Legal Action

Demand to Fix VAERS


ICAN, through its attorneys, has written to the Secretary of Health and Human Services, the Director of the CDC, and the Commissioner of the FDA about an oft repeated issue: underreporting of adverse events to VAERS.  ICAN highlights Harvard’s findings that “fewer than 1% of vaccine adverse events are reported” and shows real life examples of precisely that for reports of anaphylaxis and deaths to VAERS.  ICAN will continue to demand and take action until they fix this broken system!

The issue of underreporting to VAERS has been highlighted for over 30 years and is still an ongoing problem.  Until these very serious issues are corrected, it is necessary that both manufacturers and health care providers be mandated to report any and all adverse events, aside from mild ones, to VAERS.  This is precisely what ICAN, through its attorneys, demanded of Secretary Azar in its December 29, 2020 letter to him.

Despite the fact that it is the Secretary of Health and Human Services who has the authority to require health care providers and vaccine manufacturers to report adverse reactions, events, and contraindications following the receipt of a vaccine to VAERS, the CDC director, Robert Redfield responded to ICAN’s letter on January 19, 2021.  ICAN had requested that Azar immediately make it mandatory that all adverse events following a COVID-19 vaccination, with the exception of mild events, be reported by vaccine manufacturers and all health care providers to VAERS.

Dr. Redfield (replaced by Rochelle Walensky as CDC Director) failed to address ICAN’s specific demands and, instead, concluded just weeks after their introduction that the COVID-19 vaccines “have been shown to be safe and effective as determined from data by the manufacturers and findings from large clinical trials.”  Nothing to worry about, according to Redfield: the manufacturers who are liability-free and stand to profit from worldwide sales of these products have submitted only a few weeks of their own data to show that these vaccines, like every other vaccine, are “safe and effective.”

On April 30, 2021, ICAN sent a letter to HHS, CDC, and FDA which once again lays out the undeniable underreporting issue with VAERS and points to three clear pieces of evidence to substantiate the concern.

First, an AHRQ-funded study by Harvard Medical School tracked reporting to VAERS over a three-year period at Harvard Pilgrim Health Care involving 715,000 patients and found that “fewer than 1% of vaccine adverse events are reported.”  A U.S. House Report similarly stated: “Former FDA Commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.”  The HHS, CDC, and FDA are acutely aware of this fact.

Second, in a recent legal update, ICAN shared a letter sent to the CDC’s Director regarding its claim that “Anaphylaxis after COVID-19 vaccination is rare and occurred in approximately 2 to 5 people per million vaccinated in the United States based on events reported to VAERS.”  That claim is contradicted by a recent study at Mass General Brigham that assessed anaphylaxis in a clinical setting after the administration of COVID-19 vaccines and, in stark contrast to the CDC’s claim, found “severe reactions consistent with anaphylaxis occurred at a rate of 2.47 per 10,000 vaccinations.”  This is equivalent to 50 times to 120 times more cases than what VAERS and the CDC are reporting! HHS, CDC, and FDA are also aware of this discrepancy thanks to ICAN.

Third, an ACIP meeting again brought into clear focus this incredible level of under reporting for even cases of death.  During the January 27, 2021 meeting, Tom Shimabukuro of the CDC’s COVID-19 Vaccine Safety Task Force, Vaccine Safety Team, explained that it was expected that 11,440 deaths from long term care facilities (“LTCF”) would be reported to VAERS given the number of deaths that would naturally occur during the period directly after COVID-19 vaccination in these facilities:

Instead, VAERS only received 129 reports of deaths following COVID-19 vaccination in LTCF (or 1.1%)!  This again reflects the serious under reporting to VAERS, even for deaths, and is consistent with the study cited above.  This is especially troubling since the need to report to VAERS for deaths after COVID-19 has been repeatedly reiterated to vaccination providers and is required by law.

If anaphylaxis and death are being underreported, imagine the level of underreporting for serious adverse events that do not occur immediately after vaccination or are not easily identified!  This should seriously concern officials at HHS, CDC, and FDA but, given the response to ICAN’s previous letters addressing this topic, it does not appear there is any concern.  If deaths and anaphylaxis are being seriously underreported, there are no-doubt serious safety signals that are being missed for delayed or less obvious harms!

Ignoring and casting aside these issues in the drive to vaccinate and promote vaccine confidence may eventually be the undoing of the very confidence the public health authorities seek to instill.

ICAN made clear to the three agencies that unless and until underreporting to VAERS is addressed, underreporting to a passive signal detection system will continue to blind health agencies, medical professionals, and patients from what is really occurring in the clinic and will render true informed consent impossible.   With the drive to vaccinate every single American with COVID-19 vaccines, the safety of all Americans, literally, depends on this broken system.

ICAN’s message: FIX IT.

The first step to fix it was explained by ICAN: at the least, automate hospital and clinical medical records to automatically send VAERS reports for all clinically significant events occurring within a window of time after vaccination.  This already exists for other purposes.  It can be done for vaccines as well, which is clear from the CDC’s own publications on this topic and pages 31 to 34 of ICAN’s previous letter exchange with HHS on this issue.

ICAN will continue to raise this serious issue with those tasked with our safety.  Until the CDC and FDA, the agencies tasked with operating VAERS, fix this broken system, ICAN will never relent until the pressure to fix this system, including from the mainstream media, forces this result.