2_JA 2111384.docx

Justification for Other than Full and Open Competition:

Meso Scale Discovery at or Below the Simplified Acquisition Threshold

Project Title: Screening SARS CoV-2 monoclonal antibodies against circulating corona virus spike proteins and CoV-2 proteins of interest

Identification of the agency and contracting activity:

DHHS, NIH, NIAID, VRC, VIP

Address of the requesting lab/office: 9 W Watkins Mill Rd, Gaithersburg, MD 20878

Description of the project and supplies or services required to meet the agency's needs Project Background

· The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola and more recently SARS-CoV-2 Coronavirus. Support is through the state-of-the-art laboratory performing Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. As part of a broader strategy to accelerate the development of monoclonal antibodies as therapy for targeting SARS CoV-2 spike and its newly emerging variants, VIP has identified the electrochemiluminescent (ECL) assay format as the most reliable and sensitive assay system that offers high dynamic range in the detection of antibodies isolated specific to SARS CoV2 spike (S2P). Specifically, the VIP is in the process of developing an assay for detection of binding antibodies to subdomains of the spike such as RBD, NTD, Sl and S2, which offers high throughput measurement of immune responses elicited by infections.

· The assay kits are needed for the VIP to perform the assay testing in support of SARS CoV2 therapeutic antibody isolation and development project.

Product needed:

Manufacturer: Meso Scale Discovery

Catalog #K15567U-4, Item Description: V-PLEX SARS-CoV-2 Panel 23 (IgG) Kit (25 PL) QTY: 4 each

Identification of the statutory authority permitting other than full and open competition:

· 41 USC 1901(a)(l) and FAR Part 13.106-1(b): Only one responsible source/Brand Name

Demonstration that the proposed contractor unique qualifications or the nature of the acquisition requires use of the authority cited.

Name and address of the proposed contractor:

Meso Scale Discovery 1601 Research Boulevard Rockville MD 20850

Describe why only the requested brand name of the supply will meet the government's needs:

As the threat of COVID-19 continues in the international community with new variants emerging every week, the need for a safe and efficacious monoclonal antibody therapy at an accelerated timeline is a health care priority. To assist in this effort, the VRC-VIP needs the electrochemiluminescent (ECL) assay format which they have recently developed for a SARS CoV-2 specific assay for the detection of specific antibodies directed towards SARS CoV-2 S-2P, SARS CoV-2 Receptor Binding Domain (RBD) and SARS CoV-2 N ( nucleocapsid proteins), SARS-CoV-2 NTD, SARS CoV-2 Sl, SARS CoV-2 S2, and variants (A.23.1, A.VOI.V2, C.37, R.1, P.3, B.1.525, B.1.1.519, BV-1, and B.617.2)

Spikes that are 'printed' or 'spotted' in a single well of a MSD 96-well microtiter plate. The VRC-VIP identified the ECL assay as the most reliable and sensitive assay system over the last 10 years, that offers high dynamic range in the detection of specific serum antibodies generate towards a variety of viral proteins. This platform has the needed high throughput for the simultaneous measurement of antibodies to their epitopes. The multi-plex assays used for Phase l and Phase 3 testing is on the MSD platform, and only the V-Plex kits manufactured from Meso Scale Discovery will work with the current platform utilized in the lab.