HUNT VALLEY, Md. (SBG) — Sen. Ron Johnson, R-Wis., has stirred controversy in recent days over his concerns about COVID-19 vaccine safety.
In a July 13 letter to health agency leaders, Johnson noted a press conference he recently hosted where individuals described "neurological symptoms" they said they experienced post-vaccine. Johnson wrote that he’s not sure health officials are properly monitoring for vaccine safety issues.
“Unfortunately, your agencies’ lack of response to congressional oversight letters, combined with my discussions with agency officials and individuals who believe they have experienced vaccine injuries, leads me to believe the preauthorization safety surveillance hype does not appear to match the agencies’ actual performance,” he wrote.
A significant number of Americans share Johnson’s concerns about COVID-19 vaccine side effects, but many health experts say they’re misinterpreting the data. Jeffrey Morris, Director of the Biostatistics Division at the University of Pennsylvania, emphasizes that it's not easy to determine a causal link between a vaccine and a post-vaccine adverse event.
What is VAERS?
Johnson points to the CDC’s Vaccine Adverse Event Reporting System (VAERS), a database where health workers or individuals can submit reports about adverse events occurring after vaccination, whether or not a causal link has been determined. The system has received 6,207 reports of death following COVID-19 vaccines, according to the CDC's website, along with thousands of other adverse events.
Researchers can not assume that incidents reported in VAERS were caused by vaccines. Instead, VAERS can provide “safety signals” that researchers can study more thoroughly in other monitoring systems and estimate rates of adverse events, Morris said. Those other systems include V-safe, which involves text message check-ins from the CDC after people get vaccinated, and Vaccine Safety Datalink, which gathers medical information on over 12 million people a year from nine integrated healthcare organizations.
Morris notes that health workers are required to report serious adverse events to VAERS, “regardless of causality." This increases the likelihood that the database contains adverse events unrelated to the vaccine.
“If people are reporting to VAERS the way they’re supposed to — and, for health workers, the way they are required to — there has to be many deaths that are not caused by vaccine that should be in VAERS,” Morris said.
Another limitation with VAERS is that researchers have no way to calibrate the system to population-wide background rates.
“Because we don’t know who is reporting to VAERS — we don’t know the subgroups of which slices of the population (the older people, younger people, sicker people, healthier people) are reporting to VAERS — we really have no way to calibrate or even begin to make an inference,” Morris said.
One way to analyze the death reports in VAERS is to compare them with the number of people likely to die within a few days of vaccination by random chance. That number would be upward of 10,000, Morris noted in a recent blog post.
“If you vaccinate a randomly selected 150 million people, a little under half the country, then you would expect by random chance that 7500 x 3 x 150/330 = 10,000 or so to die within 3 days of vaccination by random chance alone, even if the ‘vaccine’ was a perfectly safe saline placebo.”
The same goes for other adverse events.
“[H]eart attack, stroke, Bell’s palsy, embolism, miscarriages, etc. all happen at a certain rate and many will happen by random chance in the days or weeks after vaccination,” Morris wrote in an email.
Morris added that it’s still possible some of the adverse events people experience are caused by the vaccine.
“Just because you can’t prove causation from VAERS doesn’t mean that nothing in VAERS is caused by vaccine,” Morris says. "It’s just about getting signals and following up.”
Johnson also acknowledges the limitations with the VAERS system.
“I realize it doesn’t prove causation,” Johnson told Sinclair. “But it’s an early warning system. It should be taken seriously, and I don’t think the health agencies are taking it seriously.”
The CDC notes that it provides "timely updates" on "serious adverse events of interest," including anaphylaxis, thrombosis with thrombocytopenia syndrome, Guillain-Barre Syndrome, myocarditis, pericarditis, and death.
Are adverse events underreported?
Adverse events may be underreported, according to studies from Harvard Pilgrim Health Care and CDC scientists. An oft-cited report from Harvard Pilgrim Health Care states that “fewer than 1% of vaccine adverse events are reported.” Preliminary data for the study were collected between 2006 and 2009.
