SOURCES SOUGHT
65 -- Foot and Mouth Disease Vaccine
- Notice Date
- 3/14/2016
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Agriculture, Animal and Plant Health Inspection Service, Administrative Services Division/Contracting, 100 North 6TH Street, Butler Square 5TH Floor, Minneapolis, Minnesota, 55403
- ZIP Code
- 55403
- Solicitation Number
- AG-6395-S-16-0086
- Archive Date
- 6/30/2016
- Point of Contact
- Jim Roloff, Phone: 6123363223
- E-Mail Address
-
james.g.roloff@aphis.usda.gov
(james.g.roloff@aphis.usda.gov)
- Small Business Set-Aside
- N/A
- Description
- Overview The U.S. Department of Agriculture, Animal and Plant Health Inspection Service, issues this sources-sought notice as a means of conducting market research to identify interested parties with the resources to manufacture, store, and deliver Foot and Mouth Disease (FMD) vaccines. The result of this market research will contribute to determining the method of future procurement. This is not a solicitation. The applicable NAICS code assigned to this procurement is 325414 with a size standard of 500 employees. Background FMD is arguably the greatest infectious disease threat to the U.S. livestock industry; even a small outbreak would result in devastating economic and animal health consequences. To ensure the safety of its susceptible livestock, the United States is seeking to improve its FMD vaccine preparedness by enhancing its existing stockpile of FMD vaccine. There are seven recognized serotypes or strains of FMD: A, O, C, Asia-1, SAT-1, SAT-2, and SAT-3. From these seven serotypes, there are derived multiple subtypes-referred to as topotypes-because they are designated by their geographical point of identification and sometimes year of detection. Regarding vaccination, there is limited cross-protection within a serotype and no practical cross-protection between the seven different serotypes (meaning a vaccine generated against an A serotype will not protect an animal from disease from an O serotype). This complicates vaccine planning because it is difficult for non-endemic countries to anticipate which topotypes from the seven serotypes to stock. This necessitates the development of large and robust vaccine banks. The current FMD vaccine stockpile for the United States is managed by the North American Foot and Mouth Disease Vaccine Bank (NAFMDVB or Bank). The Bank is a trilateral partnership between the United States Department of Agriculture (USDA), the Canadian Food Inspection Agency, and the Mexican Secretariat of Agriculture, Livestock, Rural Development, Fisheries, and Food. The Chief Veterinary Officers of each country serve as the Bank's Commissioners, who oversee its executive administration. The countries work cooperatively to acquire and manage supplies of FMD vaccine, that are currently stored as a vaccine precursor referred to as vaccine antigen concentrate (VAC), from which the high-potency FMD vaccine is derived. The VAC is apportioned in accordance to the contribution level of each country; but at the time of an outbreak, the Commissioners can reallocate all or a portion of their country's vaccine share to the country(s) experiencing an outbreak within North America and at times, countries of other continents. Historically, the United States has been aligned with a "stamping-out only" policy which included a "vaccinate to kill" option. Due to this policy, the Bank vaccine stocks had been predicated on a "vaccinate to kill" strategy as part of a greater eradication program. However given the considerable expansion of the livestock production sector since the inception of the policy, the United States determined that the country could not afford to pursue an exclusive "stamping-out only" strategy except in the most limited of outbreaks. In moderate to large-scale outbreaks, such severe actions would place an undue financial and manpower burden on State and Federal regulatory agencies in trying to contain the outbreak; depopulate animals and dispose of tons of carcasses; and could result in the collapse of the domestic animal commodities production sector. So in place of the "stamping-out only" policy, the United States has elected to pursue a "vaccinate to live" policy if the outbreak circumstances warrant this approach. Requirement To realign its strategy, the United States is seeking to increase its portion of FMD vaccine Bank holdings and acquire sufficient quantities of VAC or other long-term vaccine precursor storage form(s) to mount a "vaccinate to live" campaign in the United States. These holdings will initially be focused on inactivated products, but novel vaccine platforms or novel processes of generating inactivated vaccine will be considered, provided they meet the performance criteria detailed in this document. While this action would be a U.S.