Polio sabin bivalent vaccine for prevention of poliomyelitis types 1 and 3 (live, attenuated)
UkraineTable of Contents
Instructions for Medical Use of the Medicinal Product POLIO SABIN Bivalent Vaccine for Prevention of Poliomyelitis Types 1 and 3 (Live, Attenuated)
Composition:
1 dose (0.1 mL) of vaccine contains:
Active substances:
Poliovirus type 1, strain LSc, 2ab ≥ 106.0 CCID50;
Poliovirus type 3, strain Leon 12a, 1b ≥ 105.8 CCID50;
Excipients: magnesium chloride hexahydrate (MgCl2·6H2O); L-arginine; polysorbate 80; water for injections.
Pharmaceutical form. Oral suspension.
Main physicochemical properties: clear yellowish-pink liquid, free from foreign particles.
Pharmacotherapeutic group. Vaccines. Viral vaccines. Vaccines against poliomyelitis.
Bivalent live attenuated viral vaccine for prevention of poliomyelitis for oral administration. ATC code J07BF04.
Immunological and Biological Properties
Pharmacodynamics.
According to data from scientific literature and clinical studies conducted in Bangladesh involving more than 370 subjects aged 6 weeks and older who received POLIO SABIN Bivalent vaccine according to the 6, 10, 14 weeks or 6, 8, 10 weeks schedule, a comparable immune response against poliovirus types 1 and 3 is expected to that achieved with trivalent oral poliomyelitis vaccine.
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
POLIO SABIN Bivalent vaccine is indicated for active immunization of patients of all age groups for the prevention of infections caused by poliovirus types 1 and 3.
Contraindications.
Hypersensitivity to neomycin, polymyxin, or any other component of the vaccine (see section "Composition"). A history of contact dermatitis following the use of neomycin or polymyxin is not a contraindication to vaccination.
Hypersensitivity after previous administration of oral vaccines for the prevention of poliomyelitis manufactured by GlaxoSmithKline Biologicals.
Primary or secondary immunodeficiency. Inactivated poliovirus vaccine (IPV) is recommended for such individuals. However, according to the Expanded Programme on Immunization (EPI) recommendations of the WHO, symptomatic and asymptomatic infections caused by human immunodeficiency virus are not contraindications for vaccination with POLIO SABIN Bivalent vaccine.
Interaction with other medicinal products and other forms of interaction.
POLIO SABIN Bivalent vaccine can be administered simultaneously with vaccines for the prevention of infections caused by Haemophilus influenzae type b, hepatitis B, diphtheria, pertussis and/or tetanus, inactivated poliovirus vaccine (IPV), measles, rubella and/or mumps vaccine, or BCG vaccine, provided such administration is in accordance with the national immunization schedule.
Concomitant administration of oral poliovirus vaccine (OPV) and rotavirus vaccine does not affect the immune response to poliovirus antigens, but may slightly reduce the immune response to the rotavirus vaccine. In a clinical study involving 4200 subjects who received oral poliovirus vaccine (OPV) simultaneously with ROTARIX rotavirus vaccine manufactured by GlaxoSmithKline Biologicals, clinical protection against severe rotavirus gastroenteritis was maintained.
When POLIO SABIN Bivalent vaccine cannot be administered simultaneously with other live attenuated vaccines, an interval of at least one month should be maintained between vaccinations.
Immunosuppressive therapy may reduce the immune response, promote replication of vaccine viruses, and prolong their excretion in feces from the intestine.
Special precautions for use.
POLIO SABIN Bivalent vaccine must never under any circumstances be administered by injection.
POLIO SABIN Bivalent vaccine may not prevent disease or affect the course of illness in patients already infected with wild types 1 and 3 poliovirus.
Administration of POLIO SABIN Bivalent vaccine should be postponed in patients with severe illnesses accompanied by fever, persistent diarrhea, or vomiting. However, mild infectious diseases such as the common cold are not contraindications for delaying vaccination.
Cases of diarrhea and/or vomiting (as well as gastrointestinal infections) may affect the effectiveness of immunization with POLIO SABIN Bivalent vaccine; therefore, under such circumstances, the administered dose should not be counted toward the vaccination schedule according to the immunization calendar. The dose must be repeated after the patient has recovered.
The attenuated poliovirus replicates in the intestine of the vaccinated person. Vaccine viruses may persist in feces for several weeks and can be transmitted to individuals in close contact with the vaccinated person; therefore, such individuals should be informed about the necessity of strict adherence to personal hygiene practices.
Very rarely, unimmunized individuals in close contact with recently vaccinated patients may be at risk of developing vaccine-associated paralytic poliomyelitis.
In all cases of vaccination with POLIO SABIN Bivalent vaccine, it is also recommended to simultaneously immunize susceptible individuals in the immediate environment of the vaccinated person (e.g., unvaccinated parents).
As with other vaccines, protective immune response may not develop in all vaccinated individuals.
Prior vaccination with inactivated polio vaccines is not a contraindication to the use of POLIO SABIN Bivalent vaccine.
Vaccination of children in Ukraine is carried out in accordance with the requirements of current orders issued by the Ministry of Health of Ukraine regarding preventive vaccinations.
Use during pregnancy or breastfeeding.
Pregnancy
Despite the lack of data on the negative effects of the live attenuated poliomyelitis vaccine on the fetus, according to general immunization principles, the vaccine should not be administered to pregnant women, except in cases of evident risk of infection with wild-type poliovirus. The benefit-risk ratio of using this vaccine should be evaluated in comparison with the administration of inactivated polio vaccines.
