By C.F.M. Hendriksen
9. REFERENCES ninety bankruptcy nine: possibilities FOR substitute, relief AND REFINEMENT: HUMAN VIRAL VACCINES ninety three 1. advent ninety three 2. assessments FOR EXTRANEOUS MICROORGANISMS ninety four three. MUMPS VACCINE . . . ninety four four. HEPATITIS B VACCINE ninety five four. 1. attempt for freedom from dwell hepatitis virus ninety five four. 2. efficiency try out ninety five five. INFLUENZA VACCINE ninety six five. 1. efficiency try out ninety six five. 2. Abnormal-toxicity try out ninety six 6. MEASLES VACCINE. . . . . ninety six 6. 1. assessments for extraneous brokers ninety seven 6. 1. 1. try for Mycobacterium tuberculosis ninety seven 6. 1. 2. try out for extraneous viruses ninety seven 6. 2. Abnormal-toxicity try out ninety eight 7. POLIOMYELITIS VACCINE. . . ninety nine 7. A. Inactivated poliomyelitis vaccine ninety nine 7. A. l. creation. . . . . . ninety nine 7. A. 2. try for residual dwell virus ninety nine 7. A. three. exams for extraneous brokers a hundred 7. A. three. l. try for Mycobacterium tuberculosis . . . . . a hundred 7. A. three. 2. try for extraneous viruses a hundred 7. A. four. Tumourigenicity attempt. . . . . a hundred XII 7 . A. five. efficiency attempt . . . . . . . one hundred and one 7. A. 6. attempt for irregular toxicity 102 7. B. dwell, oral poliomyelitis vaccine 103 7. B. l. try for extraneous brokers 103 7. B. 2. try out for neurovirulence one zero five 7. B. three. try out for irregular toxicity 106 eight. RABIES VACCINE 106 eight. 1. creation 106 eight. 2. attempt for residual stay virus 107 eight. three. exams for extraneous microorganisms 107 eight. three. 1. try out for Mycobacterium tuberculosis 107 eight. three. 2. checks for extraneous viruses 108 eight. three. 2. 1. In canine 108 eight. three. 2. 2.
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Additional resources for Laboratory Animals in Vaccine Production and Control: Replacement, reduction and refinement
1:a~eg - Viral vaccines Seed Vl~l I Tissue culture - Extraneous agents - Twnourigenicity* Virus culture Liye (~t~enu~t~dl - Sterility - Extraneous viruses* - Specific toxicity* - Identity* - Abnormal toxicity* In~c~iya~eg - Sterility Extraneous viruses* Inactivation* Identity* Abnormal toxicitY* * Requires animals Note: This table gives a general outline. There may be subtle differences per vaccine product as regal:ds test procedure. tion of bovineserum content 33 5. GUIDELINES In many countries the production and quality control of human and veterinary vaccines are regulated by Acts.
Trevan (53) considered the ideal number of animals for a potency test to be 30 for each '~accine dilution. In an article published in 1939 Prigge (2) ar:rived at a concrete proposal for the potency test, based on the knowledge available: "Several groups of guinea pigs are injected with increasing amounts of antigen, ranging from a dose that is ineffective in all animals (0%) to a dose that is effective in all (100%). (Each animal receives only one antigen injection). Next, the percentage of animals which is protected when injected with varying doses of toxin is determined.
The inactivated human influenza vaccine is an exception, the determination of the vaccine's efficacy being based on an in vitro method, (single radial immunodiffusion). 30 Within the entire process of inactivated vaccine control, relatively the most experimental animals are required for the potency test. Tables 3 and 4 give a summary of the control tests for a few human bacterial vaccines and one viral vaccine, respectively, during their successive production stages. They will be discussed in the next chapter.