1. 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.

2. 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

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

4. 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.

5. 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

6. 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.

7. 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.

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

9. 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)

10. 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

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

12. 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

13. 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 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.

14. Frequently Asked Questions

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

16. 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

17. 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.

18. 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!

19. 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

20. 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

21. 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.