Advancing the Vaccine Law Dialogue
Pre-conference: September 13
Washington, D.C.
Agenda for the 2023 National Vaccine Law Conference
Please check back for additional details.
Specific venue details will be provided to registrants.
* Indicates session to be streamed
Wednesday, September 13, 2023
Pre-Conference Symposium: Celebrating VFC at Thirty Years Old and Envisioning its Future
9:00 AM – 9:30 AM
Welcome to the 2023 National Vaccine Law Conference
Richard Hughes IV, JD, MPH, Partner, Epstein Becker & Green, P.C.; Professorial Lecturer in Law, The George Washington University Law School
Lynn Goldman, MD, MPH, MS, Dean, Milken Institute School of Public Health, The George Washington University
Symposium Sessions
9:30 AM – 10:45 AM
Panelists will reflect on the cumulative efforts through development of the law, public health strategies and advocacy to vaccinate children. We will discuss the many successes prior to VFC and the ultimate realization that persistent disease threats, inequities and fragmented health care coverage demanded a stronger solution.
Cheryl De Pinto, MD, MPH, FAAP, Senior Vice President, Primary Care and Subspecialty Pediatrics, American Academy of Pediatrics
Amy Pisani, MS, CEO, Vaccinate Your Family
Jeanne Santoli, MD, MPH, Branch Chief, Vaccine Supply and Assurance, National Center for Immunization and Respiratory Diseases, CDC
10:45 AM – 12:15 PM
Panelist Sara Rosenbaum will discuss her vision for the VFC program in the earliest days of the Clinton administration and its legal framework. Panelist Tim Westmoreland will share his recollections on how the program was successfully passed into law and the political maneuvering required.
Sara Rosenbaum, JD, Professor Emerita, Health Law and Policy, The George Washington University, Milken Institute School of Public Health
Timothy M. Westmoreland, JD, Professor Emeritus, Georgetown Law
Lunch Break
12:15 PM – 1:00 PM
Symposium Sessions
1:00 PM – 2:00 PM
Former HHS Secretary Donna Shalala will share her perspective on how Americans came together in a “nonpartisan” manner to successfully improve vaccination rates and implications for vaccine policy today.
Secretary Donna Shalala, PhD, Trustee Professor of Political Science and Health Policy at the University of Miami, 18th U.S. Secretary of Health and Human Services
Break
2:00 PM – 2:30 PM
Symposium Sessions
2:30 PM – 3:30 PM
Panelists will reflect on the work of implementing the VFC Program after its passage.
Donna Garland, Deputy Associate Administrator for Communications and Marketing, Government Services Administration – (Moderator)
Richard Leach, JD, President and CEO, Main Sail Strategies
3:30 PM – 5:00 PM
Panelists will reflect on the wide-ranging opportunities after three decades of experience to optimize VFC for the long-term.
Wanda Filer, MD, MBA, FAAFP, Chief Medical Officer, VaxCare, Past President, American Academy of Family Physicians
Michelle Fiscus, MD, FAAP, Chief Medical Officer, Association of Immunization Managers; Member, American Academy of Pediatrics Board of Directors
Alexandra Bhatti, JD, MPH, Director, US Vaccine Policy, Merck & Co., Inc., Faculty Associate, College of Health Solutions, Arizona State University
Heather Entenmann, MPH, US Public Health Engagement Lead, Sanofi
Anita Patel, PharmD, Vice President, Pharmacy Services Development, Walgreen Co.
Break
5:00 PM – 5:30 PM
Vaccine Law Vanguard Award Reception: Honoring Sara Rosenbaum’s Lifetime Commitment to Vaccine Law
5:30 PM – 7:30 PM
Welcome & the Vaccine Law Vanguard Award: Honoring Leaders on the Forefront of Vaccine Law.
Denise Hill, JD, MPA – NVLC Vice-Chair; Associate Professor, Drake University; Attorney, Whitfield & Eddy, PLC
Session Tribute Remarks: Reflecting on Sara Rosenbaum’s Contributions.
Richard Hughes IV, JD, MPH, Partner, Epstein Becker & Green, P.C.; Professorial Lecturer in Law, The George Washington University Law School
A Toast to Sara Rosenbaum.
