Vaccine Vigilance

Vaccines are a miraculous invention of mankind. However, there are always two sides to a coin. Vaccines also may cause reactions; sometimes in a few minutes and rarely, years later. Different reactions/adverse events/AEFIs reported for vaccines indeed should be submitted to regulatory. Some regulatory have defined guidance and formats for reporting vaccine-related events, other than medicine/drug reporting formats while few other regulatory are in process of defining such reports and monitoring process.

World Health Organization (WHO) is relentlessly working for vaccine safety and monitoring. The global vaccine action plan, immunization surveillance, assessment, and monitoring etc. and other plan of action are available for reference on their website.

EMA is also working on this initiative by establishing Vaccine Adverse Event Surveillance & Communication (VAESCO) for recording information related to AEFIs etc. Likewise, USFDA has a VAERS form in order to report vaccine adverse events.

With automation in safety reporting, PvEdge has ensured to keep pace with electronic reporting for vaccine products. PvEdge is a platform wherein Vaccine safety recording and reporting regulatory submissions are possible.

Following are various Vaccine reporting formats in PvEdge for report submissions to different Regulatory

  • Vaccine Adverse Event Safety Reporting Form (VAERS)
  • CIOMS Form for Vaccine reporting
  • Vaccine XML for submissions to VigiFlow – Global WHO database (as per CDSCO office order of May 2015)

Prominent features of PvEdge’s Vaccine Module:

  • Automated reporting to different Regulatory
  • Different report formats utilized for regional reporting
  • Vaccine module prepared to adhere to national reporting guidelines
  • The possibility of creating cluster vaccine cases can be created
  • Filter open case list of vaccine in database
  • Submission front for :
    • maintaining submissions
    • initial/follow up track
    • archiving submitted vaccine reports
    • confirming acknowledgments
    • creating follow-ups
    • full report for vaccine product submissions
    • review of vaccine submission report for timelines, case summary, submission details, country and type of submission etc.
    • analyze delayed submissions, if any