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W911QY-21-S-0008 REQUEST FOR INFORMATION mRNA Vaccine Development Platform Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by t... W911QY-21-S-0008 REQUEST FOR INFORMATION mRNA Vaccine Development Platform Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO CBRND) is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) to design, test, manufacture, and sponsor mRNA-based vaccines against specific biological threats (see Appendix 1). The government is requesting information on capabilities in one or more of the following areas: Capabilities and experience in rapidly designing mRNA vaccines against bacteriological, virological, and/or toxin-based threat agents; include brief description of programs/methods/approaches/licensed technology used; basis for inclusion of identified protective antigen(s) in mRNA-based vaccine(s); and time/costs from when threat sequence is available until completion of design, and time between design completion and filing of IND Requisite suite of methods and approaches for selection of the most promising designed mRNA vaccine candidate to take forward into animal proof of concept studies and/or clinical trials; Good Laboratory Practice (GLP) evaluations of mRNA vaccines in suitable non-clinical animal model(s), including potential and relevant experience in testing viral, bacterial and/or toxin threats in these animal models in preparation for pre-IND and IND filing; Candidate mRNA vaccine manufacturing using current Good Manufacturing Practices (cGMP) including formulation capabilities and fill/finish, sample analysis (QA/QC), and lot activity analysis; estimate of current scale of manufacturing and ability to scale out to provide one complete vaccination to entire United States population; Regulatory sponsorship and execution of human clinical trials for safety and efficacy testing and/or development pathways based on Animal Rule where necessary; Experience in sponsoring a pivotal animal study for FDA licensure via Animal Rule to show efficacy of a candidate mRNA vaccine against a biological threat Background: JPEO CBRND is seeking capabilities from industry for development of an mRNA-based vaccine design and testing platform as outlined in the objectives above. Executing this objective may include leveraging existing relationships between industry and academia, leveraging previous investments in mRNA-based vaccine technologies, as well as leveraging any existing partnerships to satisfy FDA regulatory requirements necessary for human safety and efficacy testing. The government requires entities to execute the objective in two scenarios: Capability demonstration: Develop an mRNA vaccine against existing and known biologic threat agents as part of the current medical counter measure (MCM) development environment Rapid response: Rapidly develop mRNA vaccines against emerging biologic-based threat agents and generate safe and effective mRNA vaccines to address urgent demands due to epidemic or pandemic events. Requirements: The purpose of this RFI is to request information on the ability to develop an mRNA vaccine platform against a range of biologic threat agents. JPEO-CBRND would like responses to include ability to identify and develop mRNA-based vaccines, test candidate mRNA-based vaccines, manufacture mRNA-based vaccines, and sponsor human trials of mRNA vaccines. Performance Objectives: When responding to this RFI, please provide responses to all of the objectives listed above and limit responses to 10 pages. Responses submitted should also include answers to all of the following questions: 1) Biological Threat Agent Identification Describe existing capability to sequence biological threat agents (up to and including BSL-3 and/or BSL-4 level pathogens) and identify candidate antigenic regions within biological threat agents to develop mRNA-based vaccines Describe how this capability can be applied to both known biological threat agents and emerging biological threat agents 2) Designing mRNA vaccines against biological threats Describe experience in designing mRNA-based vaccines against bacterial and viral threat agents Include intellectual property (IP) considerations Describe the steps, timeline, and costs associated with the design of mRNA vaccine(s) from threat identification to IND filing Describe experience in designing and producing bench grade (non-cGMP) lots of mRNA vaccine for use in non-clinical animal studies 3) Animal models for biological threats, non-clinical studies Describe experience in developing and testing animal models for biological threats of interest, or existing relationships to develop animal models for biological threat agents Describe ability to run non-clinical safety and toxicology studies 4) mRNA vaccine cGMP manufacturing, formulation, fill finish, QA/QC, stability and storage Describe experience in manufacturing cGMP lots of mRNA vaccine including fill/finish, QA/QC analysis Describe the delivery, shelf life, cold chain, and formulation of ongoing or planned mRNA vaccine formulations Describe experience in manufacturing and releasing sufficient quantities of cGMP material for phase I-III Clinical and/or Animal rule studies Describe experience in assessing stability (3+ years) of cGMP runs of mRNA vaccine lots Describe any accelerated stability testing performed Describe experience in manufacturing and releasing PPQ lots for mRNA vaccine(s) Describe experience in providing ICH-compliant storage of mRNA vaccine lots for 5+ years Describe capability to develop a single-dose mRNA vaccine that provides protection for immunologically naïve human recipient 5) IND filing and Phase I/II/III clinical trials Describe experience in sponsoring regulatory filings to the FDA, including pre-IND and IND submission for human clinical trials Is capability through leveraging existing partnerships with CROs or is this an internal capability? Describe experience in sponsoring a Phase I safety trial in healthy volunteers with the candidate mRNA vaccine developed against the biological threat agent of interest Describe experience in sponsoring Phase II and/or Phase III human clinical trials for evaluation of mRNA vaccine(s) 6) BLA Filing Describe experience in directly sponsoring BLA filing(s) with the FDA of a candidate mRNA vaccine utilizing successful Phase II/III clinical trial data Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 1 July 2021. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org. Appendix 1. Biological Threat List The Government interested in potential capabilities to address the following CBRN, pandemic influenza, and emerging infectious disease threats: Virus targets Filoviruses Pandemic influenza (H5 and H7 specifically) Alphaviruses Flaviviruses (Zika virus specifically) Arenaviruses Bunyaviruses Bacterial Plague Tularemia Melioidosis Glanders Q Fever Toxin threats Botulinum toxin Ricin Conotoxins Saxotoxins