SOURCES SOUGHT
A -- Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health
- Notice Date
- 10/30/2019
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- RFI-20-Executive-Order-on-Modernizing-Influenza-Vaccines-0001
- Point of Contact
- Wendell Conyers, Phone: (202) 692-4784
- E-Mail Address
-
wendell.conyers@hhs.gov
(wendell.conyers@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION BIOLOGICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY/INFLUENZA AND EMERGING INFECTIOUS DISEASES DIVISION (BARDA/IEIDD) DATE: October 30, 2019 TITLE: Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health RFI No: RFI-20-Executive-Order-on-Modernizing-Influenza-Vaccines-0001 1.0 Description 1.1 The Influenza and Emerging Infectious Diseases Division (IEIDD), in support of the Biomedical Advanced Research and Development Authority (BARDA), is seeking information regarding ways an interested contractor could assist the U.S. Government (USG) with modernizing influenza vaccines in the United States in accordance with the recent Executive Order (EO) issued on September 19, 2019 (EO 13887). The intent is to promote national security and public health by developing better and faster influenza vaccines that provide more effective and longer lasting protection against many or all influenza viruses. BARDA is seeking this information in order to better inform development of the strategy as required by the EO. 1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY The IEIDD is issuing this RFI solely for information and planning purposes - it does NOT constitute a Request for Proposal (RFP), a promise to issue a RFP, or a commitment to issue any type of solicitation in the future. This RFI does not commit the USG to contract any supply or service whatsoever. At this time, IEIDD is not seeking development proposals and will not accept or review unsolicited proposals received. The USG will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Submission is voluntary and is not required to propose to subsequent solicitation on this topic (if any). If IEIDD chooses to release a solicitation in the future, it will be synopsized on the System for Award Management (https://www.sam.gov/SAM/) website and the Office of the Assistant Secretary for Preparedness & Response (ASPR) website at https://www.medicalcountermeasures.gov/. It is the responsibility of the potential respondee to monitor these sites for additional information pertaining to any potential requirement. 2.0 Background Within the USG, the Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), the Biomedical Advanced Research and Development Authority (BARDA) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, and natural exposure(s) to pandemic influenza and emerging infectious diseases. Prevention of disease caused by seasonal and novel influenza strains of pandemic potential continues to be a public health challenge. The current domestic enterprise for manufacturing influenza vaccines has critical shortcomings. Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires months-long production timelines, limiting their utility for pandemic control; rely on a potentially vulnerable supply chain of eggs; require the use of vaccine viruses adapted for growth in eggs, which could introduce mutations of the influenza vaccine virus that may render the final product less effective; and are unsuitable for efficient and scalable continuous manufacturing platforms. It is the policy of the United States to modernize the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable, and more effective at preventing the spread of influenza viruses. The Executive Order issued on September 19, 2019 directs actions to reduce the United States' reliance on egg-based influenza vaccine production; to expand domestic capacity of alternative methods that allow more agile and rapid responses to emerging influenza viruses; to advance the development of new, broadly protective vaccine candidates that provide more effective and longer lasing immunities; and to support the promotion of increased influenza vaccine immunization across recommended populations. 3.0 Requested Information The USG is seeking information from developers/manufacturers on approaches, estimated timelines, and costs to implement the EO in the areas described below. Respondents may address one or more of the following areas: 1. Expand and diversify domestic vaccine-manufacturing capacity using innovative, faster, and more scalable technologies, including cell-based and recombinant vaccine manufacturing, through cost-sharing agreements. • Information on vaccines currently licensed in the United States, or that are projected to be licensed in the United States in the next 1-2 years, is particularly desired. Information on current or projected domestic manufacturing capacity, and corresponding number of seasonal doses, along with suggested approaches that could be taken, in alignment with the EO, to expand capacity is requested. Information, if available, on projected pricing, and break-even points for per dose price and total selling volume are of particular interest. Also, estimated per dose pricing and delivery capability (time to first released vaccine dose from time of sequence identification and number of doses/week) for pandemic vaccine is requested, as well as requirements for capability sustainment costs. Finally, discuss willingness, cost, and time to transfer technology to public-private partnership for production of either seasonal and/or pandemic vaccine. i. Information on additional approaches that can be implemented to decrease time to release of first vaccine dose from time of sequence identification is also of interest. • If currently using an adjuvant, or plan to use one in the future, discuss capacity, cost, impact on the number of deliverable vaccine doses, and proposed approaches to expand manufacturing capabilities/capacity. • Discuss current or planned fill/finish capacity and need, if any, for increased capacity during a pandemic. 2. Expand domestic production capacity of adjuvants in order to combine such adjuvants with both seasonal and pandemic influenza vaccines. • Discuss the technology, capacity, timeline, rough order of magnitude cost, licensing of adjuvant(s) to other companies for use with influenza vaccines and transfer of manufacturing technology to other entities, such as the HHS Centers for Innovation and Advanced Development or other domestic manufacturing facilities. • Information on adjuvants licensed for other products that could be tested/used/licensed for use with influenza vaccines is of interest. 