The Food and Drug Administration now makes reports of adverse events tied to medications and certain vaccines publicly available as soon as they are submitted. The move replaces the previous lag between submission and public disclosure. FDA Commissioner Dr. Marty Makary described the new system as the embodiment of “radical transparency.”
The core mechanism behind this change is the FDA Adverse Event Reporting System, known as FAERS. It gathers reports from health professionals, manufacturers, and consumers. Though separate, the vaccine-specific VAERS feed remains in place. The revamped FAERS dashboard is now accessible online for immediate review.
In defense of the overhaul, Dr. Makary stated, “Adverse event reporting should be fast, seamless and transparent… We’re closing that waiting period and will continue to streamline the process.” The FDA’s press release labeled this update a “significant step forward in modernizing the agency’s safety monitoring infrastructure,” underlining its dedication to protecting public health in real time.
The change comes amid broader reforms at the Department of Health and Human Services. Secretary Robert F. Kennedy Jr. has previously disbanded the CDC’s Advisory Committee on Immunization Practices (ACIP), citing concerns about conflicts of interest, and replaced it with a new panel that includes Dr. Robert Malone and other critics of mRNA vaccine technologies.
