Through emergency preparedness activities, the Immunization Safety Office (ISO) identifies, assesses, and responds to vaccine-related adverse events to ensure that the benefits of vaccines continue to be far greater than the risks. Preparedness initiatives are also underway to ensure that vaccines are safe in the event of a threat of disease outbreak in which a mass vaccination campaign is needed, such as measles, influenza (flu), or varicella (chickenpox).
During an emergency, monitoring vaccine safety is important because--
- More vaccines are being given, so more health problems (adverse events) will be reported.
- More rare and serious adverse events may occur because people of all ages and health conditions will be vaccinated.
- Normal testing of a vaccine before its widespread use may be shortened to speed up its availability.
ISO's goal is to enhance existing vaccine safety programs so they can provide information quickly during a disease outbreak. Planned enhancements are described below:
- The most critical part of CDC's vaccine safety monitoring plan is to be able to take reports of health problems (adverse events) that occur after vaccination through the Vaccine Adverse Event Reporting System (VAERS). VAERS receives about 33,000 reports per year. Many more reports are expected during an emergency. To ensure reports are taken, processed, and investigated quickly, VAERS capacity will be increased.
- The Vaccine Safety Datalink (VSD) project gathers information on vaccines given to members of certain managed care organizations. This information is normally used for planned immunization safety studies. A new system called Rapid Cycle Analysis is being developed to address vaccine-associated health problems found by the VSD project very quickly.
- Vaccine safety coordinators positioned in 62 strategic locations across the United States will plan and implement health problem reporting, ensure health care providers are informed about vaccine safety issues, and work with federal government staff who oversee safety monitoring activities to obtain timely VAERS reports.
ISO's emergency planning activities are designed to protect the public's health in the event of a disease outbreak. This is primarily accomplished by working with other federal partners, state and local health departments, and vaccine manufacturers to ensure the production, distribution, and administration of safe and effective vaccines.