At the request of the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, the National Academies of Sciences, Engineering, and Medicine (the National Academies) convened the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus. In addressing its charge and preparing its final report, the committee pursued several avenues for information collection and analysis. In addition to conducting a review of the relevant literature, the committee held eight virtual meetings, three of which included open public sessions that incorporated remarks from and discussion between invited stakeholders and experts. Midway through the study process, the committee released Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, which was open for written public comment over the 4-day period September 1–4, 2020. As part of the public comment period, the committee also held a 5-hour public listening session on September 2, 2020, to hear oral comments from members of the public. This appendix describes the committee’s study process in detail, including a summary of the written public comments received by the committee and copies of the three open session agendas.
The committee held eight virtual meetings from mid-July 2020 through September 2020. The first and third meetings included portions open to the public. The committee also hosted a separate public listening session. The agendas for these open sessions are included at the end of this appendix. The remaining meetings were held entirely in closed session.
To inform its deliberations, the committee gathered information through a variety of mechanisms: (1) reviews of the literature on previous allocation efforts; (2) the first and third committee meetings, which included sessions open to the public; and (3) an open public comment period to solicit written and oral comments on the discussion draft of the committee’s framework. All written information provided to the committee from external sources is available by request through the National Academies’ Public Access Records Office.
The National Academies’ staff conducted targeted searches of literature and fast-breaking research to ensure both adequate background knowledge of key issues as well as the latest developments in coronavirus disease 2019 (COVID-19)-related science. Other targeted literature reviews were conducted iteratively and as needed as novel issues arose throughout the committee’s deliberations and authoring of the report, given the rapidly evolving nature of work around COVID-19. This research process ensured that the committee and staff were monitoring both ongoing developments regarding COVID-19 and progress regarding COVID-19 vaccines.
The first meeting’s open session provided an opportunity for the committee to hear the sponsors’ perspectives on the charge and scope of the study. This session afforded the members the chance to engage in conversation regarding anticipated challenges, points of clarification, and to define the project’s boundaries. The committee was also able to hear from a representative from the Advisory Committee on Immunization Practices (ACIP), a key stakeholder, implementer, and beneficiary of the report’s recommendations.
The third meeting’s open session served to provide updates relevant to the project’s topical landscape and to hear from experts who could inform the committee’s thinking and framing of key topics. The committee heard from stakeholders representing ongoing vaccine initiatives, local and state health department officials, those speaking about ensuring public trust and equity, and experts using statistical modeling to inform vaccine efforts in different scenarios given the innumerable unknowns and variables.
The committee made available a discussion draft of its framework to obtain input from members of the public, especially groups disproportionately affected by COVID-19, to inform the committee’s final report.
Between September 1 and September 4, 2020, the committee conducted its public comment period which consisted of written and oral comment opportunities.
The Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine1 was posted on the National Academies Press (NAP) website at 12:00 p.m. ET on September 1, 2020. Written comments were accepted through an online form until 11:59 p.m. ET on September 4, 2020. In addition, the committee hosted a public listening session from 12:00 p.m. to 5:00 p.m. ET on September 2, 2020. Beyond the formal public comment period, members of the public were able to submit comments through a link on the study webpage2 or through a designated e-mail address for the duration of the study.
Two overarching goals informed outreach strategies during the public comment period: (1) obtain input from members of the public, especially groups disproportionately affected by COVID-19, to inform the committee’s final report and (2) convey the inclusiveness of the committee’s process to foster trust and engagement around the final report.
The formal public comment period was announced on August 27, 2020, 5 days in advance of posting the discussion draft. The announcement consisted of a comprehensive overview of written and oral comment opportunities3 posted on the study webpage, as well as an e-mail4 sent to listservs maintained by the National Academy of Medicine (NAM); the Health and Medicine Division (HMD) of the National Academies; and NAP.5 In addition, the announcement was posted on NAM, HMD, and National Academies social media platforms (Twitter, Facebook, and LinkedIn), including a paid, “boosted” Facebook post using internal National Academies funds. Finally, the National Academies issued a media advisory,6 which was also distributed among congressional and government contacts.
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1 See https://www.nap.edu/catalog/25914 (accessed September 15, 2020).
2 See https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus (accessed September 15, 2020).
3 See https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocationof-vaccine-for-the-novel-coronavirus/announcement/public-comment-opportunities (accessed September 15, 2020).
4 See https://mailchi.mp/nam.edu/vaccineframeworkpublicommentopportunities (accessed September 15, 2020).
5 NAM, HMD, and NAP are entities within a single organization, the National Academies of Sciences, Engineering, and Medicine, whose legal name is the National Academy of Sciences.
