Oral polio vaccine types 1, 2, 3
(Vaccine for the prevention of polio)
International nonproprietary name
Dosage form
Oral solution
Compound
One dose (0.2 ml-4 drops) contains
active substances: live attenuated Sabin strain of poliovirus type 1 - LSc 2ab not less than 106.0 TCD50 *,
live attenuated Sabin strain of poliovirus type 2 - P712 Ch 2ab not less than 105.0 TCD50,
live attenuated Sabin strain of poliovirus type 3 -
Leon 12a1b no less than 105.5 TCD50 Excipients: magnesium chloride, kanamycin sulfate
* - TCD50 - tissue cytopathogenic doses
Description
Transparent liquid from yellowish-red to pink-crimson color without sediment, without visible foreign inclusions
Pharmacotherapeutic group
Antiviral vaccines. Anti-polio vaccines. The polio virus is trivalent for oral administration.
ATX code J07BF02
Pharmacological properties
The oral polio vaccine is a preparation from attenuated Sabin strains of polio virus types 1, 2, 3, grown on a primary culture of African green monkey kidney cells or on the same type of African green monkey kidney cell culture with one passage on a continuous cell culture of the Vero line in the form solution with 0.5% lactalbumin hydrolyzate in Earle's solution.
Immunological properties
If the vaccination schedule (vaccination and revaccination) is followed, the vaccine creates stable immunity to polio virus types 1, 2, 3 in (90-95)% of vaccinated people.
Indications for use
Active prevention of polio.
Directions for use and doses
Attention: The vaccine is for oral use only.
The vaccine is used 4 drops per dose. The vaccination dose of the vaccine is instilled into the mouth with a dropper or pipette attached to the bottle 1 hour before meals. It is not allowed to take the vaccine with water or any other liquid, or to eat or drink within an hour after vaccination.
Vaccination against polio is carried out with inactivated polio vaccine (IPV) twice to children aged 3 months and 4.5 months in accordance with the instructions for the use of IPV.
The third vaccination against polio is given to children aged
6 months oral polio vaccine (OPV).
Children staying in closed preschool institutions (children's homes, orphanages, specialized boarding schools (for children with psychoneurological diseases, etc.), anti-tuberculosis sanitary and health institutions), according to indications, are vaccinated with a three-time inactivated polio vaccine (IPV).
The first three vaccinations make up the vaccination course.
Revaccination is carried out with oral polio vaccine 3 times, at the age established by the National Preventive Vaccination Calendar.
Since vaccination schedules differ in different countries, it is recommended to use the vaccination schedule in accordance with local recommendations according to the national vaccination schedule, but the use of PPV is allowed from 6 months according to indications*.
* according to indications (depending on the indications, inactivated or
live vaccine to prevent polio)
Extending the intervals between vaccinations is allowed in exceptional cases, in the presence of medical contraindications,
shortening the intervals between the first three vaccinations is not allowed.
It is allowed to reduce the interval between the third and fourth vaccinations to 3 months, if the intervals between the first three vaccinations have been extended. Children who arrived in this territory without
vaccination documents are subject to three vaccinations. Subsequent vaccinations for these children are carried out in accordance with their age.
Vaccinations according to epidemiological indications are carried out when polio diseases occur in a children's institution or locality.
The number of persons subject to vaccination according to epidemiological indications and the frequency of vaccinations are established in each specific case, taking into account the characteristics of the polio epidemic process. Subsequently, regular scheduled vaccinations against polio are carried out at the prescribed time.
All vaccinations against polio are registered in established registration forms indicating the name of the drug, date of vaccination, dose, batch number, reaction to vaccination.
Side effects
There are practically no side effects from the administration of the vaccine.
When assessing adverse drug reactions, the following frequency data were used as the basis: very often >10%, often from 1 to 10%, occasionally from 0.1 to 1%, rarely from 0.01 to 0.1%, very rarely< 0,01 %, включая единичные случаи.
Very rarely
Some vaccinated people who are predisposed to allergic reactions may experience allergic complications in the form of a rash such as urticaria or Quincke's edema.
The occurrence of vaccine-associated paralytic poliomyelitis (VAPP) is extremely rare both in vaccinated people and in persons in contact with vaccinated people.
