Topic: Global

Vaccine Guidance Gains Global Attention

Health and Bioethics Experts: “The treatment of pregnant women in vaccine research
and deployment is unacceptable. Business as usual simply cannot continue.”

New Report Lays out Recommendations for Policymakers, Researchers, and Global Health Organizations on Including Pregnant Women in Epidemic Vaccine Development and Deployment

Even as health care responders valiantly battle the ongoing Ebola outbreak in the Democratic Republic of Congo, one highly vulnerable group is being denied a potentially life-saving vaccine: pregnant and lactating women. This and other recent epidemics of Zika, Lassa Fever, and Hepatitis E have shown how infectious disease outbreaks can severely – and at times uniquely – affect the health of pregnant women and their offspring. Despite a significantly higher risk of serious disease and death, vaccines against these devastating diseases are rarely developed and approved for pregnant women.

Changing institutional and government practices so that we have vaccines to offer pregnant women in an epidemic is one of 22 long overdue recommendations contained in the new report Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response, issued in December 2018 by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy. The report, aiming to ensure that pregnant women are no longer excluded from receiving vaccines against emerging infectious diseases, has received widespread media attention, including:

“The self-perpetuating cycle of excluding pregnant women from research and from the benefits of vaccination must end,” said Carleigh Krubiner, a lead author of the report jointly appointed at the Johns Hopkins Berman Institute of Bioethics and the Center for Global Development. “With global efforts now underway to develop a range of vaccines against devastating epidemic threats, we have to make sure pregnant women are on the agenda, so they will never again be left unprotected in the face of future outbreaks.”

The report lays out concrete steps for equitably addressing the needs of pregnant women in public health preparedness, vaccine research and development, and the deployment of vaccines during epidemics. Its recommendations include:

  • During an epidemic, the default should be to offer vaccines to pregnant women—not the reverse.
  • Vaccines that can be safely given to pregnant women need to be developed. For these vaccines, evaluation in pregnancy needs to occur as early in the clinical development process as possible.
  • During an epidemic, decisions about whether pregnant women will be offered vaccines should consider not only any potential risks of the vaccine but also, and importantly, the risks pregnant women and their babies face if vaccine is denied.
  • All decisions about inclusion or exclusion of pregnant women should be informed by those with the relevant expertise in maternal and neonatal health as well as in vaccinology and virology.
  • The perspectives of pregnant women themselves should inform vaccine research and deployment decisions that may mean life or death for them and/or their babies.

The full recommendations are available at http://vax.pregnancyethics.org/prevent-guidance.

“The way we have treated pregnant women in vaccine research and deployment is utterly unacceptable. Business as usual cannot be permitted to continue,” said Ruth R. Faden, a lead author of the report and founding director of the Johns Hopkins Berman Institute of Bioethics. “Ensuring that pregnant women affected by outbreaks have safe and effective vaccines is not only a matter of justice and health equity, it’s also critical to the public health response.”

That pregnant women affected by the ongoing Ebola crisis in the Democratic Republic of the Congo are not being offered vaccine demonstrates how urgent and serious the consequences are of the status quo exclusions of pregnant women from vaccine research and delivery. In recent UNICEF interviews, pregnant women “clearly articulated that they wanted to choose whether to be vaccinated or not.”  As one woman said, ‘now there is no option, you just send us to death.’”

“As we continue to develop new vaccines against pathogens with serious and often lethal consequences in pregnancy, pregnant women must be on the agenda every step of the way,” said Ruth A. Karron, a lead author of the report and director of the Center for Immunization Research and the Johns Hopkins Vaccine Initiative at Johns Hopkins Bloomberg School of Public Health. “We simply can’t continue to fail pregnant women as we develop new vaccines against emerging threats.  We need to generate an evidence base for safe and effective use of these vaccines during pregnancy.”

To read the full report visit vax.pregnancyethics.org/prevent-guidance. In conjunction with the report release, PREVENT has also released a video that discusses the risks of the status quo, and describes why urgent action is needed. You can watch the video at vax.pregnancyethics.org.

PREVENT is a grant-funded project led by faculty at Johns Hopkins University alongside co-investigators at Georgetown University and the University of North Carolina at Chapel Hill, with external contributions from Working Group Members. The PREVENT Project is funded by the Wellcome Trust (203160/Z/16/Z).

 

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Jean Anderson, MD

Dr. Anderson is a fellow of the American Congress of Obstetricians and Gynecologists and a member of the American Academy of HIV Medicine. She has been an invited peer reviewer for American Journal of Obstetrics and Gynecology, Journal of Women’s Health and Journal of Gynecologic Health. Dr. Anderson has been recognized six times by the Johns Hopkins Gynecology and Obstetrics House Staff with the Excellence in Teaching and Mentorship Award. She is the recipient of the 2013 Constance Wofsey Women’s Health Investigator Award from the AIDS Clinical Trials Group.

Dr. Anderson received her undergraduate degree in chemistry from David Lipscomb College and earned her M.D. from the Vanderbilt University School of Medicine. She completed her medical residency at Vanderbilt University Medical Center. Dr. Anderson joined the Johns Hopkins faculty in 1987.