6 See https://www.nationalacademies.org/news/2020/08/national-academies-to-seek-public-comment-hold-listening-session-on-draft-framework-for-equitable-allocation-of-a-covid-19-vaccineweek-of-aug-31 (accessed September 15, 2020).
A list of more than 300 stakeholder organizations was developed across the following focus areas: racial/ethnic minority populations, urban and rural populations, health care providers and public health workers, essential workers across a variety of industries, individuals with disabilities, individuals with serious illness and other health conditions, older adults, immigrants, LGBTQ+ individuals, incarcerated and homeless individuals, veterans and active service members, faith groups, community groups, and others. Representatives from these organizations received a personal e-mail or phone call from NAM staff alerting them to the public comment opportunities between August 27 and September 1, 2020.
At 12:00 p.m. ET on September 1, 2020, the discussion draft was posted on an NAP webpage7 as a free PDF for download or electronic file for in-browse reading. A prominent announcement on the page encouraged visitors to submit written comments using a simple online form available from the webpage. A second e-mail8 was sent to NAM, HMD, and NAP listservs, and an alert was posted on NAM, HMD, and National Academies social media platforms (including a second “boosted” Facebook post). The National Academies issued a press release,9 which was also distributed among congressional and government contacts. On September 4, 2020, at 9:00 a.m., a final e-mail10 was sent to NAM, HMD, and NAP listservs notifying audiences that it was the final day of the formal public comment period. The written comment form was removed from the NAP website at 12:00 a.m. ET on September 5, 2020.
On September 2, 2020, from 12:00 p.m. to 5:00 p.m. ET, the committee hosted a public listening session via Zoom. NAM president Victor Dzau provided a welcome, and committee co-chairs William Foege and Helene Gayle presented an overview of the committee’s process and discussion draft. Next, public commenters representing minority communities, state and local government and health care, health and medical professional organizations, older adults, occupational risk groups, special populations (such as children and homeless individuals), and groups representing additional considerations from groups such as pharmacists and other public
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7 See https://www.nap.edu/catalog/25914 (accessed September 15, 2020).
8 See https://mailchi.mp/nam.edu/vaccineframeworkpublicommentopportunities-667026 (accessed September 15, 2020).
9 See https://www.nationalacademies.org/news/2020/09/national-academies-release-draft-framework-for-equitable-allocation-of-a-covid-19-vaccine-seek-public-comment (accessed September 15, 2020).
10 See https://mailchi.mp/nam.edu/vaccineframeworkpublicommentopportunities-667034 (accessed September 15, 2020).
health stakeholders delivered oral comments directly to the committee during 5-minute, pre-assigned time slots. At the end of the session, all members of the public were given an opportunity to speak if desired. This session afforded the committee the opportunity to hear feedback on various components of the discussion draft of the report to ensure multiple perspectives were taken into consideration and that any recommendations would be feasible and actionable on the ground. Slides and a recording of the session are available from the National Academies website.11 A total of 55 people delivered oral comments at the public listening session, which was also attended by a total of 2,432 people.
Between September 1 and 4, 2020, the committee also accepted written comments on its discussion draft through an online form. During this period, a total of 1,403 comments were received via the online comment form, in addition to 12 comments received via e-mail or the comment link on the study webpage. Comments were submitted on behalf of an organization (410 submissions, 29 percent) or on behalf of an individual (993 submissions, 71 percent). Of those who indicated that they were submitting comments on behalf of an organization, the majority indicated that they were associated with a nonprofit organization, advocacy group, or health care organization. A majority of the comments addressed issues associated with the priority populations, foundational principles and criteria, vaccine safety and efficacy, and health disparities. All materials and comments received through the online form were placed in the committee’s Public Access File and are available by request through the National Academies’ Public Access Records Office.
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11 See https://www.nationalacademies.org/event/09-02-2020/public-listening-session-discussion-draft-of-the-preliminary-framework-for-equitable-allocation-of-covid-19-vaccine (accessed September 15, 2020).
tions, gasoline distribution), public transit, postal service, delivery/shipping (trucking and air)/port workers, classified personnel, taxi/rideshare drivers, farm, fish, and food system workers, and construction and engineering.
Safety and Health Administration, the Mine Safety and Health Administration, and state and local public health agencies, to provide additional guidance in the designation of jobs and occupations in this group. These designations should consider how states and local governments have defined them.
supply at the federal level as a reserve for deployment by CDC for use in areas of special need (identified through a vulnerability index, such as the SVI or the COVID-19 Community Vulnerability Index) or epidemiological “hot spots.”
