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
Prominent features of PvEdge’s Vaccine Module: