Interviewer: “How many people have gotten seriously injured or died after receiving the covid vaccines? So, do you have the answer to that question, senator?”

Sen. Ron Johnson (R-Wis.): “Well, I can report what’s being reported on the VAERS system. … It’s an imperfect system. In general, the complaint is a very small percentage of adverse effects actually get reported, and so you have to take this with a grain of salt, but according to the VAERS system, we are over 3,000 deaths of, after, within 30 days of taking the vaccine. About 40 percent of those occur on Day Zero, One or Two.”

Johnson this year has been making scientifically dubious claims about coronavirus vaccines, arguing that U.S. health officials and agencies are not disclosing all the relevant risks and open questions to the public.

But the information he provides in media appearances, ostensibly to fill in the gaps, is highly suspect.

Take this interview with a conservative radio host in Wisconsin. The senator was asked how many people have died after getting vaccinated against the coronavirus, which causes the disease covid-19. He cited data from the Vaccine Adverse Event Reporting System (VAERS) and suggested the death count was above 3,000.

The Centers for Disease Control and Prevention (CDC) says this data does not establish cause and effect between coronavirus vaccinations and reported deaths. A range of experts on immunology told us Johnson was misusing the data and exaggerating the known risks of getting the shot.

The CDC also says, “A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines.”

In other words, not 3,000 but zero, as far as the science shows.

The Facts

People who experience adverse health events after being vaccinated may file a report to the VAERS database co-managed by the CDC and Food and Drug Administration (FDA). These reports are not verified before they are added to the system, although officials may follow up on some. VAERS is known as a “passive surveillance system,” not an active system that tracks cases over time.

“Healthcare providers, vaccine manufacturers, and the public can submit reports to VAERS,” the CDC says. “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. Most 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.”

Johnson made no mention of these caveats. His only caveat was to note that many people do not file VAERS reports when they have an adverse event after being vaccinated, so his claim, read in full, suggests the 3,000 deaths may be an undercount.

The VAERS system had 4,434 reports of deaths after coronavirus vaccinations as of May 10. That represents a mortality rate of 0.0017 percent, whereas the mortality rate for known cases of covid-19 is much higher: 1.8 percent in the United States, according to a database maintained by Johns Hopkins University.

However, no evidence or scientific study shows any coronavirus vaccine caused any deaths. According to the CDC: “A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious adverse event — blood clots with low platelets — which has caused deaths.” As of May 4, more than 8.4 million doses of the Johnson & Johnson-Janssen vaccine had been given in the United States. U.S. officials have identified 23 confirmed cases of people who got this single-dose vaccine and later developed blood clots, which means a rate of 0.0003 percent.

Experts said the VAERS data does have an important purpose in helping to detect new patterns that may rise to a public health concern.

But, if a new pattern starts showing up in the VAERS data, “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,” the CDC says.

“These systems do not have the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine,” the CDC says.

M. Miles Braun, a professor at the Georgetown University School of Medicine who previously served in public health positions at the CDC and FDA, said Johnson’s claim was a logical fallacy and “misuse of the data.” Correlation by itself does not establish causation, he said.

“The kind of inferences he’s making, we really try to caution users not to use the data as he’s using it,” said Braun, who worked with the VAERS data for 13 years at the FDA.

Susan S. Ellenberg, a biostatistician and professor at the University of Pennsylvania Perelman School of Medicine, said: “Unfortunately, the general public may misinterpret VAERS data as documenting events that were definitely caused by vaccines.”

“A causal connection between the vaccine and an adverse event cannot be made based on any single report (with the exception of things like an anaphylactic reaction within seconds of receiving the vaccine),” Ellenberg wrote in an email. “However, a series of reports of an unusual event could signal a problem, potentially, and would lead to further investigations using other databases, such as the CDC's Vaccine Safety DataLink or the FDA's Sentinel system, in which estimates of rates of this event in vaccinated individuals can be made more reliably.”

Al Ozonoff, associate director of the Precision Vaccines Program at Boston Children’s Hospital and a pediatrics professor at Harvard Medical School, said it was “problematic” to try to draw inferences from the data Johnson used, but he noted that the senator’s claims were carefully worded. (“I can report what’s being reported on the VAERS system,” Johnson said in a preface to his answer. He did not explicitly say the vaccines caused the deaths, although the context of the interview was all about vaccine risks. Johnson also spoke in terms of adverse “effects,” which implies causation. The VAERS database uses the word “events” to avoid this sort of confusion, Braun said.)

“I often say to people the VAERS data in some situations may be an appropriate source, but rarely of sufficient quality for us to draw firm conclusions,” Ozonoff said, adding that it was “absolutely correct to say that there is no causality attributed to any of the events that are reported in VAERS.”

In response to our questions, a spokeswoman for Johnson said he “is not suggesting the deaths were directly caused by the covid-19 vaccine.”

“He is simply saying we need to take the VAERS findings seriously and research what is going on,” Johnson spokeswoman Alexa Henning said. “It is a statement of fact that there are over 3,000 reports of deaths in VAERS among people who received a covid vaccine. The reason he is concerned is that this is in contrast to the last five flu seasons, over the course of which there have been 119 reports of deaths to VAERS among people who received a seasonal flu vaccine.”

U.S. officials focused on getting coronavirus vaccines first to the most vulnerable populations, such as elderly people in nursing homes or assisted-living facilities. That’s another factor to consider when analyzing the VAERS data.

“Someone who’s in assisted living or a nursing home is there because they’re compromised in at least one major way, and sometimes multiple major ways,” Braun said.