Leonard Rubenstein, JD, LLM

He has engaged in extensive research and writing on human rights, health and national security and armed conflict. His current work focuses on health services in volatile environments. He founded and chairs the Safeguarding Health in Conflict Coalition, a group of humanitarian, human rights, health provider organizations working at the global and national levels, that seeks to reduce attacks on and interference with health workers, patients, facilities and transports.   He is a member of the Lancet Commission on Migration and Health and the editorial board of Military and Humanitarian Ethics of the International Committee of Military Medicine.His writings have appeared in professional journals and in op-eds in major media such as the New York Times and Washington Post

Mr. Rubenstein is a member of the Council on Foreign Relations and the Board of Directors of the Global Health Council. He has served on the Governing Council of the American Public Health Association and the Committee on Scientific Freedom and Responsibility of the American Association for the Advancement of Science. He has served as Chair of the Health and Peacebuilding Working Group at the United States Institute of Peace.  He is the recipient of numerous awards, including the Congressional Minority Caucuses’ Healthcare Hero Award, the Sidel-Levy Award for Peace of the American Public Health Association, and the Syrian American Medical Association recognition award.

Maria Merritt, PhD

HONORS AND AWARDS

  • Hastings Center Fellow, elected December 2020
  • Recognition for teaching excellence as principal instructor of JHSPH course, Ethics of Public Health Practice in Developing Countries (221.616.01: classroom), 4th term 2016-17, 2015-16, 2014-15, 2012-13, and 2011-12; (221.616.81: online), 4th term 2017-18 and 2016-17; and as principal instructor of Ethics in Global Health Practice (604.603.86), 2018-19.
  • Student Assembly Special Recognition Award for Outstanding Commitment to Student Success, 2017
  • Principal Investigator, NIH award number 1R01AI114458-01A1, 2015-19, “Assessing Social Justice in Economic Evaluation to Scale up Novel MDR-TB Regimens” (award issued by National Institute of Allergy and Infectious Diseases)
  • Recognition for teaching excellence as principal instructor of JHSPH course, Ethics of Public Health Practice in Developing Countries (221.616.01), 4th term 2015-16; 2014-15; 2012-13; and 2011-12
  • Co-Investigator, NIH award number 1R01AI085147-01A1, 2010-14, “Ancillary Care in Community-Based Research: Deciding What to Do” (PI Holly A. Taylor; award issued by National Institute of Allergy and Infectious Diseases)
  • Greenwall Faculty Scholars Program in Bioethics career development award, 2009-12, “Researchers’ Obligations in Community-Based Research: Resolving Dilemmas of Care”
  • Faculty Innovation Fund, 2007-08, Johns Hopkins Bloomberg School of Public Health, “Ancillary Care in Public Health Intervention Research in Resource-Limited Settings: Researchers’ Practices and Decision-Making”(Co-PI Holly A. Taylor)
  • Faculty Fellow, Edmond J. Safra Foundation Center for Ethics, Harvard University, 2005-06
  • Postdoctoral Fellow, Department of Clinical Bioethics, National Institutes of Health, 2000-02
  • Rhodes Scholar, Oxford University, 1987-90

Alan Regenberg, MBE

Alan is also engaged in a broad range of research projects and programs, including the Berman Institute’s science programs: the Stem Cell Policy and Ethics (SCOPE) Program; the Program in Ethics and Brain Sciences (PEBS-Neuroethics); and the Hinxton Group, an international consortium on stem cells, ethics and law; and the eSchool+ Initiative. Recent research has focused on using deliberative democracy tools to engage with communities about their values for allocating scarce medical resources like ventilators in disasters like pandemics. Additional recent work has focused on ethical challenges related to gene editing, stem cell research, social media, public engagement, vaccines, and neuroethics. (Publications)

Nancy E. Kass, ScD

Dr. Kass is coeditor (with Ruth Faden) of HIV, AIDS and Childbearing: Public Policy, Private Lives (Oxford University Press, 1996).

She has served as consultant to the President’s Advisory Committee on Human Radiation Experiments, to the National Bioethics Advisory Commission, and to the National Academy of Sciences. Dr. Kass currently serves as the Chair of the NIH Precision Medicine Initiative Central IRB; she previously co-chaired the National Cancer Institute (NCI) Committee to develop Recommendations for Informed Consent Documents for Cancer Clinical Trials and served on the NCI’s central IRB. Current research projects examine improving informed consent in human research, ethical guidance development for Ebola and other infectious outbreaks, and ethics and learning health care. Dr. Kass teaches the Bloomberg School of Public Health’s course on U.S. and International Research Ethics and Integrity, she served as the director of the School’s PhD program in bioethics and health policy from its inception until 2016, and she has directed (with Adnan Hyder) the Johns Hopkins Fogarty African Bioethics Training Program since its inception in 2000. Dr. Kass is an elected member of the Institute of Medicine (now National Academy of Medicine) and an elected Fellow of the Hastings Center.

Jeremy Sugarman, MD, MPH, MA

He was the founding director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke University where he was also a professor of medicine and philosophy. He was appointed as an Academic Icon at the University of Malaya and is a faculty affiliate of the Kennedy Institute of Ethics at Georgetown University.

Dr. Sugarman was the longstanding chair of the Ethics Working Group of the HIV Prevention Trials Network. He is currently a member of the Scientific and Research Advisory Board for the Canadian Blood Service and the Ethics and Public Policy Committees of the International Society for Stem Cell Research. He co-leads the Ethics and Regulatory Core of the NIH Health Care Systems Research Collaboratory and is co-chair of the Johns Hopkins’ Institutional Stem Cell Research Oversight Committee.

Dr. Sugarman has been elected as a member of the American Society of Clinical Investigation, Association of American Physicians, and the National Academy of Medicine (formerly the Institute of Medicine). He is a fellow of the American Association for the Advancement of Science, the American College of Physicians and the Hastings Center. He also received a Doctor of Science, honoris causa, from New York Medical College.