ICAN EDUCATES REPRESENTATIVE OF THE IMMUNIZATION SAFETY OFFICE REGARDING VAERS UNDERREPORTING

ICAN, through its attorneys, has written to Dr. Jeffery Duffy, who works for the CDC’s Immunization Safety Office, to point out evidence directly contradicting his remarks made at a recent Advisory Committee on Childhood Vaccinations.
 
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.”
This 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!
Mr. Duffy is apparently unaware of this study and of the severe underreporting to VAERS.  During a March 4, 2021 meeting of the Advisory Committee on Childhood Vaccinations he presented an update on behalf of the CDC’s Immunization Safety Office.  Following his presentation which included information about v-safe and COVID-19 vaccine safety surveillance, Mr. Duffy made incorrect claims regarding VAERS:
Underreporting is a recognized issue with VAERS because it is a passive surveillance system where reporting may not be 100%.  But I think one piece of information that is perhaps informative that our office published a paper last year trying to better quantitate how often reporting for serious adverse events occurs. The two we looked at were specifically Guillain-Barre Syndrome and anaphylaxis. What we did was we actually compared the incidence rates from studies done in VSD and looked at the reporting rates in VAERS. Depending on the vaccine, we looked at over 10 years’ worth of different published studies. The reporting rates definitely vary by different vaccines but I think one that was informative was during the 2009 H1N1 pandemic we found that the reporting rate of anaphylaxis following the H1N1 inactivated vaccine was about 76% of the incidents ascertained in the VSD. That gives us some sense that for serious adverse events such as anaphylaxis, we think the reporting rates are much better than the information you cited which is referring to non-serious adverse events that people may be less likely to report. I think certainly with the media attention around the COVID vaccination and anaphylaxis issue in particular, we think that there is certainly the probability people are more likely to report to VAERS.
Contrary to Dr. Duffy’s “sense” and “thoughts” of better reporting rates, there is an alarming level of underreporting of anaphylaxis by the CDC and VAERS.
This is particularly troubling because it is mandatory for medical providers to report anaphylaxis after any COVID-19 vaccine to VAERS.  In addition, the CDC reports that most of these reactions occur within 30 minutes of vaccination.  (The study reported that the mean time to reaction is 17 minutes post-vaccination.)  This means that vaccine administrators, then, should be aware of a majority, if not all, cases of anaphylaxis since vaccine recipients are supposed to be observed for 15 to 30-minute periods following vaccination at all vaccination sites.
Additionally, and specifically with regard to COVID-19 vaccines, there has actually been a push by health authorities, as Dr. Duffy stated, to inform medical providers that they need to report anaphylaxis to VAERS. Despite this, the rate of reporting still appears to be only around 0.8 to 2 percent of all cases of anaphylaxis.  (This is close to the Harvard Pilgrim study which found that approximately 1% of adverse events are reported to VAERS).
ICAN explained to Dr. Duffy, as it explained to the CDC’s Director, that this raises serious concerns regarding (i) under-reporting of other serious adverse events following COVID-19 vaccination, and (2) adverse events following other vaccines for which there has not been the same push to report adverse events. The anaphylaxis study highlights the urgency of the ongoing, well-known problem with adverse event reporting post-vaccination which ICAN has been pointing out to federal health officials numerous times this year alone.
Unless and until this is addressed by the government and individuals like Dr. Duffy who are tasked with immunization safety, underreporting to VAERS, 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.
ICAN reached out to Dr. Duffy in the hopes that he can evaluate this ongoing and serious issue.  ICAN will closely review any response from Dr. Duffy and will continue to keep you informed.
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