Vaccine Development and Production

2. Vaccine Development and Production Moderator: Arnold Monto Discussant: John Treanor Rapporteur: Kristin Nichol

3. Vaccine Development and Production Issues to Consider • Can a “strain change” approach work? • If not, what pre-licensure data are needed? • Is a “pandemic-only” approach commercially viable • How can better correlates of immunity be derived? • How can evaluation of live vaccines for pandemic influenza be facilitated? • What is the liklihood of significant heterosubtypic/variant protection?

4. Vaccine Development and Production Issues to Consider • Production Issues • How to increase US production, assuming nationalization of supplies in a pandemic • Role of cell culture-based vaccines and use of adjuvants • Regulatory challenges in an era of rapid response • How to ensure distribution according to priority recommendations for use • Animal vs human vaccination • Regulatory issues for avian vaccines

5. Vaccine Deployment Issues to Consider • How much vaccine should be stockpiled? • How often should the stockpile be updated? • What would be an appropriate trigger for deployment of the stockpile? For population wide vaccination? • Should we consider pre-priming?

6. What is the Time frame for Development of a Vaccine and How Can it be Shortened?

7. What is the Feasibility for Developing an H5N1 Vaccine?

8. What is the Potential for Flexibility of the Backbone for a Foreign Avian Insert?

9. How Do We Increase US Production of a Vaccine? • What is the potential for cell culture-based vaccines and the use of adjuvants? • What are the regulatory challenges in an era of rapid response?

10. How Can Distribution According to Priority Recommendations be Ensured?

11. Recommendation for Vaccine Priorities

12. Antiviral Priority Recommendations

13. How Should We Prioritize Animal vs Human Vaccination to Control a Pandemic?

15. Education and Communication Moderator: John Bartlett Discussant: Jeffrey Levi Rapporteur: Michael Osterholm

16. Education and CommunicationIssues to Consider • Communication of the national plan • Outreach to public and private schools and to community services • Professional groups: medical systems, HMOs, community-based organizations • Liaison relations with national societies and organizations (i.e. Rotary Club, Kiwanis, Lions, Chamber of Commerce, etc.) • Enduring materials • Professional Societies

17. How will the National Plan be Communicated and by Whom?

18. COMMUNICATION: VEHICLES • Public: TV, radio, newspapers and Internet • Other: Phones (?), beepers • Electronic networks: CDC, WHO CIDPAP, IDSA, SHEA, ProMed, ATS, SCCM

19. Who Will Provide Outreach to Public and Private Schools and to Community Services?

20. COMMUNICATION: PUBLIC • Update • Directions: Recommendations • Antivirals/vaccines – who, where, how, when • Evaluations – OPDs, hospital, EW, designated facilities • Social distancing • Travel • Penalties

21. Who Will Communicate with Professional Groups, Such as Medical Systems, HMOs, and CBOs?

22. COMMUNICATION: MEDICAL PERSONNEL • Guidelines from authorative sources (DHHS) • Policies: Regional, local institutional • Medical updates • Specifics: Personnel, supplies, beds, medical data, risks, resources

23. Who Will Handle Liaison Relations with National Societies and Organizations (i.e. Rotary Club, Chamber of Commerce, etc.)?

24. Who Will Develop and Distribute Enduring materials?

25. COMMUNICATION: LEADERSHIP • International: WHO • National: DHHS • State: Health Department • City: Health Department • Institutional: Appoint • HMO: Appoint

26. Who Will Interface with Professional Societies?

27. COMMUNICATION: LESSONS • Credibility: Mayor Guiliani (Anthrax) • Sensitivity: St. Louis, MO (Smallpox) and 1918 pandemic flu • Pre-plan: Baton Rouge (Katrina) • Clarity: NYC (anthrax, WNV) • SARS

29. Surveillance and Diagnostics Moderator: Michael Tapper Discussant: Isaac Weisfuse Rapporteur: Cathy Petti

30. Surveillance and DiagnosticsIssues to Consider • Accuracy (sensitivity and specificity) • Point of care vs. referral (confirmatory) • Networks & uniform reporting tool (centralized data base) • Discrimination regarding etiology of presenting respiratory illnesses • Reporting: who, what, where, how, when • Specimen repository (resistance testing) • Timeliness and transparency

31. Surveillance and DiagnosticsIssues to Consider • Clinical vs. laboratory diagnosis • Point of care vs. referral (confirmatory) • Bidirectional reporting: who, what, where, how, when

32. Clinical vs. Laboratory Diagnosis

33. Will Diagnosis and Treatment Occur at the Point of Care or after a Confirmatory Referral?

34. How Will the Reporting of Cases be Handled and by Whom?

36. Use of Antivirals and Antiviral Development Moderator: Andy Pavia Discussant: John Beigel Rapporteur: Anne Moscona

37. Use of Antivirals and Antiviral Development Issues to Consider • Resistance evaluation for seasonal and pandemic influenza • Dose and duration of therapy • Special populations: elderly, pediatrics, immunocompromised • Pandemic Strategy Questions • Therapy vs. prophylaxis • How large should drug stockpile be and what specific drugs should it contain? • Do you agree with the NVAC guidelines for priority groups and strategies for antiviral use as detailed in HHS Pandemic Plan? • New compounds in development that might be available in the next 1-2 years • Is there an adequate pipeline and development of new targets?

38. How Should Resistance be Evaluated for Seasonal and Pandemic Influenza?

39. What is the Appropriate Dose and Duration of Therapy?

40. How Should Antivirals be Used for Special Populations, Including the Elderly, Children, and Those Who Are Immunocompromised?

41. Pandemic Strategy Questions • Therapy vs. prophylaxis • How large should drug stockpile be and what specific drugs should it contain? • Do you agree with the NVAC guidelines for priority groups and strategies for antiviral use as detailed in HHS Pandemic Plan?

42. What New Compounds Might be Available in the Next 1-2 Years?

43. Is There an Adequate Pipeline and Development of New Targets?