To limit the circulation of the vaccine virus among those around the vaccinated person, parents should be explained the need to observe the rules of personal hygiene of the child after vaccination (separate bed, potty, bedding, clothes separate from other children and the need to isolate the vaccinated child in the family from immunodeficiency patients).
Contraindications
- hypersensitivity to kanamycin or any other components of the vaccine
Neurological disorders accompanying previous vaccination with oral polio vaccine
Patients suffering from primary and secondary immunodeficiency
Malignant neoplasms
Immunosuppression (vaccinations are carried out no earlier than 6 months after the end of the course of therapy)
Acute infectious and non-infectious diseases
Exacerbation of chronic diseases
Increase in body temperature above 38 ºС
Drug interactions
Simultaneous administration of PPV with vaccines against viral hepatitis B, diphtheria, whooping cough, tetanus, Haemophilus influenzae, measles, rubella, mumps, influenza (except for vaccines for the prevention of tuberculosis) is allowed, if this fits into the immunization scheme. Otherwise, it is necessary to ensure an interval of at least one month between the administration of two different attenuated viral vaccines.
special instructions
Routine vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature normalizes.
It is necessary to notify parents in advance about the day of upcoming preventive vaccinations for children.
When using a vaccine in a multi-dose package, avoid contact of the dropper cap with saliva.
Unused vaccine from an opened multi-dose vial can be stored for no more than 2 days at a temperature of 2 to 8 0C in a vial tightly closed with a dropper or rubber stopper. If necessary, it is allowed to draw the vaccine with a sterile syringe by piercing the rubber stopper while observing the rules of asepsis. In this case, the vaccine remaining in the vial and not changing its physical properties can be used until the expiration date.
The drug is not suitable for use in a bottle with damaged integrity, labeling, or if its physical properties (color, transparency, etc.) have changed, if the expiration date has expired, or if the conditions of transportation and storage have been violated.
Pregnancy and lactation
The possibility and specifics of the medical use of the vaccine in pregnant women and women during breastfeeding have not been studied.
Impact on the ability to drive vehicles and other mechanisms
The vaccine does not affect the ability to drive vehicles and other machinery.
Overdose
An overdose does not lead to undesirable consequences.
Release form and packaging
2.0 ml (10 doses) in bottles sealed with rubber stoppers and rolled aluminum caps.
There are 10 vials of vaccine in a cardboard box, complete with 10 dropper caps and instructions for medical use in the state and Russian languages.
Storage conditions
Store at a temperature of minus 20 0C and below or at a temperature from 2 to 8 0C.
Transported at temperatures from 2 to 8 0C.
Repeated freezing down to minus 20 0C is allowed.
Keep out of the reach of children!
Shelf life
At a temperature of minus 20 0C and below - 2 years, at a temperature from 2 to 8 0C - 6 months.
Unused vaccine from an opened vial can be stored for no more than 2 days at a temperature of 2 to 8 0C in a vial tightly closed with a dropper or rubber stopper.
A vaccine that has expired cannot be used.
Conditions for dispensing from pharmacies
By prescription (for specialized institutions).
Manufacturer
Registration Certificate Holder
Federal State Unitary Enterprise “Enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis named after. M.P. Chumakov RAMS", Russia
Address of the organization receiving complaints from consumers regarding the quality of the drug: Federal State Unitary Enterprise “Enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis named after. M.P. Chumakov RAMS"
Polio- an infectious disease affecting the nervous system. The disease is caused by poliovirus. Among wild strains, there are 3 serotypes; currently, thanks to mass vaccination, wild poliovirus type 2 has been eradicated from nature throughout the world (therefore, bivalent rather than 3-valent vaccines are now used for vaccination). Infection occurs through contaminated food and water. The virus multiplies in the intestines; most carriers do not have any symptoms of the disease, but are only sources of this infection. The most common form of the disease is paralysis, which in most cases is irreversible. Another more severe form of polio, bulbar, leads to mortality in almost 100% of cases. Circulation of wild poliovirus has been registered in 125 countries; the most endemic areas for polio are Nigeria, Pakistan, and Afghanistan.
