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CBER Vaccine ICSR – Proposed Updates

In support of the “Postmarketing Safety Reporting for Combination Products” rule, FDA is proposing to update VAERS Electronic Reporting Resources as identified below:

  • FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting Version 2.0: Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRs) for Vaccines
  • Appendix I to the FDA ICH E2B(R3) Technical Specifications Document for Vaccine Reporting Version 2.0:  eVAERS Business Rules Document 
  • Appendix II to the FDA ICH E2B(R3) Technical Specifications Document for Vaccine Reporting DRAFT Version 2.0: XML Instance Examples.  
    • Scenario 1:  Manufacturer submits a vaccine report containing 3 vaccines that does not include any combination products.  There was an Adverse Event. CombProd2019Scenario1.xml
    • Scenario 2:  Manufacturer submits a vaccine report that includes 3 vaccines, one of which is a combination product.  There was an Adverse Event, but NO malfunction:  CombProd2019Scenario2.xml
    • Scenario 3:  Manufacturer submits a report that includes a vaccine that is a combination product.   There was a malfunction, but no Adverse Event.    Vaccine was administered to a patient.   CombProd2019Scenario3.xml
    • Scenario 4:  Manufacturer submits a report that includes a vaccine which is a combination product.  There was a malfunction, but no Adverse Event.  No patient was involved.   CombProd2019Scenario4.xml
    • Scenario 5:  Manufacturer submits a report that includes a vaccine which is a combination product.   There was an Adverse Event AND a malfunction. CombProd2019Scenario5.xml
    • Scenario 6:  A minimal example containing the basic elements for an Adverse Event report, no combination product.  CombProd2019SkeletonScenario1.xml
    • Scenario 7:  A minimal example containing the basic elements for an Adverse Event report, with a combination product, no malfunction. CombProd2019SkeletonScenario2.xml
    • Scenario 8:  A minimal example containing the basic elements for a Malfunction only report, no patient.  CombProd2019SkeletonScenario3.xml
    • Scenario 9:  A mega instance file, containing all elements. CombProd2019MegaInstanceScenario.xml

These proposed revisions have not been implemented at this time.  FDA continues to accept reports in the current version (Version 1) until further notice.  System updates to implement these proposed revisions are anticipated in 2020.
Please submit any comments to Docket No. FDA-2018-D-1216.  Available at: https://www.regulations.gov/docket?D=FDA-2018-D-1216 .    FDA will review all comments received by August 1, 2019, and will consider revisions to the proposed version of the Technical Specifications and Business Rules, as appropriate. FDA anticipates completing all revisions by the end of 2019.

For more information on Combination product safety reporting and the compliance requirements timeline, please refer to the Postmarketing Safety Reporting for Combination Products site:  https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products