3. Expand domestic fill-and-finish capacity to rapidly fulfill antigen and adjuvant needs for pandemic response. • Discuss approaches to expand or otherwise improve fill-finish capacity for influenza vaccines. Include information on expected costs for process validation, estimated production capacity (millions of doses per week) as well as costs and activities to sustain the capability. 4. Proposed approaches for development and licensure of influenza vaccines utilizing alternative delivery approaches are requested. Of particular interest are approaches that are easily scalable with a small footprint and have sustainable manufacturing through utilization with other vaccines. Information on data generated with pre-pandemic influenza strains is of particular interest, as are development plans and estimated costs to license the delivery device for use with seasonal and pre-pandemic vaccine. 5. Potential clinical trials that could be conducted with adjuvanted seasonal or pre-pandemic vaccine to improve vaccine efficacy. Of particular interest are vaccine formulations that have been previously tested for safety in clinical trials, and have an active IND. Information on stage of development, and future development plans/costs are also sought. 6. Cost and timelines to develop influenza vaccines utilizing incentives for the development and production of vaccines by private manufacturers and public-private partnerships, including, in emergency situations, the transfer of technology to public-private partnerships - such as the HHS Centers for Innovation and Advanced Development and Manufacturing or other domestic manufacturing facilities -- in advance of a pandemic, in order to be able to ensure adequate domestic pandemic manufacturing capacity and capability. • Of particular interest is vaccines developed using manufacturing platforms capable of routinely producing final container vaccine within 12-weeks of strain identification, with protection at least comparable to currently licensed vaccines. Information on current vaccine status, development plans/timelines/estimated costs for taking the vaccine to licensure, as well as eventual cGMP m manufacturing facility requirements (for licensed vaccine) are requested. • Discuss the interest, technology, capacity, timeline, rough order of magnitude cost, and transfer of technology to other entities, such as the HHS Centers for Innovation and Advanced Development or other domestic manufacturing facilities. 4.0 Responses 4.1 Interested parties are requested to respond to this RFI with a white paper. 4.2 White papers shall adhere to the following: • 8.5 by 11 inch paper in a format compatible with either the Microsoft Office software package or Adobe Acrobat; and • Response shall be limited to 5 pages and submitted via email only to the individual(s) identified in Section 6.0 below. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid the USG, please segregate proprietary information. Please be advised that all submissions become USG property and will not be returned. Information marked as "Proprietary" obtained in response to this RFI will be protected from unauthorized disclosure in accordance with FAR Subpart 15.207, applicable law and HHS regulations. However, all information submitted under this RFI will be used to inform the contents of the report required under the Executive Order. 4.3 Section 1 of the white paper shall provide administrative information, and shall include the following at a minimum: 4.3.1 Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number and e-mail of designated point of contact. 4.3.2 Recommended contracting strategy 4.3.3 Business type (large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business.) The North American Industry Classification System (NAICS) Code(s) are as follows: 325412 - Pharmaceutical Preparation Manufacturing; and 325414 - Biological Product (except Diagnostic Manufacturing.) 4.3.5 The facility security clearance of the respondee (if applicable.) The number of pages in Section 1 of the white paper shall not be included in the 5-page limitation, i.e., the 5-page limitation applies only to Section 2 of the white paper. 4.4 Section 2 of the white paper shall answer the issues addressed in Section 3.0 of this RFI and shall be limited to 5 pages. 5.0 Industry Discussions BARDA representatives may or may not choose to meet with potential respondees. Such discussions would only be intended to get further clarification or possible capability to meet the potential USG need. 6.0 Submission Electronic responses to this RFI are due no later than: 12:00 PM EDT on Friday, November 15, 2019 Your white paper shall be submitted to the following individual. Wendell Conyers, Supervisory Contracting Officer Division of Contracts Management and Acquisition (DCMA) Biomedical Advanced Research and Development Authority (BARDA) E-mail: Wendell.conyers@hhs.gov Please include RFI No RFI-20-Executive-Order-on-Modernizing-Influenza-Vaccines-0001 in the subject line of all correspondence. All technical and administrative correspondence and questions regarding this announcement shall also be submitted to the above email address. BARDA intends to use electronic mail for all correspondence regarding this RFI. 7.0 Summary THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify sources that can provide feedback on MODERNIZING INFLUENZA VACCINES IN THE UNITED STATES. The information provided in the RFI is subject to change and is not binding on the USG. BARDA has not made a commitment to procure any items or services, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submission become USG property and will not be returned. This RFI is in accordance with FAR 52.215-3 Request for information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/RFI-20-Executive-Order-on-Modernizing-Influenza-Vaccines-0001 /listing.html)
- Record
- SN05486039-W 20191101/191030230605-e651464be92d05778710e31bc4fae257 (fbodaily.com)
- Source
-
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