THOUGHT LEADERSHIP

Four former FDA commissioners and Dr. Peter Marks, the FDA official responsible for the oversight of vaccines, shared their thoughts on the FDA’s role in ensuring the safety and effectiveness of COVID-19 vaccines under extraordinary circumstances, in the ongoing pandemic.

The event, entitled “Safe and Effective COVID-19 Vaccination: The Path from Here” was hosted by the Duke-Margolis Center for Health Policy on September 10, 2020.  The speakers discussed the mountain of challenges across all aspects of developing and distributing a vaccine under expedited timelines: testing, reviewing, approving, monitoring safety events, and the logistics of distribution for vaccines that may require specialized storage conditions.

The development of the Package Insert (PI), also known as the Product Information, Prescribing/Prescriber’s Information, or simply “the Label,” is a long, complex process typically managed by a regulatory professional. It is a collaborative document, incorporating contributions from chemistry, toxicology, medical/clinical, biostatistical, writing, and regulatory professionals. Drawing from experience on a recent project, I would like to focus this installment of Protocol to Package Insert on the derivation of the clinical safety data that appear in the PI.