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 |
Vaccine effectiveness
In international practice, since 2000, vaccination has been used for immunoprophylaxis of pneumococcal infection in newborns and young children. According to WHO, world experience has shown that mass vaccination reduces the incidence of pneumococcal meningitis and severe pneumonia in children by more than 80% and the incidence of all pneumonia and otitis media by more than a third. The carriage of pneumococci in children is decreasing, and accordingly, both unvaccinated children and adults get sick less.
The World Health Organization projects that global use of pneumococcal vaccinations will prevent 5.4-7.7 million child deaths by 2030. The Prevenar13 vaccine protects against the thirteen most common types of pneumococcus, which cause up to 80% of pneumococcal infections.
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.
Vaccine options
Vaccines against pneumococcal infection began to be developed only in the second half of the 20th century.
The difficulty in creating such vaccinations was (and is) the huge number of types of pneumococcus - more than 90 in total. First, a 14-valent vaccine was created. It began to be used in 1977. And in 1981 it was replaced by a 23-valent vaccine, which is still used today. But these vaccinations against pneumococcal infection could only be used by children from the age of two. And the most vulnerable group of young children still remained unprotected from pneumococci. Therefore, pharmaceutical companies around the world have begun developing a new generation of drugs - conjugate vaccines. The first such vaccine was the seven-valent pneumococcal conjugate vaccine Prevenar. It included seven types of pneumococcus, each of which was conjugated with non-toxic diphtheria protein and adsorbed on aluminum phosphate. The following vaccinations are currently used in Russia: Pneumo-23 (non-conjugated polysaccharide vaccine), 13-valent Prevenar 13, 10-valent Synflorix. Prevenar vaccinations can be administered to all children from 2 months of age, 10-valent Synflorix (polysaccharide, conjugated with D-protein of non-typeable Haemophilus influenzae, tetanus and diphtheria toxoids, adsorbed) - from 6 weeks and Pneumo-23 vaccination "- only from 2 years old.
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.
Symptoms of rotavirus infection
The main symptoms of rotavirus infection:
- diarrhea with blood in the stool;
- vomit;
- fever;
- dehydration;
- acidosis and electrolyte disturbances.
Infection with rotavirus infection occurs through the fecal-oral route; in the stool of an infected person, the concentration of viruses is extremely high. In fact, infection occurs through direct or indirect contact with an already infected person; for the development of the disease, it is enough for 10 to 100 viral particles to enter the human body.
In countries with a low standard of living, where medical care is not available to many residents, the mortality rate from rotavirus gastroenteritis is quite high. The diagnosis of rotavirus infection can only be made by a doctor, and to clarify the diagnosis it is necessary to conduct a laboratory test of the patient’s stool.
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.
Where does this “news” come from?
Why did WHO suddenly give such a forecast? Not “suddenly,” but quite reasonably: epidemiologists around the world monitor all year round which types of influenza viruses are common among the population, which ones cause people to get sick most often, and transmit this data to WHO. There, information coming from different countries is summarized and a forecast is issued six months before the next epidemic season: which strains are most likely to be expected next winter. This forecast is given twice a year: for the countries of the Northern Hemisphere this occurs at the end of February - March.
For the Southern Hemisphere, where winter comes when we have summer, data is published in September. So all countries have 6-7 months to develop an annually updated influenza vaccine based on strains named by WHO, and to immunize the population in advance.
This year we don’t have enough COVID-scourges, so the WHO has additionally “delighted” with an alarming forecast about the coming flu: three previously unheard-of strains are no joke. When new viruses arrive, they attack people more aggressively, and people who do not have immunity to new varieties of the virus get more seriously ill.
The second fear: the incidence of coronavirus may rise again in the fall, which, in fact, is already happening in many places in the world. This means that there is a high risk of “layering” of two dangerous infections. Experts don’t really know how COVID-19 and the flu will behave when they attack people together, and how this threatens the sick. But nothing good is expected - both diseases are fraught with serious complications.
