สารบัญ

Whooping-cough Vaccine

Category Active immunizing agent.

      Adsorbed Pertussis Vaccine is a sterile suspension, in saline solution or other appropriate solution isotonic with the blood, of killed Bordetella pertussis of one or more strains selected for high antigenic efficiency, which are adsorbed onto suitable adjuvant(s), such as aluminium hydroxide or aluminium phosphate. Each 0.5 ml contains not less than 4 IU of adsorbed pertussis vaccine.

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

Description Markedly turbid, whitish liquid; odour, practically odourless or of the antimicrobial agent.

Dose Intramuscular or deep subcutaneous, 0.5 ml, usually as a component in Adsorbed Diptheria, Tetanus and Pertussis Vaccine.

Contra-indication​

1. It is contra-indicated in children who have suffered a severe reaction to a previous dose.

2. It is contra-indicated in children with poorly controlled epilepsy or other neurological problems.

Warning ​

1. It may cause pain, redness, or local tenderness at the injection site.

2. Fever, drowsiness, irritable, loss of appetite or vomiting may occur.

Additional information

1. It is not recommended to use as a single vaccine.

          2. Whooping-cough is most dangerous in early life. The first dose of Adsorbed Pertussis Vaccine should be injected when the infant is 2 months old. The vaccine should not be administered after the age of 6 years. It is best used in the form of adsorbed diphtheria, pertussis and tetanus vaccine.

          3. Immunization can be carried out in children with a history of cerebral damage in the neonatal period. In children with a neurological problem that is still evolving it is recommended that immunization be deferred until the condition is stable.

          4. If a patient is receiving Diphtheria, Tetanus, and Pertussis Vaccine and Inactivated Poliomyelitis Vaccine concurrently, try to avoid giving injections of both on the same site.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 2 years from the date of the last satisfactory test for potency.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the number of IU in each single human dose; (2) the name and the amount of the adjuvant(s); (3) that it is not to be frozen; (4) that it must be well shaken before use; (5) the method used to inactivate the bacteria.

Identification

A. When injected into mice, the vaccine induces the production of pertussis antibodies. The test for potency may serve as an identification test.

          B. Agglutination of the organisms with specific antipertussis serum is served as an identity test. Mix three loopfuls of vaccine with one loopful of monospecific antiserum on a microscope slide. After mixing, rock the slide gently for a few minutes. Rapid, heavy agglutination should be observed with all three specific antisera within about 3 minutes.

pH 6.0 to 7.0 (Appendix 4.11).

Specific toxicity Use not less than 5 healthy mice each weighing 14 to 16 g for the vaccine group and for the saline control. Use mice of the same sex or distribute males and females equally between the groups. Allow the animals access to food and water for at least 2 hours before injection and during the test. Inject each mouse of the vaccine group intraperitoneally with 0.5 ml, containing a quantity of the vaccine equivalent to not less than half the single human dose. Inject each mouse of the control group with 0.5 ml of saline TS, preferably containing the same amount of antimicrobial preservative as that injected with the vaccine. Weigh the groups of mice immediately before the injection and 72 hours and 7 days after the injection. The vaccine complies with the test if: (a) at the end of 72 hours the total weight of the group of vaccinated mice is not less than that preceding the injection; (b) at the end of 7 days the average weight gain per vaccinated mouse is not less than 60 per cent of that per control mouse; and (c) not more than 5 per cent of the vaccinated mice die during the test. The test may be repeated and the results of the test combined.

Assay Carry out the “Biological Assay of Adsorbed Pertussis Vaccine” (Appendix 15.3.2). The estimated potency is not less than 4 IU per single human dose (0.5 ml) and the lower confidence limit (P = 0.95) of the estimated potency is not less than 2 IU per single human dose.