This disease can be prevented through mass immunization. To understand the need for vaccination against polio, I will provide the following statistics. Since 1988, a 99% decrease in the incidence of polio has been recorded. As of 2018, only 29 cases of the disease were recorded worldwide. Before the start of immunization against this infection, infection of children was close to 100%, and the development of paralysis occurred with a frequency of 1 in 200 children. With complete recovery from paralytic forms of poliomyelitis, 25-50% of patients develop progressive post-polio syndrome after 15-30 years.
Vaccination against polio is carried out with live and inactivated vaccines. A live vaccine forms both humoral and local immunity; in this case, an inactivated vaccine is inferior in effectiveness; it does not cause the development of local immunity.
Vaccination scheme
Vaccination begins at 3 months of age three times with an interval of 6 weeks and revaccination at 18 and 20 months, as well as at 14 years.
The first 2 vaccinations are carried out with inactivated vaccines, that is, intramuscularly. Such vaccines include Imovax polio, as well as multicomponent vaccines that include inactivated polio viruses - Pentaxim, Infanrix Hexa, Tetracococ, etc.
The third vaccination against polio should be carried out with live polio vaccine (OPV) and coincides with the period of administration of DTP 3. Thus, starting from 6 months or from the third vaccination, ORP in the form of drops and separately DTP (imported analogue “Infanrix”) are used.
The presence of diarrhea during vaccination with live polio vaccine requires a repeat dose.
Complications of vaccination
Complications after immunization with polio vaccines are extremely rare and include rashes or angioedema.
Inactivated vaccines cause allergic reactions in people allergic to streptomycin.
Vaccine-associated polio can develop in both vaccinated people and those in contact with vaccinated people with an incidence of 1:1 million with the first vaccination and 1:6-12 million with repeated doses. The risk of developing vaccine-associated polio through contact with a vaccinated child in the family is negligible and amounts to 1:14 million.
The development of vaccine-associated polio is associated with the presence of primary immunodeficiency. In this connection, primary vaccination is carried out with an inactivated vaccine (intramuscular) with the administration of one or two doses.
Contraindications to polio vaccination
- Presence of immunodeficiency for administration of oral polio vaccine (inactivated vaccine is administered to such patients)
- Disorders of the central nervous system due to previous administrations of this vaccine.
- Medical withdrawal for mild acute respiratory viral infections, acute respiratory infections and other diseases accompanied by an increase in temperature to 38 lasts until the temperature drops.
- A contraindication for inactivated polio vaccine is an allergy to streptomycin.
Get vaccinated correctly and be healthy!
Catad_pgroup Vaccines for specific population groups
Imovax Polio - instructions for use
vaccine for the prevention of polio, inactivated
INSTRUCTIONS
on the use of a medicinal product for medical use
Registration certificate:
Trade name
Imovax Polio
International nonproprietary name
Vaccine to prevent polio
Dosage form
Suspension for intramuscular and subcutaneous administration.
The drug Imovax Polio is a suspension of polio viruses types 1, 2 and 3, cultured on the VERO cell line, purified and then inactivated with formaldehyde.
Compound
One dose (0.5 ml) contains:
*cultured on VERO cells
**Hank's medium 199 (without phenol red) is a mixture of amino acids (D,L-alanine, arginine hydrochloride, D,L-aspartic acid, cysteine hydrochloride monohydrate, cystine dihydrochloride, D,L-glutamic acid monohydrate, glutamine, glycine, histidine hydrochloride monohydrate, D,L-isoleucine, hydroxyproline, D,L-leucine, lysine hydrochloride, D,L-methionine, D,L-phenylalanine, proline, D,L-serine, D,L-threonine, D,L- tryptophan, tyrosine disodium, D,L-valine), mineral salts (calcium chloride, ferric nitrate nonahydrate, potassium chloride, magnesium sulfate heptahydrate, sodium chloride, potassium dihydrogen phosphate, sodium hydrogen phosphate), vitamins (ascorbic acid, biotin, ergocalciferol, calcium pantothenate , choline chloride, folic acid, inositol, menadione, nicotinic acid, nicotinamide, para-aminobenzoic acid, pyriloxal hydrochloride, niridoxine hydrochloride, riboflavin, thiamine hydrochloride, retinol acetate, disodium alpha-tocopherol phosphate) and other components (adenine sulfate, triphosadenine disodium , adenosine phosphate, cholesterol, deoxyribose, dextrose, glutathione, guanine hydrochloride, disodium hypoxanthine, ribose, sodium acetate, thymine, polysorbate 80, uracil, sodium xanthine), dissolved in water for injection.
