SS-RFI-7200AA-25-IMVB.pdf

To: Sources Sought (Attachment B)– Small Business Only; RFI (Attachment C) - All Interested Organizations.

Reference Number: SS-RFI-7200AA-25-IMVB Release Date: December 2, 2024 Response Date: January 3, 2025

Subject: Sources Sought/Request for Information RFI - Innovations in Malaria Vaccines and Biologics Development (IMVB)

PURPOSE:

Referring to FAR Part 10, FAR 15.201(e) the United States Government, represented by the United States Agency for International Development (USAID), is publishing the subject Sources Sought/Request for Information (RFI) for the Innovations in Malaria Vaccines and Biologics Development (IMVB). The estimated range for this activity is $25-50 million dollars over a 5- to 10-year period.

As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in the development of its design and acquisition strategy for a possible Request for Proposal (RFP), to be issued at a later date, and in determining whether any type of small business set-aside is possible for this procurement or whether full and open or other competitive procedures should be utilized. If full and open or other competition is ultimately pursued, responses to this synopsis will be used to aid in establishing small business subcontracting goals.

The purpose of this Sources Sought/RFI is twofold:

1) Sources Sought

USAID is conducting this Sources Sought to identify small business contractors who possess the capabilities to provide services as specified in the Attachment A: DRAFT SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK and to determine their availability, capability, and adequacy. If your firm may be interested in this requirement, is a qualified small business for the NAICS code 541715 (size standards in number of employees: 1,000) according to SBA Table of Small Business Size), and has performed similar projects, we request the information specified in the Attachment B: Sources Sought Information. An organization that is not considered a small business under the applicable NAICS code should not submit a response to the Attachment B of this notice.

2) RFI

USAID is soliciting feedback on the technical design of a new Activity and notify the industry that USAID is interested in identifying organizations that may have the institutional capacity to implement the conceptual program or components of the program described in the Attachment https://www.sba.gov/sites/default/files/2022-07/Table%20of%20Size%20Standards_Effective%20July%2014%202022_Final-508.pdf

A: DRAFT SECTION C – DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK. The solicited information is found in the Attachment C titled RFI Questions.

SUBMISSION INFORMATION:

Please submit your response to requested information in the Attachment B and/or C electronically to imvb@usaid.gov no later than January 3, 2025, 5 p.m. EST. Please indicate the RFI/Sources Sought reference number provided above in the subject of the email. You will receive only an electronic confirmation acknowledging receipt of your response. No individualized feedback or suggestions will be sent to responders. Your responses may contribute to upcoming activity design(s). However, this RFI/Sources Sought will not be construed as a commitment by the U.S. Government (USG) to issue any solicitation or pay for any information submitted in response to this request. Responders are responsible for adequately marking proprietary or restricted information contained in their responses.

No basis for claims against the U.S. Government shall arise because of a response to this RFI/Sources Sought or from the USG’s use of such information. Specific questions about this RFI/Sources Sought should be directed only to the email addresses identified above. This office will not respond to any telephonic or other inquiries regarding this notice.

Please note USAID is not seeking technical or cost proposals currently. Do not submit any proposal in response to this RFI/Sources Sought. Only the information as requested in the Attachment B and C as applicable will be considered.

CONTENT:

Attachment A – DRAFT SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Attachment B – Sources Sought Information Attachment C – RFI Questions

Sincerely, Natalia Kornilova, Contracting Officer, M/OAA/GH

Attachment A

DRAFT SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 PURPOSE

The purpose of this contract is to support the efforts of the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP) to develop malaria vaccines or monoclonal antibodies (mAbs) that reduce morbidity and mortality due to malaria caused by infection with Plasmodium falciparum. The Innovations in Malaria Vaccine and Biologics (IMVB) activity is a part of the MVDP portfolio that will support strategic research of new or improved malaria vaccines that target the pre-erythrocytic and/or erythrocytic stages of the parasite life cycle that will include prototype vaccine development, preclinical studies, and/or early clinical studies of promising vaccine candidates that offer improvements in efficacy, durability, and affordability over the currently WHO-recommended vaccines, with hopes of meeting the World Health Organization’s (WHO) Preferred Product Characteristics (PPCs) for malaria vaccines.1 The activity may also support research on mAbs for use in development of improved malaria vaccines and passive protection against malaria.