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus
First Committee Meeting Public Agenda
Friday, July 24, 2020
4:30 p.m.–5:30 p.m. ET
Zoom Webinar
Meeting Objective
Hold an open session to hear from sponsoring agencies on their perspectives of the Statement of Task.
Friday, July 24, 2020
OPEN SESSION
| SESSION | Sponsor Briefing: Discussion of the Committee’s Charge |
| 4:30 p.m. |
Welcome and Introductions
VICTOR DZAU President National Academy of Medicine |
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WILLIAM FOEGE, Committee Co-Chair Presidential Distinguished Professor of International Health (Emeritus) Rollins School of Public Health Emory University |
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HELENE GAYLE, Committee Co-Chair President and Chief Executive Officer The Chicago Community Trust |
|
| 4:45 p.m. |
Sponsor Perspective on Charge to the Committee
FRANCIS COLLINS, Sponsor Director National Institutes of Health |
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JAY BUTLER, Sponsor Deputy Director for Infectious Diseases Centers for Disease Control and Prevention |
|
| 5:00 p.m. |
Presentation from the Advisory Committee on Immunization Practices
JOSé ROMERO Chair Advisory Committee on Immunization Practices |
| 5:10 p.m. | Discussion with Committee |
| 5:30 p.m. | ADJOURN OPEN SESSION |
Third Committee Meeting Public Agenda
Friday, August 7, 2020
3:15 p.m.–6:15 p.m. ET
Zoom Webinar
Meeting Objective
Hold an open public session to hear from experts who can inform the committee’s thinking and framing of key topics such as updates on relevant COVID-19 work, downstream allocation and distribution considerations, and modeling needs.
DAY 1—Friday, August 7, 2020
OPEN SESSION
| 3:15 p.m. |
Welcome and Introductions
WILLIAM FOEGE, Committee Co-Chair Presidential Distinguished Professor of International Health (Emeritus) Rollins School of Public Health Emory University |
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HELENE GAYLE, Committee Co-Chair President and Chief Executive Officer The Chicago Community Trust |
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| SESSION I | Updates from Relevant Ongoing SARS-CoV-2 Vaccine Activities |
| 3:20 p.m. |
Operation Warp Speed Update: Understanding the SARSCoV-2 Vaccine Development and Procurement Landscape in the United States
MONCEF SLAOUI Chief Advisor Operation Warp Speed |
| 3:30 p.m. | Discussion with Committee |
| 3:40 p.m. |
Ethics and Process Considerations: A Perspective from the WHO SAGE Working Group on COVID-19 Vaccines
RUTH FADEN Founder and Philip Franklin Wagley Professor of Biomedical Ethics Berman Institute of Bioethics Johns Hopkins University Member, WHO SAGE Working Group on COVID-19 Vaccines |
| 3:50 p.m. | Discussion with Committee |
| SESSION II | Downstream Allocation and Distribution Considerations |
| 4:00 p.m. |
Health Department Perspectives: Learning from Past Experience and Understanding Current Needs
CARA CHRIST Director Arizona Department of Health Services |
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NGOZI EZIKE Director Illinois Department of Public Health |
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| 4:20 p.m. | Discussion with Committee |
| 4:40 p.m. |
Ensuring Public Trust and Equity in SARS-CoV-2 Vaccine Efforts
MONICA SCHOCH-SPANA Senior Scholar, Johns Hopkins Center for Health Security Senior Scientist, Department of Environmental Health & Engineering Johns Hopkins Bloomberg School of Public Health Co-Lead and Author, The Public’s Role in COVID-19 Vaccination |
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STEVEN WAKEFIELD Former External Relations Director (Retired) HIV Vaccine Trials Network Fred Hutchinson Cancer Research Center |
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JULIE MORITA Executive Vice President Robert Wood Johnson Foundation |
| 5:00 p.m. | Discussion with Committee |
| SESSION III | Modeling for SARS-CoV-2 Vaccine Scenarios |
| 5:20 p.m. |
Using Infectious Disease Dynamics to Inform Prioritization Efforts
MARC LIPSITCH Professor of Epidemiology Department of Epidemiology Department of Immunology and Infectious Diseases Director, Center for Communicable Disease Dynamics Harvard T.H. Chan School of Public Health |
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ALI MOKDAD Chief Strategy Officer, Population Health Director, Middle Eastern Initiatives Professor, Health Metrics Sciences Institute for Health Metrics and Evaluation, School of Medicine University of Washington |
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| 5:40 p.m. | Discussion with Committee |
| SESSION IV | Concluding the Workshop |
| 6:00 p.m. | Open Discussion with Panelists |
| 6:10 p.m. |
Workshop Synthesis and Conclusions
