# Presentation: 467236

## The Draft HHS Pandemic Influenza Plan and Ongoing Preparedness Activities

- “The pandemic influenza clock is ticking.
-   We just don’t know what time it is.”
- 				*Ed Marcuse, ACIP Member*

- Ben Schwartz, National Vaccine Program Office

## Presentation Outline

- Current status and process to finalize draft HHS pandemic influenza preparedness & response plan
- Pandemic phases and key actions by phase
- HHS pandemic preparedness activities

## HHS Draft Pandemic Influenza Preparedness & Response Plan

- Plan was released for public comment (60 days) on August 26 (Federal register and NVPO website)
- Purposes of the plan
- Provide guidance to State/local health departments and health care organizations for planning
- Outline coordination and implementation of a response
- Define preparedness needs
- Identify key issues that remain to be resolved

## Pandemic Influenza Preparedness and Response Plan Contents

- Core Plan
- Describes national coordination and decision-making
- Provides an overview of key preparedness issues
- Defines legal authorities for pandemic responses
- Lists specific response activities by pandemic phase
- Annexes (13)
- CONOPS plan
- Guidance for State/local health department planning
- Guidance for health care system planning
- Detailed information by topic area

## Pandemic Influenza Preparedness & Response Plan Annexes 

- Influenza and influenza pandemics
- Surveillance
- Vaccine development
- Vaccination strategies
- Antiviral drug strategies
- Public health interventions to decrease disease spread
- Communications
- Research
- Lessons learned from the swine influenza program
- Comparison of planning/preparedness for pandemic influenza, SARS, and smallpox

## “Finalizing” the HHS Pandemic Influenza Plan

- Resolve key issues, especially related to vaccine and antiviral priorities and strategies
- Respond to public comments
- Modify table of response actions by pandemic phase to reflect revised WHO system
- Increase specific guidance on public health measures to decrease disease spread internationally and in communities
- Goal is to finalize the plan by end of Spring

## WHO Pandemic Influenza Phases, 2005

**Inter-pandemic phase** – no novel human infection
- Level 1: No substantial animal influenza threats
- Level 2: Substantial animal influenza threat present
**Pandemic alert phase** – novel human infection
- Level 1: Low risk – no/minimal person-to-person spread
- Level 2: Cluster with little pandemic risk
- Level 3: Cluster with substantial pandemic risk
**Pandemic phase** – sustained transmission in the general population
- Includes disease in other countries, globally, and between waves
**Post-pandemic phase**

## Critical Activities by WHO Pandemic Phase 

| Pandemic Phase | Critical activities |
| --- | --- |
| Pandemic alert, level 1: human cases, no p-to-p transmission |  Enhance surveillance
 Develop/test candidate vaccine
 Accelerate/monitor preparedness  |
| Pandemic alert, level 2 & 3: p-to-p transmission, local outbreak(s)  |  Activate HHS Secretary’s command center
 Enhance surveillance
 Investigate outbreak/define epidemiology
 Implement containment activities
 Initiate pandemic vaccine production
 Continue/accelerate preparedness
 Implement communications plan |

## Critical Activities by WHO Pandemic Phase

| Pandemic Phase | Critical activities |
| --- | --- |
| Pandemic phase, early |  Implement strategy to decrease intl spread
 Respond to initial U.S. cases
 Define epidemiology/identify risk groups
 Initiate vaccination
 Prepare for full-scale pandemic response |
| Pandemic phase, widespread disease |  Implement strategy to decrease community spread
 Implement full-scale pandemic response |

## U.S. Pandemic Influenza Preparedness: Surveillance

- Enhanced global surveillance
- Support for CDC bilateral cooperative agreements with Asian countries
- Support for personnel stationed at WHO and WPRO
- Support for specimen transport to WHO Collaborating Center laboratories

## U.S. Pandemic Influenza Preparedness: Vaccines

- Vaccine security and supply
- Contract to assure year-round egg availability
- Contract providing incentives for cell culture vaccine development and U.S. licensure & production
- Requests for proposals pending
- Cell culture or recombinant vaccine
- Antigen sparing strategy (adjuvant or alternate route of administration)
- Improvement of manufacturing process

