Prevenar 13: vaccine against pneumococcal disease

Prevenar vaccine

recommended for the prevention of pneumonia in children and adults.
Clinical trials of Prevenar 13 demonstrate a pronounced immune response against all serotypes of pneumococcus that are included in the drug. To date, more than 90 different serotypes of the pneumonia virus have been laboratory identified, but in humans the disease is provoked by only a small percentage of all currently existing serotypes. That is why the Prevenar 13
is used almost all over the world, and allows for the prevention of severe disease in children and adults.

Pneumonia often affects the lungs of adults, and in people over 50 years of age, the risk of complications from infectious diseases increases significantly. vaccine for what?

It contributes to a significant reduction in morbidity rates.

Features of the vaccine

Description of the drug

The Prevenar vaccine is a drug for the prevention of pneumococcal infection in children starting from 2 months and adults.

Pneumococcal infection is one of the leading causes of child mortality; 800 thousand children under 2 years of age die each year worldwide due to pneumococcal infection. Pneumococcal infection causes a number of dangerous diseases, such as meningitis, pneumonia, bronchitis, otitis media, septicemia, sinusitis, and endocarditis. Often pneumococcal infection occurs in the form of a “regular” ARVI, which complicates diagnosis and increases the risk of developing life-threatening conditions. Vaccination against pneumococcal infection is aimed at preventing the disease, as well as reducing complications from pneumococcal infection and deaths. Indications for use

Prevention of diseases caused by Streptococus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F), including sepsis, meningitis, pneumonia, bacteremia and otitis.

The vaccine is intended for use from 2 months of age.

Indications for vaccination

Prevenar vaccination

is a specially developed vaccine that promotes the formation of immunity resistant to the activity of pneumococcal infections. Thanks to this, it is possible to reduce the incidence of the disease and reduce the possibility of complications due to respiratory viruses, influenza, and rhinitis, especially in patients with chronic pathologies. Thus, indications for vaccination include:

Reduced immunity.
Patients with diabetes mellitus, diseases of the cardiovascular system, and respiratory organs.
Smoking.
Children born prematurely.
Labor activity that is carried out in crowded places or organizations with a large number of workers.
People traveling abroad to countries where mandatory immunization is required, including against pneumonia.

Experts recommend buying Prevenar

and do it in cases where a cold often turns into a bacterial infection. Vaccination is indicated for frequent acute respiratory viral infections with complications that recur more than 5 times a year.

Vaccination scheme

Children aged 2-6 months: individual immunization: 3 doses with an interval of at least 4 weeks between doses. The first dose can be administered from 2 months. Revaccination is carried out once at the age of 11-15 months. Mass immunization of children: 2 doses with an interval of at least 8 weeks between administrations. Revaccination is carried out once at the age of 11-15 months.
Children aged 7-11 months: 2 doses of the drug with an interval of 1 month or more. Revaccination is carried out at the age of over 1 year.
Children aged 12-23 months: 2 doses of the drug with an interval of at least 2 months. Revaccination is not carried out.
Children over 2 years old: 1 dose of the drug. Revaccination is not carried out.

Vaccination procedure

Immunization with Prevenar 13 is carried out twice in childhood, according to current recommendations enshrined in the vaccination calendar. Thus, two doses of 0.5 ml are administered alternately one after another at intervals of 1 month.

Children over 5 years old are vaccinated once in a dose of 0.5 ml.

Children over 12 years of age and adults are also vaccinated once every 2 years. Patients suffering from chronic diseases need to be vaccinated more often - every 1.5 years.

How is vaccination carried out?

Vaccination is carried out in a vaccination room, in compliance with all sanitary requirements. All drugs are certified. A certificate for the drug is provided upon request.

Without reminders, before vaccination, the medical worker must show the drug and the expiration date of the vaccine.

Only sterile and disposable instruments are used. The vaccination must be carried out using disposable medical gloves.

