Pandemic Influenza Preparedness Subpanel Update

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Defense Health Board Pandemic Influenza Preparedness Subpanel Update Gregory A. Poland, MD Co-Vice-President, Defense Health Board Chair, Pandemic Influenza Preparedness Subpanel 12 November 2009

Subpanel Membership Dr. Gregory Poland (Mayo Clinic) Dr. Francis Ennis (University of Massachusetts Medical School) Dr. Joseph Silva (University of California, Davis) Dr. Michael Oxman (University of California, San Diego) Dr. Edward Kaplan (University of Minnesota) Dr. Mark Miller (Fogarty Center, NIH) Dr. Walter Dowdle (Emory University) Dr. Pierce Gardner (Fogarty Center, NIH) Dr. Clifford Lane (NIH) Dr. John Clements (Tulane University) Dr. David 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 the DHB s 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 Plasma Therapy (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

Recent Activity 16 September 2009 Meeting Representatives present from Health Affairs, DHHS, and MILVAX Received updates concerning DoD preparedness and response in regard to the H1N1 pandemic - Pneumococcal and H1N1 Vaccine Plans - Antiviral and PPE stockpiles - Active and passive vaccine safety surveillance plans following H1N1 vaccination

Findings Nationwide collaborative efforts regarding H1N1 vaccine safety surveillance DoD, HHS, and CDC NVAC s Vaccine Safety and Assessment Working Group (Poland and Garman) Sharing of information in the effort to standardize and synchronize entries across different databases Vaccine Safety Datalink as model for DoD data structure approach and statistical techniques to be employed

Findings Potential significant challenges in the event pandemic worsens include: Availability of trained providers within DoD Shortage of ICU nurses and supplies Budget issues

Findings Recent activities undertaken by DoD include: Standardization of definitions and risk windows Identification of ICD-9 codes for surveillance foci H1N1 vaccine three-phase surveillance study protocol submitted for IRB approval Heightened active surveillance: DoD increasing expansion of rapid diagnostic platform for agent identification and confirmation Pursuit of various communication approaches to inform providers and public and mitigate concerns regarding H1N1 vaccine safety

Findings Careful attention should be paid to diagnostic criteria and role of expert panel that would determine whether a case meets definition for a specific adverse event Lessons learned from Guillain-Barré Syndrome experience Reiterate previous recommendation regarding ensuring essential resources be available in event of surge capacity

DISCUSSION