. IPI is usually defined as a disease associated with the isolation of pneumococcus from normally sterile human blood or that follows the spread of the pathogen through the bloodstream from other parts of the body, such as meningitis or septic arthritis; it does not extend to places such as the middle ear, where the infection spreads directly from the nasopharynx.

Most diseases are sporadic. Outbreaks of pneumococcal infection are uncommon, but can occur in closed communities, for example, in nursing homes, children's day hospitals and other similar institutions.

However, large outbreaks of meningitis caused by serotype 1 have been reported in the African meningitis belt. Of the 8.8 million children under 5 years of age who died in 2008, WHO estimates that 476 000 (333 000 – 529 000) deaths were due to pneumococcal disease. Morbidity and mortality rates are higher in developing than in economically developed countries; most deaths occur in Africa and Asia.

In Europe and the United States, S. pneumoniae causes an estimated 30–50% of community-acquired pneumonia (CAP) requiring hospitalization in adults.

In many countries, routine use of pneumococcal conjugate vaccines has sharply reduced the incidence of IPD, and in some areas IPD caused by vaccine serotypes has virtually disappeared, even among age groups not targeted by the immunization program (herd immunity effect).

S. pneumoniae is a Gram-positive encapsulated diplococcus. The bacterial polysaccharide capsule is an essential virulence factor in more than 90 pneumococcal serotypes, which are defined based on differences in the composition of this capsule. In general, immunity induced by infection is serospecific, but cross-protection among related serotypes may also occur. While a wide variety of serotypes cause noninvasive diseases such as otitis media and sinusitis, serotypes 1, 5, 6A, 6B, 14, 19F, and 23F commonly cause IPD in children under 5 years of age. Serotypes 1, 5 and 14 together across all regions are associated with 28–43% of FDI and with 30% of FDI in 20 of the world's poorest countries; serotypes 23F and 19F are responsible for 9-18% of IPD cases worldwide. Serotype 18C is widespread in regions with a large number of high-income countries (ie Europe, North America and Oceania). Some serotypes, such as 6B, 9V, 14, 19A, 19F and 23F, are likely to be more associated with drug resistance than others.

Laboratory diagnosis of S. pneumoniae, based on virus isolation by culture, can be performed in most clinical microbiology laboratories, although pretreatment with antibiotics, improper sample handling and transportation, or use of inappropriate culture media may result in failure to isolate the organism. Some of the observed geographic variation in seroprevalence may be explained by factors including differences in patient selection, frequency of use and quality of blood culture media, pneumococcal immunization programs, and antibiotic policies.

Pneumococcal infection can affect various body systems, which causes a certain number of disease syndromes. Although transient colonization of the nasopharyngeal mucosa, the primary site of infection, rarely progresses to disease, certain serotypes of pneumococcus can sometimes enter the bloodstream, causing bacteremia and possibly infection of secondary organs such as the brain, causing meningitis. In other cases, direct spread of the pathogen from the nasopharynx can cause diseases such as otitis media or sinusitis. Pneumonia often occurs when pneumococcus is inhaled from the nasopharynx. When the occurrence of pneumonia is associated with bacteremia, the disease is classified as IPD.

Due to the high reliability of microbiological diagnosis, the incidence of IPD is often used as an estimate of the incidence of acute pneumococcal infection in general. On average, about 75% of cases of IPD and 83% of cases of pneumococcal meningitis occur in children under 2 years of age, but these rates vary widely, as does the prevalence of cases in the under 2-year age group. Between 8.7% and 52% of pneumonia cases occur in infants younger than 6 months of age.

The case fatality rate for IPD can be high, ranging from 20% for septicemia to 50% for meningitis in developing countries. Mortality rates are highest among young children. Even in industrialized countries, the overall case fatality rate for pneumococcal bacteremia can reach 15-20% among adults and 30-40% among the elderly, despite appropriate antibiotic therapy and intensive treatment. Among those who recover from meningitis, 58% of cases experience long-term neurological consequences, such as hearing loss, mental and motor impairment and seizures.

Risk factors for pneumonia, including pneumococcal pneumonia in infants and young children, are lack of breastfeeding, nutritional disorders, and indoor air pollution. In addition to the high incidence among children under 2 years of age, the risk of pneumococcal infection is increased among elderly people (over 65 years of age) and among alcohol and tobacco abusers. This risk is also increased among people with chronic diseases such as cardiovascular disease, pulmonary disease, diabetes or asplenia or other conditions that suppress the immune system, as in advanced HIV infection.

The development of resistance to commonly used antibiotics such as penicillin, macrolides, cephalosporins and co-trimoxazole is a serious problem in some areas of the world. However, as a result of the widespread introduction of immunization against pneumococcal infection, a decrease in the circulation of drug-resistant strains has been observed.

A clear diagnosis of pneumococcal infection can be made by isolating the organism from blood or other normally sterile body components such as cerebrospinal fluid, but etiological diagnosis is problematic in cases of pneumococcal pneumonia not accompanied by bacteremia.

Vaccines have been used to prevent pneumococcal disease for more than 30 years. There are currently two different types of pneumococcal vaccines on the market:

(1) 23-valent pneumococcal polysaccharide vaccine (PPV23), which has been available since 1980, and

(2) two pneumococcal conjugate vaccines available on the market since 2009,

Prevenar (instructions for the vaccine)

Recently, among mothers there has been a fashion for vaccines Prevenar. Parents are confident that after this vaccine their children will not be afraid of otitis media, meningitis, etc. Usually no one even tries to read the instructions before vaccination. For those who care about what their child is injected with as part of the vaccine Prevenar We publish instructions. Be sure to read until the side effects of the drug.