The pH value is adjusted with hydrochloric acid or sodium hydroxide.
Antibiotics (streptomycin, neomycin and polymyxin B) are used in vaccine production but are not present in detectable quantities in the final product.
The vaccine complies with the requirements of the European Pharmacopoeia and WHO recommendations.
Description
Transparent colorless liquid.
Pharmacotherapeutic group
MIBP vaccine
ATX code J07BF03
Immunological properties
1 month after three-time vaccination with Imovax Polio, the detection rate of antibodies to polio viruses types 1 and 3 is 100%, and to type 2 virus – 99-100%.
In children aged 1 to 3 years, revaccination leads to a significant increase in the geometric mean titer (GMT) of antibodies, and the detection rate of antibodies in the blood serum approaches 100%. Protective SHT of antibodies to polio viruses of all three types persists 4-5 years after revaccination. After the 1st revaccination, immunity persists for at least 5 years.
In previously immunized adolescents and adults, revaccination leads to a pronounced immune response with a high level of seroprotection, approaching 100%, and a significant increase in antibody levels.
Indications for use
Specific prevention of polio for both primary immunization and revaccination of children, adolescents and adults.
Contraindications
Allergy to the active component, to one of the excipients included in the vaccine, neomycin, streptomycin or polymyxin B; an allergic reaction to a previous injection of the Imovax Polio vaccine.
- Disease accompanied by fever, acute infectious or chronic disease in the acute stage. Vaccination is carried out 2-4 weeks after recovery or during the period of convalescence or remission. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature has normalized.
Carefully
In case of thrombocytopenia or blood coagulation disorders, the vaccine should be administered subcutaneously.
If there is a need to take medications that suppress the immune system, as the immune response to the vaccine may be reduced. In such cases, it is recommended to postpone vaccination until the end of treatment. If vaccination cannot be delayed, the patient's antibody levels should be checked after vaccination to ensure they are sufficient to provide protection against polio.
- In very premature babies (born at 28 weeks or earlier). The potential risk of developing apnea and the need to monitor breathing for 48-72 hours should be considered when administering the primary course of immunization to children born at or before 28 weeks, especially those with a history of signs of respiratory immaturity. Because the benefits of immunization for this group of children are high, vaccination should not be delayed or considered contraindicated.
Use during pregnancy and breastfeeding
There are no sufficient data on the use of the vaccine during pregnancy. Animal studies have not provided sufficient data on the effects of Imovax Polio on pregnancy, embryonic and fetal development, childbirth and postnatal development. Potential risk unknown.
If necessary, the Imovax Polio vaccine can be used during pregnancy.
Breastfeeding is not a contraindication to vaccination.
Directions for use and doses
The vaccine is administered intramuscularly or subcutaneously in a single dose of 0.5 ml. The intramuscular route of administration is preferred.
In children under 2 years of age, the vaccine is administered into the upper outer surface of the middle part of the thigh.
In children over 2 years of age, adolescents and adults, the vaccine is administered to the deltoid muscle area.
Before administering the drug, you must make sure that the needle does not enter a blood vessel.
The vaccine should not be used if its appearance changes.
Routine vaccination against polio is carried out for all children by administering one dose of vaccine at 3 and 4.5 months according to the National Preventive Vaccination Calendar.
The third vaccination and subsequent revaccinations are carried out with live polio vaccine within the time limits specified in the National Preventive Vaccination Calendar.
The Imovax Polio vaccine is used for the third vaccination and subsequent revaccinations of children born to mothers with HIV infection, children with HIV infection, as well as children in orphanages, in accordance with the age and intervals between vaccinations and revaccinations specified in the National Calendar preventive vaccinations - at 6, 18, 20 months and 14 years.
If an oral live vaccine is used for vaccination and revaccination, the instructions for its use should be followed.
