Vaccine security meeting - usa cvm perspective-P.Hauer

Vaccine security meeting - usa cvm perspective-P.Hauer

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  U.S. Perspective onthe Security of Vaccine Supply against FAST Diseases Paul Hauer, DVM, PhD Director- Policy, Evaluation and Licensing Center for Veterinary Biologics 1920 Dayton Avenue Ames, Iowa USA 50010 Email: [email protected] Animal and Plant Health Inspection Service
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  Current Status ofU.S. Veterinary Vaccine Reserves North American Foot and Mouth Disease Vaccine Bank- • Established in 1982 • Supervised by the Chief Veterinary Officers of U.S., Canada, and Mexico • Historically had antigens stored on Plum Island, New York • Stores frozen antigen instead of final product to dramatically increase shelf-life National Veterinary Stockpile • Established in 2004 • provides animal vaccines (other than FMD), antivirals, or therapeutic products, supplies, equipment, and response support services • Goal is to provide logistical support within 24 hours to deliver appropriate countermeasures to combat a high consequence animal disease outbreak
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  AVMA wants expandedFMD vaccine bank By Greg Cima, AVMA Published on August 15, 2018 United States Government Accountability Office Report to Congressional Requesters March 2019 FOOT-AND-MOUTH DISEASE USDA’s Efforts to Prepare for a Potential Outbreak Could Be Strengthened United States has short supply of FMD vaccine, report says Published on May 08, 2019 Alimited vaccine supply could hurt the U.S. response to a foot-and-mouth disease outbreak, according to a federal repor APHIS to develop strategy for FMD vaccine for U.S.-only bank The first priority of the National Animal Vaccine and Veterinary Countermeasures Bank is to acquire and maintain foot-and-mouth disease vaccine for the U.S. USDA | Sep 10, 2019 Veterinarians Call for FMD Vaccine Bank Bovine Veterinarian July 12, 2017 03:19 PM FMD bank less than sought, but should boost fight against the disease 01/09/19 5:19 AM By Fran Howard Liz Wagstrom National Pork Producers Council ncba nppc In a major win for livestock and poultry producers, the Animal Disease Prevention and Management provisions included in the recently passed farm bill authorize a U.S. vaccine bank, a diagnostic laboratory network, and state block grants, while providing mandatory spending for all three. USDA starts new veterinary vaccine bank By Greg Cima, AVMA Published on September 25, 2019 APHIS Announces Sources Sought Notice to Gather Information for the National Animal Vaccine and Veterinary Countermeasures Bank Last Modified: Sep 10, 2019 Foot-and-mouth vaccine bank cost a sticker shock for Perdue (National Hog Farmer) Perdue warns the budget is the biggest challenge for the USDA. So, finding $150 million annually for foreign animal disease preparedness could be difficult
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  The U.S. 2018Farm Bill included funding to establish the National Animal Vaccine and Veterinary Countermeasures Bank. This new initiative is meant to strengthen and augment the existing North American Foot and Mouth Disease Vaccine Bank and the National Veterinary Stockpile. The National Animal Vaccine and Veterinary Countermeasures Bank will is designed to be a US-only vaccine bank for the highest consequence animal diseases that threaten U.S. agriculture.
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  Consider Recombinant PlatformProducts  Once the initial product is licensed  The platform is considered “established”  No changes can occur except a variant of the GOI  A variant of the same GOI can be swapped for the original GOI and licensed with reduced requirements  Example: Influenza H1 Influenza H1 Influenza H3 Influenza H1 + H3Influenza N1 YES NO
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  Platform Products (cont.) CVB recognizes the need and desire to get new or updated products to the market faster  Platform/Recombinant technologies allow for a standardized manufacturing process  Platform products rely on this standardization to provide increased flexibilities  VS Memorandum No. 800.213, Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products (2018)