Lynn Goldman, MD, MPH, MS, Dean, Milken Institute School of Public Health, The George Washington University
Sara Rosenbaum (Vaccine Law Vanguard Award Recipient): Special Remarks.
Sara Rosenbaum, JD, Professor Emerita, Health Law and Policy, The George Washington University, Milken Institute School of Public Health
Thursday, September 14, 2023
Continental Breakfast
7:30 AM – 8:15 AM
Conference Opening Plenary Session
8:15 AM – 10:00 AM
The first University to offer a Vaccine Injury Litigation Clinic
Dayna Bowen Matthew, JD, PhD, Dean, Professor The George Washington University Law School
Since the first National Vaccine Law Conference convened a year ago, there have been substantial developments in every area of vaccine law. This session will outline the major changes and trends in the law of vaccine regulation, intellectual property, access and funding, mandates and exemptions, injury compensation, and responses to antivaccine misinformation.
Denise Hill, JD, MPA, Associate Professor, Drake University; Attorney, Whitfield & Eddy, PLC – (Moderator)
Brian Dean Abramson, JD, LLM, Adjunct Professor of Vaccine Law, The Florida International University College of Law; Principal, Vaccination Program Counsel, PLLC
Richard Hughes IV, JD, MPH, Partner, Epstein Becker & Green, P.C.; Professorial Lecturer in Law, The George Washington University Law School
Dorit Rubinstein-Reiss, JD, Professor of Law, Chair of Litigation, University of California Hastings College of the Law
This session addresses federal vaccine law developments from regulators’ point of view. Listen to attorneys from the Office of General Counsel as they share updates from the agencies they serve.
Daniel Barry JD, Principal Deputy General Counsel, U.S. Department of Health & Human Services (HHS) – (Moderator)
Mark Raza, JD, Chief Counsel, FDA Office of Chief Counsel/HHS Office of General Counsel Food and Drug Division
Susan Sherman, JD, MS, Senior Attorney, HHS Office of General Counsel, Administration for Strategic Preparedness and Response
Melisa Thrombley, JD, MPH, Senior Attorney, HHS Office of General Counsel, Centers for Disease Control & Response
Break
10:00 AM – 10:20 AM
— BREAKOUT CONFERENCE TRACKS —
- Regulation (R, D & IP)
- Finance, Equity & Access
- Safety, Injury & Public Confidence
- Employers & Providers
Breakout Session 1
10:20 AM – 11:20 AM
This session will describe the regulatory process of developing and licensing a vaccine, from initial formulation through clinical trials, potential EUA authorization, full FDA licensure, and post-licensure inspection and policing of vaccines.
Brian Malkin, JD, Associate General Counsel – Regulatory Law, Teva Pharmaceutical Industries – (Moderator)
Cathy Burgess, JD, Partner, Alston & Bird
Justin Coen, JD, Partner, Venable LLP
Nicholas Diamond, LLM, JD, MBE, Partner, Jackson Walker
Pharmacist Educational Objectives:
- Describe the complete regulatory process of developing and licensing a potential vaccine.
- Define Emergency Use Authorization (EUA) vs. full FDA licensure.
- Discuss post-licensure inspection processes and policing of vaccines.
This panel will explore current issues in coverage and reimbursement of vaccines, including new coverage requirements under the IRA for Medicare and Medicaid, the coverage pathways for monoclonal antibodies, coverage of travel and shared clinical decision-making vaccines.
Richard Hughes IV, JD, MPH, Partner, Epstein Becker & Green, P.C.; Professorial Lecturer in Law, The George Washington University Law School – (Moderator)
Abby Bowens, Partner and Coalition Manager, Adult Vaccine Access Coalition
Chris Regal, Clinical Innovation, AHIP
Leena Scaria, MPP, Director, U.S. Vaccine Public Policy, Merck & Co., Inc.
Jennifer Tinney, Arizona Partnership for Immunization
Pharmacist Educational Objectives:
- Describe current issues in coverage and reimbursement of vaccines.
- Review new coverage requirements under the Inflation Reduction Act (IRA) for Medicare and Medicaid.
- Describe the coverage pathway for monoclonal antibodies.
- Discuss coverage of vaccines required for international travel.
This session will provide an update about the latest vaccine law related trends and developments at the state and local level. Discussion about the significance of these trends and what stakeholders might expect in the future will also be addressed.
