By Pradheep J.
Shanker
Friday, May 07,
2021
Social media have been a source of fabulous exchanges of data, ideas, and suggestions during this coronavirus pandemic, which otherwise has prevented us from communicating directly with other experts in the medical field. Early on in the pandemic, the ability to exchange ideas on a minute-to-minute basis likely saved many lives, especially as medical professionals struggled with dealing with this previously unseen and unpredictable disease.
But data, like social media, can be and often are misused. There are those in the media who have either failed to understand what the evidence and data meant, and then those who appear to be purposefully distorting the evidence for their own questionable ends.
Fox News host Tucker Carlson falls into this latter group.
On Wednesday night, he reported on the “questionable” deaths being reported following administration of various COVID-19 vaccines. He specifically mentioned data coming from the Vaccine Adverse Events Reporting system, more conveniently known as VAERS.
VAERS was established in 1990 by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug administration (FDA). It was proposed as a form of national warning system, to alert medical experts to possible safety problems with commonly used vaccines. The system was built as a passive apparatus, meaning that it relies on individuals to send in reports. As such, the system was never intended to determine if a vaccine caused specific health problems. The goal was to collect data, and then look for patterns that could indicate that there could be a safety problem that required further, more in-depth investigation.
The system uses an online reporting process that specifically asks health-care providers to report events that are specifically looked for in specific vaccines, and that have been known to be possible issues. This is spelled out clearly:
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
VAERS is supposed to be casting a wide net to capture any complication that has even the remotest possibility of being related to the vaccine. Any adverse event is considered reportable. This ranges from direct symptoms, such as fevers or hematomas, to events such as death from blunt trauma in a car accident (which, of course, is highly unlikely to be related to the vaccine). More severe complications tend to be reported more often. And unlike the case with health professionals, VAERS requires that any evidence of complications that are known by vaccine manufacturers be reported, under penalty of law.
On his show Wednesday night, Tucker Carlson appeared to have largely failed to understand not only the goals of VAERS, but its limitations. First, he stated that less than 1 percent of adverse events were reported. This is in fact true . . . but if you see my previous paragraph, the reason for this is not some vast conspiracy. The reason is that the vast majority of adverse events are so meaningless and trivial that neither patients nor physicians bother reporting them. Tucker says he won’t speculate what the number of ‘real’ adverse events is, but he specifically is speculating that the low reporting rate of adverse events could be hiding a large number of severe complications, such as hospitalization and death. That speculation is clearly absurd, given the reporting standards stated above.
Carlson continues, stating the following:
Between late December of 2020 and last month, a total of 3,362 people apparently died after getting the COVID vaccine in the United States. That is an average of roughly 30 people every day. So, what does that add up to? By the way, that reporting period ended on April 23, and we don’t have numbers past that. . . . Not quite up to date, but we can assume another 360 people at that rate have died in the 12 days since. You put it all together, that is a total of 3,722 deaths, almost 4,000 people who died after getting the COVID vaccine. The actual number is almost certainly higher than that, perhaps vastly higher than that.
Carlson continues by saying that this is not even close to normal, and that we have not seen this with previous vaccines. But he’s missing the context, which means everything here.
Since most vaccines in normal times are administered to children, the symptoms following vaccinations largely are related to childhood ailments. Additionally, because this is a passive system, ailments are usually underreported. This is especially true of symptoms such as fevers, body aches, and arm pain, which are so commonplace that most patients and doctors simply ignore the symptoms.
The most common adult vaccine is the influenza vaccine. Less than half of adults in this country receive the vaccine on average. In 2019–2020, around 170 million doses were administered, by far the most of any vaccine in the U.S. Compare this with childhood vaccines, which are given to a far smaller number of patients yearly. For example, the measles vaccine is only administered to about 8 million children yearly.
The COVID-19 vaccines are unique in many ways. First, they were all investigated in a faster-than- normal process, under the power of Emergency Use Authorization (EUA). That simply means the process was fast-tracked; evidence of efficacy and complications was still required and had to be evaluated by the FDA.
The Johnson & Johnson vaccine used an older technology: a vector vaccine, which uses the shell of a virus to introduce genetic material into our cells. This material then produces proteins that target the coronavirus. The Pfizer/BioNTech and Moderna vaccines use a newer technology, called mRNA vaccines. These vaccines contain genetic material that directly enters our cells, and, like the vector vaccines, then produces proteins that target COVID. The ultimate end process (producing proteins targeting COVID-19) is the same; the only difference is the process by which the genetic material is sent to our cells.
