Goal 2: Enhance the Vaccine Safety System

The U.S. has a robust vaccine safety system. The goal of this system is to identify in a timely manner and minimize the occurrence of adverse events from vaccines. Past successes and challenges offer insights into areas where the existing vaccine safety system can be enhanced. Advances in information technology enhance the ability to conduct active surveillance. Improvements in understanding of immunology and genomics create opportunities to better comprehend the immune response and biological mechanisms important for understanding the safety of vaccines.

Vaccine safety is a key element of any immunization program. The vision of Goal 2 is to specifically address safety-related issues, strengthen the system that monitors the safety of vaccines throughout production and use, and advance the safety profile of vaccines. Specifically, this goal aims to prevent adverse events and fully characterize the safety profile of vaccines in a timely manner.

Vaccine safety science is often challenging because it may require studying very rare outcomes. However, tools have been developed that help detect and quantify exceedingly rare events. Importantly, a vaccine safety monitoring system should have the capacity to distinguish a potential increased risk of a vaccine adverse reaction from an adverse event following immunization that is occurring because of other diseases or exposures. Every day, people suffer from heart attacks, severe headaches, and other health problems and some of these will naturally coincide with vaccination. Moreover, as the ability of epidemiology to rule out a very rare event is difficult, new technologies and multi-disciplinary research can help elucidate biological mechanisms and subpopulations at increased risk for adverse events and help address these scientific challenges.

Several important vaccine safety issues are addressed in other goals of the 2010 National Vaccine Plan. For example, Goal 1 addresses vaccine research and development that includes the importance of safety assessments in pre-clinical and clinical vaccine evaluation. Issues related to education, risk communications, behavioral science research, and stakeholder engagement on vaccine safety are included in Goal 3. Because vaccine safety is an important component of every immunization program, whether in the United States or globally, it is also featured in Goal 4 and Goal 5.

Objectives

  • Ensure a robust vaccine safety scientific system that focuses on high priority areas.
  • Facilitate the timely integration of advances in manufacturing sciences and regulatory approaches relevant to manufacturing, inspection, and oversight to enhance product quality and patient safety.
  • Enhance timely detection and verification of vaccine safety signals.
  • Improve timeliness of the evaluation of vaccine safety signals, especially when 1) a high-priority new vaccine safety concern emerges or 2) when a new vaccine is recommended, vaccination recommendations are expanded, or during public health emergencies such as in an influenza pandemic or other mass vaccination campaign.
  • Improve causality assessments of vaccines and related AEFIs.
  • Improve scientific knowledge about why and among whom vaccine adverse reactions occur.
  • Improve clinical practice to prevent, identify and manage vaccine adverse reactions.
  • Enhance collaboration of vaccine safety activities.

For more information on this goal and the defined set of strategies for achieving each objective mentioned above, view the National Vaccine Plan.

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