Dorit Rubinstein-Reiss, JD, Professor of Law, Chair of Litigation, University of California Hastings College of the Law – (Moderator)
Maggie Davis, JD, MBE, PMP, Director, State Health Policy, ASTHO
Elizabeth Platt, JD, Director of Research and Operations, Center for Public Health Law Research, Beasley School of Law, Temple University
Y. Tony Yang, ScD, LLM, MPH, Professor in Health Policy, Executive Director, Center for Health Policy & Media Engagement at The George Washington University School of Nursing
Pharmacist Educational Objectives:
- Review the latest vaccine related trends and developments at the state and local level.
- Describe vaccine requirements, restrictions, prohibitions and vaccine surveillance.
- Discuss stakeholder concerns and issues related to vaccine law and vaccine administration.
Looking for an unstructured opportunity to network, take a deeper dive into issues addressed during the opening plenary, or discuss vaccine law developments with colleagues from different organizations and disciplines? This is the place for you.
Hosted by NVLC staff
Break
11:20 AM – 11:30 AM
Breakout Session 2
11:30 AM – 12:30 PM
Many new vaccines and other prophylactic assets are in the clinical and preclinical phases of development. This panel will explore the full pipeline and highlight the most promising aspects of development; and discuss the legal structures needed to facilitate them.
Phyllis Arthur, MBA, Vice President for Infectious Diseases & Diagnostics Policy, Biotechnology Innovation Organization – (Moderator)
Melinda Morton Hamer, MD, MPH, FACEP, Deputy Director for Operations, Congressionally Directed Medical Research Programs, DARPA
CDR Valerie Marshall, MPH, PMP, GWCPM, Senior Public Health Advisor, National Vaccine Program (NVP), Office of Infectious Disease Policy & HIV/AIDS Policy, Office of the Assistant Secretary for Health
Julian Ritchey, MBA, Vice President, Head of Public Affairs & Patient Advocacy, US Vaccines, Sanofi
Pharmacist Educational Objectives:
- Identify new vaccines and vaccine-like products in the clinical and pre-clinical phases of development.
- Describe the full vaccine and related products pipeline and highlight the most promising aspects of development.
- Discuss the legal structures needed to facilitate current and future vaccine development.
This session will examine potential inequities in the mechanisms for developing and distributing vaccines in the U.S and abroad, and for responding to concerns arising from the distribution of the same. Presenters will address distribution structures and contracting standards designed to avoid disparate health outcomes for marginalized populations, and the establishment of mechanisms for compensation of adverse events in such populations as a means to reduce vaccine hesitancy.
Dr. Daniel Ali, PhD, Assistant Scientist, Johns Hopkins University – (Moderator)
Julia Barnes-Weise, JD, CPE, Executive Director of the Global Healthcare Innovation Alliances Accelerator (GHIAA)
Katherine Bliss, PhD, Senior Fellow and Director, Immunizations and Health Systems Resilience, Global Health Policy Center, Center for Strategic & International Studies, Adjunct Professor, Georgetown University
John D. Winter, JD, Partner, Patterson Belknap
Developing relationships and educating legislators often provides the best opportunity to influence vaccine-related law and policy. Participants in this session will hear directly from lawmakers and experienced advocates about best practices in vaccine-related advocacy and their own challenges dealing with these issues. Tips for developing a reputation as a credible source of information, explaining complex scientific concepts in simple terms, articulating value propositions, and crafting a clear “ask” will be covered.
Abby Bownas, Partner and Coalition Manager, Adult Vaccine Access Coalition – (Moderator)
Hon. Ghazala Hashmi, State Senator, Virginia
Hon. Clarence Lam, MD, MPH, State Senator, Maryland
Richard Pan, M.D., MPH, Former State Senator, California
Although the COVID-19 Public Health Emergency has expired, employers still have decisions to make about the role of vaccines in their workplaces. During this interactive hands-on session explore how lessons learned and proven vaccine-related compliance strategies can work in your own organization. Issues such as incentives, premium discounts, negotiations with labor, and appropriate responses to vaccine exemption and accommodation requests will be covered. Utilize a hands-on-tool to ensure that your organization’s policies and on-site vaccination programs meet your needs and legal obligations.
