สารบัญ

Category Active immunizing agent.

      Oral Poliomyelitis Vaccine is a preparation of approved strains of live attenuated poliovirus type 1, 2 or 3 grown in vitro cultures of approved cells, containing any one type or any combination of the three types of Sabin strains, presented in a form suitable for oral administration.

      The vaccine complies with the requirements stated under Vaccines, with the following modifications.

Description Clear liquid; may be coloured owing to the presence of a pH indicator. It is generally frozen.

Strength available 10^6.0 CCID₅₀ of type 1, 10^5.0 CCID₅₀ of type 2, and 10^5.5 CCID₅₀ of type 3 per human dose.

Dose One human dose as stated.

Contra-indication

          1. It is contra-indicated in individuals with primary immunodeficiencies or in individuals with suppressed immune response resulting from human immunodeficiency virus (HIV) infection, leukemia, lymphoma, other malignancies affecting the bone marrow or lymphatic system, certain blood dyscrasias, or therapy with immunosuppressive agents since replication of attenuated polioviruses may not be limited in such individuals.

2. Do not administer parenterally.

Warnning

1. Defer vaccination of persons with any acute, febrile illness until after recovery.

2. Postpone or avoid the vaccine in the presence of persistent vomiting or diarrhea and in patients with any advanced debilitated condition.

Additional information It is recommended for outbreak control if local epidemics of wild-type poliomyelitis occur.

Expiration date The expiration date is not later than 1 year from the date of the last satisfactory test for virus titre, when stored at a temperature below –5º, and not later than 2 years, when stored at a temperature below –20º.

Packaging and storage Oral Poliomyelitis Vaccine shall be stored, whenever possible in a frozen state, and protected from light. When thawed it shall be kept at a temperature of 2º to 8º and used within 30 days; such vaccine may be kept for longer periods of time if a suitable stabilizer has been added during manufacture. When exposed to higher temperature it shall be used within a few hours.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the strain and type of poliomyelitis virus contained in the vaccine; (2) the cell substrate used for the preparation of the vaccine; (3) the nature and amount of any stabilizer present in the vaccine; (4) the nature and amount of any antibiotics used in the preparation of the vaccine; (5) the amount of virus of each type contained in one recommended dose; (6) the number of doses in the container; (7) that the vaccine is not for injection.

Identification When the vaccine is mixed with an appropriate amount of specific poliomyelitis antiserum, it is no longer able to infect susceptible cell cultures.

Thermal stability Maintain not less than three vials of the final lot at 37º±1º for 48 hours. Determine the total virus concentration as described under Assay in parallel for the heated vaccine and for vaccine maintained at the temperature recommended for storage. The estimated difference between the total virus concentration of the unheated and heated vaccines is not more than 0.5 log₁₀ infectious virus units (CCID₅₀) per single human dose.

      The test is not valid if:

      – the confidence interval (P = 0.95) of the logarithm of the virus concentration of the reference preparation is more than ±0.3;

      – the virus concentration of the reference preparation differs by more than 0.5 log CCID₅₀ from theassigned value;

      – the range of virus concentrations found for the replicates of any sample is more than 0.8 log CCID₅₀.

Assay Titrate for infectious virus using not less than three separate vials of vaccine, following the method described below. Use one vial of an appropriate virus reference preparation to validate each assay. If the vaccine contains more than one poliovirus type, titrate each type separately, using appropriate type-specific antiserum (or preferably a monoclonal antibody) to neutralize each of the other types present.

      For a trivalent vaccine, the estimated mean virus titres must be: not less than 10^6.0 infectious virus units (CCID₅₀) per single human dose for type 1; not less than 105.0 infectious virus units (CCID₅₀) for type 2; and not less than 105.5 infectious virus units (CCID₅₀) for type 3. 

      For a monovalent or divalent vaccine, the minimum virus titres are decided by the competent authority.

      METHOD Inoculate groups of 8 to 12 flat-bottomed wells in a microtitre plate with 0.1 ml of each of the selected dilutions of virus followed by a suitable cell suspension of the Hep-2 (Cincinnati) line. Incubate the plates at a suitable temperature. Examine the cultures on days 7 to 9.

      The assay is not valid if:

      – the confidence interval (P = 0.95) of the logarithm of the virus concentration of the reference preparation is greater than ±0.3;

      – the virus concentration of the reference preparation differs by more than 0.5 log CCID₅₀ from theassigned value;

      – the range of virus concentrations found for the replicates for any sample is more than 0.8 log CCID₅₀