The choice must be informed!

suspension for intramuscular injection 0.5ml/dose 1dz

Wyeth Pharmaceutical Division of Wyeth Holdings Corporation (USA)

International nonproprietary name

Available with prescription

Pneumococcal conjugates (polysaccharide + CRM197):

Polysaccharide serotype 6B

Polysaccharide serotype 9V

Polysaccharide serotype 14

Oligosaccharide serotype 18C

Polysaccharide serotype 19F

Polysaccharide serotype 23F

Polysaccharide serotype 9V 2 μg

Polysaccharide serotype 14 2 μg

Polysaccharide serotype 18C 2 μg

Polysaccharide serotype 23F 2 μg

Polysaccharide serotype 4 2 μg

Polysaccharide serotype 6B 4 μg

Polygosaccharide serotype 18C 2 μg

Polysaccharide serotype 19F 2 μg

Polysaccharide serotype 23F 2 μg

The introduction of the vaccine causes the production of antibodies to capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, providing specific protection of the body against the infections they cause. In children of the first year of life, starting from 2 months of age, using various vaccination regimens, the formation of a protective immune response was demonstrated after a series of primary vaccinations and a secondary immune response to the last dose, i.e. during revaccination. After three doses of primary vaccination and subsequent revaccination, a significant increase in antibody levels was observed. In children aged 2 to 5 years, a pronounced formation of antibodies to all serotypes of the vaccine is observed after a single injection, while the immune response practically coincided with that in children of the first two years of life after a series of primary immunizations.

Hypersensitivity due to previous administration of the vaccine, hypersensitivity to excipients and/or diphtheria toxoid; acute infectious and non-infectious diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or in remission).

General and local reactions: reaction at the injection site (redness, hardness/swelling, pain/soreness); hyperthermia from 38°C and above (per rectum measurement), irritability, drowsiness, restless sleep, tearfulness, swelling/hardening of the injection site and redness of more than 2.4 cm, pain at the injection site leading to short-term limitation of the range of motion of the limb, hyperthermia > 39 °C (measurement per rectum), episodes of hypotension-hyporeactivity, hypersensitivity reactions at the injection site (dermatitis, itching, urticaria). Hematopoietic and lymphatic system: regional lymphadenopathy. Immune system: hypersensitivity reactions, including anaphylactic shock, angioedema, Quincke's edema, bronchospasm, dyspnea. Nervous system: seizures, including febrile seizures. Gastrointestinal tract: vomiting, diarrhea, decreased appetite. Skin and subcutaneous tissue: urticaria, erythema multiforme.

The vaccine can be administered to children simultaneously (on the same day) with other vaccines included in the National Schedule of Preventive Vaccinations (except for BCG), as well as with the vaccine against Hemophilus influenzae type b (Hib) and the hexavalent Infanrix vaccine, according to the prescribed immunization schedule. Vaccines must always be administered to different areas of the body. Prevenar is supplied in a ready-to-use syringe, the contents of which should not be transferred to another container or mixed with other medications.

Symptoms: increased side effects. Treatment: symptomatic.

Directions for use and dosage

The vaccine is administered only intramuscularly into the anterolateral surface of the thigh (children under 2 years old) or into the deltoid muscle of the shoulder (children over 2 years old). Do not administer Prevenar intravenously!

The need for any additional dose after each of the above immunization regimens has not been established.

Prevenar is not used in adults. There are no data on the safety of the Prevenar vaccine during pregnancy and lactation. Administration of the vaccine should be delayed if the patient has an acute illness accompanied by moderate or severe hyperthermia.

In case of possible rare cases of anaphylactic reactions, the patient should be under appropriate medical supervision for at least 30 minutes after administration of the vaccine. Due to the potential risk of apnea, consideration should be given to monitoring the patient for 48 to 72 hours during the initial vaccination series in children under 28 weeks of age, especially if there is a history of respiratory immaturity.

Prevenar does not provide protection against Streptococcus pneumoniae serotypes not included in the vaccine or against other organisms that cause invasive disease or otitis media.

During revaccination, a slight decrease in the content of antibodies to Hib was described while maintaining the protective level. An inconsistently decreased response to pertussis antigens as well as to inactivated polio vaccine (IPV) has been described. There is limited data on the co-administration of Prevenar with measles, rubella and mumps vaccine and varicella vaccine.

Prevenar should not be given to children with thrombocytopenia or other bleeding disorders for whom intramuscular injection is contraindicated, unless the potential benefit of the vaccine significantly outweighs the risk posed by the vaccine. The use of the Prevenar vaccine cannot replace standard immunization against diphtheria. The CRM197 carrier protein is a genetically modified, non-toxic form of diphtheria toxin.

HIV infection or other causes, there may be a decrease in antibody production in response to vaccination. There are no data yet on the safety and immunogenicity of the vaccine in children from other high-risk groups for invasive pneumococcal diseases (for example, children with hereditary or acquired splenic dysfunction, HIV infection, malignant neoplasms, nephrotic syndrome). The decision to vaccinate high-risk children should be made individually.

Prophylactic administration of antipyretics is recommended for all children receiving Prevenar together with whole-cell pertussis vaccines due to a higher risk of febrile reactions; as well as children with a history of seizure disorders, including “febrile” seizures.

Store at a temperature of 2 to 8 degrees. C. Do not freeze.

Prevenar (or Prevnar) is one of the most widely used vaccines in the world from Wyatt, which was recently acquired by pharmaceutical giant Pfizer.

