Compound
| Suspension for intramuscular administration | 1 dose (0.5 ml) |
| active substances: | |
| pneumococcal conjugates (polysaccharide - CRM197): | |
| 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 CRM197 | »32 mcg |
| 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 |
Pharmacological (immunobiological) 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 pneumococcal vaccines, the equivalence of the immune response of the Prevenar® 13 vaccine was determined according to 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 (GPA titer ≥1:8 and geometric mean titers (GMT). For adults, the protective level of anti-pneumococcal antibodies has not been determined and a serotype-specific GMT is used.
The Prevenar® 13 vaccine includes up to 90% of the serotypes that cause invasive pneumococcal infections (IPI), incl. resistant to antibiotic treatment.
Review by E. Komarovsky: when to get the pneumococcal vaccine?
Should children be vaccinated against pneumococcal infection? Every disease and inflammation in a child is stressful for a growing organism, as is the administration of a vaccine. Dr. Komarovsky claims that pneumococcus causes the most dangerous diseases and complications in the body. These include pneumonia, accompanied by severe symptoms, and otitis media, sinusitis, which bother children with high regularity. Opponents of vaccines argue that pneumococcal infection can be cured without vaccinations, using only antibiotics. But we should not forget that the cases of severe infections caused by pneumococcus, which are difficult to treat, have increased sharply.
Komarovsky notes that these diseases are serious and only laymen can deny the usefulness of early vaccination against pneumococcus. However, most ARVIs are caused by viruses and pneumococcus has nothing to do with this. Therefore, the pneumococcal vaccine will not help in this situation.
Side effects
The safety of the Prevenar® 13 vaccine was studied in healthy children (4429 children/14267 vaccine doses) from 6 weeks to 11–16 months and 100 children born prematurely (<37 weeks of gestation). 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 - 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 the Prevenar® 13 vaccine, a higher frequency of local reactions was observed than in children of the first year of life.
When 13 premature infants (born at a gestational age of ≤37 weeks) were vaccinated with the Prevenar® vaccine, including extremely 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.
People 18 years of age 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 50 years of age 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 these 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 2–17 years of age, with the exception of headache, vomiting, diarrhea, fever, fatigue, arthralgia, and myalgia , which were very common in such patients.
The adverse reactions listed below are classified according to the frequency of their occurrence in all age groups as follows: very often (≥1/10); often (≥1/100, but <1/10); uncommon (≥1/1000, but <1/100); rare (≥1/10000, but <1/1000) and very rare (<1/10000).
Adverse reactions identified in clinical studies of the Prevenar® 13 vaccine
Very often - hyperthermia; irritability; skin redness, pain, thickening or swelling measuring 2.5–7.0 cm at the injection site (after revaccination and/or in children 2–5 years old); vomiting (in patients 18–49 years old), drowsiness, worsening sleep, worsening appetite, headache, generalized new or worsening 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 2.5–7.0 cm at the site of vaccine administration (after a series of primary vaccinations in children under 6 months of age), vomiting, diarrhea, rash.
Uncommon: skin redness, thickening or swelling greater than 7.0 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**.
*Observed only in clinical studies of the Prevenar® vaccine, but also possible for the Prevenar® 13 vaccine.
**Noted during post-marketing surveillance 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 5–17 years of age. 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.
Reviews about Pneumo 23
There are often opinions on the Internet about how effective the Pneumo 23 vaccination is. There are various reviews. Many parents write that after vaccination, the child began to suffer from infectious diseases much less. After vaccination, the diseases disappear quickly, without significant complications. It is important to vaccinate correctly and follow all doctor's advice.
Side effects are rarely mentioned in reviews; local manifestations are mainly noted, which quickly disappear. When discussing how effective the Pneumo 23 vaccine is, reviews from doctors are mostly positive.
The famous pediatrician Komarovsky, as well as other doctors, recommend vaccination to prevent the development of diseases.
Interaction
There are no data on the interchangeability of Prevenar® 13 with other pneumococcal conjugate vaccines. When immunized simultaneously with Prevenar® 13 and other vaccines, injections are made into different parts of the body.
