Johnson sent the letter to National Institutes of Health (NIH) Director Francis Collins, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, and Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, asking about the agencies’ efforts to monitor and report about adverse reactions to the coronavirus vaccines through the Vaccine Adverse Event Reporting System (VAERS).

In his letter, Johnson noted that VAERS has recorded, in less than seven months, over 400,000 adverse events. This is 15 times greater than the weekly average prior to the coronavirus. Johnson noted that although the VAERS data does not prove causality, the VAERS statistics should be taken seriously. The senator wrote:

In October 2020, prior to any vaccine receiving an EUA, your agencies were expressing and conveying a great deal of confidence in your early warning vaccine safety systems like VAERS. Both CDC and FDA included VAERS as one of the primary passive surveillance tools for monitoring COVID-19 vaccine safety. CDC highlighted that VAERS covered the entire U.S. population and its ability to ‘rapidly detect safety signals’ and ‘detect rare adverse events.’ Now, nine months and 438,441 reported adverse events later, health care professionals are publicly downplaying the effectiveness and validity of these same systems. For example, on May 3, 2021, Dr. Paul Offit, who is a member of an FDA advisory committee, stated ‘So [VAERS is] a noisy system that frankly is more frightening than helpful.’ Which is it?

With the inclusion of foreign adverse events, VAERS is reporting 9,048 deaths, 26,818 hospitalizations, 56,915 emergency room visits, and 438,441 total reports. Those adverse events have been recorded over a time span of 29 weeks for an average of 15,000 per week – 15 times the weekly average prior to the COVID-19 vaccines.