Yellow Fever Vaccine (Live) is a freeze-dried preparation of the 17D strain of yellow fever virus grown in fertilised hen eggs.

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1 YELLOW FEVER VACCINE Yellow Fever Vaccine (Live) is a freeze-dried preparation of the 17D strain of yellow fever virus grown in fertilised hen eggs. Production General provisions The production of vaccine is based on a virus seed-lot system. The production method shall have been shown to yield consistently the yellow fever vaccine (live) of acceptable immunogenicity and safety for man. The production method is validated to demonstrate that the product, if tested, would comply with the test for safety and efficacy. Reference preparation. In the test for neurotropism, a suitable batch of vaccine known to have satisfactory properties in man is used as the reference preparation. Substrate for virus propagation Virus for the preparation of master and working seed lots and for all vaccine batches is grown in the tissues of chick embryos from a flock free from specified pathogens (2.7.7). SEED LOT The 17D strain shall be identified by historical records that include information on the origin of the strain and its subsequent manipulation. Virus seed lots are prepared in large quantities and stored at a temperature below -60. Master and working seed lots shall not contain any human protein or added serum. Unless otherwise justified and authorised, the virus in the final vaccine shall be between passage levels 204 and 239 from the original isolate of strain 17D. A working seed lot shall be only one passage from a master seed lot. A working seed lot shall be used without intervening passage as the inoculums for infecting the tissues used in the production of a vaccine lot, so that no vaccine virus is more than one passage from a seed lot that has passed all the safety tests. Only a virus seed lot that complies with the following requirements may be used for virus propagation. Identification The master and working seed lots are identified as containing yellow fever virus by serum neutralisation in cell culture, using specific antibodies. Extraneous agents (2.7.3). Each working seed lot complies with the test for extraneous agents. PROPAGATION AND HARVEST

2 All processing of the fertilised eggs is done under aseptic conditions in an area where no other infectious agents or cells are handled at the same time. Two per cent but not less than twenty and not more than eighty eggs are set aside as uninfected control eggs. After inoculation and incubation at a controlled temperature, only living and typical chick embryos are harvested. The age of the embryo at the time of virus harvest is reckoned from the initial introduction of the egg into the incubator and shall not be more than 12 days. After homogenisation and clarification by centrifugation, the extract of embryonic pulp is tested as described below and kept at -70 or colder until further processing. Virus harvests that comply with the prescribed tests may be pooled. No human protein is added to the virus suspension at any stage during production. If stabilisers are added, they shall have been shown to have no antigenic or sensitising properties for man. Only a single harvest that complies with the following tests may be used in the preparation of the final bulk vaccine. Identification The single harvest contains virus that is identified as yellow fever virus by serum neutralisation in cell culture, using specific antibodies. Extraneous agents (2.7.3). Complies with the tests for extraneous agents. Control eggs. Complies with the tests for extraneous agents (2.7.3). Virus concentration. In order to calculate the dilution for formulation of the final bulk, each single harvest is titrated as described under Assay. FINAL BULK VACCINE Single harvests that comply with the tests prescribed above are pooled and clarified again. A test for protein nitrogen content is carried out. A suitable stabiliser may be added and the pooled harvests diluted as appropriate. Only a final bulk vaccine that complies with the following tests may be used in the preparation of the final lot. Sterility (2.2.11). Carry out test for sterility using 10 ml of bulk for each sterility medium. Protein nitrogen content (2.3.30). The protein nitrogen content, before the addition of any stabiliser, is not more than 0.25 mg per human dose. FINAL LOT The final bulk vaccine is distributed aseptically into sterile, tamper-proof containers and freeze-dried to a moisture content shown to be favourable to the stability of the vaccine. The containers are then closed so as to prevent contamination and the introduction of moisture.