WILLIAM FOEGE, Committee Co-Chair Presidential Distinguished Professor of International Health (Emeritus) Rollins School of Public Health Emory University |
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HELENE GAYLE, Committee Co-Chair President and Chief Executive Officer The Chicago Community Trust |
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| 6:15 p.m. | ADJOURN OPEN SESSION |
Public Listening Session on Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine
September 2, 2020
12:00 p.m.–5:00 p.m. ET
Zoom Webinar
Meeting Objectives
Wednesday, September 2, 2020
OPEN SESSION
| 12:00 p.m. |
Welcome and Introductions
VICTOR DZAU President National Academy of Medicine |
|
WILLIAM FOEGE, Committee Co-Chair Presidential Distinguished Professor of International Health (Emeritus) Rollins School of Public Health Emory University |
|
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HELENE GAYLE, Committee Co-Chair President and Chief Executive Officer The Chicago Community Trust |
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| SESSION I | Overview of Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine |
| 12:10 p.m. |
Presentation by Committee Co-Chairs
WILLIAM FOEGE, Committee Co-Chair Presidential Distinguished Professor of International Health (Emeritus) Rollins School of Public Health Emory University |
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HELENE GAYLE, Committee Co-Chair President and Chief Executive Officer The Chicago Community Trust |
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| SESSION II | Public Comment Period with Confirmed Speakers |
| 12:20 p.m. |
Public Comment Period: Minority Communities
Randall Morgan, W. Montague Cobb/NMA Health Institute Elizabeth Ofili, Association of Black Cardiologists Ellen Provost, Alaska Native Tribal Health Consortium EpiCenter Elena Rios, National Hispanic Medical Association Jim Roberts, Alaska Native Tribal Health Consortium Winston Wong, National Council of Asian Pacific Islander Physicians |
| 12:50 p.m. |
Public Comment Period: State and Local Government and Health Care
Oscar Alleyne, National Association of County & City Health Officials David Gerstner, Dayton (OH) Metropolitan Medical Response System Syra Madad, NYC Health + Hospitals (NY) (Individual) Aaron Payment, Chairperson, Sault Ste. Marie Tribe of Chippewa Indians Marcus Plescia, Association of State and Territorial Health Officials Christian Ramers, Family Health Centers of San Diego (CA) Umair Shah, Harris County (TX) Public Health |
| 1:25 p.m. | BREAK |
| 1:40 p.m. |
Public Comment Period: Health and Medical Professional Organizations
Claire Hannan, Association of Immunization Managers Michelle Hood, American Hospital Association Anthony Hsu, American College of Emergency Physicians Scott Knoer, American Pharmacists Association Kathleen O’Laughlin, American Dental Association |
| 2:05 p.m. |
Public Comment Period: Older Adults
Louise Aronson, University of California, San Francisco (Individual) Timothy Farrell, American Geriatrics Society Brendan Flinn, LeadingAge Nicole Lynch, VOYCE Mark Parkinson, American Health Care Association/National Center for Assisted Living David Schless, American Seniors Housing Association Chad Worz, American Society of Consultant Pharmacists |
| 2:40 p.m. |
Public Comment Period: Occupational Risk
Debbie Berkowitz, National Employment Law Project Scott DiMauro, National Education Association/Ohio Education Association Alexis Guild, Farmworker Justice Gary Ludwig, International Association of Fire Chiefs Peter Matz, Food Industry Association Rebecca Reindel, AFL–CIO Mily Trevino-Sauceda, Alianza Nacional de Campesinas Randi Weingarten, American Federation of Teachers |
| 3:20 p.m. | BREAK |
| 3:30 p.m. |
Public Comment Period: Special Populations
Alleanne Anderson, SchoolHouse Connection Gabriella Barbosa, Children’s Partnership Chandra Crawford, National Alliance to End Homelessness Charles Lee, American College of Correctional Physicians Karen Mountain, Migrant Clinicians Network Oluwaferanmi Okanlami, University of Michigan (Individual) Amy Pisani, Vaccinate Your Family |
| 4:05 p.m. |
Public Comment Period: Additional Considerations
Georges Benjamin, American Public Health Association Paul Conway, American Association of Kidney Patients Nicole Cruz, California State University, East Bay (Individual) Anna Legreid Dopp, American Society of Health-System Pharmacists Ann Kimball, Rotary (Individual) Harald Schmidt, University of Pennsylvania (Individual) Lynlee Swartz, Body Politic (Individual) |
| SESSION V | Open Public Comment Period with the General Public |
| 4:40 p.m. | Open Public Comment Period with the General Public |
| 5:00 p.m. | Closing Comments from Co-Chairs and Adjourn Meeting |
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