Women of childbearing age lacking immunity to poliomyelitis should use contraceptive measures for 3 months following vaccination.
Breastfeeding
The effect of the vaccine on infants when administered to their mothers was not assessed during clinical trials. No contraindications have been established. The vaccine may be administered to breastfeeding women.
Ability to influence reaction rate while driving or operating machinery.
Studies on the ability of the vaccine to affect reaction speed while driving or operating machinery have not been conducted. However, considering the adverse event profile, it is unlikely that this vaccine would impair reaction speed while driving or operating machinery.
Administration and Dosage
Vaccination should be carried out in accordance with national recommendations or WHO guidelines.
The POLIO SABIN Bivalent vaccine is intended for oral use only.
One dose of the vaccine (0.1 mL) corresponds to 2 drops of the suspension, administered using the polyethylene dropper provided in the package.
The vaccine may be administered directly or mixed with food or drinks that do not contain substances capable of inactivating polioviruses (e.g., preservatives). Suitable products include plain syrup, milk, bread, and sugar cubes. Due to the slightly bitter taste of the vaccine, it may be given together with syrup or a sugar cube, especially to young children.
For breastfed infants, administration of the vaccine is recommended either 2 hours before or 2 hours after breastfeeding, in order to avoid contact with antibodies present in breast milk.
Contact between the dropper and the patient's saliva should be avoided.
The vaccine should be visually inspected for the presence of any foreign particles prior to administration.
Due to minor fluctuations in pH, the color of POLIO SABIN Bivalent vaccine may vary from yellow to pink. Color changes within this range are not indicative of vaccine deterioration.
Overdose
Isolated cases of overdose with the trivalent oral poliomyelitis vaccine manufactured by GlaxoSmithKline Biologicals have been reported. Overdose did not result in the development of disease.
Data regarding overdose with this vaccine are limited.
Adverse reactions.
Very rarely, cases of paralysis associated with vaccination have been observed after administration of trivalent oral poliomyelitis vaccine (less than one case per million doses administered). Most cases of vaccine-associated paralytic poliomyelitis occurred after administration of the first dose.
Frequency of adverse reactions is defined as follows:
very rare (< 1/10000).
| System organ class |
Frequency |
Adverse reactions |
| General disorders and administration site conditions |
Very rare1 |
Pyrexia2 |
| Gastrointestinal disorders |
Very rare1 |
Diarrhea2, vomiting2 |
| Immune system disorders |
Very rare1 |
Allergic/anaphylactoid3 reactions |
| Infections |
Very rare1 |
Vaccine-associated paralytic poliomyelitis3 |
1 Frequency based on post-marketing data from studies of trivalent polio vaccines.
2 Adverse reactions reported during clinical trials in Bangladesh.
3 Adverse reactions known from post-marketing data from studies of trivalent polio vaccines.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after a medicinal product has been authorized is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.
Shelf life.
24 months – if stored at –20 °C; 6 months – if stored at +2 °C to +8 °C.
Storage conditions.
Store at –20 °C. The vaccine may be stored at +2 °C to +8 °C for up to 6 months. Store in a place protected from light. Keep out of reach of children.
When stored at temperatures not exceeding –20 °C, the vaccine retains its properties until the expiry date indicated on the packaging.
To maintain optimal vaccine properties, exposure to room temperature (outside the refrigerator) should be minimized, and exposure to direct sunlight should be avoided.
Transportation must be carried out under refrigerated conditions, especially in hot climates.
A study was conducted to evaluate the effect of freeze-thaw cycles on the titers of poliovirus types 1 and 3. In this study, purified pools of poliovirus types 1 and 3 underwent freeze-thaw cycles under the following conditions:
- thawing at room temperature for two days;
- freezing at –45 °C for at least one week.
Virus titer analysis was performed after five freeze-thaw cycles and compared with samples stored continuously at –45 °C.
Five freeze-thaw cycles did not have a significant impact on the titers of poliovirus types 1 and 3. The purified pools of poliovirus types 1 and 3 used in the study were not stabilized with magnesium chloride.
Thus, this study was conducted under "worst-case" conditions compared to the finished POLIO SABIN Bivalent vaccine in vials stabilized with magnesium chloride.
If the vaccine is not expected to be used or distributed in the near future, it is recommended to store it at –20 °C, as this halts the process of declining potency.
After opening, the multidose vial should be stored in a refrigerator; the vaccine must be used within 8 hours due to the risk of contamination. Any unused vaccine should be discarded.
Store in the original packaging to protect from light.
Incompatibilities.
This medicinal product must not be mixed with other medicinal products.
Packaging.
100 vials containing 10 doses (1 mL) of vaccine in a cardboard box.
100 vials containing 20 doses (2 mL) of vaccine in a cardboard box.
Prescription status. Prescription only.
Manufacturer.
GlaxoSmithKline Biologicals S.A., Belgium/GlaxoSmithKline Biologicals S.A., Belgium.
Manufacturer's address and location of its operations.
Rue de l'Institut, 89, 1330 Rixensart, Belgium/Rue de l'Institut, 89 1330 Rixensart, Belgium.
Marketing authorization holder and/or its representative.
LLC "GlaxoSmithKline Pharmaceuticals Ukraine".
Address of the marketing authorization holder and/or its representative.
1-V Pavla Tychyny Avenue, Kyiv, 02152, Ukraine; tel: (044) 585-51-85; fax: (044) 585-51-92.
All suspected adverse reactions and lack of efficacy of the medicinal product can be reported to LLC "GlaxoSmithKline Pharmaceuticals Ukraine" via the 24-hour hotline (044) 585-51-85 or by email at [email protected].