Side effect
Adverse events are listed according to systemic organ class and frequency of occurrence. The frequency was determined based on the following criteria: very often (≥1/10), often (≥1/100 to<1/10), нечасто (≥1/1000 до <1/100), редко (≥1/10000 до <1/1000), очень редко <1/10000), частота неизвестна (нельзя оценить по имеющимся данным).
Clinical trial data
Local and general reactions
Often: pain at the injection site, fever after vaccination with the 1st and 2nd dose;
Often: erythema at the injection site, fever after revaccination with the 3rd dose;
Infrequently: swelling at the injection site.
From very often to often: an increase in body temperature to 38.5-39.5 °C, transient within 24-48 hours after vaccination/re-vaccination with the drug Imovax Polio.
Post-marketing surveillance data
Since reports of adverse events during commercial use of the drug were received very rarely and from a population with an unknown number of patients, their frequency was classified as “frequency unknown.”
The safety profile of the Imovax Polio vaccine does not vary significantly among patients of different ages, given the relative frequency of adverse events and the fact that some events are age specific (for example, seizures in infants and children 2 to 11 years of age, myalgia/arthralgia in adolescents and adults). In addition, due to the simultaneous administration of other vaccines with the Imovax Polio vaccine, a precise cause-and-effect relationship between the occurrence of adverse events and the use of the vaccine cannot be established.
The most common adverse events: local reactions and increased body temperature (approximately 20% and 10% of all registered adverse events, respectively).
Local and general reactions
Swelling, pain, redness at the injection site, appearing in the first 48 hours after injection and lasting 1-2 days; fever in the first 24-48 hours after vaccination.
From the side of the central nervous system
Excitement, drowsiness, irritability in the first hours or days after vaccination (short-term).
From the nervous system
Brief convulsions, febrile convulsions in the first few days after vaccination; headache; transient mild paresthesia (mainly in the extremities) in the first 2 weeks after vaccination.
In very rare cases, seizures may occur later than the specified time. However, after 7 days, there is no evidence linking seizures to vaccination.
From the skin and subcutaneous tissues
Rash, hives.
From the immune system
Allergic reaction, anaphylactic reaction, anaphylactic shock.
From the musculoskeletal system
Mild and transient arthralgia and myalgia in the first few days after vaccination.
From the hematopoietic organs
Lymphadenopathy.
In extremely premature infants (born at or before 28 weeks of gestation), prolonged breathing intervals may occur within 2-3 days after vaccination (see Precautions).
The patient should be warned that if he experiences any adverse events not listed in these instructions, he should consult a doctor
Overdose
No data available.
Interaction with other drugs
The drug Imovax Polio can be administered simultaneously with different syringes into different parts of the body with other vaccines of the National Preventive Vaccination Calendar (except for BCG and BCG-M vaccines).
The vaccine cannot be mixed in the same syringe with other vaccines or medications.
special instructions
Vaccination of persons with chronic immunodeficiencies, such as HIV infection, is recommended even if the immune response to vaccine administration may be reduced due to the underlying disease.
Vaccination is also indicated for persons for whom oral live vaccine is contraindicated and for revaccination of persons. primary vaccination which was carried out with an oral vaccine.
Impact on the ability to drive vehicles and engage in other potentially hazardous activities
The effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities has not been studied.
Release form
Suspension for intramuscular and subcutaneous administration 0.5 ml/dose.
One dose (0.5 ml) in a 1 ml syringe made of type 1 glass with an elastomer piston, with a fixed needle and a protective cap for the needle or without a needle with a protective cap for the cannula of the syringe complete with two separate needles.
1 or 5 syringes with a fixed needle or without a needle, complete with two separate needles in a closed blister pack (PET/PVC).
When packaged at Sanofi Pasteur S.A., France
1 closed cell package (blister) (PET/PVC), containing 1 syringe with a fixed needle or without a needle, complete with two separate needles in a cardboard pack with instructions for use.
When packaging at the Federal State Unitary Enterprise “Enterprise for the production of bacterial and viral preparations of the Institute of Poliomyelitis and Viral Encephalitis named after. M.P. Chumakov RAMS"
1 closed cell package (blister) (PET/PVC) containing 1 syringe with a fixed needle in a cardboard pack with instructions for use.
4 closed cell packages (blisters) (PET/PVC), containing 5 syringes each with a fixed needle or without a needle, complete with two separate needles, in a cardboard pack with instructions for use.
