USDA Issues RFP For FujianH5 Vaccine

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USDA has issue another RFP for a Fujian (clade 2.3.4.4) H5 vaccine

 

https://www.aphis.usda.gov/wps/portal/aphis/newsroom/stakeholder-info/ct_stakeholder_announcements/!ut/p/a1/rVPBctowEP2WHHLUaJFsSz4CScAGSie0KfjiWdsCq7FlYjtp6ddXdug07RTCobpp9d7Oe6u3NKJrGhl80TtsdWWw6O6RFzuBZIwDC-QnIWEIYz9cBg8A3LWAjQXAiTOEnh8up2wwsvzlLPAg-PBwD6PpzQBWnH6hEY1S0-7bnG5wn-smTivTKtPGhU5qrA_X0GBs1LemrqqyvzQtPqq8KjJVN9eQtm8LMRpTPZtUlbZF0zXfpzqjG49zxBSQuMwB4ripJAlmimwTQCWVEIkQRzNn1P5hZrLyb7vnu4WcC76cOkf-eDKcOmJu7TuSQXBjycJfAATeZfwzgHc-ox_mOwp6wLn_-kvk5HZkNdzNP4pZyGDm0o0VKU6K9B26-j31hPlb8JgiXA6QOGnCCbroEuZm2yxLU8G5oOEFY2H1YrzY2bbY5kSbbUXXNghodIlFnOlGYaPirl6XfXRfn180mjhXWNhwrW1OXgsWVjwr8wN_EY-WTg029N5auihI4QVr8w9LZ6NsKfrr01M0tPvSbcj3lq7__8Lsy8-l5AetyeO9tEqLHcFEHnixu7r6CZ8B7dM!/?1dmy&urile=wcm%3apath%3a%2FAPHIS_Content_Library%2FSA_Newsroom%2FSA_Stakeholder_Announcements%2FSA_By_Date%2FSA_2015%2FNovember%2FUSDA%2BIssues%2BSecond%2BRequest%2Bfor%2BProposals%2Bfor%2BHighly%2BPathogenic%2BAvian%2BInfluenza%2BVaccine

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USDA Issues Second Request for Proposals for Highly Pathogenic Avian Influenza Vaccine

Published: Nov 20, 2015

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Agency Continues to Prepare for the Potential Return of this Disease
 

November 20, 2015 -- The United States Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) continues to prepare for the potential return of highly pathogenic avian influenza (HPAI).  APHIS is issuing its second request for proposals (RFP) for vaccine manufacturers with the interest and capability to supply a variety of EA H5 vaccines in sufficient numbers to add to the emergency stockpile. 

APHIS has not approved the use of vaccine to respond to HPAI to date; however, the Agency is preparing to ensure that vaccine is available should the decision be made to use it. Any decision to use vaccination in a future HPAI outbreak would require careful consideration of the efficacy of the vaccine, any impacts of using HPAI vaccine in the field, and the potential trade impacts.  In response to the first RFP issued in August, APHIS awarded contracts for doses of two vaccines for the Eurasian H5 (EA H5) virus strain, which became part of the National Veterinary Stockpile.

Vaccines will be carefully evaluated on a number of factors including their efficacy against EA H5 viruses, and products must meet all of APHIS’ safety, potency, and purity standards.  All eligible products to be considered must be either conditionally or fully licensed or permitted at the time of submission.  Vaccine manufacturers will be evaluated on their ability to produce such vaccines in a timely manner in adequate numbers to meet the needs of the response. 

The RFP is available here.

Although no decision has been made to use vaccine in the event of a future HPAI outbreak, APHIS will continue to issue RFPs for vaccine manufacturers on a quarterly basis through September 2016, to allow additional products to be developed and considered for the stockpile should an HPAI outbreak occur. 

 

 

USDA is an equal opportunity provider and employer. To file a complaint of discrimination, write: USDA, Office of the Assistant Secretary for Civil Rights, Office of Adjudication, 1400 Independence Ave., SW, Washington, DC 20250-9410 or call (866) 632-9992 (Toll-free Customer Service), (800) 877-8339 (Local or Federal relay), (866) 377-8642 (Relay voice users).

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Avian Influenza Vaccines, Eurasian HPAI H5

Solicitation Number: AG-6395-S-16-0005

Agency: Department of Agriculture
Office: Animal and Plant Health Inspection Service
Location: Administrative Services Division/Contracting

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Complete View Original Synopsis Presolicitation Nov 06, 2015 10:13 am Changed Nov 20, 2015 9:25 am Solicitation

Solicitation Number: AG-6395-S-16-0005 Notice Type: Solicitation   Synopsis: Added: Nov 06, 2015 10:13 am The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) intends to award multiple commercial, indefinite-delivery indefinite-quantity (IDIQ) contracts for vaccines and vaccine combinations effective against Eurasian highly pathogenic avian influenza virus H5 clade 2.3.4.4 (EA H5) in order to establish an emergency vaccine stockpile. The 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.   NVS's 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 may persist within the wild bird compartment which could serve as a reservoir and 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 and maintain 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 that will have the following components:  1) Production and banking of AI vaccine or vaccine precursors: Contractors would produce and store product and must demonstrate a storage capacity of 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; 2) Vaccine must be fully licensed, conditionally licensed, or permitted (only products permitted for general distribution and sale will be considered) in accordance with the Center for Veterinary Biologics (CVB) regulations in order to be eligible for award. Delivery anywhere within the continental U.S. 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; 3) 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; 4) 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; 5) Samples of finished vaccine and/or serum samples from vaccinated birds will be provided to CVB if requested by the CVB;  6) Product will be stored by the manufacturer in a manner that ensures the longest shelf life while retaining satisfactory potency as determined by the CVB (e.g., vaccine antigen concentrate) which shall be no less than two years;   The contracts will have a guaranteed minimum of $6 million worth of doses up to a maximum of 500 million doses of vaccine or vaccine precursor effective against EA H5. The North American Industry Classification System code is 325414 with a small business size standard of 500 employees. Solicitation number AG-6395-S-16-0005 will be will be issued on an unrestricted basis and posted on FBO during the latter part of November, 2015. Any questions or inquiries must be e-mailed to Jim Roloff, contracting officer, at [email protected]. Please consult the list of document viewers if you cannot open a file. Solicitation 1 Type:  Solicitation Posted Date:  November 20, 2015 Solicitation_AG-6395-S-16-0005.pdf (473.45 Kb) Description: Solicitation   Contracting Office Address: 100 North 6TH Street Butler Square 5TH Floor Minneapolis, Minnesota 55403  Primary Point of Contact.: Jim Roloff, Contracting Officer [email protected] Phone: 6123363223