Ethics of Vaccines: Project Overview
OVERVIEW
Recognizing the gap in bioethics research and policy analysis in the vaccines field, the
The project was formally launched in December 2005 with seed funding from the Penn Provost’s Interdisciplinary Seminar Fund and Penn Center for Aids Research (CFAR) http://www.uphs.upenn.edu/aids/.
A working group was formed, drawn from across the Penn community including the School of Medicine, the Law School, Wharton, the Annenberg School, and a number of life science disciplines, as well leaders from outside Penn from the public health community, the media, collaborating faculty at Columbia and Johns Hopkins, as well as from The Wistar Institute and major vaccine makers. Members of this distinguished group are listed at http://www.bioethics.upenn.edu/vaccines/?pageId=4&subpage=194
The Ethics of Vaccine Project goals continue:
- identify and articulate emerging issues affecting the vaccine enterprise overall,
- engage and provide training for a cadre of informed, thoughtful spokespersons for vaccines across diverse fields ranging from law and public policy, vaccine manufacturing, public health, the media and beyond through open dialogue and focused examination of vaccine issues,
- serve as an incubator of new projects which will focus on specific vaccines and ethical/policy issues surrounding them (e.g. HPV vaccine), and new academic coursework across disciplines around these issues,
- use the approaches above to develop and communicate/advocate a practical ethics and values framework to inform and guide the entire vaccine life cycle.
In late 2006, the
Also in 2006, Children’s
The project has gained important validation with continuing funding from Penn, a number of foundations, early stage funding from Merck and sanofi pasteur, and continuing in-kind support from GSK.
Leveraging three years of program development in the continuing Ethics of Vaccines Project, the Center for Bioethics, Wistar and CHOP are leading formation of a Center for Vaccine Ethics and Policy. In 2007-08, funding will be sought to launch a number of pilot projects providing proof-of-concept that the larger, more ambitious Center for Vaccine Ethics and Policy initiative can make a needed and material contribution to vaccine ethics and public policy.
VACCINES: ETHICS AND POLICY CHALLENGES
Vaccines are clearly the single, most powerful and cost-effective medical intervention ever developed. Vaccines will likely do more to improve global health than any other approach over the coming decades. Vaccines deliver:
- effective preventive benefit to
individuals
- effective group benefit through herd
immunity and limiting the spread of communicable disease
- excellent benefit-to-risk performance
- significant economic benefit by
preventing disease and premature deaths, and avoiding health care
costs associated with disease
treatment
But 3 million premature deaths per year occur from vaccine-preventable diseases, and another 7 million from diseases where vaccines are in development or early deployment. Why? What are the impediments?
We see vaccines as “under-performing assets”:
- existing vaccines take
decades to become widely available and affordable due to regulatory
issues, public health funding priorities, ethical and political issues,
and pricing, marketing and related business practices
- new vaccine development faces
continuing resource constraints, despite the extraordinary global disease
burden from diseases which can arguably be addressed through new vaccines
But effective vaccine policy is also impeded by ethical issues!
- Safety concerns, perceived
risks, liability concerns
- Primacy of individual rights
over mandates and obligations to community in many settings
- Challenges in informed consent
processes
- Clinical trial standards,
especially in developing countries
- Cost
- Burdensome regulatory
processes
- Sexism, Racism, Ignorance,
Fear, Lack of Trust
We believe the ethical imperative for vaccine policy is to accelerate the development and delivery of needed vaccines − providing safe. affordable and effective access, and producing sustained immunity, for all people at risk regardless of circumstance or geography.
We believe there is no trusted locus of advocacy and global collaboration for addressing vaccine performance, policy and ethical issues. Other organizations involved in the vaccines enterprise do not, or cannot, function in this role:
- Not pharma/vaccine manufacturers or
associated industry associations.
- Not government (FDA/CDC) or federal
governments generally in their unique sovereign roles.
- Not the World Health Organization (WHO)
or major NGOs given their defined constituencies.
Our Response
We believe a new organization − trusted by patients, public health leadership, industry, government, academia and non-governmental organizations (NGOs) − can advance vaccines through a coherent bioethical framework and effective advocacy.
The Center for Vaccine Ethics and Policy.
By 2012, the Center will be recognized as a global leader for vaccine bioethics, policy and advocacy as the result of significant and measurable contributions to effective public health policy and action, accelerating vaccine development and the availability, affordability, and effective delivery of vaccines worldwide.
Background:
Monthly Seminar Series
The Ethics of Vaccines Project working group has held a monthly seminar meeting and has focused on the following topics to date:
- History and Regulation
of Vaccines in the Global Context (December 2005)
- The HIV Pandemic and
Vaccines: An Ethics Template (January 2006)
- Vaccines and Public
Health Realities: Here and Now (February 2006)
- The Business of
Vaccines: Responsibility, Profitability, Liability (March 2006)
- Clinical
Trials/Regulatory Processes/ Marketing/Pricing (April 2006)
- Public Health Literacy,
Risk Communications, Education Strategies (May
2006)
- Vaccines and Federal
Pandemic Planning: Ethical and Practical Implications (Oct 2006)
- Clinical Trials II: Vaccine Best
Practices, Registries (October 2007)
- Clinical Trials II: Developing Nation
Contexts (November 2006)
- Health Care Worker Immunization: The
Mandates Issue (December 2006)
- Vaccines: Intellectual Property and
Licensing Issues (January 2007)
- Pandemic Planning II: Vaccines at
Federal, State and Local Public Health Management Levels (February 2007)
- HPV Vaccines and the Mandates Issue:
Must? Ought? Should? (March 2007)
- Vaccines and Informed Consent: Best
Practices, Best Effects (April 2007)
- Clinical trials in Developing Countries:
The Rotavirus Vaccine Experience (May
2007)
- An Ethical Framework for
Vaccines: Initial Draft (June 2007)
- HIV Vaccine Development: Status
and Issues; Healthcare Worker Vaccination Policy (October 2007)
Vaccines: The Week in Review
Since early 2006, the Project has publishd a weekly overview of major policy, ethics and organizational developments in the vaccines field. The weekly summary is posted on this project site (se site menu.
