A BMJ investigation found the CDC isn’t following its standards for maintaining VAERS, is missing safety signals, and essentially maintains two databases.
The nation’s primary early warning system used to detect possible safety problems with vaccines is “overwhelmed,” raising concerns the system may be broken and isn’t being adequately managed by the Centers for Disease Control and Prevention (CDC), according to a new investigation.
The report published on Nov. 10 by The BMJ (previously British Medical Journal) found the Vaccine Adverse Event Reporting System (VAERS) has received an unprecedented number of reports attributed to COVID-19 vaccines, and there aren’t enough staff to meet the requirements for reviewing and following up with serious reports, including deaths. Additionally, the investigation revealed that VAERS is neither transparent, user-friendly, nor responsive, and suggests the government essentially maintains two VAERS systems—only one of which the public can access.
Co-managed by the U.S. Food and Drug Administration (FDA) and CDC, VAERS collects reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination to capture post-marketing safety signals and determine if there are any unusual or unexpected reporting patterns for adverse events.
According to the CDC, healthcare providers are “strongly encouraged” to report any adverse event following vaccination to VAERS, even if they’re unclear whether the vaccine caused the adverse event. In contrast, vaccine manufacturers are required by law to report all adverse events that “come to their attention.”
Although VAERS accepts reports from anyone, knowingly filing a false VAERS report violates federal law and is punishable by fine and imprisonment. This allows VAERS to serve as an “early warning system to detect rare adverse events” and deters false reporting. Even so, VAERS has been shown to reflect only 1 percent of actual vaccine adverse events, according to a Harvard Pilgrim Health Care study.
CDC Isn’t Investigating Serious Adverse Events for COVID-19 Vaccines
According to the CDC, in 2019—prior to the pandemic—VAERS received more than 48,000 reports of vaccine adverse events, 85 to 90 percent of which were mild. After the COVID-19 vaccine rollout, The BMJ found an “unprecedented” 1.7 million adverse events were reported to VAERS, with 1 million reported in 2021 and an additional 660,000 received thereafter. Nearly 1 in 5 cases met the criteria for a “serious” adverse event, and most reports were attributed to COVID-19 vaccines.
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