This is one in a series of guidance documents intended to assist you, an applicant, in making postmarket regulatory submissions in electronic format to the Center for Biologics Evaluation and Research (CBER) at FDA. The guidance provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products, including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program established in response to the National Childhood Vaccine Injury Act2 of 1986, which requires health professionals and vaccine manufacturers to report specific adverse events that occur after the administration of routinely recommended vaccines. VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. The guidance is applicable to vaccine products marketed for human use with approved biologics license applications (BLAs) for which CBER has regulatory responsibility. The guidance does not apply to any other biologic product.
This guidance finalizes the draft guidance of the same title, dated July 2014, and supersedes the FDA guidance entitled “Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1),” dated September 1998.
Postmarketing ICSRs and ICSR attachments for biological products, which are not addressed by this guidance, are processed into the FDA Adverse Event Reporting System (FAERS) database.
For general information pertaining to electronic submission of postmarketing safety reports, including ICSRs and ICSR attachments for these other products, please refer to the FDA draft guidance entitled, “Providing Submissions in Electronic Format – Postmarketing Safety Reports” dated June 2014. 5 Agency guidance on electronic submissions will be updated as necessary to reflect the evolving nature of the technology and the experience of those using this technology.