On the day of vaccination, the child is examined by a pediatrician and the temperature is measured. In the absence of contraindications, vaccination is carried out. Information about the vaccination performed is entered into the card, vaccination certificate, and detailed recommendations for caring for the child in the post-vaccination period are given.

Before vaccination, the doctor will answer all your questions. Be sure to bring information about previous vaccinations to your appointment!

Please note that vaccination of a child, Mantoux test, Diaskintest can only be carried out in the presence of parents or legal representatives of the child (guardians), or if the accompanying person has a NOTARIZED power of attorney to carry out the manipulation (indicating the drug planned for administration) . Otherwise, vaccination will be denied. We comply with the laws of the Russian Federation.

Only here!

Contraindications

The range of contraindications includes the presence of individual intolerance to the components contained in the vaccine. It is also not recommended to perform immunization in the following cases:

Exacerbation of diseases present in the patient's medical history.
Presence of infectious processes or ARVI at the time of vaccination.
The patient has hyperthermia.
Against the background of pregnancy.
Against the background of breastfeeding.
Ailments of various kinds.

Immunization with the Prevenar 13 vaccine should be carried out only if the patient feels well and has fully recovered from respiratory diseases, and in case of chronic diseases during periods of their subsidence.

Possible reactions due to vaccination

In most cases, the Prevenar 13 vaccine is well tolerated, including in young patients and those at risk. You can buy Prevenar in Moscow, followed by an injection for the purpose of immunization. However, in some situations, negative reactions such as pain at the injection site, low-grade fever, malaise, and weakness are observed. In most cases, all these symptoms disappear on their own within a few days without the use of special medications. In extremely rare cases, anaphylactic shock is possible, so at the time of immunization a doctor must be present who can provide first aid with all the necessary equipment.

Possible side effects

In children 6 weeks to 17 years of age, the most common side effects are irritation, redness or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever.

Serious but very rare side effects in infants and toddlers include pneumonia, bronchiolitis and gastroenteritis (inflammation of the stomach and small intestine) (0.9% of all vaccine recipients). A temporary pause in breathing after vaccination occurs in some babies born prematurely.

The high safety of vaccination has been confirmed by 230 million years of experience in administering Prevenar 13 over the past 10 years. The vaccine is registered in 88 countries and is included in the national vaccination calendars of 30 countries.

Do I need to be vaccinated against hemophilus influenzae and with what?

There is still the issue of HIB, Haemophilus influenza, which until recently was considered necessary only for babies at increased risk of the disease. Unfortunately, this is no longer the case. In the current situation, for a child whose parents follow the National Calendar, immunization with Pentaxim or Infanrix Hex is optimal. This allows you to simultaneously protect him from several diseases and at the same time get rid of it with only one injection. According to the National Calendar, the first dose is administered at the age of 3 months, subsequent doses at 4.5 months and 6 months. Another injection, which consolidates the effect, is given at 18 months (one and a half years).

If a young patient has previously been given DPT or ADS-M for tetanus and diphtheria, you should consult your pediatrician. The fact is that, unlike the imported Infanrix Hex and Pentaxim, they do not contain antigens that protect against HIB. Perhaps it would be optimal to include Hiberix or another analogue of it in an individual schedule, which fights directly against Haemophilus influenzae.

Adult patients are recommended to be vaccinated against HIB if they have a pathology accompanied by a severe decrease in the body's natural defenses: for example, they have had their spleen removed, they need to undergo chemotherapy, or they have HIV.
One way or another, your attending physician can give you a recommendation based on the benefits of immunization for you. MAKE AN APPOINTMENT PRICES

What causes pneumonia and can you get vaccinated against it?

