Fall 2022 Course Schedule

Vaccines & the Law (Compressed, Online) (LAW-795VZ-E001)
Sonali Gunawardhana

Meets: 09:00 AM - 02:00 PM (Sa)

Enrolled: 20 / Limit: 22

Administrator Access


This class meets live online on Saturday, September 24, from 9am-2pm EST (with 0.5 hours of break), Saturday, October 29 from 9am-2pm EST (with 0.5 hours of break), and Saturday, November 5 from 9am-10am EST. Two hours of additional class time will be experienced independently by students through asynchronous material. Attached is a DRAFT syllabus, which the instructor will update leading up to the start of the semester.


As the government determines or influences virtually every aspect of how vaccines are developed and delivered to patients, it is important to understand the complex framework governing biological innovation and patient access to new therapies. This course will introduce students to the broad range of legal and policy issues that impact the biopharmaceutical industry in the United States. Through reading materials, lectures and discussions, students will explore the complex regulatory framework governing biopharmaceutical innovation and patient access to new therapies. This course will delve into the laws and regulations related to vaccines and vaccination and discuss policy implications, including: • FDA oversight, enforcement, and regulation of the research and development process • Public mandates, including mandatory child vaccinations, opposition, and the legal consequences of failure to vaccinate, as well as medical, religious, and philosophical exemptions • State law considerations related to exemptions, administration of vaccines, and isolation and quarantine matters • Compensation for vaccine injuries under the National Vaccine Injury Compensation Program (VICP) • Injury claims outside the VICP such as products liability, failure to warn, medical malpractice, punitive damages.

Textbooks and Other Materials

The textbook information on this page was provided by the instructor. Students should use this information when considering purchases from the AU Campus Store or other vendors. Students may check to determine if books are currently available for purchase online.

First Class Readings

Not available at this time.


Use your MyAU username and password to access the syllabus in the following format(s):