The Florida surgeon general, Joseph Ladapo, MD, Ph.D., wrote a letter against COVID-19 vaccines to FDA Commissioner Robert Califf, MD, and CDC Director Rochelle Walensky, MD, MPH using problematic Vaccine and Adverse Events Reporting System (VAERS) data. Drs. Califf and Walensky replied with a scathing letter back to the Florida surgeon general.
This article will review what Ladapo wrote and the response from the FDA and CDC to his ridiculous and unsupported claims. But mostly, I’m going to describe why dumpster-diving into VAERS is so useless as a tool to support claims about vaccine side effects.
What is VAERS?
The Vaccine Adverse Event Reporting System (VAERS) is one of the systems employed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to monitor vaccine safety. VAERS is a post-marketing surveillance program, collecting information about adverse events (including death) that occur after the administration of vaccines to ascertain whether the risk-benefit ratio is high enough to justify the continued use of any particular vaccine.
VAERS, the Vaccine Safety Datalink (VSD), the FDA’s Post-licensure Rapid Immunization Safety Monitoring System (PRISM), and the Clinical Immunization Safety Assessment Network (CISA) are the major tools used by the CDC and FDA to monitor vaccine safety. These are powerful tools that provide full information about each patient so that correlation and causation may be determined through powerful case-control or cohort analyses of the data.
And in contrast to VAERS, PRISM, VSD, and CISA are active reporting systems in that electronic health records are actively monitored for AEs after vaccination to identify potential safety signals.
However, there are no analyses that can establish any type of causation between the vaccination and the claimed adverse event that is reported to the VAERS database. Frankly, it can be gamed by those with nefarious intentions, which can limit the value of the VAERS data.
To be honest, VAERS is a feel-good system for those who think that there’s a link between vaccines and something terrible, but without an active investigation, the data is just above the level of totally meaningless. Most epidemiologists know it is valueless as a database to determine correlation and/or causation. Even the VAERS system itself says that the data cannot be used to ascertain the difference between coincidence and true causality.
According to the CDC:
Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.
The VAERS website adds the following disclaimer:
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
What the Florida surgeon general wrote
Dr. Ladapo claimed that Florida saw a 1,700% increase in VAERS reports after COVID vaccines became available, compared with a 400% increase in vaccine administration over the same period. He also wrote that the reporting of life-threatening conditions increased by over 4,400%.
Lapado concluded that his findings were “likely to reflect a pattern of increased risk from mRNA COVID-19 vaccines.”
Ladapo referenced an earlier unauthored, unpublished, and non-peer-reviewed report that he used to recommend against vaccinating men ages 18 to 39 in Florida because of the debunked link between the vaccine and cardiovascular issues.
Ladapo also wrote that healthcare professionals “should have the ability to accurately communicate the risks and benefits of a medical intervention to their patients without fear of retaliation by the federal government.”
The FDA and CDC response to Florida surgeon general
I’m not going to repeat the blow-by-blow response from the FDA and CDC commissioners because they repeat so much that I have written about VAERS over the years.
First, the Florida Surgeon General totally misused the VAERS system. The commissioners were forced to remind Ladapo of several points:
- VAERS is a self-reported system, so the accuracy of claims needs to be confirmed medically.
- VAERS only finds “safety signals,” which need to be confirmed with further research
- VAERS cannot show a correlation between the COVID-19 vaccines and adverse events because a medical link cannot be established. Of course, as I mentioned above, some databases allow real scientists, something outside of Ladapo’s skills apparently, to find correlations with case-control and cohort studies.
- VAERS cannot establish causation between vaccines and adverse events.
- Ladapo had the ability to corroborate the VAERS claims by examining the medical records of each VAERS complaint from Florida to determine if there was an actual link between the vaccines and the cardiovascular adverse events.
- Ladapo did the absolute minimum amount of work to support his claims — he basically dumpster-dived into the data, and picked out data that supported his a priori beliefs. That is NOT science.
Kristen Panthagani, MD, Ph.D., of Yale University, also noted in a tweet that there were only 20 deaths among men ages 18 to 39 during the risk period, meaning that if “even just a few of these have another cause (which is highly likely), they lose statistical significance.” This again goes back to Ladapo not doing even a little bit of science to determine if there was a legitimate link between the vaccine and the adverse event claims.
Moreover, Panthagani added that the study didn’t appropriately control for whether people had COVID-19, thus “susceptibility to COVID confounded their analysis, and COVID (not COVID vaccination) very well could have contributed to some of these deaths.”
“Overall these results are largely unreliable, and personally I would not base any decisions on them,” Panthagani summarized in another tweet.
Summary
I’ve come to the point in my analysis of the “science” of the anti-vaccine world that if they use VAERS for data, I know they are lazy, lack any scientific analysis skills, and haven’t a clue about epidemiology. There are much better databases for analyzing vaccine safety, but they require intelligence and analytical skills to use them.
Florida Surgeon General Joseph Ladapo, instead of attempting to protect the health of the residents of his state, stoops to using baseless and easily refuted claims to “prove” that the COVID-19 vaccine is unsafe. His analysis was lazy and weak, and it showed absolutely nothing about the vaccine’s safety and effectiveness.