In children, the causative agents of the bacterial form of this disease are:

Streptococcus pneumoniae is the most common cause of pneumonia. It causes 20-60% of all cases in children under 18 years of age, with the highest proportion occurring between 6 months and 7 years of age. In adults, S. pneumonae is responsible for 35-40% of cases. It has 91 varieties, but only 23 of them are responsible for 90% of human infections. Despite its name, S. pneumoniae causes more than just pneumonia: along with the meningococcus Neisseria meningitidis, it is one of the main causes of bacterial meningitis, which is sometimes transient and extremely life-threatening.
Vaccines – Prevenar 13, Pneumovax 23.
Mycoplasma pneumoniae, Mycoplasma pneumoniae, is a very small bacterium that causes 5-50% of cases of illness in children, depending on age. Mycoplasma pneumonias are atypical and community-acquired (as a rule, they develop outside the walls of a medical institution, since their diagnosis is very difficult).
There is no vaccine for it.
Chlamydia pneumoniae, Chlamydia pneumoniae, is an intracellular parasite that causes 5-15% of cases (as in the previous paragraph - atypical) in children, depending on age. Chlamydia trachomatis is responsible for another 3-10%.
There is no vaccine for chlamydia, but research is currently underway to make one possible in the future.
Haemophilus influenzae, Haemophilus influenzae, causes 3-10% of pneumonia in children.
May also cause meningitis and epiglottitis. In total, Haemophilus influenzae has 6 serotypes, of which type b is dangerous for humans.
Vaccines - Hiberix, Act-HIB, Pentaxim (combined, also includes antigens of whooping cough, diphtheria, tetanus and polio), Infanrix Hexa (combined, includes everything that Pentaxim does, + hepatitis B).

The remainder of the statistics accounts for infection with enterobacteriaceae, Staphylococcus aureus, group A streptococcus Streptococcus pyogenes, chlamydia Chlamydia psitacci (the causative agent of psittacosis) and Coxiella burnetti (the causative agent of Q fever). These are quite rare and specific variants in which, for example, rodents, birds and cattle act as carriers of the infection.

The statistics for adult patients are somewhat different from those for children. The risk group primarily includes older people: for example, Legionella pneumophila appears among the pathogens. 75-80% of recorded cases of infection occur in people over 50 years of age. However, the championship is still held by Streptococcus pneumoniae, responsible for 30-50% of pneumonia in adults.

Thus, it is possible to protect yourself from severe complications if you get vaccinated against Streptococcus pneumonia and Haemophilus influenza type b - this way you can prevent up to 70% of the chance of infection.

Compatibility with other vaccines

The Prevenar vaccine is combined with all types of vaccinations, so it can be performed simultaneously with them. The exception is the BCG vaccine, which is incompatible with Prevenar 13.

Simultaneous immunization with several vaccinations implies compliance with the basic rules: injections are performed in different parts of the body, and in no case should they be mixed into one syringe.

Prevenar 13 is a high-quality vaccination that provides prevention of serious illness with the ability to prevent complications in people with chronic diseases. The relevance of the vaccine is obvious for use in children and adults, especially those who often suffer from colds and viral diseases.

Why is the Prevenar vaccine needed?

This vaccine is used to prevent most diseases caused by pneumococcus. This bacterium can infect the lungs, blood, brain and other human organs, causing serious complications and causing death. The microorganism is dangerous not only for children, but also for adults.

Most often, a collision with pneumococcus ends in bacterial pneumonia or meningitis. Children and adults with weakened immune systems who have had inflammation of the brain often remain disabled for life. The Prevenar vaccine reduces the risk of infection and complications by 93%. The protective properties of the drug last for 5 years.

VACCINE PREVENAR (PNEUMOCOCCAL POLYSACCHARIDE CONJUGATED ADSORBED)

Pharmacodynamics

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 pneumococcal vaccines, the equivalence of the immune response of Prevenar® 13 was determined by three criteria: the percentage of patients who achieved a concentration of specific IgG antibodies ≥ 0.35 μg/ml; geometric mean concentrations (GMC) of immunoglobulins and opsonophagocytic activity (OPA) of bactericidal antibodies (GMA tiger ≥ 1:8 and geometric mean titers (GMT)). For adults, the protective level of antipneumococcal antibodies has not been determined and a serotype-specific SPA (SST) is used.

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

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

After three doses

With Prevenar® 13, during 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 two doses

During primary vaccination with 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; for serotypes 6B and 23F, IgG levels ≥ 0.35 μg/ml were 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. 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.

