February 1-2, 2006 L’Enfant Plaza Hotel Washington, DC

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

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?

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

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?

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

What is the Feasibility for Developing an H5N1 Vaccine?

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

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?

How Can Distribution According to Priority Recommendations be Ensured?

Recommendation for Vaccine Priorities Tier 1Sub-Tier AVaccine and antiviral manufacturing (~40,000) Medical workers with direct patient contact (8-9 million) Sub-Tier B Persons  65 years with a risk condition, other age groups with two or more high risk conditions. (18.2 m, 6.9 m) Sub-Tier CPregnant women, contacts of children < 6 months of age, of immunocompromised. (3 m, 2.7 m, 6.9 m) Sub-Tier DPublic health emergency response workers (150,000) Key government leaders Tier 2Sub-Tier AOthers age groups with risk one condition (35.8 million) Healthy 65 years and older (17.7 million) Healthy 6-23 year olds (5.6 million) Sub-Tier BOther emergency, utility and transportation workers. (7 m) Sub-Tier COther key governmental decision makers. Funeral directors, etc. (62,000) Sub-Tier DRest of population (180 million)

Antiviral Priority Recommendations 1.Patients admitted to hospitalTreatment 2.Health care workers with direct patient contactTreatment 3.Highest risk outpatientsTreatment 4.Pandemic health responders, Public safetyTreatment 5.Increased risk outpatientsTreatment 6.Outbreaks in nursing homePEP 7.Healthcare workers – critical settingsProphylaxis 8.Critical infrastructure workersTreatment 9.Other outpatientsTreatment 10.Highest risk outpatientsProphylaxis 11.Other healthcare workers with direct patient contactProphylaxis

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

February 1-2, 2006 L’Enfant Plaza Hotel Washington, DC

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

Education and Communication Issues 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

How will the National Plan be Communicated and by Whom?

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

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

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

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

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

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

Who Will Develop and Distribute Enduring materials?

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

Who Will Interface with Professional Societies?

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

February 1-2, 2006 L’Enfant Plaza Hotel Washington, DC

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

Surveillance and Diagnostics Issues 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

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

Clinical vs. Laboratory Diagnosis

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

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

February 1-2, 2006 L’Enfant Plaza Hotel Washington, DC

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

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?

How Should Resistance be Evaluated for Seasonal and Pandemic Influenza?

What is the Appropriate Dose and Duration of Therapy?

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

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

Is There an Adequate Pipeline and Development of New Targets?

February 1-2, 2006 L’Enfant Plaza Hotel Washington, DC