Denise Hill, JD, MPA, Associate Professor, Drake University, Attorney and Mediator, Whitfield & Eddy, PLC – (Moderator)
Ronda Esaw, JD, Labor and Employment Attorney
Ron Peppe, JD, MA, Executive Vice President, Shared Services, Canam Steel Corporation
Jo Ellen Whitney, Attorney and Senior Shareholder, Dentons Davis Brown
Lunch
12:30 PM – 1:30 PM
Breakout Session 3
1:30 PM – 2:30 PM
A history of inappropriate human subjects research has cast a long shadow on vaccine research; engendering a shortage of diverse research participants, lack of vaccine acceptance, and less than optimal health outcomes–particularly among certain segments of the populations. In response to these concerns, today’s vaccine clinical trials are tightly regulated to ensure they meet high epistemic and ethical standards. This session will address key legal and ethical requirements surrounding vaccine clinical trials; with an eye towards recent experiences, issues, and debates.
Lindsay Androski, JD, MBA, CFA, Founder, President and CEO, Roivant Social Ventures
Sonali Gunawardhana, JD, LLM, MPH, Assistant General Counsel, Regulatory Cardinal Health
Despite the most rapid development and manufacturing scale-up of vaccines in history, the COVID-19 response was slowed by a variety of factors, both upstream and downstream, that impeded equitable procurement and distribution of COVID-19 vaccines. Further, the pandemic also laid bare persistent inequities in access to routine vaccines among low- and middle-income countries (L/MICs). This panel discussion will touch upon policies and laws across the value chain and how they enable multisectoral collaboration to ensure equitable access to vaccines both within and across countries.
Nicholas Diamond, LLM, JD, MBE, Partner, Jackson Walker – (Moderator)
Ripley Ballou, ADVANCE Senior Scientific Advisor and Project Lead, HIV bnAbs
Rachel Mitrovich, DrPH, MPH, Director, Global Vaccines Policy Strategy and Partnerships at Merck
Lauren Sullivan, JD, Associate General Counsel, Bill & Melinda Gates Foundation
Misinformation and disinformation around vaccines was exacerbated by the Covid-19 pandemic and vast public reliance on social media platforms. In this environment, effective strategies for countering vaccine misinformation and disinformation are crucial to ensure sound public policy and legal decisions are made. Speakers on this panel will share examples and best practices for responding to misinformation and grounding decisions in science.
Dorit Rubinstein-Reiss, JD, Professor of Law, Chair of Litigation, University of California Hastings College of the Law – (Moderator)
Meghan Jendrysik, PhD, Managing Editor, Elsevier, Fellow, NIH
Jessica Malaty Rivera, MS, Science Communication Lead, The COVID Tracking Collective, The Rockefeller Foundation COVID Tracker
Scott Hamilton Kennedy, President, Black Valley Films, Writer/Director/Producer, Shot in the Arm
Pharmacist Educational Objectives:
- Discuss misinformation and disinformation concerning vaccines for SARS-CoV-2 during the COVID-19 pandemic.
- Define vaccine confidence and vaccine hesitancy.
- Describe effective strategies and best practices to counter vaccine misinformation and disinformation.
Informed consent in vaccination can already be a challenge; however, what is a provider to do when parents disagree (Married or Divorced) or there are concerns about abuse or coercion from surrogate decision-makers? Listen to recommendations and best practices about how to deal with these medico-ethical situations during this practical session.
Denise Hill, JD, MPA, Associate Professor, Drake University, Attorney and Mediator, Whitfield & Eddy, PLC – (Moderator)
Daniel Bousquet, JD, Visiting Associate Professor, Friedman Fellow at the Family Justice Litigation Center, The George Washington University Law School
Michelle Fiscus, MD, FAAP, Chief Medical Officer, Association of Immunization Managers; Member, American Academy of Pediatrics Board of Directors
Ethan Lindenberger, Youth Vaccine Advocate, Director, Ace of Swords
Break
2:30 PM – 2:40 PM
Breakout Session 4
2:40 PM – 3:30 PM
This panel will explore the current makeup of the adult immunization schedule, the increasing complexity of the schedule, implementation issues in clinical practice, quality measurement for adult immunization and opportunities for optimization.
