ALTERNATIVE ROUTES OF ADMINISTRATION and/or ALTERNATIVE FORMULATIONS FOR INFLUENZA IMMUNIZATION

REQUEST FOR INFORMATION BIOLOGICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY/INFLUENZA AND EMERGING INFECTIOUS DISEASES DIVISION (BARDA/IEIDD) TITLE: ALTERNATIVE ROUTES OF ADMINISTRATION and/or ALTERNATIVE FORMULATIONS FOR INFLUENZA IMMUNIZATION RFI No: RFI-19-BARDA-ALT-FLU-IMMUNIZATION-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 alternative route of administration and/or formulations approaches for pandemic/pre-pandemic influenza vaccines. The intent is to improve the concept of operation for a mass vaccination and/or accelerate the time to reach protective immune response. 1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY 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 Federal Business Opportunities (FedBizOpps) 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. Traditional parenteral vaccinations are the primary medical intervention for prevention of infections with these viruses. In an effort to improve preparedness capabilities and the 2017 Pandemic Influenza Plan (PIP) calling for the first doses of vaccines to be available at 12 weeks, (https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf ) the USG is seeking to gather information from developers for alternative Routes of Administration for pandemic/pre-pandemic influenza vaccines. Technologies/mechanisms can include, but are not limited to, micro-needles, patches and/or other needle free options, and devices not requiring specialized medical training. The use of alternative Routes of Administration (such as microneedles and/or patches) to deliver vaccine could ease the continuity of operations (con-ops) of responding to a pandemic (potentially eliminate cold chain shipping and storage requirements, reduce the need for vials, needles and syringes and, as a result, reduce medical waste). Additional benefits could result in an increased update in immunizations and improved dissemination of vaccine to remote areas in both domestic and international settings. The USG is also seeking information on alternative and/or improved formulations for influenza vaccines for pandemic strains. Unlike seasonal vaccine (other than certain pediatric populations), vaccines against pandemic strains of virus typically require two doses of adjuvanted antigen given at least 21 days apart. Alternative and/or improved formulations that would allow for protection that meets the US Food and Drug Administration's (FDA's) requirements for influenza vaccine licensure after a single dose are of high interest. Alternative and/or improved formulations that improve stability, provide a more robust/broader immune response and/or otherwise allow for improved stockpiling are also of interest. Finally, new adjuvants that could broaden the protective response, further reduce the amount of antigen required, and/or otherwise improve pandemic vaccine response capabilities are also of interest. 3.0 Requested Information The USG is seeking information from developers/manufacturers on how best to collaborate with the USG with recommendations to address the identified below: 1. Type of alternative vaccine Route of Administration technology and/or alternative/improved vaccine formulations and adjuvants. - Discuss the technology and provide a synopsis, including any data that may be relevant to the BARDA mission 2. Prime (alternative delivery) /product (vaccine) sponsor relationships, if any - Discuss any product development partnerships to avoid contractual relationship issues while maintaining the items outlined in 1) above. 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 7 pages for Section 2 and submitted via email only to the individual(s) identified in Section 6.0 below Proprietary information, in 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. 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 10-page limitation, i.e., the 10-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 10 pages. 5.0 Industry Discussions BARDA representatives may or may not choose to meet with potential responders. 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, October 18, 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-19-BARDA-ALT-FLU-IMMUNIZATION-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 ALTERNATIVE VACCINE DELIVERY OPTIONS OR ALTERNATIVE FORMULATION. 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.