U.S Vaccine Roll-Out Information
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Goals

To provide information on the global vaccine roll-out, specifically a country-by-country timing on when the world will receive vaccines, as well as information on when other countries will open their borders to travelers from the US. This data may be used to inform marketing strategies. Check out our comprehensive research on the use of contact tracing to fight COVID-19.

The US government, through the Operation Warp Speed (OWS) mechanism, expects to distribute at least 40 million doses of vaccines by the end of the year. And it intends to achieve these distributions through the strategic framework of the OWS. Below, is an overview of this strategy. Other useful insights on when other country borders will be opened for US travelers may be found on this research report.

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US COVID Vaccine Distribution Strategy: Operation Warp Speed (OWS)

Overview of Operation Warp Speed (OWS)

  • Operation Warp Speed (OWS) is a multi-agency, public-private partnership established by the US government on May 15, 2020. The mechanism is led by the Department of Health and Human Services (including CDC, FDA, NIH, and BARDA) and the Department of Defense. Alex Azar, the HHS secretary, and Christopher Miller, the acting defense secretary, both oversee the activities and operations of OWS, with Dr. Moncef Slaoui designated as chief advisor and General Gustave F. Perna confirmed as the chief operating officer.
  • The goal of OWS is “to produce and deliver 300 million doses of safe and effective vaccines by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).” It is committed to the fast provision of free or low-cost COVID-19 countermeasures, including vaccines, as to the US populace. It will achieve these by investing in and coordinating countermeasure development.
  • The OWS has already made huge progress around the development and manufacturing of new vaccines and therapeutics. These include the aggressive funding for the development (clinical trials) and manufacturing of several candidate vaccines such as Johnson & Johnson’s (Janssen), Moderna’s mRNA vaccine, AstraZeneca, Regeneron’s REGN-COV2, Novavax, Pfizer, Sanofi and GlaxoSmithKline’s (GSK) investigational adjuvanted vaccine, Eli Lilly and Company’s bamlanivimab (LY-CoV555), Emergent BioSolutions, among others.

Pre-Ordered Vaccines and Doses

  • Through the efforts of the OWS to invest over $10 billion in funding to support research, development, manufacturing, and distribution of eight different candidate COVID-19 vaccines, “the US government has already effectively purchased hundreds of millions of doses of these vaccines, from multiple manufacturers, even as clinical trials and federal regulatory review are ongoing.”
  • Duke’s Global Health Institutes quotes that “the US government has already made agreements to purchase enough doses to cover 230% of its population and could eventually control 1.8 billion doses.” These vaccines and the number of pre-ordered/owned doses are AstraZeneca AZD1222 adenovirus-vector vaccine (300 million), Janssen (Johnson & Johnson) AD26.COV2.S adenovirus-vector vaccine (100 million), Merck/IAVI V591 recombinant vesicular stomatitis virus (rVSV) vector vaccine (none reported), Moderna mRNA-1273 RNA vaccine (100 million), Novavax NVX-CoV-2373 recombinant protein vaccine (100 million), Pfizer BNT162b2 RNA vaccine (100 million), and Sanofi/GlaxoSmithKline recombinant SARS-CoV-2 Protein Antigen + AS03 Adjuvant (100 million).
  • These contracts and agreements between the US government, executed through OWS, and these pharma companies also include options for the US to acquire even more additional doses. This can be seen with Janssen (additional doses up to a quantity sufficient to vaccinate 300 million people), Moderna (additional 400 million doses), Pfizer (additional 500 million doses), and Sanofi/GlaxoSmithKline (additional 500 million doses).

