Summer 2021 Course Schedule

Vaccines & the Law (LAW-795VZ-001)
Sonali Gunawardhana

Meets: 11:00 AM - 04:00 PM ( Su)

Enrolled: 11 / Limit: 22

Administrator Access


All summer 2021 classes will be taught online. This course will meet on Sundays, 6/6, and 6/13 from 11:00 am - 4:00 pm ET. Three hours of additional class time will be experienced independently by students through asynchronous material


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 • Reporting via the Vaccine Adverse Event Reporting System (VAERS), and • Access to and promotion of vaccines, and funding and cost issues.

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.

This course uses textbook entitled “Vaccine, Vaccination and Immunization Law” (BNA Books, Dec 31, 2018); all other readings will be posted on the syllabus and/or MyWCL.

First Class Readings

Not available at this time.


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