CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines.

The launch of the system, which is part of the Vaccine Adverse Event Reporting System (VAERS) run jointly by FDA and the Centers for Disease Control and Prevention, follows guidance released in August 2015 that offers recommendations on the electronic submission of postmarketing safety reports involving vaccines, including individual case safety reports (ICSRs) and attachments to ICSRs.

The new system, known as the VAERS eSubmitter program, is a software program that can be downloaded for free and used voluntarily by companies subject to mandatory postmarketing requirements for vaccines including applicants, manufacturers, packagers and distributors to electronically submit ICSRs and ICSR attachments as required by the final rule titled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” from 2014.

“The purpose of the ICSR eSubmitter template is to facilitate the electronic submission of postmarketing vaccine safety reports using internationally adopted data standards to enhance regulatory review, exchange and dissemination of vaccine safety information,” FDA said. “Applicants and others who choose to use the eSubmitter program for required postmarketing reporting of adverse events for human vaccine products must first download the eSubmitter software and then manually enter information into the ICSR template form to create each electronic ICSR or ICSR attachment for submission to FDA through the ESG for uploading to the VAERS database.”

The software also helps companies and health practitioners prepare submissions that contain the minimum elements necessary for FDA to perform a comprehensive review.

FDA is currently offering two voluntary options for electronic submission of ICSRs and ICSR attachments into VAERS: (1) Direct database to database submission through the Electronic Submissions Gateway (ESG), and (2) submission of safety reports through the VAERS eSubmitter program as described on the CBER eSubmitter website.

VAERS

VAERS reports are usually submitted by health care providers, vaccine manufacturers, vaccine recipients (or their parents/guardians) and state immunization programs. FDA encourages parents and guardians of patients to seek the help of a health-care professional in reporting to VAERS.

VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in the US. The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report:

• Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine.
• Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination.

Center for Biologics Evaluation and Research eSubmitter Program for Electronic Submission of Postmarketing Adverse Event Reports for Human Vaccine Products