A more recent study, released in November 2020 by CDC scientists, suggests the reporting rates could be much higher, specifically for anaphylaxis and Guillain-Barre Syndrome.
“VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%," the researchers wrote.
Morris notes the latter study was published at a time when people “were not very worried” about vaccine side effects. To say VAERS only captures 1% of deaths isn't reasonable, he added.
Some COVID-19 vaccine skeptics have pointed out a massive spike in VAERS reports since the COVID-19 vaccines were authorized. Morris says it’s difficult to assess the significance of this spike, partly because many more people know about VAERS now than they did before the pandemic.
“Would we have been talking about VAERS last year?” he asked.
Johnson says he thinks "the vast majority of people" have never heard of VAERS, noting that he hadn’t heard of it until a few months ago. Johnson added that when he asked his colleagues if they’d been following VAERS, “they don’t know what I’m talking about.”
Johnson says some people who believe they’ve been harmed by the vaccine say their doctors are “highly reluctant” to acknowledge that the vaccine might be causing the adverse event, as many physicians recommend the vaccine.
“People don’t like to be wrong, particularly when people’s health or lives are really at stake here,” he said.
He added that people are hesitant to contradict their physicians.
“They’re not doctors. Who are they to say?” Johnson said. “So, there’s a real reluctance to come forward and say, ‘No, this is a vaccine injury,’ when your own doctor isn’t willing to admit that possibility.”
What did the clinical trials show?
While VAERS can’t be used to assess causation, health agencies use several other tools. That includes the clinical trials providing the basis for the FDA’s emergency use authorization late last year.
“I’m actually surprised people don’t talk about the clinical trials more,” Morris said, “If you want to establish causation in terms of efficacy or safety, double-blind, placebo-controlled, randomized trials are the cleanest, strongest way to do that.”
In the Pfizer and Moderna trials, eight out of approximately 35,000 vaccine recipients were reported to have died, compared with 11 in the placebo groups. If researchers examined the eight deaths from the vaccine groups alone, extrapolating them to the millions who have been vaccinated so far, the result would be thousands of deaths. But the comparable number of deaths in the placebo arm indicates there's no such cause for concern, Morris said.
“There was no higher rate of deaths in the vaccination group versus placebo," he said. "The same is true for serious adverse events.”
Still, the clinical trials don’t rule out the possibility that the vaccines are harming a minority of the population, Morris said. Serious adverse events occurring at a rate of less than one in 10,000 are unlikely to show up in the trial, with one in 50,000 being very unlikely.
“This shows us that the vaccines aren’t inherently dangerous for most people,” he said. “But it could be dangerous for some people. There could be some minority harm.”
Senator Johnson agrees that serious adverse events don’t occur in large swaths of the population.
“I happily acknowledge that more than 300 million doses of the vaccine have been administered,” he said. “The vast majority have been administered without adverse effect whatsoever.”
A spokesman previously said Johnson has not taken a COVID-19 vaccine, according to the Milwaukee Journal Sentinel. Johnson also notes that he had a COVID-19 infection, followed by an antibody test showing a prevalence of antibodies, he said.
Johnson emphasizes that he is “pro-vaccine,” has probably had every flu vaccine since the swine flu, and is “up to date” on all other vaccinations. He says charges that he’s an “anti-vaxxer” are completely false.
Johnson says he wants “full transparency” and wants people to have as much information as possible before making a decision to get vaccinated. He also emphasized that he doesn’t want the FDA to “short-circuit” the approval process for the vaccine, saying this will make it more likely for vaccine mandates to be implemented.
“I think full FDA approval would be rushed, I don’t think it’s warranted, I don’t think it should be done,” he said. “I think it opens up the possibility for a more avoidable type of harm.”
The CDC initially reported 6,079 post-vaccine deaths, but recalculated the total to 6,207 after finding an error on its website. This story has been updated to reflect that change.