Vaccine Sharing Formula Among States and Distribution Plans

  • “Experts from DoD are partnering with the CDC and other parts of HHS to coordinate supply, production, and distribution of vaccines.” And to manage vaccine distribution and administration, “Operation Warp Speed is using a software platform called Tiberius, which incorporates state and local data and provides decision-support tools to help jurisdictions finalize their micro plans.”
  • Once the FDA approves a vaccine, the federal government, along with the CDC-approved 64 state, local, and territorial jurisdictional immunization programs will commence the overseeing of vaccine doses delivery to approved administration sites across the country.
  • It is expected that initially, available doses will be limited; hence, the federal government will determine the number of doses allocated to each jurisdiction based on the approved vaccine(s), available doses, the population of jurisdictions, and potentially other factors. Each approved location will receive a minimum delivery requirement of the vaccine, which is 975 doses by Pfizer, and 100 doses by Moderna.
  • The populations of focus for initial COVID-19 vaccination may include:
    • Healthcare personnel (paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials);
    • Non-healthcare essential workers;
    • Adults with high-risk medical conditions who possess risk factors for severe COVID-19 illness;
    • People 65 years of age and older (including those living in LTCFs).
  • For jurisdictions, the distribution of vaccines will occur in phases: phase 1, phase 2, and phase 3.
    • Phase 1: “An initial limited supply of vaccine doses would be available, and therefore likely be prioritized for certain groups and distribution and administration are more tightly controlled.”
    • Phase 2: “The vaccine supply would be increased and access expanded to include a broader set of the population, with additional providers involved in administration.”
    • Phase 3: “There would likely be sufficient supply to meet demand, and distribution would be integrated into routine vaccination programs.”
  • For these vaccines to be dispatched to any jurisdiction, CDC pre-approved administration sites will make requests for vaccine doses to their jurisdiction’s immunization program. The programs will review the requests based on the allocation plans of the federal government. Jurisdictions’ immunization programs will then submit orders to the federal government (initially to OWS, potentially later to CDC as well). “Once reviewed by federal officials, vaccine doses will be delivered by a central distributor, McKesson Corporation, to administration sites within 48 hours of approval.”
  • For private partners, such as large retailers and pharmacies, the federal government may also ship doses to designated secondary vaccine depots, receive orders, and then ship the doses directly to them.
  • While the federal, state, and local government will determine how to prioritize the allocation of limited vaccines doses to specific population groups typically during phase 1, the National Academies of Medicine (NAM) framework, in with CDC’s Advisory Committee on Immunization Practices (ACIP), “indicate that high-risk workers in health care facilities, first responders, and persons at elevated risk from COVID-19 disease such as the elderly, are likely to be among the groups prioritized for receipt of the early, limited number of vaccine doses.”
  • Jurisdictions’ immunization programs and the federal government will set up distribution sites which may include, from indications, a wide variety of locations — “public and private hospitals and clinics (e.g., federally qualified health centers, rural health centers), medical practices, pharmacies, and potentially government-run mass vaccination locations.” OWS indicates that it intends “to deliver vaccines beyond the normal brick and mortar facilities, including potential mobile or on-site delivery of vaccines to long-term healthcare facilities and other hard to reach populations.”
  • These documents — OWS Vaccine Distribution Process (Sept. 6th), OWS Vaccine Distribution Process, COVID-19 Vaccination Program Interim Playbook, and From the Factory to the Frontlines — provide broader details of OWS’ distribution strategy.

Expected Distribution Timelines / Distribution Timelines

  • OWS has also undertaken several strategic steps to facilitate the distribution of new vaccines. These include various aspects of distribution contracts with ApiJect ($138 million), Corning ($204 million), SiO2 Materials Science ($143 million), McKesson Corporation, CVS and Walgreens, and large chain pharmacies and networks across the US.
  • While the US government’s $1.2 billion vaccine development support for Astrazeneca’s candidate vaccine was projected to see a delivery of the first doses of their vaccine as early as October 2020, initial doses are now expected to be available by January 2021. OWS is charged with the design and implementation of countermeasures, which include “the distribution of safe and effective vaccines, therapeutics, and diagnostics to counter COVID-19 by January 2021.”
  • Reports also show that it is possible that one or more of the OWS vaccine candidates will become available for public use over the next several months (as of October), as four of the candidate vaccines are already in phase III clinical trials. However, vaccines will still have to be approved through the FDA’s Biologic License Application (BLA) process, which could be completed for some vaccine candidates in 2021 although an Emergency Use Authorization (EUA) can be issued during pandemics.
  • Recently, Pfizer and BioNTech completed the Phase III trial of their COVID-19 vaccine and they plan to apply for an Emergency Use Authorization (EUA) with the FDA. Moderna also published positive interim Phase III trial results. Reports project that Pfizer’s vaccine may obtain FDA approvals for use by December 10, 2020.
  • By December 17, 2020, the FDA is expected to sit and evaluate Moderna’s EUA request with decisions expected to take 24 to 72 hours (i.e., December 21).
  • “Alex Azar, secretary of Health and Human Services, revealed that the U.S. will have about 40 million doses of the two vaccines by the end of the year,” as the OWS is prepared to begin distribution within 24 hours of receiving regulatory approvals (i.e., December 11-12).
  • COVID-19 vaccine delivery dry runs are already underway across the U.S.

Pfizer and Moderna's Timeline

Funding, Investments, and Cost

  • The OWS is mainly funded by the US government, with the “US Congress having directed almost $10 billion to this effort through supplemental funding, including the CARES Act. Congress has also appropriated other flexible funding. The almost $10 billion specifically directed includes more than $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.”
  • More realistically, Bloomberg pegs the overall budget at being as much as $18 billion. Below, it also provided a breakdown of the amount the federal government has invested in new vaccines and non-vaccine investments, including distribution agreements with Apijet and Corning, through the OWS:

Operation Warp Speed Vaccine InvestmentsSome of OWS’s Non-Vaccine Investments

  • In all these, however, “a critical and potentially limiting factor in the distribution of a COVID-19 vaccine is resource constraints faced by state and local health departments, who will have the main responsibility for managing vaccine distribution.” The majority of released funds went into vaccine-related activity, as “the CDC awarded $200 million from CARES Act funds to jurisdictions for vaccine preparedness, well below what is likely needed for such a large scale effort.”
  • While there have been requests from cohorts (such as the Senate Appropriations Subcommittee, the National Association of City and County Health Officers, the Association of Immunization Managers, and the National Governors Association) on the need to increase the funding on vaccine distributions for state and local health departments, the negotiations between Congress and the US government on a fifth COVID-19 relief bill, which would have included billions (likely $140 million) for vaccine distribution, are yet to be concluded.
GLENN TREVOR
Glenn is the Lead Operations Research Analyst at The Digital Momentum with experience in research, statistical data analysis and interview techniques. A holder of degree in Economics. A true specialist in quantitative and qualitative research.

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