FDA Draft Guidance on Reporting Vaccine-Related Adverse Events Details E-Submission Requirement

Manufacturers reporting adverse events suspected to be caused by vaccines should submit their individual case safety reports via the agency’s electronic submissions gateway in XML format, says a new draft guidance that completely overhauls a 1998 predecessor.

Vaccine makers today are submitting adverse event reports either on paper or via PDF, Center for Biologics Evaluation and Research spokeswoman Lise Stevens told DID. The guidance, released Friday, details the technical specifications that vaccine makers will be required to use next year when the agency switches to the new electronic system harmonized with the International Conference of Harmonisation format, she added.

The guidance elaborates on a recently released final rule that makes electronic submission of all individual case safety reports (ICSR) mandatory by June 2015, and gives applicants the choice of using a database-to-database format or the FDA’s eSubmitter tool.

The new ICSRs will have two parts, the agency says. The first is the ICSR 3500A “Medwatch” form that asks for information such as the vaccine’s name and manufacturer, as well as the date and time that the dose in question was administered. The FDA asks that applicants submit this form in XML format.

The second part covers attachments to the ICSR form, which provides supplemental information such as autopsy reports, medical reports or hospital discharge summaries. The ICSR attachments should be submitted to FDA along with the associated ICSR file or submitted afterwards. These attachments do not, however, need to be resubmitted along with any follow-up information posted to each event file.

Parties submitting an ICSR for the first time should let the FDA know at esgprep@fda.hhs.gov to get assistance in the process. Once a report is received, the agency will send messages indicating successful receipt and processing, the guidance says. This should take no more than 24 hours. The electronic ICSRs will be housed in the CDC/FDA Vaccine Adverse Event Reporting System.

In the spring, the agency launched a pilot study to evaluate whether its e-submission gateway would be adequate for this purpose (DID, Mar. 27).

Should a vaccine maker encounter extenuating circumstances necessitating the waiver of the electronic submission requirement, the FDA asks that the company submit a justification of its request, along with  the time it expects to recover the online application capability, via postal mail.

According to Johns Hopkins’ Institute for Vaccine Safety, VAERS receives roughly 11,000 vaccine-related reports every year, of which 10 to 15 percent involve hospitalization or permanent disability and two percent involve deaths.

Comments on the draft guidance are due to regulations.gov by Sept. 17. View it at www.fdanews.com/ext/resources/files/07/07-18-14-2014vaccineguidance.pdf and the ICSR “Medwatch” form at www.fdanews.com/ext/resources/files/07/07-18-14-Medwatchform.pdf. — Lena Freund