February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC
Vaccine Development and Production
Moderator: Arnold MontoDiscussant: John TreanorRapporteur: 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 1 Sub-Tier A Vaccine 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 C Pregnant women, contacts of children < 6 months of age, of immunocompromised. (3 m, 2.7 m, 6.9 m)
Sub-Tier D Public health emergency response workers (150,000)
Key government leaders
Tier 2 Sub-Tier A Others 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 B Other emergency, utility and transportation workers. (7 m)
Sub-Tier C Other key governmental decision makers.
Funeral directors, etc. (62,000)
Sub-Tier D Rest of population (180 million)
Antiviral Priority Recommendations
1. Patients admitted to hospital Treatment
2. Health care workers with direct patient contact Treatment
3. Highest risk outpatients Treatment
4. Pandemic health responders, Public safety Treatment
5. Increased risk outpatients Treatment
6. Outbreaks in nursing home PEP
7. Healthcare workers – critical settings Prophylaxis
8. Critical infrastructure workers Treatment
9. Other outpatients Treatment
10. Highest risk outpatients Prophylaxis
11. Other healthcare workers with direct patient contact Prophylaxis
How Should We Prioritize Animal vs Human Vaccination to Control a
Pandemic?
February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC
Education and Communication
Moderator: John BartlettDiscussant: Jeffrey Levi
Rapporteur: Michael Osterholm
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
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, 2006L’Enfant Plaza Hotel
Washington, DC
Surveillance and Diagnostics
Moderator: Michael TapperDiscussant: Isaac Weisfuse
Rapporteur: Cathy Petti
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
Surveillance and DiagnosticsIssues 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, 2006L’Enfant Plaza Hotel
Washington, DC
Use of Antivirals and Antiviral Development
Moderator: Andy PaviaDiscussant: 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, 2006L’Enfant Plaza Hotel
Washington, DC