The seven-valent conjugate vaccine Prevnar (or Prevenar) is designed to protect against seven strains of pneumococci. It is developed by Wyatt and licensed in the United States and more than 70 other countries. However, this vaccine does not include two serotypes (types 1 and 5) that cause a significant proportion of pneumococcal infections in developing countries.

Wyeth has also completed trials of a nine-valent conjugate vaccine that includes serotypes 1 and 5.

The 7-valent vaccine Prevenar (Prevnar) is also used in Russia. According to the manufacturer, it protects against 7 strains of pneumococcus and is intended for the prevention of diseases caused by Streptococcus pneumoniae, including sepsis, meningitis, pneumonia, bacteremia and acute otitis media in children aged 2 months to 5 years.

But the vaccine Prevnar (Prevenar) is banned in the Netherlands

Dutch authorities have temporarily banned the use of Pfizer's Wyeth vaccine Prevnar, designed to prevent pneumococcal infections, after three children died within 10 days of vaccination.

A representative of the Dutch Institute of Health RIVM said that on average there are from 5 to 10 deaths among children after vaccination with Prevenar. The exact causes of death of the children are still unknown. An investigation is underway.

Pfizer spokeswoman Gwen Fisher says preliminary results from the company's own investigation have found no link between the childhood deaths and vaccinations. The company announced a temporary “quarantine” for the use of this batch of the vaccine (about 110 thousand doses).

Vaccination Prevenar 13 - why is it done, what vaccination schedule for children is provided for in the instructions for use?

Today, vaccination of the population is one of the most powerful ways to prevent many dangerous diseases. In addition to mandatory (scheduled vaccinations), additional ones are sometimes used, usually in case of epidemic indications. Until recently, this included vaccination against pneumococcal infection. Since 2015, it has been included in the national vaccination calendar, but its use is advisory. Today, the most popular vaccine is Prevenar, which is considered the most effective.

Vaccine Prevenar 13 against pneumococcal infection

Composition and release form of the vaccine

The vaccine contains a number of pneumococcal conjugates, 13 to be exact. This is the name given to artificial molecules that combine two particles with different properties, that is, a “non-live” vaccine. One dose of the drug (0.5 ml) contains hybrid molecules - polysaccharides of serotypes 1, 2, 3, 4, 5, 6, 7, 9, 14, 19, 23, oligosaccharide serotype 18 and carrier protein.

The Prevenar vaccine also includes excipients:

aluminum salt of phosphoric acid;

sodium chloride;

succinic acid;

polysorbate;

water.

What does Prevenar protect against?

Many parents do not see the point in vaccinating their child “against pneumonia.” However, this is not the only indication for the drug. What else does Prevenar protect against? This vaccine activates immunity against pneumococcal (Streptococcus pneumoniae) infection.

Pneumococci are bacteria of the streptococcus genus that cause a lot of dangerous diseases. Among them:

pneumonia - inflammation of the lung tissue with damage to the alveoli;

acute otitis media;

purulent meningitis;

endocarditis (damage to the inner lining of the heart);

pleurisy (inflammation of the pleura - the surface layer of the lungs);

arthritis.

In children, pneumococcal infection is usually a complication of some disease. Sometimes pneumococcal pneumonia is diagnosed when a child has suffered from acute respiratory viral infection or influenza. These bacteria often cause exacerbation of chronic bronchitis. Otolaryngologists also note the occurrence of otitis media caused by Streptococcus pneumoniae against the background of rhinitis.

Who is vaccinated?

Vaccination is indicated for several population groups. Let's look at the cases in which Prevenar vaccination is prescribed for children:

• all children over 2 months of age;
• premature babies;
• frequently ill children;
• children with chronic diseases - diabetes, asthma, disorders of the cardiovascular system, HIV-infected.

Adults are not usually vaccinated. This is due to the fact that they have an immune system that inhibits pneumococci as soon as they enter the body. However, among the adult population there are several risk groups for whom vaccination is indicated:

• Elderly persons. In developed countries, people over 65 years of age are required to receive this vaccine.
• Patients with extensive liver damage (cirrhosis), endocrine diseases (diabetes mellitus), kidney disorders, and cardiovascular abnormalities.
• Those who have blood pathologies (sickle anemia).
• HIV-infected.
• Persons who are forced to constantly be in crowded places.

There are few contraindications for this vaccine. These include:

• individual intolerance to one of the components of the drug;
• acute phase of ARVI, influenza;
• childhood infectious diseases (chickenpox, measles, etc.).

Also, you should not vaccinate with Prevenar if the child feels unwell or has a slightly elevated temperature. In addition, they do not vaccinate if the baby has an exacerbation of a chronic disease.

The child is vaccinated in a clinic or, at the request of the parents, in a private medical office. The vaccine is sold in sealed packaging, so it can be purchased at a pharmacy.

According to the instructions, the suspension should be shaken before administration to get rid of possible sediment. Do not use the vaccine if the solution is cloudy or has a color other than white. Let's consider the drug administration regimen, as well as the dosage depending on the age of the children.

Prevenar is administered intramuscularly. Let's look at where exactly the injection is given:

• For children under 2 years of age - in the anterolateral surface of the thigh, since it is in this place that there are fewer nerve endings and adipose tissue that prevent the active absorption of the drug.
• It is not recommended to inject the drug into the gluteal muscle of infants to avoid damage to the sciatic nerve.
• For children over 2 years old, the injection is given into the deltoid muscle of the shoulder.
• The manufacturer warns that the vaccine should not be administered intravenously.

If Prevenar is administered concomitantly with pertussis vaccine, prophylactic use of antipyretics is recommended due to the potential for febrile reactions.

