Avian Influenza Vaccines, Eurasian HPAI H5

The Animal and Plant Health Inspection Service (APHIS), National Veterinary Stockpile (NVS) is the nation's repository of critical veterinary supplies, equipment, and service resources. It exists because of the nation's concern over animal diseases of catastrophic proportions that would
- deplete State and local response inventories,
- generate surge requirements that would overwhelm commercial sources, and
- prevent unaffected States from providing significant help for fear of the threat crossing their borders

The NVS' ability to deploy within 24 hours large amounts of critical veterinary resources ensures states have what they need to respond to catastrophes and other outbreaks. The arrival and subsequent evolution of Eurasian HPAI H5 viruses of clade 2.3.4.4 lineage (EA H5 viruses) in North America has resulted in a catastrophic epiornitic, affecting both domestic poultry and captive avian wildlife. These viruses are likely to persist within the wild bird compartment which will serve as a reservoir and continue to pose a significant threat to U.S. poultry and avian collections.

Therefore, NVS seeks sufficient supplies of vaccine, to be used singly or in combination with other vaccines that are effective against EA H5 viruses, suitable for use in chickens and/or turkeys ranging from one-day of age up to ≥ 3 years of age. The goal is to acquire an emergency/supplementary stockpile of EA H5 vaccines available for delivery anywhere in the United States within 24 hours of order by the NVS.

Such products might include but not be limited to the following formulations/platforms: finished vaccine with shelf-life ≥ 1 year; vaccine precursors that can be rapidly processed into finished vaccine (e.g., antigen concentrates for inactivated vaccines) with potency retention of ≥ 2 years; and modified-live, or nonviable/nonreplicating vaccines that can be stored in a manner to ensure potency retention of ≥ 2 years. This vaccine stockpile would be used for emergency vaccination and to supplement commercial supplies as part of a larger vaccination campaign. All finished vaccines or vaccine precursors would be stored and maintained at the manufacturer.

Nationally, the placement rate of laying hens and meat turkeys is approximately 20 million birds per month. With each bird requiring two doses of vaccine prior to placement, 80 million doses per month will be needed just for these two sectors alone. Therefore, vaccine companies should minimally have a production capacity ≥ 100 million doses per month to address these two sectors.

NVS seeks a contract will have the following components:
- Production and banking of AI vaccine or vaccine precursors: Contractors would produce and store a minimum of 100 million doses to a maximum of 500 million doses of vaccine or vaccine precursor that are effective against EA H5 viruses, whether used alone or as combinations of different vaccines;
- Vaccine must be fully licensed, conditionally licensed, or permitted in accordance with the CVB regulations. Delivery anywhere within the continental US of up to 100 million doses of finished vaccine eligible for distribution and sale must be made within 10 calendar days of order as directed by the NVS;
- Vaccine or vaccine precursor must be stored in a manner consistent with the longest potency viability of the product, and demonstrate satisfactory potency when tested at twelve (12) month intervals throughout the duration of the contract;
- Small serials of finished vaccine from vaccine precursor will be produced by the manufacturer every twelve (12) months and potency tested by the manufacturer and provide potency data for review by the CVB;
- Samples of finished vaccine and/or serum samples from vaccinated birds will be provided to CVB if requested by the CVB;
- Based on the satisfactory results of the yearly potency testing, NVS reserves the right to extend storage of the vaccine or vaccine precursor for up to five (5) years from the date of manufacture;
- Contracts for vaccines failing to meet minimum potency criteria at any time during the period of performance would be terminated.

The intent is to award multiple Indefinite-Delivery, Indefinite-Quantity contracts with a guaranteed minimum of 100 million doses up to a maximum of 500 million doses of vaccine or vaccine precursor effective against EA H5. This procurement is pending USDA approval of the use of full and open competition. The North American Industry Classification System code is 325414 with a small business size standard of 500 employees. Solicitation number AG-6395-S-15-0133 will posted on or about July 27, 2015. Any questions or inquiries must be e-mailed to Jim Roloff, contracting officer, at james.g.roloff@aphis.usda.gov.