-only acquisition, it would be transacted within the context of the Bank whose other partners may elect to pursue a similar strategy in the future. Commensurate with this goal, the United States is seeking information from FMD vaccine manufacturers who can meet the objectives and criteria in this document. These broadly include the following: • Possess an extensive FMD virus master seed library to include both current and previously circulating topotypes; and/or, be able to generate a construct equivalent to a master seed (e.g., recombinant virus or genetically altered virus/vector); • Have sufficient resources to quickly generate a master seed (or equivalent construct) when a novel topotype is identified that has no or poor extant vaccine matching; • Manufacture products that have a reasonable expectation to be safe and effective in all target species (i.e., cattle, swine, sheep, and goats); • Supply and maintain high potency vaccine (≥ 6 PD50 or the equivalent) in the form of VAC or other vaccine precursor storage form(s) in sufficient quantities necessary for a "vaccinate to live" campaign within the United States; and • Possess the capacity to meet U.S. FMD vaccine needs during a prolonged vaccination campaign after the VAC or other long-term storage form(s) is exhausted. Vaccine Precursor To meet the needs of a "vaccinate to live" campaign for susceptible U.S. livestock; the amount of vaccine precursor (e.g., VAC) or other long-term storage form(s) apportioned to the United States in the Bank will need to be significantly increased. Requirements are as follows: • Build an inventory of emergency vaccine precursor that would encompass the top ten FMD topotypes posing the highest risk to North America as determined by the NAFMDVB and based on data from the OIE World Reference Laboratory for FMD, The Pirbright Institute; • The minimum amount of vaccine precursor required for such an effort would be approximately 25 million doses per high-risk topotype. As resources permit, this minimum amount should be increased for select high-risk topotypes; lower risk topotypes may be added to the Bank over time (but not necessarily in the same amounts as the high-risk topotypes); • It is important that manufacturers can acquire novel or emerging topotypes that are deemed as high-risk to North America, and be capable of developing a master seed virus or the equivalent in a timely manner so that the product derived from that topotype can be represented in the inventory. Such emerging topotypes would be in addition to the ten high-risk topotypes, and may encompass two to three additional topotypes added to the base high risk ten topotypes or to replace no longer relevant topotypes as needed; • Vaccine precursor would be maintained by the manufacturer for a period of not less than two years from the date of manufacture, and replaced on a predetermined rotational schedule while performing periodic quality assurance assessments to ensure sustained potency with results to be reported to the United States; o Vaccine precursors with prolonged shelf lives beyond two years would be given favorable consideration in a future solicitation; o Manufacturers providing rebates for replacement precursor would be given favorable consideration in a future solicitation; and • The United States seeks to identify vaccine manufacturers who can produce vaccine precursor in these volumes on a reasonable schedule and maintain the vaccine precursor until it is needed. Finished Vaccine • All finished FMD vaccines must be supplied in the form of high-potency vaccine (≥ 6 PD50 or an equivalent validated measure of potency); • All eligible FMD vaccines must be either licensed (fully or conditionally) or permitted by the USDA Center for Veterinary Biologics (CVB) for distribution and sale within the United States; or authorized by the Administrator to be used under the supervision and control of the Department as described in the 9 CFR 106.1 with the condition the manufacturer is actively engaged in the pursuit of obtaining a USDA CVB product license (full or conditional) or permit; • All FMD vaccines to be considered must have a reasonable expectation to be safe and effective in all target species (i.e., cattle, swine, sheep, and goats); • All FMD vaccines must be efficacious when employing a standard vaccination schedule; specifically a priming dose, plus booster (if necessary), with an anticipated duration of protective immunity of ≥ six months; products providing duration of immunity of > six months or convey sufficient immunity for at least six months with only one vaccine dose would be given favorable consideration in a future solicitation; • Acceptable FMD vaccine formulations would include but not limited to inactivated vaccine products; vectored vaccine products; DNA/RNA vaccine products; or any other novel vaccine platform, providing that said platform(s) meets all purity, safety, efficacy, and potency requirements as established by the CVB; • Vectored or nonviable/nonreplicating delivery systems may not be considered if they cannot be used solely in a prolonged vaccination campaign. Specifically, if the vector induces immunity against itself such that successive boostering with that product results in diminishing immunity, then such products may not be viewed favorably unless they provide extraordinary immunity (e.g., long duration, very rapid onset) or act synergistically with other products to provide extraordinary immunity; • The cost-benefit of any product(s) must be equivalent or superior to high-potency (≥ 6 PD50 or the equivalent) inactivated FMD vaccine, unless that product(s) conveys extraordinary immunity such as rapid onset or unusually long duration