Scheme and timing of child vaccination

The schedule and timing of Prevenar vaccination are based on official recommendations. If the child is no more than six months old, the schedule involves 3-time administration of the vaccine and subsequent revaccination. Babies from six months to a year are vaccinated 2 times. Children over 13 months are vaccinated 1 or 2 times according to a different schedule. The table shows all options for administering the vaccine.

Premature babies, babies up to 28 weeks, as well as those with a history of a diagnosis of “underdevelopment of the respiratory system” should be observed after vaccination for at least 2-3 days. This is associated with the risk of apnea.

How to prepare your baby for vaccination?

No preparation for vaccination is required. Usually, before administering the vaccine, the doctor examines the child and takes the temperature. If no abnormalities are found, the baby is vaccinated.

However, some pediatricians recommend taking a blood test before vaccination to make sure that there are no hidden inflammatory processes in the child's body. Since Prevenar 13 can cause allergies, children with allergies are advised to prepare more thoroughly - start taking antihistamines three days before the procedure and continue to take them for the same amount of time after it.

How does a child tolerate vaccination?

Any vaccination can cause an inadequate reaction from the body. The Prevenar 13 vaccination is no exception. At the same time, pediatricians note that in most cases, vaccination is well tolerated. However, it is worth finding out what the side effects of Prevenar 13 may be, as well as possible complications.

Let's look at the body's normal reaction, why complications can arise, and how to behave if atypical symptoms appear.

Normal reaction and side effects

Prevenar is a modern pneumococcal vaccine that provides the formation of antibodies to all 13 serotypes. During this period (about a week), slight discomfort and pain at the injection site are possible. Such reactions of the body are considered quite normal and occur infrequently. An increase in temperature is observed in 1% of vaccinated people, a local reaction is observed in 5%.

It is worth keeping in mind other possible side effects of the vaccine. How long can it take for them to appear? As a rule, if no problems arise within three days after vaccination, you can breathe easy.

Let's consider the likely side effects, as well as the correct actions of parents:

1. Sleep disturbance, irritability, loss of appetite. If you wait out the difficult period, your child’s appetite and sleep will improve.
2. Temperature rises to 39-40°C. In this case, it is recommended to use antipyretics - Paracetamol or Ibuprofen.
3. Pain at the injection site, complaints of limited movement of the arm or leg. You can lubricate this area with Traumeel, Heparin, Troxevasin. You will have to see a doctor if the problem does not disappear on the third day.
4. Induration at the injection site, tissue swelling exceeding 7 cm in diameter. Pediatricians recommend lubricating this area with drugs to resolve the tumor.
5. Nausea. Absorbing agents shown are Enterosgel, Polysorb, Smecta.

Possible complications

Complications after vaccination are said to occur if you have to consult a doctor to relieve symptoms. Complications can arise for various reasons - a poor-quality vaccine, violation of the rules for administering the drug, or an individual reaction of the body.

Let's look at possible problems:

1. An allergic reaction in the form of skin manifestations - a rash, itchy pink spots all over the body or in some areas. Similar situations arise when there is intolerance to any component of the vaccine.
2. Anaphylactic shock, Quincke's edema, suffocation are also allergic reactions affecting the respiratory system.
3. Inflammation of tissue at the injection site - swelling, compaction, hyperemia.
4. Cramps.
5. Fever, joint aches, headache, weakness. All these symptoms resemble the onset of a viral disease.

After vaccination, it is advisable not to leave the clinic for half an hour. This must be done if there is a possibility of an allergic reaction. Next, it is important to monitor the child’s condition at home and, if necessary, call a doctor.

6. It is better not to take your child to public places for three days after the procedure. This is necessary in order to avoid infection with ARVI, which can complicate the adaptation period and lead to unpredictable consequences. At the same time, the baby is allowed to walk outside.
7. If a baby receives complementary feeding, a new product should not be introduced into his diet a week before and for 7 days after vaccination.
8. If the temperature rises and there is a local reaction (redness, hardening of tissue at the injection site), you can give your baby an antipyretic and an antihistamine.

If necessary, you can select an analogue of the vaccine with an almost identical composition. Among them are the following:

vseprorebenka.ru

Pneumococcal vaccine "Pneumo 23"

Sanofi Pasteur, France

9. Release form: 1 syringe / 1 dose / 0.5 ml.
10. Vaccination schedule: once for children over two years of age and adults.

Revaccination no earlier than after 3 years.

Instructions for use

Registration Certificate Holder:

SANOFI PASTEUR, S.A. (France)

ATX code: J07AL01 (Pneumococcus, purified polysaccharides antigen)

Active substance: pneumococcal polysaccharide vaccine

Ph.Eur. European Pharmacopoeia

solution for intramuscular and subcutaneous administration 0.5 ml/1 dose: syringes 1 dose

reg. No.: P N011092 dated 07/02/10 - Indefinitely

Release form, composition and packaging

Streptococcus pneumoniae polysaccharides (23 serotypes; 25 mcg of each serotype)

1 dose - syringes (1) - plastic contour packages (1) - cardboard packs.

Clinical and pharmacological group: Vaccine for the prevention of diseases caused by Streptococcus pneumoniae

Pharmacotherapeutic group: MIBP vaccine

The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.

pharmachologic effect

Highly purified polyvalent vaccine. It is a purified polysaccharide of Streptococcus pneumoniae of 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F , 23F, 33F. Causes the formation of immunity to the specified serotypes of Streptococcus pneumoniae. Immunity is acquired 10-15 days after a single vaccination and lasts for at least 5 years. After administration of this vaccine, seroconversion occurs in at least 90% of vaccinated individuals.

