The U.S. reporting system is designed to identify possible safety issues related to vaccines and should be user-friendly, responsive, and transparent. However, a recent survey by the British Medical Journal revealed that the system did not meet its own standards.
Journalist Jennifer Block explained that the Vaccine Adverse Event Reporting System (VAERS), administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), collects reports of symptoms, diagnoses, hospitalizations, and deaths after vaccination that may indicate possible safety concerns with the vaccine.
It relies on voluntary adverse event reporting by physicians and patients, as well as mandatory reporting by vaccine manufacturers, who are required by law to report all adverse events known to them.
According to VAERS' standard operating procedures for COVID-19, it must be processed quickly within a few days of receiving the report.
But the British Medical Journal understands that in the face of an unprecedented 1.7 million reports since the rollout of the COVID-19 vaccine, the staffing of VAERS may not be commensurate with the requirement to review serious reports submitted, including death reports.
The Freedom of Information Act (FOIA) documents seen by the British Medical Journal (BMJ) show that Pfizer has more than 1,000 more full-time employees than CDC, although the latter is responsible for handling adverse event reports from all manufacturers.
What's more, other countries have acknowledged deaths that are "probable" or "probably" related to mRNA vaccination, while the CDC says it has reviewed nearly 20,000 reports (far more than other countries) but has not acknowledged deaths related to mRNA vaccines.
The British Medical Journal has spoken to more than a dozen people, including a number of doctors and a state medical examiner, who have submitted reports of VAERS of a serious nature on their own behalf or on behalf of their patients, but the clinical reviewers have never been contacted, or have been contacted for months.
Some were told conflicting information about updating the report or were not encouraged to do so at all.
Between 2021 and 2022, a group of physicians and advocates met with FDA representatives several times to express their concerns that the system was not working as expected and was missing signals.
In response to several questions about these meetings and the issues raised in them, the FDA responded via email that the agency "is actively participating in the safety monitoring of these vaccines to identify and address potential safety concerns" and that "physicians and epidemiologists from the FDA and CDC are constantly screening and analyzing COVID-19 vaccine data from VAERS to identify potential signals that indicate the need for further investigation." ”
BMJ also found that the FDA and CDC essentially maintain two separate VAERS databases — a public-facing database containing only initial reports, and a private back-end system containing all updates and corrections — for example, formal diagnoses,** or deaths.
The CDC told the British Medical Journal that this is to protect patient confidentiality. Interestingly, however, Block noted that the FDA's Adverse Event Reporting System (FAERS), which collects drug reports, does maintain a publicly accessible database that is updated, as does the medical device reporting system, which raises the question of why VAERS can't do the same.
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Neither the CDC nor the FDA provided an explanation. A spokesperson for the U.S. Food and Drug Administration told the British Medical Journal that "patients can submit a formal request under the Freedom of Information Act to obtain a complete record of their report."
For serious cases, VAERS reporters should receive an email prompting them to make an update. It includes a ** and a link to upload, but journalists interviewed by the British Medical Journal did not receive a confirmation email, and if they search the database for their report, it will remain the same. Similarly, if a journalist succeeds in ** their diagnosis and improves, or confirms that the cause of their illness is not related to the vaccine, this will not be reflected in public databases.
Narayan Nair, director of the FDA division who oversees VAERS, admitted in a meeting with advocates that when people look for updated reports, they get frustrated, find the original report intact, and feel like they've been "overlooked." "They never saw it on the front end because we wouldn't change the original report.
Reference: "Is the U.S. Vaccine Adverse Event Reporting System Broken?" by Jennifer Block, British Medical Journal, November 10, 2023.
doi： 10.1136/bmj.p2582