Established Safety Surveillance for Smallpox Vaccine

Objectives for Safety Monitoring (22:V7:2)

According to the World Health Organization’s guidelines on immunization safety monitoring, the major goal of immunization safety monitoring is early detection and appropriate quick response to adverse events in order to lessen the negative impact on the health of individuals and on the immunization program.

Potential objectives of immunization safety surveillance include:

  1. Detecting, correcting, and preventing program errors.
  2. Identifying usually high rates or types of adverse events associated with specific vaccine lots or brands.
  3. Ensuring that coincidental events are not falsely blamed on immunization.
  4. Maintaining confidence in the immunization program and properly responding to community concerns about immunization safety while increasing awareness about vaccine risks.
  5. Generating new hypotheses about vaccine reactions that are specific to the population.
  6. Estimating adverse event rates in the population compared with trial and international data. 
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