Prevention of infections of pneumococcal etiology, especially respiratory tract infections, in individuals at risk, starting from 2 years of age.

The vaccine is administered subcutaneously or intramuscularly. Primary vaccination is carried out with one dose of this vaccine once. Revaccinations are carried out every five years. The interval between revaccinations may be shortened in individuals at high risk or in patients receiving immunosuppressants.

Possible weakness, slight increase in body temperature, chills, headache (duration - no more than 24 hours); local reactions - redness, mild pain or hardness at the injection site.

Contraindications for use

Severe reaction to a previous vaccine administration; anti-pneumococcal vaccination or previous pneumococcal infection (caused by one of the serotypes contained in the vaccine) for a period of time up to 5 years before the planned vaccination with this vaccine.

Use during pregnancy and breastfeeding

Despite the fact that there is no information about adverse effects on the fetus when using this vaccine during pregnancy, vaccination of pregnant women at risk is not recommended.

Vaccination is especially indicated for patients with sickle cell disease, as well as for those with asplenia who have had or are undergoing splenectomy.

If revaccination is carried out earlier than scheduled, severe local reactions may occur.

Due to the possibility of developing serious adverse reactions (such as the Arthus phenomenon), contraindications should be strictly observed during vaccination and the benefits of vaccination should be assessed. It should be taken into account that the effectiveness of anti-pneumococcal vaccination was determined only in individuals from risk groups.

Immunosuppressive therapy may reduce or completely suppress the immune response to this vaccine.

In recent years, the world has developed an ambiguous attitude towards vaccinations. Despite the fact that universal vaccination against some diseases has led to their almost complete disappearance, the ranks of opponents of mandatory vaccinations are growing. This is facilitated by widespread misconceptions regarding vaccination.

Unknown infection is the main danger

Intestinal infections, a wave of tick-borne encephalitis and southern infections brought by Russians from vacation - these are the medical results of the summer.

One of the most famous infectious disease specialists in Russia, Academician Viktor Maleev, spoke about our smallest, but no less dangerous enemies.

The national calendar of preventive vaccinations includes far from the most complete list of vaccines existing in the world. When compiling it, a great many factors are taken into account, and not the least important.

Comprehensive response to colds and flu

With the onset of the cold season, the incidence of acute respiratory viral infections (ARVI), influenza and other respiratory tract infections increases annually, reaching epidemic proportions at the peak of cold weather.

SYNFLORIX™Vaccine for the prevention of pneumococcal infection (polysaccharide antigen) and untyped Haemophilus influenzae, conjugated, adsorbed (SYNFLORIX™ pneumococcus purified polysaccharides antigen and Haemophilus influenzae, conjugated)

GlaxoSmithKline Biologicals s.a. J07A L52

susp. d/in. 1 dose vial. monodose 0.5 ml, No. 1

susp. d/in. 1 dose syringe 0.5 ml, with 2 needles, No. 1

susp. d/in. 1 dose syringe 0.5 ml, with needle, No. 1

1 dose (0.5 ml) contains: 1 mcg of pneumococcal polysaccharide of serotypes 1 1.2, 5 1.2, 6B 1.2, 7F 1.2, 9V 1.2, 14 1.2, 23F 1.2 and 3 μg each of pneumococcal polysaccharide of serotypes 4 1.2, 18C 1.3 and 19F 1.4.

1 adsorbed on aluminum phosphate - 0.5 mg Al 3+;

3 conjugated with tetanus toxoid protein ≈ 8 mcg;

No. UA/15363/01/01 from 08/15/2016 to 08/15/2021 According to DC prescription

Date added: 01/17/2018

The 2016 Compendium reference book on this drug provided the following information

1 adsorbed on aluminum phosphate - 0.5 mg Al 3+;

2 conjugated to protein D (derived from an atypical strain Haemophilus influenzae) ≈ 13 μg;

4 conjugated with diphtheria toxoid protein ≈ 5 mcg.

epidemiological data. The 10 pneumococcal serotypes included in this vaccine represent the main pathogenic serotypes in Europe, accounting for approximately 56-90% of invasive pneumococcal infections (IPI) in children aged<5 лет. В этой возрастной группе серотипы 1; 5 и 7F является причиной 3,3-24,1% ИПИ в зависимости от страны и исследуемого периода.

Pneumonia of various etiologies is a leading cause of childhood morbidity and mortality worldwide. Prospective studies have found that Streptococcus pneumoniae in 30-50% it was the probable cause of the development of pneumonia.

Acute otitis media (AOM) is a common childhood disease of various etiologies. Bacteria may be responsible for 60-70% of clinical episodes of AOM. Streptococcus pneumoniae and non-typeable strain Haemophilus influenzae are the most common causes of bacterial AOM worldwide.

Efficacy in clinical studies. In a multicentre, double-blind, cluster-randomized controlled phase III/IV clinical trial in Finland (FinIP), children were randomized into 4 groups, according to two infant vaccination regimens: 2+1 (3rd and 5th month followed by booster at month 11) or 3+1 (months 3, 4 and 5 followed by a booster at month 11) to receive either Synflorix™ (2/3 clusters) or control vaccines against hepatitis (1/3 clusters). In the tour cohorts (pre-vaccination by age), children aged 7-11 months received the first dose of Synflorix™ vaccine or control vaccine against hepatitis B, in accordance with a two-dose regimen, followed by a booster dose, and children aged 12-18 months received the first vaccinations received two doses of Synflorix™ vaccine or control hepatitis A vaccine. The median duration of follow-up from the first vaccination was 24-28 months for invasive disease, diagnosed hospital-acquired pneumonia, and outpatient antimicrobial treatment. During the cluster study, infants were followed up for up to 21 months to assess the effect on nasopharyngeal carriage.

