"PREVENAR" - vaccination against pneumococcal infection
Pneumococcal polysaccharide vaccine, conjugated, adsorbed, thirteen-valent
Manufacturer: Wyatt Holdings Corporation, USA.
Protects against diseases: neumococcal infection.
Used: in children under 2 years of age. Revaccination at 4, 6 and 12-15 months
Included in the national vaccination calendar.
Advantages of the Prevenar vaccine
Prevnar (Prevnar 13, PCV13, Pneumococcal, pneumococcal conjugate) is a high-quality vaccine produced in the USA by Wyeth Pharmaceuticals Inc. and registered in Russia, which helps protect a child from 13 strains of pneumococcal infection (Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F), causing diseases such as pneumonia, bronchitis, meningitis and sepsis.
- Invasive pneumococcal infection can cause brain damage or even death. Prevenar 13 may help protect children. Vaccination today is a safe and economically feasible method of preventing the development of infections. The vaccine is also approved for children 6 weeks to 5 years of age to prevent otitis media (an ear infection) caused by 7 of the 13 strains. The vaccine also stimulates the immunity of the mucous membranes, which leads to a decrease in nasopharyngeal bacterial carriage.
- Vaccination can be given to infants starting at 2 months of age (as directed by a doctor from 6 weeks) with booster vaccinations at 4, 6 and 12-15 months to create effective immune protection against the most common types of pneumococcal bacteria.
- Prevenar is not 100% effective and will only protect against the 13 strains included in the vaccine. It helps the body develop natural defenses, promoting the development of immunity to diseases. Like some other vaccines, it is given in 4 doses.
- Infants should receive all 4 doses to help the infant's developing immune system develop effective, specific defenses against pneumococci.
- Each subsequent vaccination is prescribed 4-8 weeks after the previous one, and the 4th dose cannot be prescribed earlier than 2 months after the 3rd vaccination. Children with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response to vaccination.
Prevenar 13
The vaccine consists of capsular polysaccharides of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F individually conjugated to the diphtheria protein CRM197 and adsorbed on aluminum phosphate.
Administration of the vaccine causes the production of antibodies to capsular polysaccharides of 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 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 titer ≥ 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 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 of the vaccine were administered during the primary vaccination of children under 6 months of age, a significant increase in the level of antibodies to all vaccine serotypes was observed.
After the administration of two doses during primary vaccination with the drug 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 babies (born at gestational age
Immunogenicity in children and adolescents aged 5 to 17 years
Children aged 5 to 10 years who had previously received at least one dose of pneumococcal 7-valent conjugate vaccine, as well as previously unvaccinated children and adolescents aged 10 to 17 years who received one dose of 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 the vaccine to children aged 5-17 years can provide the necessary immune response to all serotypes of the pathogen included in its composition.
Immunogenicity of the vaccine in adults
In adults aged 60-64 years who have not previously received the polysaccharide pneumococcal 23-valent vaccine (PPV23), after administration of the Prevenar 13 or PPV23 vaccines, and in adults aged 50-59 years who received one dose of the drug vaccine, immunological equivalence for 12 serotypes common to PPV23. In addition, for 8 serotypes common to PPV23 and for serotype 6A, a drug unique to the vaccine, a statistically significantly higher immune response to the drug was demonstrated.
The immune response to the vaccine in people aged 50–59 years for all 13 serotypes was equivalent to that of 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.
Immune response of adults previously vaccinated with PPV23
In adults aged 70 years and older vaccinated with a single dose of PPV23 ≥ 5 years ago, the drug was noninferior to the response to PPV23 for 12 common serotypes, with a statistically significant response to the drug for 10 common serotypes and serotype 6A. higher compared to the response to PPV23. The drug has been shown to produce a more pronounced immune response compared to booster vaccination with PPV23.
Immune response in special patient groups
Patients with the conditions described below are at increased risk of pneumococcal infection. The clinical significance of the immune response induced by the drug in patients of these groups is currently unknown.
Sickle cell anemia: in an open-label, non-comparative study, it was shown that administration of the first dose of the vaccine with two immunizations with an interval of 6 months led to a statistically significantly high immune response (GK IgG for each serotype, determined by enzyme-linked immunosorbent assay (ELISA), and GST opsonophagocytic activity (OPA). SHT) for 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 CD4 count ≥ 200 cells/μl (average 717.0 cells/μl), viral load
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 with satisfactory partial remission in the case of lymphoma and myeloma received three doses of the drug at intervals of less than 1 month between doses. The first dose of the drug was administered 3-6 months after HSCT. The fourth (booster) dose 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 the vaccine was significantly higher for all serotypes compared to the response to the primary series of immunization.
Compatibility with other vaccines
"Prevenar" is combined with any other vaccines included in the immunization schedule for children in the first years of life. "Prevenar" can be administered to children simultaneously (on the same day) with any of the following antigens included in both monovalent and combined 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.
When simultaneous vaccination with Prevenar and other vaccines, injections are made in different parts of the body.
Contraindications
Only a doctor can decide whether Prevenar is suitable for a child to be vaccinated
Prevenar vaccination is contraindicated if there is a history of an allergic reaction to any component of the vaccine, as well as in the following cases:
- Hypersensitivity reactions to previous administration of Prevenar drugs (including anaphylactic shock, severe generalized allergic reactions);
- Hypersensitivity to diphtheria toxoid and/or excipients;
- Acute infectious or non-infectious diseases, exacerbation of chronic diseases (vaccination is carried out after recovery or during remission).
- If an acute or exacerbation of a chronic disease occurs, the child receives a deferment until complete recovery or a period of remission. The pediatrician determines the required duration of delay from vaccinations, guided primarily by the risk of complications. In most cases, the delay is about 1 month. In case of meningococcal meningitis and other severe diseases of the nervous system, vaccinations are postponed for a longer period - up to six months from the onset of the disease.
- The main contraindications to vaccination, which provide grounds for medical withdrawal from vaccinations, are strong reactions and post-vaccination complications after the administration of the previous dose of the vaccine. A strong reaction is understood as an increase in body temperature above 40 °C with the occurrence of swelling and redness at the site of vaccine administration over 8 cm in diameter, severe allergic reactions, anaphylactic shock, the development of infectious diseases and damage to individual body systems.
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.
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 over the past 10 years. The vaccine is registered in 88 countries and is included in the national vaccination calendars of 30 countries.
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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.
