Issues to be addressed during this 60-minute forum are:

1. What challenges regarding benefits and risks in designing pediatric vaccine clinical trials, and in evaluating ongoing trials?
2. What regulatory questions must IRBs consider when approving pediatric vaccine clinical trials?
3. What are the ethical and regulatory considerations specific to clinical trials of SARS-CoV-2 vaccines?

Learning objectives:

• Identify the unique ethical challenges inherent in pediatric vaccine clinical trials.
• Describe the arguments for pursuing pediatric vaccine trials in parallel versus in sequence with adult trials.
• Apply the ethical considerations relevant to pediatric vaccine trials to the development of vaccines for SARS-CoV-2.

Speaker:

Steven Joffe, MD, MPH, is the Founders Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine, Acting Chair of the Department of Medical Ethics and Health Policy, Chief of the Division of Medical Ethics, and Director of the Penn Postdoctoral Training Program in the Ethical, Legal and Social Implications of Genomics. He is also Professor of Pediatrics at the Children’s Hospital of Philadelphia.

Dr. Joffe attended Harvard College, received his MD from the University of California San Francisco (UCSF), and received his public health degree from UC Berkeley. He trained in pediatrics at UCSF and in pediatric hematology/oncology at the Dana-Farber Cancer Institute and Boston Children’s Hospital. His research addresses the ethical challenges that arise in the conduct of biomedical investigation and in genomic medicine and science. He is a member of the FDA’s Pediatrics Ethics Subcommittee and the National Human Genome Research Institute’s Genomics and Society Working Group.