Postapproval vaccine safety surveillance for COVID-19 vaccines in the US

Vaccines are key to worldwide containment of COVID-19, observers concur, and there are hundreds of possibilities moving through the development pipeline. None will succeed, warns Grace M. Lee, MD, of Stanford University School of Medicine, absent public confidence in a vaccination program. Writing with José R.

Vaccines are key to worldwide containment of COVID-19, observers concur, and there are hundreds of possibilities moving through the development pipeline. None will succeed, warns Grace M. Lee, MD, of Stanford University School of Medicine, absent public confidence in a vaccination program. Writing with José R. Romero, MD, of the University of Arkansas for Medical Sciences, and Beth P. Bell, MD, MPH, of the University of Washington School of Public Health, she emphasizes the importance of demonstrating vaccine efficacy and safety during clinical trials. Just as important, there must be a robust postlicensure vaccine safety monitoring system in place to continuously evaluate the risk-benefit profile of the new products. Specifically, they add, there is a need for active or enhanced passive safety surveillance systems—rather than simply passive ones—such as those employed by FDA/CMS, the Veterans Administration, and CDC's Vaccine Safety Datalink. Novel approaches will add to the process. The right approach to quickly identify adverse events of interest, according to the authors, will collect the necessary data to support timely and appropriate decisions regarding vaccine use. "Coordination of postapproval vaccine safety monitoring efforts through harmonized protocols and outcomes will enable timely identification and evaluation of safety signals," they conclude. "Confidence in vaccines, and therefore a successful vaccination program, can only be attained when there is transparency in the process of decision-making, awareness of how vaccine safety will be monitored, and timely communication about safety monitoring and the benefit-risk balance of COVID-19 vaccines."