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.
Pneumococcal vaccination: everything you need to know
The pneumococcal vaccine is a “newcomer” in the Russian National Vaccination Calendar; it was introduced there only in 2014. The appearance of this vaccine caused a mixed reaction: some people perceived it with approval and understanding, others saw in the new drug another attempt to “conduct experiments” on a long-suffering population. Is it really needed? Let's figure it out.
Why is pneumococcus dangerous? Eight out of ten people with pneumonia and one in three who have had meningitis are victims of this infection. Streptococcus pneumonia is the name in Latin for the culprit of the most serious illnesses that have already ended tragically for one and a half million inhabitants of the Earth. Rapidly spreading through the bloodstream throughout the body, pneumococcal infection affects not only the lung tissue, but also other vital centers: the brain, heart, intestines, hematopoietic system, ENT organs... How infection occurs Pneumococcus can be infected both from already sick people and from bacteria carriers who themselves are healthy, but shed the infection through their breath or when sneezing. Carriers do not get sick because their infection nests in the nasopharynx, but the barrier organs do not allow it to go down to the lungs. Nasal mucus, saliva, ciliated cells of the respiratory organs and the secretion they produce, which helps cleanse the mucous membranes of pathogenic organisms, also prevent its reproduction and spread. This is if the person is generally healthy. However, this protective system of the body is sometimes disrupted by the influence of external and internal factors: • Hypothermia • Overfatigue • Mental stress • Lack of vitamins All together or individually, these factors weaken the immune system - and then the next attack of pneumococcal infection ends in illness. Who needs vaccination most? Victims of pneumonia caused by Streptococcus pneumonia most often become preschool children and elderly people who have crossed the sixty-year mark. In the Russian Federation, every year up to 70 thousand children fall ill with pneumococcal pneumonia, and approximately 2.5 million more go to the doctor with symptoms of otitis media - an extremely unpleasant infectious disease that is fraught with dangerous complications, including the development of complete deafness. The best and easiest way to protect a child or elderly family member is to get vaccinated against pneumococcal infection at a clinic. Vaccination is also necessary for those who have undergone surgery to remove the spleen, an important hematopoietic organ that also performs a protective function in the body. Vaccination against pneumococcal infection is mandatory for children raised in orphanages and for elderly people living in nursing homes. This is due to the crowded living conditions and the high likelihood of outbreaks of lobar pneumonia if one person suddenly falls ill. Vaccines For pneumococcal vaccinations, Russian doctors use imported vaccines - Prevenar and Pneumo-23. The drug "Prevenar" was created specifically for children. Initially, its scope of use was limited to seven serotypes of Streptococcus pneumonia, but several years later, American pharmacists added six more antigens to the development. "Pneumo-23". The number 23 in the name of this drug means that it fights twenty-three types of pneumococcal serotypes at once. The vaccine produces the best effect in combination with a flu shot - this is the combination that immunologists recommend it in. Vaccination against pneumococcal infection with the Pneumo-23 vaccine is performed once, its effect lasts for five years, after which revaccination is recommended. Weakened patients with nephrotic syndrome, chronic renal failure and other severe pathologies that cause a rapid decrease in antibodies to pneumococcus are re-vaccinated more often - after 1-3 years. Both the American and French vaccines are available in a dose of 0.5 immediately in syringes for ease of administration. It is important that they are compatible with most other vaccination materials that are recommended for use by the National Vaccination Program. The only exception is the BCG vaccine. The best age for vaccination The first pneumococcal vaccination is recommended in infancy: it is prescribed when the baby is two to three months old, after which he receives two more injections at an interval of 1.5 months. Then revaccination at one and a half years of age is highly desirable. But this vaccination schedule is valid only for Prevenar, an American drug that is considered the number one vaccine in the world against pneumococcal infection. French "Pneumo-23" can only be administered from two years of age. It is also recommended