Live Attenuated Bivalent Poliomyelitis Vaccine (bOPV) (15 doses)
Type and form of vaccine:
Live, attenuated poliomyelitis liquid
Each dose of the vaccine (2 drops or 0.1 ml) contains:
- At least 106 (106 CC1D50) of attenuated polio virus, Sabin strain, serotype I
- At least 10'i (105.5 CCID50) of attenuated polio virus, Sabin strain, (RNA derived) serotype III
- Maximum 5 micrograms of kanamycin and neomycin
- 9.5 milligrams of magnesium chloride
- Maximum 2 micrograms of phenol red
- For replication of the virus used in this vaccine, human diploid cells (MRC-5) are used.
This vaccine is used for active immunization against polio.
Administration route and dosage:
Each dose of the vaccine consists of 2 drops or 0.1 ml taken by mouth. For correct vaccination:
1- Remove the cap
2- Place 2 drops in the mouth
3- Replace the cap to prevent contamination
Recommended vaccination program:
Vaccination age and sensitive individuals requiring immunization depend on the epidemiology of the disease and sensitive individuals in the region. Therefore, vaccination should be performed according to the National Immunization Committee's guidelines.
In cases of endemic or epidemic, the vaccine should be administered in the shortest time possible (1-2 days), and all susceptible age groups in the region should be covered.
Use during pregnancy and lactation:
In normal conditions, administering this vaccine to pregnant women is not permissible. However in case of an epidemic and with the orders of the National Immunization Committee, use of this vaccine is permissible.
- In individuals with congenital or acquired immune system deficiency
- In children with high fever or any severe disease with fever
- In children being treated with corticosteroids or medications weakening the immune system until 2 weeks after treatment - In known sensitivities to any component of the vaccine such as neomycin
- The oral polio vaccine (Sabin) is the least harmful oral vaccine in the world. However, in some cases flaccid paralysis has been reported.
- In rare cases, in adults receiving the oral vaccine, Vaccine-Associated Paralysis (VAP) has been reported.
- The rate of paralysis due to oral polio vaccine is I case in 750,000 doses (initial dose); and I case in 2.4 million doses (booster doses).
- This vaccine does not interfere with other vaccines covered by the National Immunization Schedule.
- Medications weakening the immune system (2 weeks before and after vaccination) cause reduced or no immune response to the vaccine.
Precautions and warnings:
- In case of vomiting and diarrhea during or after administering the vaccine, the second dose is suggested to be repeated after these symptoms subside.
- Tonsillectomy is not permitted until 2 weeks after the last dose of this vaccine.
- The prepared vaccine may be used until up to 8 hours, if cold chain and aseptic conditions are observed. - Do not use vaccine after the expiration date.
Safe disposal of waste or partially used vaccines:
Single-use equipment used, and empty vaccine vials should be placed in the sharp-equipment container, and sterilized correctly (autoclave, burning, or using appropriate chemicals), and then buried hygienically.
- This vaccine should be stored and transported at -20°C or lower
- The opened tube should be stored at 2-8°C and away from sunlight, and should be used within 8 hours.
- Do not repeatedly freeze and thaw the vaccine.
- After dissolving the vaccine, its color may change from light yellow to red. This is normal and has no effect on vaccine quality.
- If the dissolved vaccine is not clear, it is not usable and should be discarded,
- If the vaccine is stored and transported at -20°C, it may be used up to the expiration date indicated on the tube
This vaccine is distributed in 15-dose (1.5 ml) tubes.
1- Immunization schedule and guidelines approved by the National Immunization Committee, 1394
2- Martindale, the complete drug reference, 39th edition.
Recommendations to assure the quality, safety and efficacy of live attenuated poliomyelitis vaccines (oral), WHO, 2012