When vaccinating premature infants (born at a gestational age of <37 weeks), including extremely preterm infants (born at a gestational age of <28 weeks), starting at the age of two months, it was noted that the level of protective specific anti-pneumococcal antibodies and their TFA after the completed course of vaccination reached values above protective in 87-100% of those vaccinated to all thirteen serotypes included in the vaccine.

Immunogenicity in children and adolescents aged 5 to 17 years

Children aged 5 to <10 years who have previously received at least one dose of pneumococcal 7-valent conjugate vaccine, and previously unvaccinated children and adolescents aged 10 to 17 years who have received one dose of Prevenar® 13 vaccine, demonstrated an immune response to all 13 serotypes, equivalent to that in children 12-15 months vaccinated with four doses of Prevenar® 13.

A single administration of Prevenar® 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

Invasive pneumococcal disease (IPI)

After the introduction of Prevenar® in a 2+1 regimen (two doses in the first year of life and revaccination once in the second year of life), after four years 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, a further decrease in the frequency of IPI was noted. caused by vaccine-specific additional serotypes, ranging from 76% in children aged <2 years 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% (serotype 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 inclusion of Prevenar® 13 in national immunization programs, 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 followed by a transition to 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 detected, as well as by 89% reduction in the frequency of OM caused by serotypes 1,3, 5, 7F and 19A.

Pneumonia

When switching from Prevenar® to Prevenar® 13, a 16% reduction in the incidence of all cases of community-acquired pneumonia (CAP) in children aged 1 month to 15 years was noted. Cases of VVP with pleural effusion decreased by 53% (p < 0.001), pneumococcal VVP decreased by 63% (p < 0.001). In the second year after the introduction of Prevenar® 13, there was a 74% reduction in the incidence of VAP caused by 6 additional serotypes of Prevenar® 13. In children under 5 years of age, after the introduction of Prevenar® 13 vaccination according to the 2+1 schedule, a 68% (95% CI: 73) was observed ; 61) reduction in the number of outpatient visits and 32% (95% CI: 39; 22) reduction in the number of hospitalizations for alveolar VVP of any etiology.

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 regimen. Prevenar® unvaccinated 13 individuals 65 years of age and older demonstrated a 25% reduction in IPI, with an 89% reduction in IPI caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and a 64% reduction in IPI caused by 6 additional serotypes (1, 3, 5, 6A, 7A, 19A). The incidence 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 one 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 Prevenar® 13 was demonstrated. In adults aged 18-59 years, opsonophagocytic activity FHT (OPA FHT) to all Prevenar® 13 serotypes were not 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 administration demonstrated immunological equivalence for 12 common serotypes compared with the response to PPV23, with an immune response to Prevenar® 13 for 10 common serotypes and serotype 6A. 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 years with sickle cell disease previously vaccinated with one or more doses of PPV23 at least 6 months before study entry, the first dose of Prevenar® 13 double immunization with an interval of 6 months led to a statistically significantly high immune response (IgG SGC to each serotype, determined by enzyme-linked immunosorbent assay (ELISA), and SHT OFA to each serotype). After the second dose, the immune response was comparable to those after the first dose of the drug.

HIV infection

HIV-infected children and adults with a CD4 count ≥ 200 cells/μl (mean 717.0 cells/μl), viral load < 50,000 copies/ml (mean 2090.0 copies/ml), and no active AIDS-associated diseases and who had not previously received vaccination with the pneumococcal vaccine, received 3 doses of Prevenar® 13. Indicators of IgG SGC and OFA were significantly higher after the first vaccination with Prevenar® 13 compared to the pre-vaccination level. At the second and third doses (6 and 12 months later), a higher immune response developed than after a single vaccination with Prevenar® 13.

Hematopoietic stem cell transplantation

Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT), aged ≥ 2 years with complete hematological remission of the underlying disease or with satisfactory partial remission in the case of lymphoma and myeloma, received three doses of Prevenar® 13 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 Prevenar® 13 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.