for vaccination of older people after they reach 65 years of age. Vaccination for adults is carried out once. What about younger people? They also have a risk of contracting pneumonia - especially if they work in hospitals, educational institutions, retail establishments and transport. Vaccination against pneumococcal infection will provide reliable protection against a serious and dangerous disease, so if your profession involves people, it is better to find time to get vaccinated. How to prepare for vaccination? If you are to be vaccinated against pneumococcus, you need to fulfill a number of important conditions that will help avoid complications in the future: 1. At the time of vaccination, a healthy child or adult should not have any signs of a cold - cough, runny nose or fever. To know this for sure, it is better to take basic clinical tests of blood and urine 2. Chronic diseases must be treated before vaccination in order to achieve stable remission. Vaccination against pneumococcal infection in children should be carried out only on the day of a healthy child - contacts with sick children waiting for their turn in the clinic corridors , can lead to infection with other infections, which will make themselves felt in a few days, and will look like complications after receiving the vaccination. Contraindications The pneumococcal vaccination can be done without fear for your health. The vaccines described above are high quality and have only standard contraindications: • Intolerance to the components of the vaccine material; • Previously noted allergy to the same vaccination, if it is already time for revaccination; • The first two trimesters of pregnancy, unless there are separate recommendations from a doctor; • Respiratory diseases at the time of vaccination; • Exacerbation of chronic pathologies; • Feverish conditions of any origin Side effects After vaccination against pneumococcal infection, most children and adults usually do not experience any significant side effects, but doctors warn about possible ailments that may appear in the first 12-24 hours after vaccination. This is a short-term rise in temperature, redness, soreness or mild itching at the injection site, and general malaise - weakness, drowsiness (or, conversely, insomnia). All these symptoms are harmless and disappear within a day. If they appear two or three days after vaccination against pneumococcus, then we can say with confidence: the vaccine is definitely not to blame. Perhaps on the day of vaccination the person already had a slight cold, and a small dose of the drug accelerated the disease - the same ARVI or flu. That is why doctors especially insist on examination before any vaccinations, so as not to provoke the onset of another infectious disease. How to behave after vaccination? • Rest more on the first day • If the temperature rises above 38, take an antipyretic - paracetamol or nurofen • Do not treat the injection site with anything • It is quite possible to wash a baby or an adult: water does not affect the skin around the vaccination in any way You will definitely need to see a doctor if you have a fever lasts (or even worsens) for longer than a day, and at the injection site there is swelling of more than five centimeters, thickening and discharge. What does mass vaccination against pneumonia provide? Research shows that if mass vaccination campaigns are carried out, the incidence of lobar pneumonia, purulent meningitis and other variants of the course of pneumococcal infection decreases by six times. Vaccinated children and adults are less likely to get sick with other forms of respiratory diseases - influenza, ARVI, bronchitis. The number of otitis media, sinusitis and sore throats is significantly reduced. Even if pneumococcal infection does occur, the disease is much milder and never ends in death, and the treatment time is significantly shortened. In addition, there is no need to use strong and expensive drugs in therapeutic regimens. Croupous pneumonia This is the name for inflammation that involves the entire lobe of the lung. This severe variant of the disease is most often caused by pneumococcus; another pathogen is the root cause quite rarely. When the lungs are affected, clinically it looks like this: • Severe cough with chest pain and shortness of breath • High temperature • Intoxication - weakness, tachycardia Somewhat later, these symptoms are joined by herpetic rashes on the wings of the nose and around the lips, sometimes a bluish tint of the skin is noted on the fingertips , around the mouth. When listening to breathing, the chest on the affected side of the lung “lags behind”; on the first day, characteristic tympanic sounds are heard, which then become dull. On the second day of the disease, dry, fine-bubble wheezing with