Covid Broke Vaccine Reporting System: BMJ
A BMJ investigation has raised concerns that the federal government’s vaccine adverse event system is not operating as planned and safety signals are likely being missed. The national Vaccine Adverse Event Reporting System (VAERS) is co-managed by FDA and the Centers for Disease Control and Prevention (CDC).
Investigations by the BMJ have revealed that VAERS is not holding up to its own standards. “Not only have staffing levels failed to keep pace with the unprecedented number of reports since the rollout of Covid vaccines but there are signs that the system is overwhelmed, reports aren’t being followed up, and signals are being missed,” the BMJ article says.
BMJ spoke to more than a dozen people, including physicians and a state medical examiner, who have filed VAERS reports about a serious adverse event and they were never contacted by clinical reviewers or were contacted months later. “Our investigation has also found that, in stark contrast to the U.S. government’s handling of adverse reaction reports on drugs and devices, the publicly accessible VAERS database on vaccines includes only initial reports, while case updates and corrections are kept on a separate, back-end system,” the article says. Officials told the BMJ that this was to “protect patient confidentiality — but this means that patients, doctors, and other public users of the database have access only to an incomplete and uncorrected version.”
Before Covid, VAERS was receiving about 60,000 adverse event reports each year. But in 2021, this shot up to a million reports that year, and another 660,000 have been filed since. Despite the unprecedented increase in reporting, “VAERS’s staffing was likely not commensurate with the demands of reviewing the serious reports submitted, including reports of death,” BMJ says. “While other countries have acknowledged deaths that were ‘likely’ or ‘probably’ related to mRNA vaccination, the CDC — which says that it has reviewed nearly 20,000 preliminary reports of death using VAERS (far more than other countries) — has not acknowledged a single death linked to mRNA vaccines.”
In response to questions about issues raised in the investigation, FDA responded to BMJ by email and it appeared to dismiss the concerns. FDA said it “is actively engaged in safety surveillance of these vaccines to identify and address potential safety concerns” and that “physicians and epidemiologists from the FDA and CDC continuously screen and analyze data from VAERS for Covid-19 vaccines to identify potential signals that would indicate the need for further study.”