Subtask. 5 – Reaccreditation Support via the Risk Management Framework (RMF). The contractor shall provide mitigation and POA&M analysis support for the reaccreditation of software baseline via the RMF certification and accreditation process. The contractor shall support the security team throughout the RMF process to include: reassessing RMF controls, remediate findings, deliver artifacts, update finding matrix, etc.
Subtask. 2 Data from this subtask will consist of EPR current densities and potentials and the corresponding fixed test parameters, passive current densities at multiple potentials, passive current density transients resulting from step changes in potential, potentiostatic Electrochemical Impedance Spectroscopy (EIS) data, and current-voltage curves for hydrogen evolution/oxygen reduction. Electronic data will be collected, reduced, and recorded according to QAP-3.1, “Control of Electronic Data.” The data generated will be plotted and/or tabulated where appropriate. Data analysis and reduction will be performed using the above listed software packages (spreadsheet calculations, image processing, diffusion data reduction) as appropriate. Significant graphical results will be printed and pasted into or attached to the appropriate Scientific Notebooks (SNs). Numerical results will be recorded in the appropriated SN’s. Data will be submitted to the UCCSN Technical Data Archive (TDA) in accordance with QAP-3.6, “Submittal of Data” through the UCCSN data coordinator. Data that have not undergone technical review or are otherwise non-qualified, will be labeled “for scoping or corroborative use only,” and traceability to their origin and nature will be maintained in documents in which the data are presented. Non-qualified data will be used for preliminary scoping purposes only and will not be used to reach any conclusions.
Subtask. Raw Materials – Obtain Critical Starting Materials for Adjuvant Manufacturing Sufficient Saponin to manufacture up to 100M vaccine doses will be purchased (Desert King, headquartered in San Diego, CA, facilities in Chile). Long-lead, critical, and limited-supply materials ([***]) will be purchased for the additional 560M vaccine doses to meet the contact requirement, in order to ensure capability to rapidly manufacture to meet surge requirements with little advance notification and demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed.
Subtask. Raw Materials – [***] Intermediates to Produce Matrix-M Adjuvant Matrix-M Adjuvant [***] to supply large-scale manufacturing of vaccine doses will be manufactured at [***] and PolyPeptide (Torrance, CA & Malmö, Sweden). Technology transfer and start-up of the PolyPeptide facility in Torrance, CA will be completed. Long lead, critical, and limited supply materials will be purchased in order to achieve the goal of large-scale production. 3.1.4
Subtask. Matrix-M Adjuvant Manufacturing to Supply 100M Vaccine Doses Matrix-M Adjuvant bulk components will be manufactured at ACG Biologics (Seattle, WA) to supply 100M vaccine doses. Technology transfer and start-up of the AGC Bio facility in Seattle will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site. 3.1.5
Subtask. Antigen Manufacturing to Supply 100M Vaccine Doses Antigen will be manufactured at Fuji (2 sites – College Station, TX and Research Triangle Park, NC) to supply 100M vaccine doses. Technology transfer and scale-up activities will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site. 3.1.6
Subtask. Fill/Finish of 100M Vaccine Doses 100M doses of finished vaccine in [***] vials will be manufactured at Xxxxxx (Bloomington, IN, USA). This will include secondary packaging. Technology transfer and scale-up activities will be completed. An analytical comparability manufacturing study and validation studies will be performed as part of the tech transfer to each manufacturing site. 3.1.7
Subtask. Shipping and Storage Novavax assumes that it will maintain a Vendor Managed Inventory (VMI) system for a period of 12 months, with shipments to 10 geographic zones in the USA. Novavax will perform activities to establish compliance with DSCA to the extent applicable at the time of manufacturing, by statute and FDA interpretive guidance thereof. 3.2
Subtask. Phase 3 Global Efficacy Study, Adults ≥ 18 and < 75 years Study: Phase 3 – Global Efficacy Study (to be harmonized with other USG studies), 2019nCoV-301. Population: Adults ≥ 18 years, inclusive of subjects with more severe co-morbid conditions. Locations: North America, Europe; may include Africa, Asia, Oceania, South America. Primary Objectives: Clinical efficacy, safety, immunogenicity. Design: Randomized, observer-blinded, placebo-controlled.
Subtask. Phase 2 Efficacy Expansion (US), Adults ≥ 18 and < 75 years Study: Phase 2 - Part 3 efficacy expansion (US), 2019nCoV-204. Population: Adults ≥ 18 and < 75 years. Locations: USA. Primary Objectives: Clinical efficacy, safety, immunogenicity. Design: Randomized, observer-blinded, placebo-controlled. Test Product(s); Dose Regimen; Route of Administration: Vaccine + Matrix-M – [***]; not greater than 25 µg antigen + 50 µg adjuvant, [***] to allow for rapid initiation. Placebo. ~0.5 mL dose IM injection, up to 2 doses at Day 0 and Day 21. Enrollment: TOTAL: [***]. [***]. Adjusted for expected event occurrence. Event driven analysis. Initiation of study gated on completion of Phase 1 study, dose-selection and regulatory approval. 3.2.3
