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Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
Interpandemic Vaccination  Controversy, Challenge, Opportunity
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Interpandemic Vaccination Controversy, Challenge, Opportunity

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Pandemic influenza vaccine development strategic planning

Pandemic influenza vaccine development strategic planning

Published in: Health & Medicine, Technology
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  • 1. Interpandemic Vaccination Controversy, Challenge, Opportunity Robert W Malone, MD, MS [email_address]
  • 2. Overview: Interpandemic vaccines, a potential business opportunity? <ul><li>Introduction: Interpandemic vaccination, a metaphor for a new approach to vaccine development. </li></ul><ul><li>Context: Is this the right time for serious consideration of this issue? </li></ul><ul><li>Feasibility: Are Interpandemic vaccines technically possible, would they be useful, and could they be viable as product candidates? </li></ul><ul><li>Strategy: Is “pandemic” influenza the right target, or are there others? </li></ul><ul><li>Conclusion: Possible action items. </li></ul>
  • 3. Interpandemic vaccination, a metaphor for a new approach to vaccine development. <ul><li>Current metaphor: Vaccine products are designed to provide protection against disease caused by currently circulating pathogens and toxins </li></ul><ul><li>Interpandemic metaphor: Develop, license, and implement vaccine products designed to provide protection from potential threat agents (pathogens, toxins, other antigenic biologically active substances) </li></ul>
  • 4. Interpandemic vaccination, a metaphor <ul><li>Current vaccine metaphor: </li></ul><ul><ul><li>Protection from disease caused by virus, bacteria, or toxin known to represent a significant current public health threat (typically with a well defined cost-benefit ratio) </li></ul></ul><ul><ul><li>Protection from disease caused by an emerging or predictable threat with known biological properties </li></ul></ul><ul><ul><ul><li>Influenza: WHO defined seasonal influenza strains </li></ul></ul></ul><ul><ul><ul><li>Biodefense: Weaponized versions of natural pathogens </li></ul></ul></ul>
  • 5. Interpandemic vaccination, a metaphor <ul><li>“ Interpandemic” metaphor: </li></ul><ul><ul><li>Protection from disease caused by a potential but not yet circulating biologically active agent. </li></ul></ul><ul><ul><ul><li>Potential pandemic influenza </li></ul></ul></ul><ul><ul><ul><li>Engineered biowarfare/bioterror threats </li></ul></ul></ul><ul><ul><li>A proactive approach to public health in which “herd immunity” may be used to reduce risk of emerging pathogens. </li></ul></ul><ul><ul><ul><li>Constrain evolutionary options available to existing pathogens </li></ul></ul></ul><ul><ul><ul><li>Anticipate and mitigate risks of engineered threat agents </li></ul></ul></ul><ul><ul><ul><li>Complement “chinks in the armor” of existing innate and adaptive immune system </li></ul></ul></ul><ul><ul><li>Associated with unique regulatory affairs “strategic challenges” </li></ul></ul>
  • 6. Context: Is this the right time ? <ul><li>Pandemic influenza planning and preparation </li></ul><ul><ul><li>Traditional approach inadequate </li></ul></ul><ul><ul><ul><li>Mismatch between epidemiologic modeling and manufacturing/distribution timelines </li></ul></ul></ul><ul><ul><li>Scientific knowledge has advanced </li></ul></ul><ul><ul><ul><li>Molecular virology studies are successfully identifying specific determinants of influenza A infectivity and pathogenesis </li></ul></ul></ul><ul><ul><li>Market exists </li></ul></ul><ul><ul><ul><li>Multiple governments are purchasing and stockpiling vaccine products in anticipation of a pandemic </li></ul></ul></ul><ul><ul><li>Regulatory pathways for licensure have been (partially?) created </li></ul></ul>
  • 7. Context: Is this the right time? <ul><li>Biodefense: </li></ul><ul><ul><li>Current focus is on known (existing) threat agents </li></ul></ul><ul><ul><li>Near-future focus will be on potential engineered pathogens </li></ul></ul><ul><ul><li>Forward-looking programs (DoD DTRA/JPO-Bio) are identifying biologic mechanisms and pathways which may be exploited to create threat agents (“chinks in the armor”) </li></ul></ul><ul><ul><li>A variety of funding programs are available to support product development </li></ul></ul><ul><ul><li>Novel regulatory solutions for licensure have been created (“correlates of protection, animal rule”) </li></ul></ul>
