ICAN, through its attorneys, has once again written to Dr. Rochelle Walensky, the new Director of the CDC, this time to demand an answer as to why the CDC’s reporting of anaphylaxis following COVID-19 vaccination is not in line with a clinical study conducted which shows much higher rates following these vaccinations.
The CDC tells the public 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.” However, ICAN reviewed a recent study at Mass General Brigham that assessed anaphylaxis in a clinical setting after the administration of COVID-19 vaccines. This study, 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!
In a letter to Dr. Walensky, ICAN explained that this alarming underreporting of anaphylaxis by the CDC and VAERS 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, of these cases as 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 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. Walensky 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 for years.
Unless and until this is addressed, 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 continues to ask the hard questions of Dr. Walensky and others. ICAN will closely review any response from Dr. Walensky and will continue to push for improved transparency regarding vaccines and their development, clinical trials, and safety surveillance.