POLIOVIRUS VACCINE LIVE ORAL TRIVALENT

Connaught

Poliovirus Types 1, 2 and 3

Active Immunizing Agent

Pharmacology: The purpose of administering any attenuated, live virus vaccine is to stimulate the immune system to produce an active immunity by stimulating natural infection without producing clinical symptoms of the disease. To accomplish this with live poliovirus vaccine, it is necessary for the virus to multiply in the intestinal tract. A primary series of this vaccine is designed to produce an antibody response to poliovirus types 1, 2 and 3. This immune response is comparable to that induced by natural disease. The antibodies thus formed help protect the individual against clinical poliomyelitis infection by any one of the 3 types of poliovirus.

The immune response to Poliovirus Vaccine Live Oral Trivalent is similar to that induced by natural infection with poliovirus and includes the development of secretory antibody within the intestinal tract. This is believed to prevent subsequent infection with “wild” polioviruses and their dissemination by the fecal-oral route to susceptible individuals in the community. OPV also interferes with simultaneous infection with “wild” poliovirus and is thus of particular value in the control of epidemics.

The virus persists in the throat for 1 to 2 weeks; it is excreted in the feces for several weeks, and, rarely, for more than 2 months. This may lead to infection of close contacts which is regarded as largely beneficial since it results in protection of more individuals than the number actually vaccinated. In a very small number of infected contacts, especially adults, paralytic disease may occur.

Indications: Primary immunization of infants, children and adolescents against poliomyelitis caused by poliovirus types 1, 2 and 3.

Booster immunization of vaccinated adults.

Immunization of unvaccinated adults travelling in less than 4 weeks to endemic areas when time does not permit administration of at least 2 doses of inactivated poliovirus vaccine (IPV).

Outbreak Control: If a case of paralytic poliomyelitis caused by “wild“ virus appears in a community, OPV should be administered to all individuals (including infants) who have not been completely immunized or whose immunization status is uncertain.

IPV is not recommended for the control of outbreaks of poliomyelitis.

Contraindications: Do not administer Poliovirus Vaccine Live Oral Trivalent (OPV) parenterally.

Individuals with a known allergy to polymyxin B, neomycin or streptomycin should not receive the vaccine.

It is recommended that OPV not be administered to those acutely ill.

Administration of OPV is contraindicated in all cases of leukemia, lymphoma, generalized malignancy or advanced debilitated states. OPV must never be given to patients who are immunodeficient including persons known to be HIV infected, those on immunosuppressive therapy, and to persons who will have household, or similar close contact with such patients in the following 4 weeks. These patients and their contacts may be given IPV without risk, but the protection afforded to immunocompromised persons may be limited.

Warnings: The virus persists in the throat for 1 to 2 weeks; it is excreted in the feces for several weeks, and, rarely, for more than 2 months. This may lead to infection of close contacts which is regarded as largely beneficial since it results in protection of more individuals than the number actually vaccinated. In a very small number of infected contacts, especially adults, paralytic disease may occur.

Any vaccine showing particulate matter or turbidity should be discarded.

As with any vaccine, administration of Poliovirus Vaccine Live Oral Trivalent may not result in seroconversion in 100% of susceptible subjects given the vaccine.

Precautions: For unvaccinated adults not at special risk, primary immunization with IPV is recommended.

The possibility of allergic reactions in individuals sensitive to the components of the vaccine should be evaluated.

Epinephrine HCl Solution (1:1 000) should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Pregnancy: There is no evidence to suggest that a pregnant women or her fetus is at greater risk from OPV than other persons and therefore OPV should be used for pregnant women during control of an outbreak. When polio vaccination is indicated in other circumstances during pregnancy, IPV should be used.

Drug Interactions: One live vaccine may interfere with the effectiveness of another, and to minimize this possibility, 2 or more live vaccines should preferably be administered either on the same day or be separated by an interval of at least 1 month.

Poliovirus vaccine live oral trivalent should not be mixed with chlorinated water. No other interactions with food are known.

Adverse Effects: In rare instances, OPV has been associated temporally with paralytic disease in vaccine recipients or their close contacts.

Between 1965 and 1988, vaccine-associated paralysis in Canadian recipients or OPV occurred at the rate of 1 case per 9.5 million doses of vaccine distributed, and in contacts of vaccinees, 1 case per 3.2 million doses distributed.

The effectiveness of OPV in preventing and controlling paralytic poliomyelitis is so great that the extremely small risk of vaccine-associated paralysis is not a contraindication to its widespread use in routine immunization programs for infants and children.

Dosage: Single Dose Dispenser: One dose is the entire expellable contents (0.5 mL) of the single dose dispenser.

10 Dose Dispenser: One dose is 2 drops from the 10 dose dispenser.

In infancy, the primary series is usually integrated with Diptheria, Tetanus and Pertussis (DPT) vaccination. Poliovirus Vaccine Live Oral Trivalent can be administered simultaneously with DPT, MMR or Haemophilus influenzae type b (Hib) conjugate vaccines without increased side effects; the immune response to each antigen is adequate and comparable to that found in patients receiving these vaccines according to the routine schedule. It is recommended that individual live virus vaccines be administered either simultaneously or be separated by an interval of at least 30 days of one another because of theoretical concerns that the immune response to one live-virus vaccine might be impaired if given within 30 days of another. See Table I.

Methods of Administration: The vaccine must be administered orally. It must not be administered parenterally.

The vaccine must be completely thawed prior to use. For single dose dispensers, a single dose can be obtained by inverting the plastic dispenser and squeezing to dispense the entire contents.

For the 10 dose dispenser, hold the tube upright and tap lightly to remove any product from the neck of the tube. Carefully remove the cap by twisting it slowly. Invert the plastic dispenser, hold vertically (tip down) and apply even pressure to express 2 drops. Before replacing the cap, hold the tube upright and tap lightly to remove any product from the neck of the tube. Replace the cap with a careful slow twist to assure a good seal and to avoid damage to the tip of the dispenser. Damage to the tip could alter the drop size and so change the dose.

The vaccine should be administered by dispensing the dose into a plastic disposable spoon. The 10 dose plastic dispenser must not be used for feeding the vaccine nor allowed to come into contact with any contaminated dispensing spoons.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the health care provider also maintain a permanent record of the immunization history of each individual. This office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Information for the Patient: See Blue Section - Information for the Patient “Poliovirus Vaccine Live Oral Trivalent”.

Supplied: Single and 10 dose plastic dispensers.

Store at -20°C or lower for a period not exceeding the expiry date on the label. Alternatively, the thawed vaccine may be stored between 2 and 8°C for up to 4 months. The vaccine must not be administered beyond the expiry date on the label.

Once opened, the 10 dose dispenser may be used for up to 3 days provided it is kept constantly between 2 and 8°C during this period. The contents of opened dispensers must be examined for turbidity prior to use. Vaccine showing turbidity must be discarded.

Each dose of Poliovirus Vaccine Live Oral Trivalent (OPV), prepared in human diploid strain WI-38 cell cultures from attenuated poliovirus (Sabin) types 1, 2 and 3 contains single, and 10 dose plastic dispensers. See Table II.

The vaccine is clear with color ranging from orange to pale yellow due to the presence of trace amounts of phenol red indicator.