1. Overview of Pandemic Influenza Planning Guide for SLTT
Pascale Wortley, MD, MPH
Health Services Research and Evaluation Branch
Immunization Services Division
NCIRD

2. Pre-pandemic vaccine Pre-pandemic stockpile
Purpose: protection of critical infrastructure
Trigger: sustained person-to-person transmission
Current: Clade million doses formulated and filled, 4.4 million bulk
Goal: 20 million courses for critical infrastructure by 2008
Facilitating vaccine manufacturing is primarily an OPHEP/HHS function…

3. Pandemic vaccine
4-6 month lag in manufacturing from identification of pandemic strain
Manufacturing capacity in flux, new manufacturers and cell-based methods
Use of adjuvants will stretch capacity
Once production of pandemic vaccine begins, it will be produced at a steady rate
Facilitating vaccine manufacturing is primarily an OPHEP/HHS function…

4. Pandemic vaccine, cont’d
Manufacturing capacity:
Facilitating vaccine manufacturing is primarily an OPHEP/HHS function…

5. Vaccine Priority Groups
Interagency Working Group reviewing priority groups under different scenarios of severity
DHS defining critical infrastructure
Timeline: April 2007
Actions:
The National Infrastructure Advisory Council (NIAC), chartered by DHS, has been charged with identifying critical infrastructure.
An interagency working group headed by NVPO/HHS has been charged with updating vaccine prioritization recommendations. Final prioritization recommendations will be issued in 4/07.
HHS and CDC will work to develop a vaccine allocation scheme for the 62 project areas.
Gaps:
Method for allocation is TBD. The most reasonable way to allocate would appear to be allocation on a per capita basis. However, it may be necessary to make some adjustments for population density of critical infrastrucutre workers and those in priority groups. This sets up a potential conflict (states who perceive that they have a high concentration of critical infrastrucuture workers or citizens in priority groups versus those that don’t have high concentrations.

6. Purchase and allocation
Federal government will purchase vaccine initially
Most vaccine will be allocated per population (some exceptions for critical infrastructure)
Vaccine will be shipped from manufacturers/distributors to project area-designated ship-to sites (process coordinated by CDC)
Actions:
The National Infrastructure Advisory Council (NIAC), chartered by DHS, has been charged with identifying critical infrastructure.
An interagency working group headed by NVPO/HHS has been charged with updating vaccine prioritization recommendations. Final prioritization recommendations will be issued in 4/07.
HHS and CDC will work to develop a vaccine allocation scheme for the 62 project areas.
Gaps:
Method for allocation is TBD. The most reasonable way to allocate would appear to be allocation on a per capita basis. However, it may be necessary to make some adjustments for population density of critical infrastrucutre workers and those in priority groups. This sets up a potential conflict (states who perceive that they have a high concentration of critical infrastrucuture workers or citizens in priority groups versus those that don’t have high concentrations.

7. Planning for key components of vaccination program (1)
General
Preparedness/Immunization collaboration
Phased program
Flexibility
Sustainability
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

8. Planning for key components of vaccination program (2)
Distribution/allocation
Identifying ship-to sites
Allocating within a project area
Ensuring vaccine security
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

9. Planning for key components of vaccination program (3)
Vaccination of priority groups
Vaccination plans may differ for occupationally-defined and risk-based priority groups.
Vaccination of some occupationally-defined groups may be delegated to agencies/institutions
Verification of priority group membership
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

10. Planning for key components of vaccination program (4)
Logistical aspects of vaccination planning
Number and location of sites
Staffing needs
Crowd control
Infection control
2 dose schedule
Ancillary supplies
Security
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

11. Planning for key components of vaccination program (5)
Communications
Cross cutting
Specific issues: location of vaccination, rationale for priority groups, 2nd dose
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

12. Planning for key components of vaccination program (6)
Tribal populations
Ensure inclusion of these populations in planning
Ensure cross-border coordination, where applicable
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

13. Planning for key components of vaccination program (7)
Special needs populations, issues to consider
Homebound persons
Physically disabled persons
Those relying on public transportation
Locally spoken languages
Appropriate communication channels
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

14. Planning for key components of vaccination program (8)
Vaccine tracking
Tracking administration of doses administered through registry, CRA or other system
Recording minimum data elements and other data
Process for flow of information from vaccination site to LHD, SHD, CDC must be defined (method, staffing, training)
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.

15. Planning for key components of vaccination program (9)
Adverse event monitoring
VAERS is the foundation
Designated vaccine safety coordinator
Administration under EUA or IND
EUA most likely
Actions:
CDC is working with project areas to identify vaccine ship-to sites, which will be the in-state delivery sites where control of pre-pandemic and initial pandemic vaccine will shift from federal to state control.
HHS is the lead for planning and coordinating physical distribution of vaccine from manufacturers storage sites to ship-to sites (includes security).
CDC is developing an automated system to monitor vaccine doses administered via state immunization registries and the Countermeasure Response Administration (CRA) system.
Adverse event monitoring will occur through VAERS and possibly VSD.
Gaps:
Coordination b/w immunization and preparedness programs has historically been poor. Need to ensure coordination between immunization programs and preparedness programs when states select their ship-to sites. Will work with CDC immunization and preparedness project officers to facilitate state-level coordination.
Approximately 85% of states indicate they can use registries to report vaccine doses administered. We suspect it’s much less and that many will have to use the CRA. Plan to pilot test system in selected states using seasonal influenza vaccination clinics.
ISO believes VAERS will need substantial capacity upgrading along with additional staff to handle surge during a pandemic vaccination campaign. Working with ISO to develop a budget and a plan.