Good morning, it is a pleasure for us to be hear at the National immunization Conference. Today, I’d like to introduce the Strategic National Stockpile to you.

Vaccines and the Division of Strategic National Stockpile (DSNS): Inventory, Roles, and Responsibilities Yesterday, some of you may have heard about the SNS in the session titled - Hurricane Katrina: Lessons Learned for Future Preparedness In this presentation, I will explain more about the SNS and highlight our roles in responses that may include stockpiled vaccines. Steven A. Adams MPH Director (Acting) Division of Strategic National Stockpile Coordinating Office for Terrorism, Preparedness and Emergency Response

Agenda Mission Formulary Emergency Response Concept Vaccine Inventory Frequently Asked Questions Roles Responsibilities

Deliver critical medical assets to the site of a national emergency Mission Deliver critical medical assets to the site of a national emergency Vision The nation’s premier medical materiel preparedness and response organization:  we deliver the right assets where they are needed, when they are needed As a stand alone stockpile, our mission is to deliver critical medical assets to the site of an emergency, especially when the responders are in need of immediate pharmaceutical/medical supplies that may not be readily available through commercial venues.

Formulary Composition Contents Pharmaceuticals Medical Supplies Medical Equipment Vaccines Botulinum Antitoxin Based on Category A Threat Agents Smallpox, anthrax, botulism, viral hemorrhagic fevers, plague & tularemia Chemical nerve agents Recommended by Subject Matter Experts Government and non-government representation Experts in: Biological, chemical, and radiological threats Other medical specialties We based our initial formulary on the 1999 DHHS Operating Plan for Anti-Bioterrorism Initiative in addition to inputs from various intelligence agencies and the advice of subject matter experts. Our goal was to give local authorities the items they needed to respond to Category A biological and chemical threat agents. We update our formulary as new information becomes available. Our subject matter experts meet periodically to review current formulary items and to suggest possible changes. These experts come from government and non-government organizations and have years of experience in the fields of biological, chemical, and radiation agents, pediatrics, infectious disease, critical care, burn and trauma, and emergency medicine. Ability to cause disease by the aerosol route Stable enough in the environment after aerosol release to cause disease Most of the civilian population is susceptible to disease caused by these agents Many have high morbidity and mortality Some are (smallpox, pneumonic plague) contagious person-to-person Many are difficult to diagnose and/or treat Most have been identified as agents that were previously researched/developed as biological weapons by offensive biological weapons programs

Emergency Response Concept (1 of 4) Provide rapid delivery of a broad spectrum of support for an ill-defined threat in the early hours of an event Provide large shipments of specific materiel when a threat is known Provide technical assistance to receive and distribute SNS materiel during an event Our concept for responding to a large-scale public health emergency includes: Providing rapid delivery of a broad spectrum of drugs and other items in the early hours of a terrorist event to allow local authorities to begin responding to an ill-defined threat. Providing shipments of large and continuous quantities of specific items once a threat is known. Providing technical assistance from our Technical Advisory Response Unit or TARU during an event. The TARU consists of 5-7 individuals who will work with state and local authorities to help them receive, distribute, dispense, and replenish Program materiel. The TARU will remain for as long as it is needed.

Emergency Response Concept (2 of 4) 12-hour Push Packages Pre-packed and configured materiel in transport-ready containers Pre-positioned in secure facilities near major transportation hubs Delivered rapidly by world class transport partners Color coded and numbered for rapid identification by state and local authorities 12 Hour Push Package is the core of our response – We deliver materiel to the safe location that is designated by the state. The state is then responsible for all subsequent local transportation of materiel. The location designated is likely to be a Receipt, Staging, Storage (RSS) where materiel is received and broken down into smaller quantities to facilitate deliver to local destinations such as dispensing and treatment sites.