C.2 BACKGROUND

Despite successes in malaria control over the past several decades, over 608,000 people still die from malaria annually and the 2023 World Malaria Report estimates 249 million cases of malaria in 2022, an increase of five million cases compared with 2021.2 Malaria control and elimination programs face several challenges including drug and insecticide resistance and the need for sustained investment to maintain gains in malaria control. Two malaria vaccines, RTS,S/AS01 and R21/Matrix-M are currently WHO-prequalified and recommended for use for the reduction of malaria morbidity and mortality in children living in endemic areas, prioritizing areas of moderate and high malaria transmission.3 While providing high impact, neither of these recommended malaria vaccines provide the high efficacy or durability outlined by the WHO PPCs. USAID supports the development of “next generation” malaria vaccines and biologics that demonstrate a high level of protective efficacy and durability as envisioned by the WHO and other global partners, as well as those that are more affordable.

USAID initiated its Malaria Vaccine Development Program (MVDP) in the 1960s in response to the end of the first malaria eradication program. Several milestones in the malaria vaccine development pathway were achieved with support from the USAID MVDP, including malaria parasite culture, early development and clinical evaluation of circumsporozoite protein (CSP) and blood stage vaccines, the first field trials of blood stage vaccines in East and West Africa, and evaluation of the first blood stage vaccine to reduce parasite growth rate after controlled human malaria infection. The USAID MVDP made investments through interagency agreements with U.S. government partners, including the Walter Reed Army Institute of Research (WRAIR), the Naval Medicine Research Command (NMRC), and the National Institute of Allergy and Infectious Diseases (NIAID), as well as through partnerships with the private sector. These partnerships included a cooperative agreement with the PATH Malaria Vaccine Initiative

1 Malaria vaccines: preferred product characteristics and clinical development considerations. Geneva: World Health Organization; 2022. Available from: https://iris.who.int/bitstream/handle/10665/362694/9789240057463-eng.pdf?sequence=1 2 World Malaria Report 2023. Geneva: World Health Organization. 2023. Available from:

https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2023 3 Malaria vaccines: WHO position paper https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2023

(MVI) (2004-2014), a contract with Leidos, Inc (2015-2021), and the Innovations in Malaria Vaccine Development (IMV) contract with PATH (2020-2026).

The USAID MVDP’s research and development (R&D) portfolio currently includes subunit vaccine development aimed at the pre-erythrocytic (sporozoite) or blood stages of parasite development. USAID supports research toward an improved CSP vaccine by evaluating various vaccine formulations, including virus-like particles (VLPs) or mRNA, containing potentially protective epitopes from CSP. Additionally, USAID supports preclinical and clinical studies of blood stage antigens, including RH5 complex proteins, to build evidence sufficient to move forward along the vaccine development pipeline with these antigens. For more information on the USAID MVDP, please see:

https://www.usaid.gov/global-health/health-areas/malaria/research-innovation/malaria-vaccine-development-program-mvdp

C.3 PROPOSED STATEMENT OF WORK

The Contractor will implement a series of research and development (R&D) projects as directed by USAID. The Contractor must provide the appropriate personnel to oversee, support and implement the projects. Through the Contractor, USAID will invest in those projects that USAID determines to be the needed next steps relevant to the proof-of-concept of several malaria vaccine or monoclonal antibody (mAb) regimens. The Contractor will be an integral contributor to the overall USAID MVDP portfolio, which also includes work by other partners. The specific projects that the Contractor will be directed to implement will depend on USAID’s assessment of developments in the field of malaria vaccine or mAb research at any given time as determined from the scientific literature, oral presentations and scientific discussion with persons knowledgeable in the relevant areas of investigation, including contractor staff as appropriate. The projects can best be characterized as strategic research to inform a decision for a vaccine product development program.