Richard Hughes IV, JD, MPH, Partner, Epstein Becker & Green, P.C.; Professorial Lecturer in Law, The George Washington University Law School – (Moderator)
David Kim, MD, CAPT, U.S. Public Health Service, Director, National Vaccine Program Division, Office of Infectious Disease & HIV/AIDS Policy, U.S. HHS
Candace Lerman, JD, MS, HCC, Attorney, Adheris Health, Patient Advocate, RareCandace.com
Kelly Moore, MD, MPH, CEO, Immunize.org
Angela Shen, ScD, MPH, Visiting Research Scientist, Vaccine Education Center, Children’s Hospital of Philadelphia, retired Captain, US Public Health Services
Pharmacist Educational Objectives:
- Highlight any significant changes to the CDC 2023-24 Adult Immunization Schedule.
- Identify best practice recommendations from the CDC Advisory Committee on Immunization Practices (ACIP).
- Discuss any new vaccine additions or changes in administration schedules for vaccines currently recommended in the adult schedule.
State-specific school entry immunization laws and school-located vaccination (SLV) clinics have long been credited with creating a robust system of childhood vaccination against vaccine-preventable diseases in the US. In recent years, expansion of allowable exemptions, lax enforcement of requirements, and the COVID-19 pandemic have steadily eroded that system. During this session participants will discuss trends in school vaccination laws and regulations, the impact of school-specific policies and procedures, and best practices for school nurses and others responsible for vaccine verification, exemptions, and SLV clinics.
Michelle Fiscus, MD, FAAP, Chief Medical Officer, Association of Immunization Managers; Member, American Academy of Pediatrics Board of Directors – (Moderator)
Robin Cogan, MEd, RN, NCSN, Clinical Coordinator of the School Nurse Program, Rutgers School of Nursing
David Nash, JD, Director, LEGAL ONE Foundation for Educational Administration
Richard Pan, M.D., MPH, Former State Senator, California
Pharmacist Educational Objectives:
- Discuss trends in school vaccination laws and regulations.
- Describe the impact of school-specific vaccine policies and procedures.
- Identify best practices for school nurses and others responsible for vaccine verification, exemptions and school-located vaccination (SLV) clinics.
Experts in this session will explore a variety of legal strategies proven to contribute to increased vaccination among individuals who are high-risk, historically under vaccinated, unhoused, or living in rural communities.
Brian Dean Abramson, JD, LLM, Adjunct Professor of Vaccine Law, The Florida International University College of Law; Principal, Vaccination Program Counsel, PLLC – (Moderator)
Mordecai Bell, MHA, Program Services Coordinator and Director of Rural Vaccine Confidence Initiative, National Rural Health Association
Kasia Shaw FNP-C, Sr. Director of Medical Respite and Nursing Services, PathForward
Julissa Soto, Commissioner, Health Equity Commission for the Colorado Department of Public Health, CEO and Founder, Julissa Soto Latino Health Equity Consulting
During this practical session, health care organizations, professionals, and their advisors will share real-world stories about the impact that vaccine regulations, laws, and policies have on the patients and communities they serve. Key legal, policy, and ethical issues will be addressed from a provider point-of-view. Panelists will offer clinical and compliance strategies that participants can utilize in their own practice settings.
Denise Hill, JD, MPA, Associate Professor, Drake University, Attorney and Mediator, Whitfield & Eddy, PLC – (Moderator)
Jacqueline Fox, JD, LLM, Professor, School of Law, University of South Carolina
Mary Winter Subramanian, PharmD, Clinical Pharmacy Manager/PGY2 Pediatric Residency Director, Atrium Health Wake Forest Baptist
Jo Ellen Whitney, JD, Attorney and Senior Shareholder, Dentons Davis Brown
Break
3:30 PM – 3:45 PM
Plenary Session
3:45 PM – 4:40 PM
Brent Ewig is the co-author of Vaccinating America with Michael Fraser. The book is the most comprehensive account of the efforts by state and local public health officials to vaccinate every American during the COVID-19 pandemic. It provides an in-depth look at how those on the ground marshaled limited resources and overcame challenges across levels of government to successfully reach their citizens with life-saving vaccines.
