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    Defense Production Act is shot in the arm for Warp Speed’s mission

    OWS visits manufacturing site

    Courtesy Photo | Operation Warp Speed leaders made several industry visits in the fall of 2020.... read more read more

    The Defense Production Act is bolstering Operation Warp Speed’s mission to get safe and effective COVID-19 vaccines and therapeutics to the American people.

    Since August, companies received a total of 18 priority ratings under the Defense Production Act, boosting their precedence when it comes to securing the important supplies and components needed to manufacture their products and helping to expand domestic manufacturing capacity for vaccines and therapeutics.

    Operation Warp Speed Senior Counsel, Gregory Gillette, explained that approving a priority rating under the Defense Production Act is a deliberate, informed decision, made only after fully understanding the benefits and the second and third order effects of prioritizing a U.S. Government contract over others.

    “We understand that several of the larger companies with whom we contracted also have agreements to provide vaccines all over the world,” Gillette said. “It is our obligation to ensure that a company only uses the Defense Production Act to benefit U.S. Government orders.”

    When the vaccine development process began, the U.S. domestic capacity to produce vaccines and therapeutics at the required scale and timeframe didn’t exist, said Operation Warp Speed Manufacturing Lead Navy Capt. Brian Durant.

    “These priority ratings are akin to ‘head-of-the-line’ privileges to help us manage scarce supplies, raw materials, and equipment in support of the end state,” Durant said.

    Through its partnership with the U.S. Department of Health and Human Services, Operation Warp Speed leveraged two components of the Defense Production Act – the Defense Priorities and Allocations System (DPAS) and the Health Resources Priority and Allocations System (HRPAS) – to help accelerate the manufacturing and distribution of vaccines and therapeutics.

    The Defense Priorities and Allocations System ensures the timely delivery of industrial items and may be used to prioritize and allocate materials, services and facilities necessary to promote national defense. The Health Resources Priority and Allocations System provides priorities and allocations for resources that include biological products, medical devices and other health-related items.

    Managing the Defense Production Act priority rating for a contract is no simple matter, according to Gillette.

    “There is an understanding that when the U.S. Government approves a request under the DPA that everything magically runs itself,” Gillette said. “But all these companies helping to provide COVID-19 countermeasures are competing in a crowded space. In order to aggressively and legally maximize the benefit of the Defense Production Act for U.S. national defense, while minimizing impact on other companies and other products, each priority rating is meticulously managed by Operation Warp Speed leaders and logistics experts, in coordination with each company and their up-stream suppliers.”

    Once a priority rating under the Defense Production Act is granted, Durant provides training to companies, explaining how the governing Code of Federal Regulations binds them, how to flow the rules to their vendors, and ensuring the companies understand that a priority rating can only be used to assist with U.S. Government orders.

    “We help the companies pull a thread from the vaccine down to a company who manufactures a custom-made screw for a machine in the plant or produces the sugars and proteins that are building blocks of vaccine production if necessary,” said Durant, who often steps in to clarify the authorities to suppliers.

    To date, all six vaccine candidates in the Operation Warp Speed portfolio – Moderna, AstraZeneca, Novavax, Jannsen, Sanofi and Pfizer – and companies manufacturing therapeutics, such as AstraZeneca, Eli Lilly, Regeneron and SAb BioTherapeutics, have priority ratings under the Defense Production Act and have all received extensive assistance from Operation Warp Speed to acquire access to scarce supplies, materials, and equipment, Gillette said. Additionally, the Defense Priorities and Allocations System expanded capacity to help manufacture more vaccines and therapeutics at companies like Fujifilm Diosynth Biotechnologies, Emergent Biosolutions, Corning and Cytiva.

    The Defense Production Act is not the only means available to assist companies working as part of the whole-of-America effort to defeat COVID-19. Technology Investment Agreements, managed through the U.S. Army Corps of Engineers, are another tool that helps expand the domestic industrial base to accomplish the Operation Warp Speed mission. These agreements assisted several companies with expansion and construction projects to manufacture the vials, needles and ancillary items necessary to support vaccine and therapeutic distribution and administration.

    “Operation Warp Speed has used and will continue to use the Defense Production Act and any other available authority whenever it helps a company more quickly deliver vaccines or therapeutics to the American people,” Gillette said.

    Operation Warp Speed’s use of DPA authorities and Technology Investment Agreements:
    Health Resources Priority and Allocations System: AstraZeneca; Eli Lilly; Janssen; Moderna; Merck; MicroLab; Novavax; Regeneron; SAb BioTherapeutics; Sanofi, Pfizer.

    Defense Priorities and Allocations System: Fujifilm Diosynth Biotechnologies; Emergent; Moderna; Corning; Cytiva; McKesson.
    Technology Investment Agreements: Becton-Dickenson; Corning; Cytiva; Fujifilm Diosynth Biotechnologies RTI; SiO2; Smiths Medical; Thermo Fisher.



    Date Taken: 12.31.2020
    Date Posted: 12.31.2020 10:58
    Story ID: 386211
    Location: US

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