Emergency Response Concept (3 of 4) Specific Item Support Vendor Managed Inventory (VMI) Stockpile Managed Inventory (SMI) Vaccines Buying Power/Surge Capacity

Emergency Response Concept (4 of 4) Technical Advisory Response Unit (TARU) Comprised of public health, emergency responders and logistics experts Provides advice & technical assistance regarding use of SNS materiel Team deploys with the 12-hour Push Package TARU MISSION _ Facilitate the deployment and arrival of the Strategic National Stockpile (SNS) and guide the effective employment of SNS assets that are rapidly dispatched to a terrorist, natural, or technological disaster TARU DUTIES – Please Note that TARU and SNS consultants defer mass vaccination planning and organization to NIP Assist S/L authorities with ordering additional materiel as needed Provide technical assistance on Receipt, Staging, and Storing (RSS) operations, distribution and dispensing Anticipate and advise S/L on future needs Oversee SNS materiel not released to S/L authorities TARU TEAMS - SNS maintains 5 fixed TARU teams Two teams = 90 minute recall 24/7/365; 7-9 SNS Program Staff Lead Operations Logistics (2) Liaisons (2) Communications US Marshals (2)

Vaccines & Antitoxins (Currently in Inventory) Anthrax Vaccine Adsorbed (AVA)* Anthrax Immune Globulin Smallpox vaccine ACAM 2000 (Acambis) WetVax (Aventis Pasteur) DryVax (Wyeth)* Vaccinia Immune Globulin* *Licensed by FDA Those of you familiar with the Smallpox program are somewhat familiar with the SNS vaccines. We hold the nation’s supply of spox vaccine and now Anthrax AVA. Anthrax- Bacteria

Vaccines & Antitoxins (Currently in Inventory) Smallpox vaccine diluents Diluent ACAM 2000 1:1 Diluent Aventis 1:5 (Allergy Labs) Diluent DryVax 1:1 (Baxter) Diluent DryVax 1:5 (CBL) Bifurcated needles Transfer needles

Vaccines & Antitoxins (Currently in Inventory) Botulinum Antitoxin Heptavalent ABCDEFG (Cangene) Heptavalent ABCDEFG (PerImmune) Bivalent AB (Aventis Pasteur)* Monovalent E (Aventis Pasteur) Monovalent A (Cangene) *Licensed by FDA

Future Vaccines rPA vaccine (anthrax) MVA vaccine (smallpox) “Anthrax therapeutics” (anthrax) H5N1 vaccine In bulk, at manufacturer ? Seasonal influenza vaccine Ancillary supplies ! You may recall that HHS is procuring a supply of H5N1 vaccine. At this time, while it is being “stockpiled”, we do not hold the vaccine. - Follow-up; it is held by the manufacturer until completion of clinical trials/licensure/etc. In the 2004-2005 Influenza Season; DSNS was the holder of the IND vaccine purchased for use if called for. At this stage in the Pandemic Plans, DSNS is being asked to procure ancillary supplies that may be in short supply should a pandemic occur.

Frequently Asked Questions

What about….?? Tetanus toxoid vaccine Rabies vaccine Rabies immune globulin No requirement or directive at this point to include

Where are the SNS vaccines? NOT in the 12-hour Push Packages Vaccine Repositories 24 hr monitoring systems Located around the US Meet cGMP standards Quality agreements with manufacturers for IND products

What is the DSNS Role in Vaccines? Store vaccines and antitoxins Monitored conditions Delivery to affected location Delivery protocols Maintain cold chain Guide state planners for preparing for PODs/vaccination clinics Written Guidance, technical assistance, evaluation Seated with me is our PPB Director, Tim Quinn. Tim’s crew of state consultants work with each project area to assure the receiving authority is ready to further distribute the SNS assets.

DSNS Role in Vaccines What We Don’t Do Administer vaccines Provide treatment recommendations Retrieve unused vaccines Re-distribution of vaccines Re-distribution guidance Cold chain management , storage, and mass vaccination requires a large planning effort before the stockpile ever arrives. We are hear today, in hopes that your immunization programs and your SNS/BT/emergency Management programs are well harmonized before SNS vaccine arrive. In many cases you, the immunization program managers, will become the emergency response “experts” in an immunization event!

How Do We Ship Vaccines? What About Non-FDA Approved Vaccines/Antitoxins? IND protocols Held by CDC DSNS not involved with protocols Allow assets to be shipped across state lines EUA Eliminates need for informed consent Must still inform Allows assets to be shipped across state lines

Summary of FAQs DSNS has limited number of vaccines, some in limited quantities Shipments dictated by event Cold Chain will be maintained during shipment DSNS does not make treatment recommendations DSNS does not provide redistribution of vaccines

Questions? We would like to answer all of your questions. DSNS has representatives here today from our Science Branch, Program Preparedness, and the Program Coordination Branch.