The primary objective of this contract is development and implementation of projects in the three workstreams listed below under the direction of USAID.

After a review of the current state of the science at the time of the award (which may include, but is not limited to one or more of the following: consultations between USAID and the Contractor, a desk review, or another form of evaluation TBD at the time of award), the Contractor’s work may include, but is not limited to, research and development projects in the following workstreams:

Workstream 1. Circumsporozoite protein (CSP): A next-generation vaccine that improves on vaccine efficacy and durability of currently available pre-erythrocytic malaria vaccines.

Workstream 2. Blood stage: A vaccine that Improves on immunogenicity/efficacy seen with the most advanced blood-stage vaccine candidate (currently RH5.1/Matrix-M).

Workstream 3. CSP + blood stage: Eventual combinations of workstreams 1 and 2 for increased efficacy and avoidance of potential breakthrough infections.

https://www.usaid.gov/global-health/health-areas/malaria/research-innovation/malaria-vaccine-development-program-mvdp https://www.usaid.gov/global-health/health-areas/malaria/research-innovation/malaria-vaccine-development-program-mvdp

These workstreams may include development and/or testing of mAbs for improved malaria vaccines and/or, in limited cases, passive protection against malaria.

Under these three workstreams, the Contractor shall, as determined by USAID, support one or more the following activities:

● Generation of novel vaccine candidates.

● Determination of the performance of vaccine candidates (i.e., immunogenicity and potency) in nonclinical assays and animal models.

● Determination of the performance of candidate vaccines in early clinical studies to generate clinical safety, immunogenicity, and efficacy data to enable decision-making for advancement to later phase studies.

The Contractor shall develop (either in-house or in coordination with subcontractors) projects in the three workstreams and submit project plans for each project to USAID for review and approval. The Contractor shall then perform the approved activities. All protocols and study designs shall be reviewed and approved by USAID before initiation either as part of the initial or updated project plan or annual work plan approval process or through separate review and approval.

Additional tasks in support of the primary objective include:

1. Coordination of scientific meetings as directed by USAID, including the USAID MVDP Scientific

Advisory Committee (SAC) meetings.

A) Approximately once a year, the Contractor shall coordinate the annual SAC meeting.

The SAC is a Federal Advisory Committee operated by USAID. The SAC meeting is usually a two-day event with up to 75 participants including USAID staff and USAID MVDP partners on day one; day two will include only SAC members and USAID staff (totaling up to 20 people). The SAC charge and meeting agenda, as well as a list of participants to be invited, will be prepared by USAID. All content will be directed by the USAID MVDP team. Meetings will be chaired by the SAC Chair. The Contractor will not be involved in any drafting of the meeting report and/or minutes. Coordinating this event shall include, but is not limited to the following:

a. Arranging and advanced scheduling of the venue, including, as appropriate, reservation of hotel rooms for traveling participants;

b. Provision of audio-visual equipment;

c. Provision of supplies; and

d. Arranging meals during the meeting.

B) Work planning and other technical meetings as determined by USAID. In consultation with USAID, the Contractor will leverage travel to other scientific meetings to convene the Contractor and subcontractor(s), as well as other USAID MVDP partners, for workstream and other planning meetings and to coordinate research efforts and exchange information across the USAID MVDP portfolio or invite other participants for technical area discussions. When directed by USAID, the Contractor shall support travel arrangements for non-USG invitees. USAID will assist the Contractor in developing the invitation lists and agendas and USAID will approve the invitation lists to these and all other USAID-supported meetings.

2. In limited circumstances and as directed by USAID, the Contractor will procure necessary materials and supplies in support of USAID MVDP’s research and development activities, including but not limited to the following:

a) antigens, adjuvants, and monoclonal antibodies;

b) excipients;

c) reagents;

d) equipment and supplies; and,

e) other required items not yet identified.