a characteristic crunching sound (crepitus) becomes clearly audible in the lungs. The symptoms of lobar pneumonia depend on the location of the outbreak. Thus, the inflammatory process in the upper lobe of the right lung can add to the picture of the disease phenomena that can be confused with the onset of meningitis: • Convulsions • Rigidity of the neck • Intense headache • Vomiting If the focus is in the lower lobe of the right lung, then it provokes the appearance of abdominal pain , which are similar to the symptoms of appendicitis, food poisoning, pancreatitis. In addition, patients complain of diarrhea, bloating and belching, which further complicates diagnosis and requires the doctor to be especially careful when interpreting the examination results. In order not to make a mistake with the diagnosis, the doctor must refer the patient for an x-ray, sputum analysis and a general blood test, which show changes specific to lobar pneumonia. The peak of the disease occurs approximately on the third day: the cough intensifies, becomes even more painful, and the secreted sputum turns brownish. Shortness of breath becomes more pronounced, cyanosis increases. The temperature can last up to ten days, and the disease itself can last up to three weeks. The body spends up to one and a half months after recovery to restore lung tissues affected by pneumococcal infection. Head of the pulmonology department of TGKB 5 Andrey Arsentievich Martynov : - Pneumococcus is now the causative agent of approximately half of all cases of pneumonia. And statistics kept since 2014 show: where mass vaccination against pneumococcus takes place, the morbidity and mortality of the population from pneumonia decreases sharply. So I highly recommend not neglecting this vaccination, at least vaccinating your children, and if you have chronic diseases - diabetes, heart failure, asthma, COPD - then you absolutely must get vaccinated, for your body this will be the main protection against illness, which is deadly for you. Let me also remind you that pneumococcus causes not only pneumonia, but also many different forms of acute respiratory infections, sinusitis, otitis, and meningitis. By the way, the same statistics show that if you at least vaccinate children, adults around you get sick less. So take advantage of the fact that childhood vaccines are included in the National Immunization Schedule and protect your child.
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.
Types of vaccines against rotavirus infection
The international market can offer two standard vaccines for vaccination against rotavirus infections:
- monovalent, officially known as RV1 or "Rotarix";
- pentavalent, in medicine called RV5 or “RotaTek”.
Composition RV1 was obtained during laboratory development based on a human strain, composition RV5 contains 5 viral recombinants, which were obtained on the basis of bovine and human strains. The RotaTek vaccine (which is pentavalent RV5) is used in the Russian Federation, and it is an oral version of the drug with five recombinants of the virus in its composition. There is no data regarding the interchangeability of modern vaccines such as RV1 and RV5, since this issue has not been studied.
Prevalence of rotavirus infection
When there were no vaccinations against rotavirus infections, outbreaks of rotavirus gastroenteritis were quite common. According to WHO statistics, every year about 2 million children are hospitalized with this diagnosis, and the mortality rate from this infection is also quite high.
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.
Principles and purposes of vaccination
Pneumococcal disease is one of the leading causes of morbidity and mortality worldwide. Serious diseases often caused by pneumococci include pneumonia, meningitis, and bacteremia with fever. In 2005, WHO estimated that 1.6 million people die each year from pneumococcal disease. Therefore it must be prevented.
By the end of 2013, pneumococcal vaccination had been introduced in 103 countries, and immunization coverage had reached 25%. By order of the Ministry of Health of the Russian Federation No. 125 of March 21, 2014, vaccination against pneumococcal infection was introduced into the National Calendar of Preventive Vaccinations of the Russian Federation.
Contraindications
For pneumococcal conjugate vaccines: increased sensitivity to previous vaccination (severe generalized allergic reactions); hypersensitivity to diphtheria toxoid and/or excipients; acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccinations against pneumococcal infection are carried out after recovery or during remission. Pneumococcal polysaccharide vaccines: pronounced reaction to the previous vaccination, PPV23 vaccination less than 3 years before the intended PPV23 vaccination.