After many months of enduring the profound effects of COVID-19, the U.S. is looking with hope toward the lifesaving benefits of a vaccine or vaccines. Development, clinical testing, and FDA’s emergency authorization of COVID-19 vaccines have occurred at a record pace while continuing to ensure safety and efficacy. How does FDA regulate vaccines, and how does the vaccine approval process differ from emergency authorization? Speakers will discuss topics such as clinical trial development, ensuring safety and efficacy in a diverse study population, manufacturing supply chain and scaling considerations, logistical issues in vaccine distribution and administration to a large population, adverse event reporting requirements, and navigating possible liability issues, among other topics. COVID-19 vaccine examples will be discussed throughout the course.

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Agenda

Thursday, February 4

11:00–11:15 AM
Welcome and Course Overview
Melissa Scales, Assistant Director, Educational Programs, FDLI

11:15–11:45 AM
I. Introduction to Vaccine Regulation
Julia C. Tierney, Acting Chief of Staff, FDA

The first step of understanding vaccine regulation is to define what a vaccine is, explore how it differs from a traditional “drug,” review its regulatory history and statutory framework, and discuss how it is regulated by FDA’s Center for Biologics Evaluation and Research.

  1. Definition of a Vaccine
  2. “Drug” and “Biological Product”
  3. Vaccine Regulation History and Statutory Framework
  4. Role of FDA Center for Biologics Evaluation and Research

12:00–1:00 PM
II. Vaccine Development and Clinical Trials

Michael L. Gruver, Senior Corporate Counsel, Pfizer Inc
Jonathan Walland, Senior Corporate Counsel, Pfizer Inc

Determining that a vaccine will be a safe and effective response to an infectious disease starts with laboratory testing of a scientific concept. It then moves to animal and human testing. This section will explore the development and clinical trial processes, using examples of the COVID-19 vaccines to improve understanding. 

  1. Development
  2. Clinical Trials

 

1:15–2:15 PM

III. Pathways to Market

Colleen M. Heisey, Partner, Jones Day

Once the vaccine sponsor believes it has generated sufficient data to meet FDA’s safety and effectiveness requirements, the sponsor can submit a Biologics License Application (BLA) or request for an Emergency Use Authorization (EUA) to FDA. This section will describe these procedures, as well as the rigorous process FDA uses to review the data in consultation with the Vaccines and Related Biological Products Advisory Committee (VRBPAC). We will also discuss other considerations such as the role of other government entities and post-approval pharmacovigilance. The illustration of COVID-19 vaccines in relation to this process will also be discussed.

  1. BLA Standard
  2. EUA Standard
  3. Role and Process of Vaccines and Related Biological Products Advisory Committee
  4. Role of Other Government Entities
  5. Post-Approval Pharmacovigilance

 

2:45–4:00 PM

IV. Manufacturing, Scaling, Supply Chain, and Administration Issues

Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP

Once a vaccine is ready for market, a company must adhere to continuing manufacturing, reporting, inspection, and other requirements. The sponsor company must also scale up production in preparation for widespread distribution and ensure that components and other materials used in the manufacturing process are readily available. Lastly, the vaccine must be distributed, stored, and administered to the population. This section will describe the different requirements at play, utilizing COVID-19 vaccine-related practical examples and considerations.

  1. Establishment Registration and Listing
  2. Manufacturing Standards
  3. Inspections
  4. Scaling Up
  5. Post-Approval Changes
  6. Use of Defense Production Act for COVID-19 Vaccine Manufacturing
  7. Distribution, Storage, and Supply Chain Issues
  8. Determining Priority Populations
  9. Encouraging Vaccine Administration

 

4:15–5:15 PM

V. Enforcement and Litigation

Gregory H. Levine, Partner, Ropes & Gray LLP
Beth P. Weinman, Counsel, Ropes & Gray LLP

A last consideration of vaccine regulation is possible exposure to enforcement actions, which can include warning letters, recalls, civil penalties, or criminal prosecutions. The Public Readiness and Emergency Preparedness (PREP) Act provides targeted liability immunity to covered entities for measures taken in relation to certain countermeasures during a public health emergency. This section will discuss the above enforcement concepts and provide examples related to COVID-19.

  1. Prohibited Acts Under the Federal Food, Drug, and Cosmetic Act
  2. FDA and U.S. Department of Justice Enforcement Tools and Procedures
  3. Liability Protection and Vaccine Injury Compensation under the PREP Act

5:15 PM
Adjournment

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.