Best before date
3 years.
A drug that has expired cannot be used.
Storage conditions
Store at a temperature of 2 to 8 C, protected from light. Do not freeze.
Keep out of the reach of children.
Vacation conditions
For a package containing 1 syringe:
Dispensed by prescription.
For a package containing 20 syringes:
For medical and preventive institutions.
Legal entity in whose name the registration certificate was issued
Sanofi Pasteur S.A., France
Manufacturer
Sanofi Pasteur S.A., France
Sanofi Pasteur S.A.,
or
Sanofi Pasteur S.A., France
Sanofi Pasteur S.A.,
Parc Idustriel d'Incarville, 27100, Val De Reuil, France
Issue quality control
Sanofi Pasteur S.A., France
Sanofi Pasteur S.A.,
1541, avenue Marcel Merieux 69280, Marcy L'Etoile, France
or
Sanofi Pasteur S.A., France
Sanofi Pasteur S.A.,
Parc Industriel d'Incarville. 27100, Val De Reuil, France
or
Federal State Unitary Enterprise "Enterprise for the production of bacterial and viral preparations
Institute of Poliomyelitis and Viral Encephalitis named after. M.P. Chumakov RAMS",
142782, Russia, Moscow, Moskovsky settlement, pos. Poliomyelitis Institute
Consumer complaints should be sent to an address in Russia:
Federal Service for Supervision in Healthcare (Roszdravnadzor)
109074, Moscow. Slavyanskaya square.. 4. p. 1
and/or
JSC "Sanofi Aventis Group"
125009, Moscow, st. Tverskaya, 22
BiVac Polio is a vaccine for the prevention of polio; oral, live attenuated types 1, 3, bivalent (contains two types of virus).
Release form and composition
BiVac polio is produced in the form of an oral solution: a pink-raspberry to yellow-red transparent liquid, without visible foreign inclusions or sediment.
Composition of 1 dose (4 drops – 0.2 ml):
- active substance: polio virus, attenuated Sabin strains type 1 - not less than 10 6.0 TCD 50 (tissue cytopathogenic doses) and type 3 - not less than 10 5.5 TCD 50 IE (infectious units) of the virus;
- additional components: magnesium chloride, kanamycin.
Indications for use
BiVac polio solution is intended for the active prevention of poliomyelitis.
Contraindications
- neurological disorders noted during previous vaccination with oral polio vaccine;
- primary (congenital) immunodeficiency conditions;
- severe reaction (including temperature above 40 ° C) or complications to a previous vaccine administration;
- malignant neoplasms;
- acute diseases (infectious or non-infectious nature), exacerbation of chronic diseases (vaccination is allowed only 2-4 weeks after complete recovery or remission);
- immunosuppression (vaccination is allowed no earlier than 12 weeks after completion of treatment);
- pregnancy;
- hypersensitivity to any of the components of the vaccine.
The safety of the drug during breastfeeding has not been established.
Directions for use and dosage
The BiVac polio vaccine is intended for oral administration only!
The drug is prescribed in a vaccination dose of 0.2 ml (4 drops) per dose. The vaccine is instilled into the mouth using a dropper attached to the bottle or a pipette 1 hour before meals. It is prohibited to take the drops with any liquid or drink/eat food for 1 hour after the procedure.
During the first and second vaccination against polio, children are administered inactivated polio vaccine (IPV) to prevent polio according to the instructions for use of IPV.
The third vaccination, as well as subsequent revaccinations against polio, is given to children with live oral polio vaccine (LOV).
The vaccination course includes three vaccinations:
- I – IPV at the age of 3 months;
- II – IPV at the age of 4.5 months;
- III – PPV at the age of 6 months.
Revaccination is carried out with PPV in three stages: at 18 months, at 20 months and at 14 years.
Children born to mothers with HIV infection, HIV-infected children or those staying in orphanages are required to receive IPV for the third vaccination and the subsequent 3 stages of revaccination against polio.
If routine immunization begins for a child at an older age, then it is also carried out according to the established scheme (I and II vaccinations - IPV, III vaccination and subsequent revaccinations - PPV).
When carrying out vaccination against polio for epidemic indications, PPV is used.