During a multicenter, randomized, double-blind, phase III clinical trial (the Otitis Media and Pneumonia Clinical Study—COMPAS), healthy infants 6 to 16 weeks of age received Synflorix™ vaccine or control hepatitis B vaccine at 2; 4 and 6 months followed by Synflorix™ or control hepatitis A vaccine at 15-18 months of age.

FPI. Cohort of infants aged<7 мес на момент зачисления

Vaccine efficacy (in the FinIP study) or vaccine effectiveness (in the COMPAS study) in preventing culture-confirmed cases of IPD due to vaccine-derived pneumococcal serotypes has been demonstrated (Table 1).

Table 1. Prevention of IPD in infants receiving at least 1 dose of Synflorix™ vaccine (total cohort of vaccinated infants)

EV—vaccine efficacy in a clinical vaccine study (FinIP) or vaccine efficacy in a clinical study (COMPAS); CI—confidence interval.

1 In the FinIP study, other serotypes causing IPD included 7F (1 case each in Synflorix™ 2+1 clusters), 18C, 19F and 23F (1 case each in control clusters). During the COMPAS study, serotypes 5 (2 cases), 18C (4 cases), and 23F (1 case) were also identified in the control group in addition to serotypes 6B and 14. 2 The two infant control clusters were combined. 3p<0,0001. 4 p=0,0009.

5 93.0% (95% CI 74.9-98.9; 2 cases out of 14) regardless of the primary regimen.

Pneumonia. The efficacy of the Synflorix™ vaccine for the prevention of community-acquired pneumonia (CAP) of probable bacterial etiology was demonstrated in the per-protocol cohort of patients (immunized with less than three doses of the primary regimen) (p≤0.002), as the primary objective of the COMPAS trial during a follow-up period of 38 weeks with at study entry: 22.0% (95% CI 7.7-34.2) 240 cases/10,295 subjects in the Synflorix™ group versus 304 cases/10,201 subjects in the control group.

CAP of probable bacterial etiology was defined as radiographically confirmed cases of CAP or alveolar consolidation/pleural effusion on chest radiograph or without alveolar infiltrates, but with a CRP level ≥40 mg/L.

The effectiveness of the vaccine in the prevention of CAP of probable bacterial etiology with the presence of alveolar consolidation or pleural effusion was 25.7% (95% CI 8.4-39.6) and in the prevention of clinically suspected CAP with referral for chest radiography was 6.7 % (95% CI 0.7-12.3).

In the FinIP trial, vaccine effectiveness in reducing hospital-acquired pneumonia was 26.7% (95% CI 4.9-43.5) in the 3+1 regimen for infants and 29.3% (95% CI 7.5-43.5). 46.3) according to the 2+1 scheme for infants. For stage vaccination, vaccine effectiveness was 33.2% (95% CI 3.0-53.4) in the cohort of children aged 7-11 months and 22.4% (95% CI -8.7 to 44.8) in a cohort of children aged 12-18 months.

CCA. The effectiveness of the vaccine in preventing AOM was assessed in the COMPAS study (Table 2).

Table 2. Vaccine efficacy against AOM 1 in the COMPAS study (per protocol 2: 5989 participants)

1 First episode; 2 follow-up period for a maximum of 40 months, starting from the 2nd week after the 3rd dose of the primary vaccination course; 3 are statistically insignificant according to the prespecified criterion (one-sided p=0.032). However, across all vaccinated cohorts, the vaccine effect in the context of clinical episodes of AOM was 19% (95% CI 4.4–31.4).

In another multicenter, randomized, double-blind study (POET) conducted in the Czech Republic and Slovakia, infants received an 11-valent investigational vaccine (11Pn-PD) containing 10 serotypes of Synflorix™ (along with serotype 3, which has demonstrated efficacy), or control vaccine, according to the vaccination schedule in the 3rd, 4th, 5th and 12-15th months. The effectiveness of the vaccine is presented in table. 3.

Table 3. Vaccine efficacy against AOM 1 in the POET study (per protocol 2: 4907 participants)

1 All episodes; 2 follow-up period for a maximum of 24 months, starting from the 2nd week after the 3rd dose of the primary vaccination course.

During the POET study, the effectiveness of the 11Pn-PD vaccine in preventing a first episode of AOM caused by vaccine serotypes was 52.6% (95% CI 35.0-65.5). The specific effectiveness of the serotypes against the first episode of AOM caused by serotypes 6B, 14 19F and 23F has been demonstrated.

Impact on antimicrobial use

In the overall cohort of vaccinated infants in the FinIP study, Synflox™ vaccination reduced amoxicillin outpatient use by 7.9% (95% CI 2.0-13.4) in the 3+1 infant regimen and 7.5% (95% CI 0). ,9-13,6) - according to the 2+1 scheme for infants.

Effect on nasopharyngeal carriage (NPC). The effect of Synflorix™ vaccination on NFN was studied in the FinIP study (5092 participants) and the COMPAS study (1921 participants). In both studies, Synflorix™ vaccine significantly reduced carriage of vaccine serotypes (combined and each of 6B, 19F and 23F) with a trend towards increased carriage of non-vaccine serotypes or serotypes not included in the NFV vaccine after booster vaccination, resulting in reduction of overall pneumococcal carriage.