Children 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 combination 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 and Infanrix-hexa vaccines were used together, the frequency of febrile reactions coincided with that for the combined use of the Prevenar® (PCV7) and Infanrix-hexa vaccines. An increased incidence of reported seizures (with and without fever) and hypotensive-hyporesponsive episodes 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.
Prevenar® 13 can be used together with meningococcal polysaccharide vaccine serotypes A, C, W and Y, conjugated to tetanus toxoid, in children aged 12–23 months. 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 (paracetamol) may reduce the immune response to the primary vaccination series with Prevenar® 13 vaccine. Immune response to booster vaccination with Prevenar® 13 vaccine in 12 months with prophylactic use of paracetamol does not change. The clinical significance of these data is unknown.
Children and adolescents 6–17 years old
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 18–49 years old
There are no data on the simultaneous use of Prevenar 13 with other vaccines.
Persons 50 years and older
Prevenar® 13 can be used in conjunction with trivalent or quadrivalent inactivated seasonal influenza vaccine (DVT or IV). 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 the Prevenar® 13 vaccine 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.
Contraindications
Only a doctor can decide whether PNEUMOVAX 23 is suitable for vaccination
Pneumovax 23 is contraindicated if there is a history of an allergic reaction to any component of the vaccine.
Vaccination with Pneumovax 23 is contraindicated in the following cases:
- Hypersensitivity to any component of the vaccine, including neomycin; symptoms of hypersensitivity to previous vaccine administration.
- Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations, except in cases where, in the opinion of a doctor, delaying vaccination entails an even greater risk.
- Vaccination during chemotherapy or radiation therapy should be avoided.
Directions for use and doses
Method of administration
Intramuscularly. The vaccine is administered in a single dose of 0.5 ml. For children of the first years of life, vaccinations are carried out in the upper-outer surface of the middle third of the thigh, for persons over 2 years of age - in 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 “Description of the dosage form” section.
Do not administer the Prevenar® 13 vaccine intravascularly or intramuscularly into the gluteal region!
If vaccination with the Prevenar® 13 vaccine has begun, 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 at which vaccination began | Vaccination scheme | Intervals and dosage |
| 2–6 months | 3+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 |
| or 2+1 | 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 every 11–15 months |
| 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® vaccine. Vaccination against pneumococcal disease started with the 7-valent Prevenar® vaccine can be continued with the Prevenar® 13 vaccine at any stage of the immunization regimen.
Persons 18 years of age and older. The Prevenar® 13 vaccine 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
In patients after hematopoietic stem cell transplantation, a series of immunizations consisting of 4 doses of Prevenar® 13 vaccine, 0.5 ml each, is recommended.
The first series of immunization consists of three doses of the drug: the first dose is administered from the third to the sixth 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 are recommended to be vaccinated 4 times. 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.
Elderly patients. The immunogenicity and safety of Prevenar® 13 have been confirmed in elderly patients.
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.
The Prevenar® 13 vaccine 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.
The drug should be transported at a temperature of 2–25 °C. Do not freeze.
Transportation at temperatures above 2–8 °C is allowed for no more than 5 days.
Analogs
Level 4 ATX code matches:
Prevenar
Analogues of this vaccine are the drugs Prevenar , Prevenar 13 .
Only a doctor can choose the most optimal remedy after an individual consultation.
Prevenar 13 or Pneumo 23 - which vaccine is better?
The Prevenar 13 vaccine contains fewer serotypes than Pneumo 23. But reviews often contain information that when using Prevenar, local side effects occur more often.
At the same time, Prevenar 13, unlike Pneumo 23, can be administered to children up to two years of age. The attending pediatrician will tell you which vaccine is best to use to immunize a child.
The advisability of using these vaccines is described in more detail by specialists, for example, Dr. Komarovsky.
Release form
Suspension for intramuscular administration, 0.5 ml/dose. 0.5 ml per 1 ml syringe made of transparent, colorless glass (type I).
1 syringe and 1 sterile needle in a plastic package sealed with plastic film. 1 plastic package together with instructions for use is placed in a cardboard box with or without first opening control. 5 syringes are placed in a plastic package sealed with plastic film. 2 plastic packages and 10 sterile needles along with instructions for use are placed in a cardboard box with or without tampering.