If there have been cases of the development of poliomyelitis caused by wild poliovirus, isolation of the latter from environmental objects or in human biosamples, the following categories of citizens are subject to mandatory single vaccination (those included in the number of contact persons in the outbreak of poliomyelitis or in cases of suspected damage, including caused by wild poliovirus):
- children aged from 3 months to 18 years;
- children aged 3 months to 15 years who arrived from countries/regions where polio is endemic (in the absence of reliable data on previous vaccinations, three-time vaccination is prescribed);
- medical workers;
- persons from 3 months of age (without age limit) who are in contact with arrivals from polio-endemic countries/regions;
- children aged 3 months to 15 years without a specific place of residence (in the absence of reliable data on previous vaccinations, three-time vaccination is prescribed);
- persons without age restrictions who work with live poliovirus or with materials potentially infected with wild poliovirus when hired.
It is not allowed to shorten the intervals between the first three vaccinations. In exceptional cases, extending the period between vaccinations is possible only if there are strict medical contraindications.
By lengthening the intervals between the first three vaccinations, the interval between the third and fourth can be reduced to 3 months.
Side effects
After vaccination with BiVac polio, immediate allergic reactions may occur during the first few hours.
Side effects that, as a rule, can only develop between the fourth and thirtieth day after taking the drug include the following:
- rarely: nonspecific symptoms - headache, vomiting, fever (may not be associated with vaccination);
- extremely rare: allergic reactions (including urticaria, Quincke's edema);
- isolated cases (registered in vaccinated people, as well as in persons in contact with them): vaccine-associated paralytic poliomyelitis (VAPP); To prevent the development of this complication, the first two vaccinations are carried out with IPV.
special instructions
All persons who are to be vaccinated with BiVac Polio must first undergo an examination by a doctor (paramedic).
It is necessary to plan vaccinations against polio in children's institutions at the same time for all children in the group.
After vaccination, strict personal hygiene rules are required to limit the circulation of the vaccine virus. A vaccinated child must be isolated from patients with immunodeficiency in the family, and he must also be provided with a separate bed, potty, bedding and clothing.
If families still have unvaccinated children (with contraindications to vaccinations or age), children belonging to the target groups should be immunized with IPV.
Vaccinations against polio are required to be registered in established registration forms, which indicate the name of the drug, batch number, dose, date of vaccination and reactions to it.
BiVac polio can be stored in an opened bottle for no more than 48 hours at a temperature of 2–8 °C; the bottle must be tightly closed with a rubber stopper or dropper.
If the integrity and marking of the bottle is damaged or its transparency, color or other physical properties change, the drug cannot be used.
If diarrhea or vomiting occurs during or immediately after taking the vaccine, a second dose should be administered only after these symptoms have resolved.
In the presence of mild forms of acute respiratory viral infections or acute intestinal diseases, vaccination should be carried out after the temperature has normalized.
If the patient is undergoing a planned operation, vaccination must be carried out no later than 30 days before the operation. When prescribing surgical intervention, the vaccine can be administered no earlier than 3–4 weeks after surgery.
There is a potential risk of apnea when using BiVac Polio in children with a history of respiratory distress or in premature infants (less than 28 weeks). As a result, children from this risk group require constant monitoring of respiratory activity for 2–3 days after taking the drug.
Drug interactions
It is allowed to take BiVac polio on the same day as vaccination with adsorbed pertussis-diphtheria-tetanus vaccine (DTP vaccine) or adsorbed diphtheria-tetanus toxoid vaccine (ADS or ADS-M toxoid). The polio vaccine can also be administered simultaneously with other drugs in the National Preventive Vaccination Calendar.
Immunosuppressive drugs can reduce the immune response to polio vaccine, multiply vaccine viruses, and increase the time they are excreted in feces.
Analogues
Analogues of BiVac polio are: Imovax Polio, Oral polio vaccine types 1, 2 and 3, Poliorix, Polymilex.
Terms and conditions of storage
Store out of reach of children, at a temperature of −20 °C and below. During transportation, maintain a temperature range of 2 to 8 °C, with possible subsequent re-freezing to −20 °C.
Shelf life: at a temperature of −20 °C and below – 24 months, at a temperature of 2–8 °C – 6 months.
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