Post-registration pharmaceutical surveillance. In Brazil, the Synflorix™ vaccine was included in the National Immunization Program (NPI) in March 2010 for use in newborns under a 3+1 scheme with a round-the-clock immunization program for children under 2 years of age. Case/control studies reported a significant reduction in cases of bacteriologically or PCR-confirmed IPD due to any vaccine serotype (83.8%; 95% CI 65.9–92.3) and IPD due to serotype 19A (82. 2%; 95% CI 10.7-96.4).

In Finland, the Synflorix™ vaccine was included in the NPI in September 2010 for use in newborns according to a 2+1 regimen without a round immunization program. The relative reduction in the incidence of IPI in children aged ≤5 years during the first 3 years after the introduction of NPI was assessed. The pre- and post-introduction NPI comparison included significant reductions in the incidence of any bacteriologically confirmed IPD (80%; 95% CI 72–85), IPD from any vaccine serotype (92%; 95% CI 86–95), and IPD due to serotype 19A (62%; 95% CI 20-85).

Immunogenicity data

Immunological potency equal to PCV7. A direct comparative study with PCV7 demonstrated immunological efficacy of the Synflorix™ vaccine that was not inferior to PCV7. established by ELISA for all serotypes except 6B and 23F. For serotypes 6B and 23F, respectively, 65.9 and 81.4% of children vaccinated at age 2; 3 and 4 months, reached the antibody detection threshold for ELISA 1 month after the third dose of Synflorix™ vaccine, compared to 79.0 and 94.1%, respectively, after three doses of PCV7.

Immunogenicity in infants aged 6 weeks-6 months.

. The immunogenicity of the Synflorix™ vaccine was assessed in various clinical studies in Africa, Asia, Europe and America according to different schedules (6-10-14 weeks, 2-3-4, 3-4-5 or 2-4-6 months) . Many clinical studies involved booster vaccination.

Primary vaccination regimen including 2 doses. The clinical study assessed the immunogenicity of Synflorix™ after a 2- or 3-dose primary vaccination regimen. Although there was no significant difference between the two groups in the proportion of subjects meeting the ELISA antibody threshold, a lower proportion of subjects meeting the OPA threshold was observed for some vaccine serotypes, as well as for cross-reactive serotype 19A in subjects receiving 2 - dose primary regimen. In both regimens, a response to booster vaccination was observed, indicating immunological preparation, for each vaccine serotype and serotype 19A.

Immunogenicity in unvaccinated infants and children ≥7 months of age (routine vaccination). During studies in pre-vaccinated children 7-11 months (2+1 schedule) and children aged 12 months to 5 years (2-dose schedule), the level of GMC antibodies determined by ELISA and OPA GMT for all vaccine serotypes and cross-reactive serotype 19A, was identical to or higher than the level induced by the 3-dose primary series in infants.

Immunogenicity in premature infants. The immunogenicity of the Synflorix™ vaccine was assessed in very preterm and preterm infants (gestation period - 27-30 and 31-36 weeks, respectively), as well as in full-term infants (3 primary doses at 2, 4, 6 months with revaccination at 15-18 months) .

After primary vaccination, for each vaccine serotype, the proportion of individuals with ELISA antibody concentrations ≥0.20 μg/ml and OPA titers ≥8 was identical, regardless of term stage.

Active immunization of infants and children aged 6 weeks to 5 years to prevent pneumococcal infection caused by serotypes Streptococcus pneumoniae 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteremia and AOM), as well as infections caused by untyped Haemophilus influenzae.

the vaccine is administered intramuscularly.

Children aged 6 weeks to 6 months

Primary vaccination regimen including 3 doses. The recommended vaccination schedule for optimal protection is 4 doses of 0.5 ml each. The primary regimen for infants consists of 3 doses, with the first dose usually given at 2 months of age, with an interval of at least 1 month between doses. The first dose can be given as early as 6 weeks of age; The 4th dose is recommended no earlier than 6 months after the 3rd dose, preferably at the age of 12-15 months.

Previously unvaccinated children over 6 months of age and children aged:

11. 7-11 months: the vaccination regimen includes 2 doses of 0.5 ml with an interval of at least 1 month between doses; The 3rd dose is recommended in the second year of life at intervals of at least 2 months;
12. 12 months-5 years: The vaccination regimen includes 2 doses of 0.5 ml with an interval of at least 2 months between doses.

Individuals who receive the first dose of Synflorix™ are recommended to complete the full course of immunization with Synflorix™.

hypersensitivity to the active and excipients of the vaccine or any carrier protein.

As with other vaccines, administration of Synflorix™ should be delayed in persons with acute illness accompanied by fever. However, the presence of mild, minor manifestations of infectious diseases, such as colds, is not a reason to postpone vaccination.

Clinical studies involved approximately 22,500 healthy children and 137 premature infants who received approximately 64 thousand doses of Synflorix™ vaccine during primary vaccination. Approximately 19,500 healthy children and 116 premature infants received a booster dose of Synflorix™ vaccine during the 2nd year of life. Safety was also assessed in 435 children aged 2-5 years, of whom 285 received 2 doses of Synflorix™. In all studies, the vaccine was administered simultaneously with other vaccines recommended for children.

In newborns, the most common adverse reactions after primary vaccination were redness at the injection site and irritability (41% and 55%). After the booster dose, the most common adverse reactions were injection site pain and irritability (51% and 53%, respectively). Most of these reactions were mild to moderate and did not last long.

When subsequent doses of the vaccine were administered according to the primary vaccination schedule, no increase in the frequency or severity of adverse reactions was observed.

Reactogenicity was higher in children simultaneously vaccinated with a vaccine for the prevention of whooping cough with a whole cell component.

