2004S-0212 - Pandemic Influenza Preparedness Plan
FDA Comment Number : EC23
Submitter : Ms. Tricia Hosch-Hebdon Date & Time: 11/09/2004 01:11:26
Organization : Idaho Department of Health and Welfare
State Government
Category :
Issue Areas/Comments
GENERAL
GENERAL
October 26, 2004



Idaho Department of Health and Welfare, Immunization Program Comments on the Draft National Influenza Pandemic Plan.



1. Priority Vaccination Groups: Members of the Immunization Program, Office of Epidemiology and Food Safety, Health Preparedness Program and several of the Idaho's Public Health Districts have indicated the need for the National Influenza Pandemic Plan to describe the process for assigning priorities groups, what priorities groups would look like if they differed from currently established priority groups and how such information would be disseminated to the state and local level. Priority groups are frequently mentioned through out the draft document but no where does it state how such priority groups will be established and how the states are suppose to implement and enforce vaccinations in these groups during a vaccine shortage. In addition, states need to know the level of flexibility that state and local governments would have in adjusting priority groups based on regional differences. In light of the current influenza vaccine shortage and the desperate need for federal guidance and input during this crisis, it is felt that during an influenza pandemic that key national guidance would be even more important and must be thoroughly addressed by the National Influenza Pandemic Plan. Further more, the necessity of standardization of guidelines across state jurisdictions will be critical for consistency and to limit regional disparities, especially in areas where cross-jurisdictional boundaries are plentiful.



2. Anti-virals: A detailed explanation of how anti-virals will be acquired and rationed during a pandemic influenza event is critical. Currently there is a great deal of confusion about how anti-virals would be acquired or distributed to state and local areas. Without a good understanding of which national programs and entities are coordinating these efforts it will make it harder for the states to be able to clearly and objectively direct resources and communications. In addition, in light of the 2004-2005 influenza vaccine shortage and the CDC's release of Influenza Antiviral Medications: 2004-05 Interim Chemoprophylaxis and Treatment Guidelines, it will be necessary to see how such guidelines effect disease transmission and treatment.



3. Vaccination Plans: A recommendation for more clear and concise guidelines for vaccine distribution, vaccine funding, vaccine redistribution and to the extent vaccine will remain private or public or a mixture of both is desperately needed. The current draft plan does not adequately address any
of these topics and has only a vague commentary on how such vaccine management and distribution practices should happen.