The Laws, Ethics & Practicalities Of Developing A Covid-19 Vaccine

Featuring Jonathan Walland, Senior Corporate Counsel, Clinical Development, Pfizer Inc.; and Beth E. Roxland, J.D., M.Bioethics, Senior Advisor on Law, Policy and Bioethics, Roxland Consultants Ltd.

Although the topic of vaccines for Covid-19 are omnipresent, little attention has been devoted to the complex legal requirements and the ethical issues raised by its development – made all the more challenging by the public health crisis.

In this session, we will provide context to the vaccine R&D process, discuss the multifaceted legal frameworks governing the clinical trial testing, and address some of the exceptional challenges Industry and others confronted in developing a vaccine during a pandemic caused by a novel virus. We will explore the legal duties of Sponsors, Principal Investigators, Academic Medical Centers and other Institutions, as well as federal laws pertaining to public health emergencies.

Finally, following a brief discussion of historical unethical conduct in human subjects research, we will examine in depth federal protections for people who participate in clinical trials, including those who are considered “vulnerable,” and the challenges and ramifications of these classification. We will also address a number of sensitive ethical issues arising from the testing and administration of the Covid-19 vaccine that have garnered much public attention.

Audience members will come away with working knowledge of laws and regulation pertaining to the conduct of clinical trials subject to FDA jurisdiction, including Informed Consent requirements and Good Clinical Practice; the various types of regulatory ‘approval’ of vaccines and drugs; and an understanding of the genesis of key ethical challenges associated with the Covid-19 vaccine. 

Agenda and Objectives 

• Introduction
• Vaccine Development Goals and Challenges
• U.S. Federal Law & Regulation of Vaccine Research & Development
• History & Regulation of Clinical Trials and Human Subjects Protections
• Case Study: COVID-19 Vaccine Development
• Ethics &  Policy
• …and more