## U.S. Pandemic Influenza Preparedness: Vaccines

- H5N1 vaccine
- Contracts with Sanofi and Chiron for investigational lots
- Contract with Sanofi for ~2 million doses of H5N1 vaccine produced using regular manufacturing process
- Addressing legal issues associated with use of reverse genetics for development of vaccine reference strains, and indemnification of pandemic vaccine manufacturers

## U.S. Pandemic Influenza Preparedness: Antiviral Drugs

- Antiviral drugs added to the Strategic National Stockpile (SNS)
- 2.3 million treatment courses of oseltamivir
- 3.5 (?) million treatment courses of rimantadine
- Meeting with DoD and VA to discuss antiviral drug strategies and stockpiling
- Draft priority groups considered

## U.S. Pandemic Influenza Preparedness: Communications

- Cross Departmental Communications working group established
- Message development, research and testing
- Material development
- Resources for local/state levels
- Linkages with emergency preparedness (e.g. _[www.Ready.gov](http://www.ready.gov/)_)
- Public Engagement Activities to broaden discussion with public at large

## U.S. Pandemic Influenza Preparedness: Support for States

- Funding provided for State/local planning through CDC BT grant program and HRSA hospital preparedness program
- Contractor (Rand) working with states to assess lessons learned from the influenza vaccine shortage and to identify “best practices” in pandemic planning & preparedness

## U.S. Pandemic Influenza Preparedness: International Activities

- Global Health Security Action Group technical working group on pandemic influenza
- Investigation of IPR for reverse genetics
- Comparison of antiviral stockpiling and use strategies
- Matrix of studies of pandemic-like vaccines
- Meeting on mathematical modeling
- Tabletop comparison of pandemic response plans
- Asia Pacific Economic Cooperation (APEC)
- Situation assessment of planning & preparedness
- Interventions to fill identified gaps

##  58th World Health Assembly, Geneva, May 16-19, 2005

- HHS-led WHA Resolution:  “Strengthening Pandemic Influenza Preparedness and Response”
- Urges member states to:
- Develop and implement national plans
- Increase vaccination coverage for annual influenza
- Consider developing domestic influenza vaccine production capacity
- Strengthen linkages and cooperation among national health and agriculture authorities
- Support an international research agenda
- U.S. to host pandemic influenza preparedness summit at WHA

## International Pandemic Influenza Research Symposium, April 4-5, 2005

- Convened (in collaboration with WHO) to discuss current state of research on pandemic influenza
- Identify research gaps and develop research priorities
- Obtain commitment from global funders to support the activities outlined in the plan
- 100+ attendees from around the world (researchers and funding organizations)
- Preliminary meeting summary to be discussed at World Health Assembly, May 2005

## Pandemic Influenza Research Priorities

- _Epidemiology_: country specific studies in animals and humans to identify risk factors
- _Reverse genetics_: studies to identify avian influenza genes with greatest interspecies transfer potential
- _Pathogenicity_: sequencing of genomes in epidemiologic and clinical framework so that genes and their function can be determined
- _Diagnostics_: Strengthen and extend global network; need for rapid and inexpensive diagnostics; clinical case definitions and syndromic surveillance

## Pandemic Influenza Research Priorities

- _Antivirals_: Clinical trials in all population groups; emergence of resistance in animal models; systematic approaches to influencing inflammatory cytokine expression in disease.
- _Immunology_: Develop, validate and standardize serologic tools; immune correlates of protection
- _Vaccines_: Optimize current flu vaccine immmunogenicity; dose sparing studies; adjuvants; live virus challenge model
- _Containment strategies_: studies on the effectiveness of public health measures; protocols for use in a pandemic; modeling
- _Viral transmission_: molecular changes associated with adaptation;  host factors that contribute to viral spread

## HHS Pandemic Preparedness Working Group

- Representatives from HHS agencies
- Objectives
- Identify pandemic preparedness activities being implemented by the agencies
- Identify potential gaps that need to be addressed
- Monitor progress and completion of preparedness activities
- Matrix and Gantt chart developed of preparedness activities and timelines