  • 8. Feasibility: Interpandemic vaccines All are required for feasibility
  • 9. Feasibility: Technical considerations (a “reality test” checklist) <ul><li>Is there a need? </li></ul><ul><li>Is there a market? </li></ul><ul><li>Is there sufficient capital? </li></ul><ul><li>Can we identify appropriate target antigens? </li></ul><ul><li>Can we develop vaccine candidates directed against identified antigens? </li></ul><ul><li>Can we demonstrate pre-clinical POC ? </li></ul><ul><li>Can we perform non-clinical pharm/tox? </li></ul><ul><li>Can we identify correlates of protection? </li></ul><ul><li>Can we assess clinical activity? </li></ul><ul><li>Can we assess clinical safety? </li></ul>All are required for feasibility!
  • 10. Feasibility: Technical considerations <ul><li>Relevant technologies include: </li></ul><ul><ul><li>Molecular modeling </li></ul></ul><ul><ul><li>Genetic drift analysis/phylogenetic modeling </li></ul></ul><ul><ul><li>“ Synthetic” viruses (reverse genetics, reassortants) </li></ul></ul><ul><ul><li>Nucleic acid vaccination </li></ul></ul><ul><ul><li>Engineered VLP </li></ul></ul><ul><ul><li>Peptide vaccines (T and B epitope) </li></ul></ul><ul><ul><li>Novel protein antigen production (Baculovirus etc.) </li></ul></ul><ul><ul><li>Animal model systems (ferret, mouse, chimeric, adoptive transfer) </li></ul></ul><ul><ul><li>Methods for assessing immunologic correlates (microneuts to tetramers) </li></ul></ul><ul><li>Not all vaccine systems may be appropriate </li></ul>
  • 11. Feasibility: Would an Interpandemic vaccine be useful? <ul><li>The current influenza vaccine manufacturing model may result in vaccine not being available until after the majority of humans have been infected. (+) </li></ul><ul><li>One explanation for the reduced mortality in older cohorts during 1918 epidemic is the earlier circulation of a related strain. (+) </li></ul><ul><li>It is possible that pre-existing titers against a related (slightly mis-matched) strain may reduce potency of strain-matched vaccine. (-) </li></ul><ul><li>Prior examples of seasonal vaccine strain “mismatch” suggest limited efficacy. (-) </li></ul>
  • 12. Feasibility: Would an Interpandemic vaccine be commercially viable? <ul><li>Currently in US, influenza vaccine is priced as a commodity </li></ul><ul><li>Various approaches currently being explored to differentiate products (Flumist, tetravalent- 2 A strains/2 B strains, filled syringe) </li></ul><ul><li>Inclusion of pre-pandemic antigens in a multivalent seasonal vaccine could be considered </li></ul><ul><li>US DoD could facilitate </li></ul><ul><ul><li>Has supported influenza vaccine innovation </li></ul></ul><ul><ul><li>Administration to DoD personnel under IND could yield robust safety database supporting licensure </li></ul></ul>
  • 13. Strategy: Is “pandemic” influenza the right target, or are there others? <ul><li>Pandemic influenza: </li></ul><ul><ul><li>Unique current global consensus supporting planning , countermeasure development and stockpiling. </li></ul></ul><ul><ul><li>Emerging recognition and consensus that current vaccine manufacturing and distribution processes may not be adequate- even if there were sufficient capacity! </li></ul></ul><ul><ul><li>Generally high level of public and professional support for planning and stockpiling (contrast to Smallpox vaccine) </li></ul></ul><ul><li>Biological threat agents </li></ul><ul><ul><li>Support (and funding) within specialized communities, public wariness </li></ul></ul>
  • 14. Conclusion: Possible action items <ul><li>Is there enthusiasm/support for interpandemic vaccine product within governmental and NGO stakeholders </li></ul><ul><ul><li>HHS/BARDA/OEP </li></ul></ul><ul><ul><li>DoD </li></ul></ul><ul><ul><li>WHO </li></ul></ul><ul><li>Is there a pathway to licensure for an interpandemic vaccine product? </li></ul><ul><ul><li>CBER </li></ul></ul><ul><ul><li>EMEA </li></ul></ul><ul><li>Is there support within influenza thought leaders, and what are the objections (if any)? </li></ul><ul><li>Could existing market opportunities be enhanced by adding a interpandemic product? </li></ul>
  • 15. Thank you for your interest and attention! Personal contact information: Robert Malone, MD, MS 771 Mitchell Road Jasper, GA 30143 Maryland physician license #DOO55466 Office 770 735 1549 Cell 240 994 3334 Email [email_address] Website www.cieloazure.com

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