A recent investigation by The BMJ has raised significant concerns about the functionality and management of the Vaccine Adverse Event Reporting System (VAERS), the primary early warning system used by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to detect potential safety issues related to vaccines.
The investigation, published on November 10, 2023, suggests that the system is “overwhelmed” and may be broken, pointing to a lack of adequate management and transparency.
According to The BMJ report, VAERS has experienced an unprecedented influx of reports linked to COVID-19 vaccines, surpassing the system's capacity. The overwhelming number of reports has strained the system's ability to review and follow up on serious cases, including deaths.
Furthermore, the investigation highlights that VAERS lacks transparency, user-friendliness, and responsiveness, and it appears that the government is essentially maintaining two separate databases—one accessible to the public and another internal system with updates, outcomes, and corrections.
The CDC, in collaboration with the FDA, oversees VAERS, which collects data on symptoms, diagnoses, hospital admissions, and deaths occurring after vaccination to identify post-marketing safety signals and unusual reporting patterns. Despite accepting reports from various sources, including healthcare providers and the public, VAERS has been criticized for reflecting only a small fraction of actual vaccine adverse events, as indicated by a Harvard Pilgrim Health Care study.
The investigation reveals a substantial increase in adverse events reported to VAERS after the rollout of COVID-19 vaccines. In 2019, prior to the pandemic, VAERS received over 48,000 reports, with the majority being mild. However, an “unprecedented” 1.7 million adverse events were reported to VAERS after the COVID-19 vaccine rollout, with nearly 1 in 5 cases classified as “serious,” most of which were attributed to COVID-19 vaccines.
The report sheds light on discrepancies in the CDC's handling of serious adverse events associated with COVID-19 vaccines. Despite the existence of Standard Operating Procedures for COVID-19, there are instances where the CDC fails to follow up with those who reported serious events, including deaths. The investigation includes accounts from healthcare professionals who submitted reports but were not contacted or received delayed responses from the CDC.
Moreover, the report indicates that the CDC may be understaffed to manage VAERS effectively. Documents obtained through the Freedom of Information Act suggest that Pfizer, a vaccine manufacturer, allocated significantly more resources to vaccine surveillance, with about 1,000 more full-time employees than the CDC. The CDC, responsible for handling adverse event reports for all products, reportedly has 70 to 80 full-time equivalent workers, raising questions about its capacity to meet the demands of the system.
Additionally, concerns have been raised about the dual nature of VAERS databases, with one accessible to the public containing initial reports and another private system on the backend with updates and corrections. The lack of publicly accessible updates raises questions about transparency and completeness, as individuals, doctors, and the public cannot access updated or complete records without submitting formal requests under the Freedom of Information Act.
The investigation underscores the importance of VAERS as a pharmacovigilance tool but suggests that its potential is hindered by deficiencies in its operation and management. The BMJ's findings raise questions about the CDC's adherence to its own standards for maintaining VAERS, the adequacy of staffing, and the transparency of the system. The implications of these concerns extend to the ability to detect and address potential safety issues related to vaccines effectively.
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