of immunity; or the ability to rapidly alter the master seed to match the circulating field virus; • Any eligible FMD vaccine products must be DIVA (differentiate infected from vaccinated animal) compatible using a diagnostic test that is, or can be, validated by the USDA National Veterinary Services Laboratories. This DIVA test must be capable of being conducted using conventional laboratory instruments that would be available in a modern veterinary diagnostic laboratory; • FMD vaccines capable of multivalent antigen formulation and delivery using a single common adjuvant (if necessary) would receive favorable consideration; specifically, USDA seeks to purchase those product lines where multiple topotypes can be combined into a single vaccine formulation with a compatible adjuvant where necessary; and • Vaccines that may be given by multiple delivery systems (e.g., needle-free devices) or by multiple routes of administration (e.g., intramuscularly, subcutaneously, orally) would be given special consideration. Pre-Outbreak Finished Vaccine Supplies In the future, the United States may also stock an amount of finished vaccine derived from the high-risk topotypes for launching an immediate vaccination campaign. Therefore, the United States is seeking vaccine manufacturers who can produce and maintain a supply of finished high-potency vaccine with an extended shelf-life. Requirements for Manufacturer • Eligible manufacturers should possess and maintain a comprehensive master seed virus collection (inactivated products) and demonstrate the capacity to efficiently isolate and produce a master seed virus; or develop and maintain a library of genomic constructs (vectored products); • All eligible manufacturers must be inspected by the CVB and have met the criteria for an Approved Manufacturing Facility; • Manufacturers who offer vaccines that exhibit epitopic dominance supported by experimental data (broad protection within serotype) will be given preference; • Favorable consideration would be given to those manufacturers who have the flexibility and manufacturing capacity to: o Dedicate manufacturing lines to United States vaccine production at the time of an outbreak; o Demonstrate sufficient surge capacity for the production of FMD vaccine commensurate with anticipated U.S. operational needs; • When responding to this request for information, manufacturers should indicate their current capacity and delivery schedule to supply the estimated amount of vaccine precursor and conventional finished vaccine listed here: *Precursor Estimate* Number of Topotypes is 10 (For this calculation, use the 10 most common topotypes and with all serotypes represented except SAT3.) *Conventional Vaccine Estimate* Qty of Vaccine Precursor Doses/week (mono/equivalent) 1. 500 million (50m per type) 1.5 million/week 2. 350 million (35m per type) 1 million/week 3. 250 million (25m per type) 500,000/week 4. 150 million (15m per type) 250,000/week • Manufacturers may also provide projected production capacities and delivery schedules if capital investments are aimed at improving such capacity within the next three to five years; • Should the vaccine precursor (e.g., VAC) be exhausted, the United States needs to ensure that an ongoing supply of conventional high-potency FMD vaccine (not produced from vaccine precursor) is available to continue the vaccination campaign: o This supply of vaccine may range from 0.5 to 1 million doses of vaccine per week for an extended period. Therefore, the United States is seeking vaccine manufacturers who possess the surge capacity for conventional high-potency FMD vaccine production to address the needs of an ongoing large-scale U.S. FMD outbreak; • Favorable consideration would be given to those manufacturers who facilitate the transition from traditional inactivated products to superior vaccine platforms as they become available and are validated; • Manufacturers must have the physical facilities (including cryogenic storage, if required, and monitoring capacity) sufficient to maintain the amount of vaccine precursor that is anticipated to be needed by the United States (approximately 250-500 million doses); and • The manufacturer would supply samples of Master Cell Stocks, Master Seed Virus, Challenge Virus, VAC samples, pilot vaccines (e.g., small serials of finished vaccine that are used to demonstrate efficacy and stability of the VAC) and antisera upon request for independent quality assurance assessment and further testing by USDA laboratories. If your organization has the potential capacity to meet this future requirement, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, business size as determined by the NAICS code, type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is voluntary. The government assumes no financial responsibility for any costs incurred. Based on responses to this sources-sought notice, this requirement may be set aside for small business or procured through unrestricted competition. No feedback or evaluations will be provided to companies regarding their submissions. All responses must be received by noon CST on April 1, 2016. Please email them to Jim Roloff at james.g.roloff@aphis.usda.gov.
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