But what is most unique about these vaccines is that they are part of the largest vaccine rollout in human history. In the U.S. alone, 250 million doses have already been administered, with the number increasing by around 2 million daily. Worldwide, including all the various global vaccines, 1.21 billion doses have been given. The numbers are staggering by any measure.
These large numbers provide unique hurdles, but also clear benefits. The vast numbers mean following the data is difficult. But it also means that if there are true, directly related complications resulting from these vaccines, we should be better able to detect those aberrant findings. But pattern recognition is the key: VAERS is meant as a ‘catch all’ system. It was meant to overestimate the risk of complications, because it was felt that it is better to have to investigate more complications that are unrelated, than to miss important complications.
Because of the ‘catch all’ system, VAERS captures a lot of data on insignificant and minor complications. That is an intended result. And with normal vaccines, where we are talking less than 10 million doses a year, this is not problematic. With the COVID vaccine, however, we reached 10 million doses after five days.
This causes unique problems for VAERS, and it is this pitfall that Tucker Carlson has fallen into. The noise in the data from VAERS is extremely high. What this means is that the data showing adverse reactions after receiving the vaccine will obviously contain a large number of false positives (reporting that is unrelated to the vaccine). The VAERS website itself warns people to understand what the data really mean:
These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination . . . vaccine providers are encouraged to report all adverse events following vaccination, whether or not they believe vaccination was the cause.
Carlson states hundreds of people have died in four months after the vaccine, versus the meningitis vaccine, about which he states only 1 person died after receiving since 2010 (and notably, even that one death wasn’t directly related, something Carlson doesn’t clearly note). The problem is that Carlson fails to understand the math. That vaccine only is administered to about 3 million people yearly. We provide that many doses of COVID vaccine daily.
In short, the scale and scope of Warp Speed, which has promised to be able to vaccinate every American within a year, is the reason for this “stunning” math, as Carlson puts it, not the threat of the vaccine itself.
Furthermore, the actual number of deaths related to receiving the vaccine appears very, very low. For example, both the European Union and the U.S. briefly halted the use of Johnson & Johnson vaccines after the reporting of a few rare cases of cerebral venous thrombosis, an exceedingly rare condition to begin with. In the U.S., total cases amounted to 6 out of 6.8 million doses administered. And as of now, not even one death has been directly related.
Compare this with the absolute risk of clots during this pandemic. A new study released in the journal Stroke last month quantifies the risk of cerebral venous sinus thrombosis in patients receiving the COVID vaccine, versus the risk in those actually becoming infected with COVID. The risk from clots following COVID infection is far, far higher than that from receiving the vaccine; it is almost ten times more likely, in fact:
“COVID-19 infection is a significant risk factor for CVST,” said Karen L. Furie, M.D., MPH, lead author of the special report, chair of the department of neurology at the Warren Alpert Medical School of Brown University, and chief of neurology at Rhode Island Hospital. But the public can be reassured by investigations from the Centers for Disease Control and Prevention and the Food and Drug Administration that the risk of developing the condition is minuscule, she added.
“The likelihood of developing CVST after a COVID-19 vaccine is extremely low. We urge all adults to receive any of the approved COVID-19 vaccines,” she said.
The problem ultimately is that Carlson clearly doesn’t understand the science and the process involved with VAERS. VAERS is doing its job appropriately. It is trying to catch any and all potential adverse reactions. Then, the experts can sift through the data, and figure out what is simply noise, and what is real. Carlson, however, has jumped all those steps and assumed that every report in VAERS is related to the vaccine when there is no evidence that is the case. In fact, with the ongoing pandemic, it is far more likely that baseline infections in the community are the result of these cases of clots and death than of the vaccines. Carlson is arguing that every death that occurs after a vaccination must be counted as caused by the vaccination, while only a few short months ago, he argued that people were overcounting COVID deaths caused by accidents or other unrelated causes because of the way states were defining viral-related mortality.
To say that Carlson’s rank misinterpretations here are problematic is to vastly understate the problem. Carlson has one of the most-viewed shows on cable-network TV, and his voice matters. His failure to understand and communicate the nuance of this data could have terrible consequences for his viewers.
The evidence still remains unmistakable: get vaccinated.
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