New Vaccine Development Establishing Priorities: Volume II, Diseases of Importance in Developing Countries (1986) / Chapter Skim
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5. Predictions of Vaccine Development
5. Predictions of Vaccine Development
Pages 63-75
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From page 63... ...
The diseases and vaccine candidates chosen for the ranking process are shown in Tables 5.1 and 5.2 and described in detail in Appendixes D-1 through D-l9. Some marginal candidates were excluded (because of Much of the material in this chapter is from New Vaccine Development: Establishing Priorities, Volume I (Institute of Medicine, 1985)
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From page 64... ...
Polypeptide produced by recombinant DNA technology 25 0.95 0.99 Japanese encephalitis Inactivated virus produced in 50 0-.50 virus cell culture (Children in epidemic and endemic areas; foreign visitors to epidemic regions) Mycobscterium leprae Armadillo-derived M
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65 Time to Time to Licensure Adoption (years ) (years )
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From page 66... ...
Glycoprotein produced by rDNA technology in mammalian cells Attenuated live vector virus containing gene for protective glycoprotein antigen 3-5 0.85 10-20 0.50 Respiratory Polypeptides produced by 25 0.80 syncytial virus recombinant DNA technology (Infants at earliest possible age) Attenuated live virus 25 0.80 Rotavirus Attenuated high passage 10 0.90 (Infants at earliest possible bovine rotavirus age, preferably with oral polio vaccine)
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67 Time to Time to Cost Licen~ure Adoption per dose (yearn) (yearn)
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From page 68... ...
Clinical Trial Dif f iculty Attenuated live vector virus containing gene for broadly cross-reacting protective antigen A combination of purified colonization factor antigens and possibly other antigens Genet ically engineered attenuated strains Conjugated polyeaccharide Attenuated live virus Polypeptide recombinant vaccine produced in yeast Polypeptide produced by recombinant DNA technology Inactivated virus produced in cell culture Armadillo-derived M leprae Conjugated capsular polysaccharides, Groups A, C,Y, and W135 Trivalent, subunit vaccine (which must contain fusion proteins)
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From page 69... ...
69 Route of Adverse Delivery Incorporation Administration Reactions Requirements into EPI Intradermal Low grade fever, Cold chain required; Yes soreness, muscle aches possible freeze drying in future Oral None Adjuvant use may reduce Yes number of doses Oral Possibly mild diarrhea Cold chain for lyophilized Yes in 20% bacteria; adjuvant may be needed Intramuscular 5% local Refrigeration If in a polyvalent vaccine Parenteral. subcutaneous, Minimal Refrigeration of As a combination with or intramuscular lyophilized preparation IPV and other antigens Subcutaneous or Minimal Refrigeration Might be combined with intramuscular other nonliving vaccines Intramuscular or Negligible Refrigeration Could be incorporated at subcutaneous present; ef f icacy much improved if delivery possible at birth, i.e., with modified EPI schedules Subcutaneous Some possibility of life threatening effects associated with current vaccines: allergic encephalomyelitis; acute viral encephalitis Nothing unusual Yes Feasible Intramuscular Minor local Refrigeration Feasible Subcutaneous None Nothing unusual Subcutaneous or No data~unknown intramuscular Subcutaneous or No data—unknown Nothing unusual intramuscular Adjuvant required, Probably probably alum Probably
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From page 70... ...
Yellow fever virus (Young children) Vera cell Glycoprotein produced by rDNA technology in mammalian cells Attenuated live vector virus containing gene for protective glycoprotein ant igen Polypeptides produced by recombinant DNA technology Attenuated live virus Attenuated high passage bovine rotavirus Attenuated low passage bovine rotavirus Rhesus monkey rotavirus Attenuated gale mutant S
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From page 71... ...
Feasible, dependent on cost low grade fever Oral Present prototypes cause Cold chain for lyophilized Feasible mild diarrhea in 20: bacteria Oral None expected Lyophilized probably will Probably promptly withstand moderate ambient in endemic areas temperatures Subcutaneous Minimal Refrigeration Feasible
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From page 72... ...
; the relative risk of illness in various geographic population groups; and accessibility to the health care system. For reasons described in the next chapter, the committee assumed that most of the vaccine candidates would be delivered through the World Health Organization Expanded Program on Immunization (WHO-EPI)
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From page 73... ...
, the availability of animal models, the number of alternatives to be tested in human clinical trials, and possible difficulties in conducting clinical trials or in establishing efficacy and safety in the target population. Time to Licensure The time to licensure is defined as the shortest time in~which a vaccine could be licensed, if all developmental stages are completed without major delays.
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From page 74... ...
The committee based its predictions in these areas on the nature of each vaccine candidate and on requirements for existing similar vaccines. Production technology and delivery requirements also affect the cost per dose, which, in turn, may affect vaccine acceptance.
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From page 75... ...
1985. New Vaccine Development: Establishing Priorities, Volume I
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