Pandemic Influenza Preparedness Subpanel

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Defense Health Board Pandemic Influenza Preparedness Subpanel Gregory A. Poland, MD Vice-President, Defense Health Board Chair, Select Subcommittee on PI Planning and Response

Purpose Brief Background and Context Review of DHB PI Preparedness Recommendations Approval Vote

Members Workgroup Members Dr.Poland (Mayo Clinic) Dr.Ennis (University of Massachusetts Medical School) Dr.Silva (University of California, Davis) Dr. Oxman (University of California, San Diego) Dr. Kaplan (University of Minnesota) Dr. Miller (Fogarty Center, NIH) Dr. Dowdle (Emory University) Dr. Gardner (Fogarty Center, NIH) Dr. Lane (NIH) Dr. Clements (Tulane University) Dr. Walker (UTMB)

Background Select Subcommittee on Pandemic Influenza Response and Preparedness established by Dr. Winkenwerder in late 2005 Goals Assist DoD in PI planning and response Specific issues of concern include: Epidemiology Response Vaccine Antivirals PPE Surveillance

ROE DoD-specific Focus on areas within our and DoD s sphere of influence Focus on both immediate and future recommendations Focus on what s feasible

Background Letter of Agreement (Dec 05) Advisory role only DoD Pandemic Planning Overview (Jan 06) PI Scenarios (Jul 06) Role of Children in PI (Jul 06) DoD PI Response Specific Planning and Research Recommendations (Mar 06, Jul 07) Use of 1203 H5N1 vaccine (Jul 07) Use of PPE (Jul 07) Recommendations on vaccine, antivirals, convalescent plasma (Jul 07) Recommendations on Southern Hemisphere Vaccine (Oct 07) Recommendations on Convalescent Plasmatherapy (Jun 08) Pandemic influenza preparedness recommendations (May 09)

Specific Issues Anti-viral Recommendations Vaccine Recommendations DoD and Interagency Decision-making PI Research Recommendations Convalescent Plasma Recommendations PPE Recommendations Novel Flu Diagnostics Recommendations Antimicrobial Stockpile Recommendations Pneumococcal Vaccine Recommendations Phase I-IV Clinical Trial Recommendations

Context Teleconferences Email Face-to-Face Meeting 8 May 2009 Representatives from all DoD branches, NIH, CDC, DoD-GEIS, Health Affairs, DHHS, NVPO Update current situation in regards to H1N1 pandemic Review prior recommendations Resulted in 20 recommendations

Heightened active surveillance Change in severity of cases Change in epi of cases Change in antiviral sensitivity Expanded surveillance in Mexico and Central America

Antivirals Follow current CDC guidance for use Special situations Shipboard Special Ops Deployed forces Congregated forces: Recruit Training, Service Academies Concerns with one drug approach Replenishment of supplies

Special Populations New consideration of populations with specific needs Children Morbid obesity

Research DoD positioned to materially assist with advancing the science Transmission (USAFA) Antiviral efficacy and resistance Surveillance (Drift) Encourage DoD to actively fund and support research

Active Surveillance Heightened alert for case severity, changes in epidemiology, etc. Expand surveillance into Mexico and Central America Identify resources for focused Southern Hemisphere and equatorial surveillance is a priority DoD-GEIS funding is a concern in timely surveillance and response

Interagency Interactions NORTHCOM, Canadian Command, and Mexican Command interactions to be encouraged and strengthened

Diagnostics Expand ability to diagnose A/H1N1 to more locations Insure continued or expanded throughput capabilities Development and dissemination of a diagnostic algorithm Anticipate confusion issues this Fall with concomitant seasonal virus circulation Approval of alternate diagnostic platforms should be accelerated FDA approval

Respiratory Disease Research DoD-internal team needed for mission-critical clinical research and vaccine trials Long-term funding needed

Vaccine Trials Assist in clinical trials of candidate H1N1 vaccines ( DoD Infectious Diseases Clinical Research Program IDCRP) Enhance collaborations with NIH, BARDA

Vaccine Trials (reiterate October 2007 recommendations) Review plan for use of vaccine Consider differences in implementing 1 vs 2 dose schedules Electronic record keeping Insure active safety surveillance capabilities Electronic data transfer and database Establish reporting mechanisms Panel would like to review vaccine admin priorities and plan

Convalescent Plasma Reiterate May 2008 recommendations Collaborations with NIH, FDA, Pharma

Pneumococcal vaccine Review and update prioritization and administration plans Conjugate pneumococcal vaccines in phase III trials and licensure expected in near future

Surge Capacity Ensure availability of surge capacity of essential resources Consider manufacturer capacity limitations (vis a vis JIT ordering)

Communication and Education needs Providers of all levels Active duty Guard and Reserve components Beneficiaries, retirees Evaluate effectiveness of strategies

DISCUSSION