Goal 2: Enhance the Vaccine Safety System

The development, production, and use of safe and effective vaccines are the cornerstone of any immunization program.  As vaccines are recommended for use among large populations, ensuring the safety of vaccines is absolutely critical.  Vaccines undergo rigorous testing to determine safety and effectiveness in support of their licensure.  Vaccines continue to be monitored closely after they are licensed and in use.  In recognition of the continuing need to strengthen our ability to detect and address potential adverse events associated with vaccines, there are aspects of our vaccine safety system addressed within each of the five goals of the National Vaccine Plan.

The vaccines that are part of today’s infant, childhood, adolescent, and adult immunization schedules are very safe, and severe adverse events related to vaccines and immunization are very rare. To ensure that continues to be the case, several agencies within the U.S. Department of Health and Human Services (HHS) continue to work to enhance safety monitoring systems, conduct research related to vaccine safety, and develop new strategies to detect adverse events quickly.  The overall goal of this work is to determine whether immunizations are causing adverse events, and if so, work to minimize their occurrence.  Examples of recent achievements in vaccine safety are provided in the State of the National Vaccine Plan 2013 Annual Report, and demonstrate HHS’s commitment to ensuring the safety of vaccines.  In addition to the work outlined in this section, the National Vaccine Program Office works on an ongoing basis to foster communication and collaboration across HHS agencies and with partners in the Department of Defense and Department of Veterans Affairs to improve our overall vaccine efforts and our response to safety-related issues.

Selected highlights:

• Vaccines and Medications in Pregnancy Surveillance System established with HHS support, which helps monitor the safety of vaccines and medications administered during pregnancy.
• The Food and Drug Administration’s Post-licensure Rapid Immunization Safety Monitoring covered >100 million patients.
• Continued support of the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.
• The Indian Health Service’s Influenza Awareness System, which helps monitor influenza vaccine safety, was created.
• Institute of Medicine reviews that focus on key vaccine safety concerns, including the safety of the childhood immunization schedule.
• Advances in using electronic health data to monitor vaccine safety.

Read more in the full State of the National Vaccine Plan 2013 Annual Report [PDF]