vaccine development gerald r. kovacs, ph.d. scientific director advanced bioscience laboratories...
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Vaccine Development
Gerald R. Kovacs, Ph.D.Scientific Director
Advanced BioScience LaboratoriesMaryland, USA
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Vaccines work by mimicking disease agents and stimulating the immune system to build up defenses
against them
Vaccine design and development
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History of Vaccines
1798 - Edward Jenner noted:• Smallpox and Cowpox:
• Milkmaids frequently contracted cowpox which caused lesions similar to that smallpox• Milkmaids who had cowpox almost never got smallpox
• Jenner’s experiment:• Collected pus from cowpox sores• Injected cowpox pus into boy named James Phipps• Then injected Phipps with pus from smallpox sores• Phipps did not contract smallpox
• First to introduce large scale, systematic immunization against smallpox
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Antigen presentation
T-helper cell
Killer T cell
B cell: antibodies(neutralize & bridge)
Antigen presentation
•Non-infectious vaccines
•Live attenuated virus•Carrier vaccines•DNA vaccines
…By inducing adaptive immunity & memory!
How do vaccines work?
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Vaccine Development
Agent Antigen ID Vaccine Candidate
Vaccine Characteri
zationPreclinical
GMP Manufact
urePhase 1 Phase 2 Phase 3
Safety
Pivotal Animal Efficacy
Animal Efficacy Model Development
Phase 4
Proof of ConceptFeasibility
FormulationIdentityPurity
StabilityRisk Assessments
PotencyToxicology
DosageSchedule
Mech. of ActionMarkersAdjuvant
GMP ProductionGLP ToxicologyGCP EvaluationQuality Control
Quality AssuranceRegulatory Affairs
IND BLAEUA
3-7 years 1-2 years 5-10 years
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Probability of transition between each phase of development
57% 72% 71% 80%79%
Pre-Clinical
Phase 1 Phase 2 Phase 3 BLA Market
Cumulative probability of success through each phase
57% 41% 32% 23% 18.4%
Probability of Success in Transition
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Vaccine Development Timeline
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1967. FluMist concept published in Nature
1991. Developed with NIAID support and licensed to Wyeth
1995. Licensed to Aviron.
2003. Approved for use.
From idea to approval can take decades and $100s of millions.
Effective vaccines for many diseases (HIV, Malaria) elusive after substantial investment of resources
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EBOLA VIRUS VACCINES
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Ebola Vaccines in DevelopmentPreclinical Phase 1 Phase 2 Phase 3
Profectus VSV
Inovio DNA
Mapp BioP ZMapp
Vaxart Oral
GSK ChAd3
Merck ∆G-VSV
GSK ChAd3,Merck VSV,
Placebo
J&J/Bavarian Nordic P/B
GSK ChAd3
NovaVax VLP
Bavarian Nordic MVA
Discovery
Novartis RNA
Protein Sciences subunit
USAMRIID replicons and VLPs
TJU Attenuated rabies vector
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Emerging and Re-emerging Infectious Diseases
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Future of Vaccines
• Public-Private Partnerships• Continued research on host-pathogen responses• Innovation and rational design of vaccines• Use of systems biology• Rapid and flexible production platforms• Effective regulatory pathways• Long term federal and private industry support
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THANK YOU