3 Only a final lot that is satisfactory with respect to thermal stability and each of the tests given under Identification, Tests and Assay may be released for use. Provided that the test for ovalbumin has been performed with satisfactory results on the final bulk vaccine, it may be omitted on the final lot. Thermal stability. Maintain samples of the final lot of freeze-dried vaccine in the dry state at 37 for 14 days. Determine the virus concentration as described under Assay in parallel for the heated vaccine and for unheated vaccine. The difference in the virus concentration between unheated and heated vaccine does not exceed 1.0 log 10, and the virus concentration of the heated vaccine is not less than the number of TCID 50 or plaque-forming units (PFU) equivalent to mouse LD 50 per human dose or IU per human dose or 3.0 log 10 per human dose. Identification When the vaccine reconstituted as stated on the label is mixed with specific yellow fever virus antibodies, there is a significant reduction in its ability to infect susceptible cell cultures. Tests Sterility (2.2.11). Complies with the test for sterility. Ovalbumin. Not more than 5 μg of ovalbumin per human dose, determined by a suitable immunochemical method (2.2.14). Abnormal toxicity (2.2.1). Complies with the test for abnormal toxicity. Bacterial endotoxins (2.2.3). Not more than 5 IU of bacterial endotoxin per human dose. Water (2.3.43). Not more than 3.0 per cent, determined by the semi-micro determination of water. Assay Titrate for infective virus in cell cultures using at least 3 separate containers of vaccine..titrate 1 container of an appropriate virus reference preparation in triplicate to validate each assay. The virus concentration of the reference preparation is monitored using a control chart and a titre is established on a historical basis by each laboratory. Calculate the individual virus concentration for each container of vaccine and for each replicate of the reference preparation as well as the corresponding combined virus concentrations using the usual statistical methods). The combined virus concentration for the 3 containers of vaccine is compared to the results of the reference preparation titrated in parallel, to obtain results in International Units. The assay is not valid if: the confidence interval (P = 0.95) of the estimated virus concentration of the reference preparation for the 3 replicates combined is greater than ± 0.3 log 10 IU;

4 the virus concentration of the reference preparation differs by more than 0.5 log 10 IU from the established value. The assay is repeated if the confidence interval (P = 0.95) of the combined virus concentration of the vaccine is greater than ± 0.3 log 10 IU; data obtained from valid assays only are combined by the usual statistical methods to calculate the virus concentration of the sample. The confidence interval (P = 0.95) of the combined virus concentration is not greater than ± 0.3 log 10 IU. The virus concentration is not less than the equivalent intcid50 or PFU of mouse LD50 per human dose or IU per human dose or 3.0 log 10 IU per human dose. If the virus concentration is determined in TCID 50 or PFU, the relationship between mouse LD50 and TCID50 or PFU is established by each laboratory and approved by the competent authority. The method shown below, or another suitable technique, maybe used to determine the mouse LD50 or IU per human dose or 3.0 log 10 per human dose. Mouse LD50. The statistically calculated quantity of virus suspension that is expected to produce fatal specific encephalitis in 50 per cent of mice of a highly susceptible strain, 4 to 6 weeks of age, after intracerebral inoculation. Appropriate serial dilutions of the reconstituted vaccine are made in diluent for yellow fever virus (0.75 per cent solution of bovine albumin in phosphate-buffered saline ph 7.4, or any other diluent that has been shown to be equivalent for maintaining the infectivity of the virus). Mice of a highly susceptible strain, 4 to 6 weeks of age, are injected intracerebrally under anesthesia with 0.03 ml of the vaccine dilution. Groups of not less than eight mice are used for each dilution; the series of dilutions is chosen so as to cover the range 0 to per cent mortality of the mice. Injection of the mice is performed immediately after the dilutions have been made. The mice are observed for 21 days and all deaths are recorded. Only survivors and deaths caused by typical yellow fever infections are counted in the computations. Mice paralyzed on the twenty-first day of observation are counted as survivors. The assay is not valid unless the confidence interval (P = 0.95) of the estimated virus concentration of the reference preparation for the 3 replicates Tests in monkeys for Yellow Fever Vaccine Each master and working seed lot complies with the following tests in monkeys for viraemia (viscerotropism), immunogenicity and neurotropism. The monkeys shall be Macacaspp. susceptible to yellow fever virus and shall have been shown to be non-immune to yellow fever at the time of injecting the seed virus. They shall be healthy and shall not have received previously intracerebralor intraspinal inoculation. Furthermore, they shall not have been inoculated by other routes with neurotropic viruses or with antigens related to yellow fever virus. Not fewer than ten monkeys are used for each test. Use a test dose of 0.25 ml containing the equivalent of not less than 5000 (3.7 log10 )IU and not more than 50,000 (4.7 log10) IU, determined by a titration for infectious virus and using the established equivalence between virus concentration and mouse LD 50 (see under Assay) determined by an in vitro titration for infectious

