FDA, CDC Reaffirm Vaccine Manufacturers’ VAERS Reporting Duties

Vaccine manufacturers operating under CBER oversight carry mandatory post-market surveillance obligations that the FDA and CDC have codified through the Vaccine Adverse Event Reporting System (VAERS), and a failure to report constitutes a compliance gap with direct regulatory consequence. The co-sponsored program, administered jointly by FDA and CDC, functions as the primary national signal-detection mechanism for adverse events following administration of US-licensed vaccines.

VAERS collects and analyzes adverse event reports to identify possible safety signals across the licensed vaccine portfolio. While reports are accepted from patients, healthcare providers, and pharmacists, vaccine manufacturers carry a distinct and non-discretionary reporting obligation that sits within the broader post-market pharmacovigilance framework governing biologics under 21 CFR Part 600 and applicable CBER guidances.

The reporting infrastructure centers on the VAERS-1 form, with FDA guidance, How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1), providing the operative instructions for manufacturer submissions. A revised VAERS-2 form was proposed and subsequently withdrawn, as noted in the Federal Register notice of April 21, 2006, leaving VAERS-1 as the current standard instrument. Manufacturers submitting to CBER-regulated product dossiers should also cross-reference the agency's guidance on regulatory submissions in electronic format.

For QA directors and regulatory affairs leads, the compliance read is straightforward: VAERS reporting is not a voluntary contribution to a public health database, it is a condition of licensure. Signal detection through VAERS feeds directly into CBER's post-market safety review processes, meaning incomplete or delayed manufacturer submissions can affect both product standing and inspection readiness. The CBER Division of Communication and Consumer Affairs remains the designated point of contact for reporting queries, reachable at (800) 835-4709 or [email protected].

Plant heads and compliance teams managing vaccine lines should confirm that internal SOPs align with current VAERS-1 submission requirements and that responsible personnel are mapped to CBER's electronic submission standards for biologics.

Manufacturers with active CBER-licensed vaccine portfolios should treat the next internal audit cycle as an opportunity to verify that adverse event capture, triage, and submission timelines meet the agency's post-market surveillance expectations.

Source: FDA Center for Biologics Evaluation and Research (CBER) via FDA.gov Vaccines, Blood and Biologics RSS Feed, August 17, 2026.