Brent Ewig, MSPH, Chief Policy and Government Relations Officer, Association of Immunization Managers
4:40 PM – 4:45 PM
Formal Announcement of NVLC Special Issue of Vaccines
Montrece McNeill Ransom, JD, MPH, Director of the National Coordinating Center for Public Health Training
Friday, September 15, 2023
Continental Breakfast
7:30 AM – 8:00 AM
Breakout Session 5
8:00 AM – 9:00 AM
This session will provide an overview of the current state of intellectual property regarding vaccines. It will include discussions about the role of patent law in the economics of vaccine development.
Brian Malkin, JD, Associate General Counsel – Regulatory Law, Teva Pharmaceutical Industries – (Moderator)
Hon. Judge Pauline Newman, PhD, LLB, MA, Circuit Judge, US Court of Appeals for the Federal Circuit
John (Jay) R. Thomas, JD, LLM, Professor, Georgetown Law
Richard Wilder, JD, Senior Scholar, O’Neill Institute for National and Global Health Law, Georgetown University, Professor of Practice, University of New Hampshire Franklin Pierce School of Law
This panel will explore current issues in reporting to and interoperability of IIS, as well as current challenges and opportunities surrounding IIS following the COVID-19 pandemic and recent CDC award reductions.
Angela Shen, ScD, MPH, Visiting Research Scientist, Vaccine Education Center, Children’s Hospital of Philadelphia, retired Captain, US Public Health Services – (Moderator)
Rebecca Coyle, MS, Executive Director at American Immunization Registry Association
Kristina Crane, Chief Strategy Officer at STChealth
James (Jim) Daniel, MPH, Lead State and Local Public Health at Amazon Web Services
Pharmacist Educational Objectives:
- Describe current issues in reporting to and interoperability of the CDC’s Immunization Information Systems (IIS).
- Identify current challenges and opportunities surrounding IIS following the COVID-19 pandemic and recent CDC award reductions.
- Discuss privacy considerations and efforts to provide wider access to/prohibiting the collection of state immunization registry data.
This session will examine the purpose and structure of the National Vaccine Injury Compensation Program primarily aimed at childhood vaccines, and issues that have arisen with respect to that program.
Renée Gentry, JD, Director, The George Washington University Vaccine Injury Litigation Clinic – (Moderator)
Hon. Patricia E. Campbell-Smith, JD, Chief Judge, United States Court of Federal Claims (USCFC)
Brian H. Corcoran, JD, Chief Special Master, NVICP
Leah Durant, JD, Owner and Principal Attorney of the Law Offices of Leah V. Durant, PLLC
Heather Pearlman, JD, Deputy Director of the Constitutional and Specialized Torts Branch U.S. Department of Justice’s Civil Division
Pharmacist Educational Objectives:
- Examine the purpose and structure of the National Vaccine Injury Compensation Program (NVICP)
- Discuss childhood vaccine injury claims adjudicated by NVICP.
- Discuss legal issues that have arisen with the NVICP.
Individuals living in residential and congregate care facilities often have heightened exposure to infectious diseases. During this session, panelists from long-term care, and higher education will address legal issues, practical considerations, and best practices for vaccination in those special settings.
Denise Hill, JD, MPA, Associate Professor, Drake University, Attorney and Mediator, Whitfield & Eddy, PLC – (Moderator)
Chris Nickell, CSP, CHMM, MPA, Sr. Risk and Safety Consultant, Holmes Murphy
Jo Ellen Whitney, JD, Attorney and Senior Shareholder, Dentons Davis Brown, Attorney and Senior Shareholder, Dentons Davis Brown
Break
9:00 AM – 9:10 AM
Breakout Session 6
9:10 AM – 10:00 AM
This session addresses legal concerns arising from the sharing and conveyance of intellectual property rights and proprietary information relating to the development and manufacture of vaccines and adjacent products, particularly where such content implicates rights of institutions such as universities and hospitals, and the interests of governmental actors.
Emily Michiko Morris, Associate Professor and Associate Director of the Center for Intellectual Property Law & Technology, Akron Law School, University of Ohio
Ana Santos Rutschman, JD, Professor, College of Law, Villanova University
Manufacturing and distribution problems, unexpected demand, and even natural disasters sometimes create a delay and/or shortage of vaccines. Presenters in this session review the legal and policy structures available to shape decision-making about the priority order for distributing available vaccines in such situations. Extraordinary measures that can be used to speed the manufacture of vaccines during a shortage are also explored.