5 virus in cell culture. Inject the test dose into one frontal lobe of each monkey under anesthesia and observe the monkeys for not less than 30 days. Viraemia (Viscerotropism).Viscerotropism is indicated by the amount of virus present in serum. Take blood from each of the test monkeys on the second, fourth and sixth days after inoculation and prepare serum from each sample. Prepare 1:10, 1:100 and 1:1000 dilutions from each serum and inoculate each dilution into a group of at least four cell culture vessels used for the determination of the virus concentration. The seed lot complies with the test if none of the sera contains more than the equivalent of 500 (2.7 log 10 ) IU in 0.03 ml and at most one serum contains more than the equivalent of 100 (2.0 log 10 ) IU in 0.03 ml.. Immunogenicity. Take blood from each monkey 30 days after the injection of the test dose and prepare serum from each sample. The seed lot complies with the test if at least 90.0 per cent of the test monkeys are shown to be immune, as determined by examining their sera in the test for neutralization of yellow fever virus described below. It has been shown that a low dilution of serum (for example, 1:10) may contain non-specific inhibitors that influence this test; such serum shall be treated to remove inhibitors. Mix dilutions of at least 1: 10, 1:40 and 1: 160 of serum from each monkey with an equal volume of 17D vaccine virus at a dilution that will yield an optimum number of plaques with the titration method used. Incubate the serum-virus mixtures in a water bath at 37 for 1 h and then cool in iced water; add 0.2 ml of each serum-virus mixture to each of four cell-culture plates and proceed as for the determination of virus concentration. Inoculate similarly ten plates with the same amount of virus plus an equal volume of a 1:10 dilution of monkey serum known to contain no neutralizing antibodies to yellow fever virus. At the end of the observation period, compare the mean number of plaques in the plates receiving virus plus non-immune serum with the mean number of plaques in the plates receiving virus plus dilutions of each monkey serum. Not more than 10 per cent of the test monkeys have serum that fails to reduce the number of plaques by 50.0 per cent at the 1:10 dilution. Neurotropism. Neurotropism is assessed from clinical evidence of encephalitis, from incidence of clinical manifestations and by evaluation of histological lesions, in comparison with ten monkeys injected with the reference preparation. The seed lot is not acceptable if either the onset or duration of the febrile reaction or the clinical signs of encephalitis and pathological findings are such as to indicate a change in the properties of the virus. Clinical evaluation. The monkeys are examined daily for 30 days by personnel familiar with clinical signs of encephalitis in primates (if necessary, the monkeys are removed from their cage and examined for signs of motor weakness or spasticity). The seed lot is not acceptable if in the monkeys injected with it the incidence of severe signs of encephalitis, such as paralysis or inability to stand when stimulated, or mortality is greater than for the reference vaccine. These and other signs of encephalitis, such as paresis, in-coordination, lethargy, tremors or spasticity are assigned numerical values for the severity of symptoms by a grading method. Each day each monkey in the test is given a score based on the scale:

