Vaccines and the Division of Strategic National Stockpile

Vaccines and the Division of Strategic National Stockpile (DSNS): Inventory, Roles, and Responsibilities 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 – Vaccine Inventory – Roles – Responsibilities

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

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

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

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

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

Vaccines & Antitoxins (Currently in Inventory) • Anthrax Vaccine Adsorbed (AVA)* • Anthrax Immune Globulin • Smallpox vaccine – ACAM 2000 (Acambis) – Wet. Vax (Aventis Pasteur) – Dry. Vax (Wyeth)* • Vaccinia Immune Globulin* *Licensed by FDA Anthrax- Bacteria

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

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

Future Vaccines • r. PA vaccine (anthrax) • MVA vaccine (smallpox) • “Anthrax therapeutics” (anthrax) • H 5 N 1 vaccine – In bulk, at manufacturer • ? Seasonal influenza vaccine • Ancillary supplies

Frequently Asked Questions

What about…. ? ? • • Tetanus toxoid 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 c. GMP 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

DSNS Role in Vaccines What We Don’t Do • • • Administer vaccines Provide treatment recommendations Retrieve unused vaccines Re-distribution of vaccines Re-distribution guidance

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?