Brian Dean Abramson, JD, LLM, Adjunct Professor of Vaccine Law, The Florida International University College of Law; Principal, Vaccination Program Counsel, PLLC
René Najera, DrPH, MPH, Director, Public Health Initiatives, College of Physicians of Philadelphia, Editor, History of Vaccines Project, Instructor
Harald Schmidt, PhD, MA, Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
The COVID-19 pandemic brought vaccine coverage and access gaps for adults into sharp relief. The Biden Administration proposed the creation of a Vaccines for Adults (VFA) program to provide vaccine access for low income adults. Additionally, the CDC continues to explore opportunities to leverage existing programs toward realization of VFA. This panel will explore challenges and opportunities surrounding vaccine access for the uninsured.
Richard Hughes IV, JD, MPH, Partner, Epstein Becker & Green, P.C., Professorial Lecturer in Law, The George Washington University Law School – (Moderator)
Brent Ewig, MSPH, Chief Policy and Government Relations Officer, Association of Immunization Managers
Charley John, Pharm D, Senior Director, Healthcare Policy & Strategy at Walgreen Co.
Vacheria Keys, Director, Regulatory Affairs, NACHC
Sara Meyer, MD, MPH, Chief Medical Officer, CDC Immunization Services Division
Having a trusted healthcare provider issue safety assurances and offer a recommended vaccine is one of the most important predictors of vaccination receipt among children and adults. This session offers evidence-based best practices for counseling vaccine-hesitant patients about vaccines and providing informed consent. The panel will also address the role of state licensing boards when a practitioner is accused of providing vaccine misinformation to patients and the public.
Michelle Fiscus, MD, FAAP, Chief Medical Officer, Association of Immunization Managers; Member, American Academy of Pediatrics Board of Directors – (Moderator)
Michael R. Anderson, MD, MBA, FAAP, FCCM, FAARC, Senior Advisor, U.S. Department of Health and Human Services (HHS), Senior Advisor, Children’s National Hospital, Physician Advisor, WittKieffer
Carl Coleman, JD, AM, Professor and Academic Director of Online Learning, Seton Hall Law School
Laura Fox, MD, Clinical Assistant Professor of Emergency Medicine, The George Washington University College of Medicine
Richard Pan, M.D., MPH, Former State Senator, California
Pharmacist Educational Objectives:
- Identify predictors of successful vaccine receipt among adults and children.
- Describe best practices for counseling vaccine-hesitant patients about vaccine administration and providing informed consent.
- Discuss state licensing boards’ ability to investigate and discipline healthcare providers alleged to disseminate vaccine misinformation to patients and the public.
Break
10:00 AM – 10:15 AM
Breakout Session 7
10:15 AM – 11:15 AM
Since the creation of the World Trade Organization Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), the relationship between intellectual property and the public interest has been widely debated.
Brian Malkin, JD, Associate General Counsel – Regulatory Law, Teva Pharmaceutical Industries – (Moderator)
Sam F. Halabi, Senior Associate Vice-President for Health Policy and Ethics at Colorado State University, Professor at the Colorado School of Public Health, Senior Scholar at the O’Neill Institute for National and Global Health Law
Andrew Michaels, JD, Assistant Professor, University of Houston Law Center
Adam Mossoff, JD, Professor, Antonin Scalia Law School, George Mason University
This session describes the experiences and lessons learned by public health professionals and institutions during the pandemic. Evidence-based strategies and advice to guide vaccine-related policies and interventions in the changing public health practice landscape will be offered. Vaccine law’s relevance to public health accreditation, workforce sufficiency, and the social/ structural determinants of health will also be addressed. As will efforts to ensure communities around the country are prepared for the next public health disaster.
Montrece McNeill Ransom, JD, MPH, Director of the National Coordinating Center for Public Health Training – (Moderator)
Darlene Huang Briggs, JD, MPH, Deputy Director, Act for Public Health Initiative, Network for Public Health Law
Heather Burris, ME, Division Chief, District of Columbia Department of Public Health
Christy Gray, MPH, CHES, CHTS – CP, Division of Immunization Director, Virginia Department of Health
Participants involved in various aspects of the NVICP will discuss whether the current program is operating as Congress intended and whether SIRVA injuries should be covered by the program. Speakers will recommend options to correct perceived deficiencies and ensure the program operates fairly and efficiently.