6 Grade 1 - rough coat, not eating, Grade 2 - high-pitched voice, inactive, slow moving, Grade 3 - shaky, tremors, in-coordination, limb weakness, Grade 4 - inability to stand, limb paralysis or death (a dead monkey receives a daily score of 4 from the day of death until day 30). A clinical score for a particular monkey is the average of its daily scores; the clinical score for the seed lot is the mean of the individual monkey scores. The seed lot is not acceptable if the mean of the clinical severity scores for the group of monkeys inoculated with it is significantly greater (P = 0.95) than the mean for the group of monkeys injected with the reference preparation. In addition, special consideration is given to any animal showing unusually severe signs when deciding on the acceptability of the seed lot. Histological evaluation. Five levels of the brain are examined including: Block I - the corpus striatum at the level of the optic chiasma, Block II - the thalamus at the level of the mamillary bodies, Block III - the mesencephalon at the level of the superior colliculi, Block IV - the pons and cerebellum at the level of the superior olives, Block V - the medulla oblongata and cerebellum at the level of the mid-inferior olivary nuclei. Cervical and lumbar enlargements of the spinal cord are each divided equally into six blocks; 15 μm sections are cut from the tissue blocks embedded in paraffin wax and stained with gallocyanin. Numerical scores are given to each hemisection of the cord and to structures in each hemisection of the brain as listed below. Lesions are scored as follows: Grade 1. Minimal: 1 to 3 small focal inflammatory infiltrates. Degeneration or loss of a few neurons. Grade 2. Moderate: 4 or more focal inflammatory infiltrates. Degeneration or loss of neurons affecting not more than one third of cells. Grade 3. Severe: moderate focal or diffuse inflammatory infiltration. Degeneration or loss of 33 to 90 per cent of the neurons. Grade 4. Overwhelming: variable but often severe inflammatory reaction. Degeneration or loss of more than 90.0 per cent of neurons. It has been found that inoculation of yellow fever vaccine into the monkey brain causes histological lesions in different anatomical formations of the central nervous system with varying frequency and severity (I. S. Levenbooket al., Journalof Biological Standardization, 1987, 15, ). Based on these two indicators, the

7 anatomical structures can be divided into target, spared and discriminator areas. Target areas are those which show more severe specific lesions in a majority of monkeys irrespective of the degree of neurovirulence of the seed lot. Spared areas are those which show only minimal specific lesions and in a minority of monkeys. Discriminator areas are those where there is a significant increase in the frequency of more severe specific lesions with seed lots having a higher degree of neurovirulence. Discriminator and target areas for Macacacynomolgus and Macaca rhesus monkeys are shown in the table 1 below: Table 1 - The discriminator and target areas for monkey. Type of monkey Discriminator areas Target areas Macaca cynomolgus Globus pallidus Substantia nigra Putamen Anterior/median thalamic nucleus Lateral thalamic nucleus Macaca rhesus Caudate nucleus Substantia nigra Globus pallidus Putamen Cervical enlargement Lumbar enlargement Anterior/ median thalamic nucleus Lateral thalamic nucleus Cervical enlargement Lumbar enlargement Scores for discriminator and target areas are used for the final evaluation of the seed lot. The individual monkey score is calculated from the sum of individual target area scores in each hemisection divided by the number of areas examined. A separate score is calculated similarly for the discriminator areas. Mean scores for the test group are calculated in two ways: (1) by dividing the sum of the individual monkey discriminator scores by the number of monkeys and (2) by dividing the sum of the individual monkey target and discriminator scores by the number of monkeys. These two mean scores are taken into account when deciding on the acceptability of the seed lot. The seed lot is not acceptable if either of the mean lesion scores is significantly greater (P = 0.95) than for the reference preparation. Labelling. The label states (1) the strain of virus used in preparation; (2) that the vaccine has been prepared in chick embryos; (3) the minimum virus concentration; (4) that contact with disinfectants is to be avoided; (5) the period of time within which the vaccine is to be used after reconstitution.

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