3. In limited circumstances and as directed by USAID, the Contractor will provide technical support services to research and development activities in other parts of the USAID MVDP portfolio.

These services include, but are not limited to:

a) biomedical assays and studies such as toxicology studies;

b) immunologic assays;

c) standard clinical laboratory services; and/or,

d) identification, deployment, and support of short-term scientific, legal, and /or business consultants to inform the USAID MVDP on specific issues and provide assistance to the USAID MVDP portfolio.

Attachment B: Sources Sought Information (For Small Business Respondents ONLY):

A. Organizational Capacity Questions (Please limit responses to 2 pages)

1. Business information: (not included in the page limit)

a. Company Profile to include:

i. Company name and address;

ii. Affiliate information: parent company, joint venture partners, and potential teaming partners;

iii. Year the firm was established and number of employees;

iv. Two points of contact (names, titles, phone numbers and email addresses);

v. UIE number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.sam.gov/:

vi. Small Business designation/status (must correlate with SAM registration):

_____ Small business _____ HUBZone _____ WOSB _____ 8(a) _____ VOSB _____ SDVOSB _____ Small Disadvantaged Business

b. Is your company eligible to receive awards under the 8(a) Program?

i. Yes

ii. No

iii. Not Applicable

2. Provide a brief summary (up to two pages) describing your organizational core technical and structural capabilities by providing examples of up to three (3) projects most relevant to the activities described in the draft Statement of Work (SOW) in the Attachment A of this document within last 5 years describing:

a. Past experience and achievements in directing and performing scientific research, especially in prototype vaccine development, preclinical studies, and/or early clinical studies of promising malaria or other vaccine or monoclonal antibody development, including those with multiple academic and private sector partners if applicable.

b. Past experience and achievements in coordinating multi-stakeholder scientific research and development programs.

The above examples should include the following information:

● Geographic locations;

● Staffing;

● If applicable, experiences working with and/or strengthening the capacity of institutions in countries with high malaria burden to perform research and development activities related to malaria vaccine(s) and/or monoclonal antibody(ies);

● If applicable, experience with USG funding including size, lengths and type of awards, and relationship (sub or prime awardee).

Firms are encouraged to take a close look at the draft SOW in the Attachment A and provide information with examples of past experience related to all areas described above.

The Government will not review any information, including attachments, more than two (2) pages.

Attachment C: RFI questions (For All Firms):

A. Business information: (not included in the page limit). Small Business Respondents who provided the company profile information per instructions in the Attachment B, Section A.1 Sources Sought should indicate that rather than responding again to this section.

1. Company Profile to include:

a. Company name and address;

b. Affiliate information: parent company, joint venture partners, and potential teaming partners;

c. Year the firm was established and number of employees;

d. Two points of contact (names, titles, phone numbers and email addresses);

e. UIE number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.sam.gov/:

B. Technical Questions (For All Firms. Please limit responses to 4 pages total)

1. Which areas of the Statement of Work (SOW), if any, need additional clarification? Are there additional items that should be added based on the current state of the art? Conversely, are there items that are not relevant?

2. With respect to the proposed SOW in the Attachment A, what are the most important opportunities, challenges, and gaps in malaria vaccine and biologics research and development (R&D) that could be addressed over the next 5-10 years, and how might you propose to address them? What approaches and activities should USAID prioritize that will complement investments of other federal agencies and global donors?

3. What opportunities and challenges exist for USAID to support malaria vaccine and biologics R&D that promotes locally-led and inclusive development in countries with high malaria burden in alignment with USAID’s Localization Vision?

4. What is the appropriate period of a contract for R&D involving malaria vaccine and/or biologics from early development through completion of proof-of-principle clinical trials? Please provide an illustrative timeline inclusive of data-based decisions for a new product.

5. Please provide any additional questions or comments you consider relevant.

http://www.sam.gov/ https://www.usaid.gov/localization/localization-usaid-vision-and-approach