Reactogenicity was similar in children <12 months of age and >12 months of age, except for pain at the injection site (39% <12 months of age and >58% of children >12 months of age). After vaccination with a booster dose, children over 12 months of age are more likely to experience injection site reactions (rash and abnormal crying) compared to infants with primary vaccination.

Adverse reactions (for all age groups) reported are divided into categories depending on the frequency of occurrence: very common (≥1/10); often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<10 000).

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Vaccination against pneumococcal infection Prevenar

ATTENTION! do not administer intravenously

Instructions for use of the Prevenar vaccine (brief)

The pneumococcal polysaccharide conjugate adsorbed vaccine includes seven active substances, which are pneumococcal polysaccharides obtained from gram-positive bacteria Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F, individually conjugated to the diphtheria carrier protein CRM197, and adsorbed on aluminum phosphate.

Vaccine for the prevention of pneumococcal infections

Administration of the Prevenar vaccine causes the production of antibodies to capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, providing specific protection of the body against the infections they cause.

In children of the first year of life, starting from 2 months of age, using various vaccination regimens, the formation of a protective immune response was demonstrated after a series of primary vaccinations and a secondary immune response to the last dose, i.e. during revaccination. Prevenar induces the formation of functional antibodies to all vaccine serotypes.

In children aged 2 to 5 years, a pronounced formation of antibodies to all vaccine serotypes is observed after a single administration of Prevenar, while the immune response is almost identical to that in children of the first two years of life after a series of primary immunizations.

Prevention of diseases caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia and acute otitis media) in children aged 2 months to 5 years.

Hypersensitivity following previous administration of Prevenar, hypersensitivity to excipients and/or diphtheria toxoid; acute infectious and non-infectious diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or in remission).

Directions for use and doses

The vaccine is administered only intramuscularly into the anterolateral surface of the thigh (children under 2 years old) or into the deltoid muscle of the shoulder (children over 2 years old).

1 dose once

The safety of Prevenar has been studied in healthy children aged 6 weeks to 18 months. In all cases, Prevenar was administered concomitantly with other recommended childhood vaccines. The most common adverse reactions were pain at the injection site and fever (increased temperature).

During revaccination, the most common cases observed were cases of quickly passing pain at the injection site (36.5%), as well as cases of short-term limitation of the range of motion of the limb due to pain at the injection site (18.5%).

In older children who received a single dose of the vaccine, a higher incidence of local reactions was observed than in children under 1.5 years of age, but these reactions were short-lived.

Several cases of overdose of Prevenar, as well as the administration of the subsequent dose earlier than prescribed, have been described. The adverse reactions observed during overdose corresponded to those observed when using the recommended single doses of Prevenar.

Interaction with other drugs and other types of interactions

Prevenar can be administered to children simultaneously (on the same day) with other vaccines included in the National Vaccination Schedule (with the exception of BCG), as well as with the Hemophilus influenzae type b vaccine (Hib) and the hexavalent Infanrix vaccine, according to the prescribed immunization schedule. Vaccines must always be administered to different areas of the body.

0.5 ml of the drug in disposable syringes made of transparent, colorless borosilicate glass.

Transportation and storage conditions

At temperatures from 2 to 8 0C.

Shelf life: 3 years

For detailed information on the use of Prevenar, see the full instructions for medical use.

What does the Prevenar vaccine protect against?

Pneumococcal infection complicates the course of bronchitis, meningitis, otitis media, sinusitis and pneumonia. Reliable prevention is required to avoid serious health consequences. Modern pediatrics is well aware of the Prevenar vaccine: what vaccination saves from is described in detail in the instructions. Doctors perform immunization in a hospital setting, after first examining the child for colds. Find out about all the advantages and disadvantages of the American medicine for the prevention of pneumonia and the French analogue.

Instructions for pneumococcal vaccination Prevenar

Many pediatric specialists have heard about the innovative drug Prevenar; some strongly recommend choosing this preventive vaccination. The description of the medicinal product states that the active component is pneumococcal polysaccharides from gram-positive bacteria. It is necessary to administer a dose of the drug - an artificial infection from it will provoke the production of antibodies. After such interaction, the body of an adult and a child receives protection against pneumococcal infection and its consequences.

The medical calendar indicates when preventive vaccination is required. The actions of doctors are specified in WHO standards - the preventive vaccination calendar. To ensure stable immunity, the medicine must be administered several times at different ages. What is the Prevenar vaccine prescribed for? Among the indications, the prevention of the following diagnoses should be highlighted:

A pneumonia vaccine called Prevenar is given in childhood. Single serving – 0.5 ml. This dose is enough not to cause side effects, but to ensure the stability of the antibodies. If it is necessary to vaccinate a child under 6 months of age, the Prevenar vaccination regimen is offered to choose from:

13. three-time primary vaccination with a temporary break of 1 month;
14. two-time vaccination against pneumonia with a 2-month limitation;
15. The first dose of the medicine can be administered up to 2 months of life, and revaccination is best done up to a year.

This pneumococcal vaccine is a guarantee of health, an opportunity to avoid fatal diagnoses and not put the life of a small child at risk. If Prevenar or Pneumo 23 is not administered to infants, the sequence of actions is as follows:

• primary vaccination in the period of 7-11 months with a time interval of 1 month. Revaccination – at 2 years;
• at 1-2 years of age, carry out double vaccination with a time interval of 2 months;
• administer Prevenar once at the age of 2-5 years.

Who is the manufacturer of Prevenar 13

The pneumococcal vaccine is highly effective, but is not a development of domestic pharmacology. The drug is serially produced by the American manufacturer Pfizer (USA). The drug is expensive and not available to all families with small children. A worthy alternative was the Pneumo 23 graft, a budget option made in France.