Renée Gentry, JD, Director, The George Washington University Vaccine Injury Litigation Clinic – (Moderator)
Brian H. Corcoran, JD, Chief Special Master, NVICP
Junying (June) Zhao, PhD, MPH, MBBS, Assistant Professor/Health Economic Policy Researcher, University of Oklahoma
Pharmacist Educational Objectives:
- Discuss whether the NVICP is operating as Congress originally intended.
- Debate whether shoulder injury related to vaccine administration (SIRVA) should be covered by the program.
- Recommend options to correct perceived deficiencies in the NVICP to ensure the program operates fairly and efficiently.
This panel will explore issues surrounding vaccine access in the pharmacy setting, including: scope of practice; implementation of shared clinical decision making recommendations in the pharmacy; coverage and reimbursement of pharmacist-administered immunization; and barriers to pharmacy recognition in the Vaccines for Children Program.
Spreeha Choudhury, Associate Attorney, Epstein Becker Green – (Moderator)
Ilisa Bernstein, PharmD, JD, FAPhA, Chief Executive Officer, American Pharmacist Association
Joni Cover, Vice President, Strategic Initiatives at National Alliance of State Pharmacy Associates
Charley John, Pharm D, Senior Director, Healthcare Policy & Strategy at Walgreen Co.
Pharmacist Educational Objectives:
- Discuss issues surrounding vaccine access in the pharmacy setting.
- Describe scope of practice issues concerning pharmacy-based immunization delivery, including implementation of shared clinical decision making.
- Discuss coverage and reimbursement of pharmacist-administered vaccines.
- Identify barriers to pharmacy recognition in the Vaccines for Children Program.
Break
11:15 AM – 11:30 AM
Closing Plenary & Conference Close
11:30 AM – 12:30 PM
During this engaging closing session, renowned physician, and scientist Dr. Peter Hotez provides a behind-the-scenes glimpse at how the recombinant protein COVID-19 “peoples vaccine” was developed. That vaccine: now administered to more than 100 million adolescents and children in India and Indonesia, is a success story demonstrating the impact that developing new, low-cost, and accessible vaccines can have on global health. Dr. Hotez will also cover the findings in his book “The Deadly Rise of Anti-Science – A Scientist’s Warning” that was just released this week. In it he describes how the escalating anti-science movement poses a persistent and lethal threat to scientific innovation and global security. Dr. Hotez proposes that comprehensive, interdisciplinary, and concerted efforts, such as the National Vaccine Law Conference, are fundamental to countering anti-science rhetoric and restoring public confidence in the lifesaving power of vaccines.
Peter Hotez, MD, PhD, DSc (hon), FASTMH, FAAP, Dean, National School of Tropical Medicine, Baylor University, Author, “The Deadly Rise of Anti-Science – A Scientist’s Warning”
Brian Dean Abramson, JD, LLM, Adjunct Professor of Vaccine Law, The Florida International University College of Law; Principal, Vaccination Program Counsel, PLLC – (Moderator)
Brief Closing Remarks & Reminders.
NVLC organizers
Post Conference Events
12:45 PM – 2:30 PM
Pediatric COVID Vaccination Roundtables & Lunch
NVLC organizers
Southeastern Continuing Medical Education Consultants, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity will provide up to a total of 7.0 live continuing education contact hours (0.7 CEUs) for pharmacists. No fractional hours of credit will be awarded.
Registration for the 2023 National Vaccine Law Conference is now open.
Date & Location
September 13 : Vaccines for Children Pre-Conference
September 14-15: National Vaccine Law Conference
The George Washington University
Washington, DC
“The National Vaccine Law Conference provides the opportunity to share insights on panels, connect with peers and learn from others.”
-Alexandra Bhatti, JD, MPH
“We need a broad multi-stakeholder defense of vaccines including the legal foundations.”
-Mark Del Monte, JD
CEO of AAP
For questions regarding registration,
contact TaylorMade Experience at info@vaccinelawconference.org
To secure your NVLC sponsorship,
contact Heidi Kotzian at Heidi@artsti.com or +1 (202) 258-1961