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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

FDA Provides Recommendations for Electronically Submitting Vaccine Postmarketing Safety Reports

Aug. 24, 2015

Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says.

In either case, reports should include a unique case identification number to allow the agency to link initial and follow-up reports in the VAERS database.

The recommendations on electronically submitting vaccine postmarketing safety reports are outlined in final guidance released Monday.

Both options require submitting XML files to the agency’s Electronic Submissions Gateway. Once a submission is received and decrypted, an ESG message delivery notice will be sent to the sender and this will serve as the official ICSR submission date. Vaccine makers will be notified within 24 hours of this occurring, and again when the report or attachment is successfully loaded in VAERS.

ISCRs should include the date and time of the adverse event, the name of the vaccine and the name of the manufacturer of a vaccine administered in the four weeks prior to the vaccination at issue, the FDA says. ISCR attachments comprise supporting information such as relevant hospital discharge summaries, autopsy reports and death certificates.

Follow-up ICSRs should provide a picture of the current understanding of an adverse event, not just changes or updates to the original ICSR, and should include any new information or attachments.

The descriptive portion of a postmarketing safety report may be submitted as a periodic adverse experience report, a periodic safety update report or a periodic benefit-risk evaluation report, the agency says. The description portion, ICSRs and attachments make up the overall postmarketing safety report on a vaccine product.

In rare circumstances, an applicant may request a waiver from submitting the information electronically. If the waiver is granted, the FDA will describe an acceptable alternative in its response letter.

This guidance replaces the 1998 guidance, How to Complete the Vaccine Adverse Event Reporting System Form.

View Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines at www.fdanews.com/08-18-15-VaccineSafetyReport.pdf. — Kellen Owings