In the same radio interview, Johnson said: “I’m talking to doctors who have since Day One been concerned about vaccines [for] people who have already had covid, because you die not of covid, you die of the immune-system overreaction to covid.”

Ozonoff said, “There’s no evidence that I know of that would support the assertion that Senator Johnson makes.” But it’s an area of study that is still developing, he added.

“More research needs to be done to understand the various factors that contribute to disease severity and death,” he said. The same is true for the 1918 flu pandemic. Researchers do not fully know why that strain of influenza was so deadly more than 100 years ago, Ozonoff said.

Earlier in the coronavirus pandemic, some health professionals had theoretical concerns that a vaccine could trigger a harmful overreaction in the immune system, Braun said, but studies have not proven this to be the case now that vaccinations are actually happening.

“Some of the serious pathology that happens in covid illness is related to an immune dysregulation; that’s why it’s treated with steroids,” he said. “The very advanced, severe covid is treated with steroids. There were some theoretical concerns. I don’t think they’ve been borne out by the evidence.”

Braun added: “There are data from studies of people who were infected with covid and then they were later vaccinated, and the measurable immune response that they had to vaccination showed that they created a more robust immune response after vaccination than they had prior.” (We covered this issue in a previous fact check of Johnson.)

The senator’s office sent us a statement from Hooman Noorchashm, a retired heart surgeon and immunologist who said, “The concern is that force-activating the immune system using the vaccine in people who’ve had recent infections could hyperactivate a covid inflammatory response.”

Noorchashm added: “Anecdotally, I think it’s highly likely that this is what happened to Dr. J. Barton Williams of Memphis, TN and to Mr. Christopher Sarmiento of NM.”

Williams, a doctor who was 36, died weeks after receiving his second dose of a coronavirus vaccine. After speculation began to emerge that the vaccine contributed to his death, Williams’s family authorized his medical team to speak out publicly. Officials and doctors involved in the case have not attributed Williams’s death to the vaccine. The cause of death was multisystem inflammatory syndrome, a rare disease that mostly afflicts children and inflames various body parts.

“Like children, adults who have been infected with the virus that causes COVID-19 can develop symptoms of MIS-A days to weeks after getting sick,” the CDC says.

One of the doctors who treated Williams, Stephen Threlkeld, said he would have wanted others to be vaccinated. “The way to avoid this rare, albeit terrible, illness is to get the vaccine,” Threlkeld said. “The way to avoid it is to prevent the infection in the first place.”

Sarmiento, a 33-year-old teacher from El Paso who worked in Las Cruces, N.M., was positive for covid-19 when he got the vaccine and died. The CDC says people with covid should wait until recovery to get vaccinated and patients who were treated with monoclonal antibodies or convalescent plasma should wait 90 days.

Noorchashm said he, his children and elderly parents are all vaccinated. He argues that people should be screened for covid immunity before deciding whether to get the vaccine, and laments U.S. officials’ “one-size-fits-all” approach.

Noorchashm in an email asserted, “Up to 100,000,000 Americans are already naturally immune.” As of this writing, the United States had 32.7 million recorded cases of covid-19, of which 1.8 percent resulted in death. The country’s total population is 331 million.

Noorchashm and Henning pointed to an Israeli study that found that both the Pfizer-BioNTech “vaccine and prior SARS-CoV-2 infection are effective against both subsequent SARS-CoV-2 infection and other COVID-19-related outcomes.” The same study noted “the remarkable curtailing of the outbreak in Israel which followed the high vaccine uptake by the Israeli population.”

U.S. researchers have found that the length of natural immunity to covid-19 varies by person, while vaccine immunity has the potential to be durable. The same studies show that vaccination was effective in boosting covid-19 antibody levels for all groups.

“The senator has spoken with doctors all over the world and he will not name names because they fear reprisal from the media, from their own institutions, and from the government,” Henning said.

Before we get to the Pinocchios, it’s worth noting that Johnson previously said: “It is a legitimate question as to whether people at very low risk of suffering serious illness from covid, particularly the young and healthy, should be encouraged to take a vaccine that is being administered under an Emergency Use Authorization — in other words, before it has been fully tested and fully approved.”

Vaccines typically undergo years of study before they are fully approved. The coronavirus vaccines have not undergone that extensive review and are currently authorized under emergency powers due to the swift and global scale of the crisis.

That doesn’t mean the vaccines are unsafe or untested. For example, the FDA this week extended the emergency authorization for the Pfizer-BioNTech coronavirus vaccine to children ages 12 to 15, stating that the benefits outweighed the “known and potential risks.” That came after a study of 2,260 people in this age group. The vaccines proved effective in building immunity and “the side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older,” the FDA said.

We asked Henning whether Johnson is an anti-vaxxer. “He doesn’t have anything against vaccines and has gotten annual flu shots since the 1970s and is up-to-date with all other standard vaccinations,” she said. Henning said her responses “proved there’s nothing untrue or misinformation.”

(Note: This article has been updated to include information about the Johnson and Johnson-Janssen vaccine and its relationship to blood clots, and to note Noorchashm’s background as an immunologist.)

The Pinocchio Test

Johnson laments that U.S. health officials are not fully forthcoming with information about the risks of getting a coronavirus vaccine, but he is not being fully forthcoming in presenting the information he uses to sound the alarm.

Correlation is not necessarily causation. This is a guiding principle of scientific research — and we have awarded many bushels of Pinocchios over the years to politicians who blur the line.

Johnson was asked how many people had died after getting a coronavirus vaccine. He said upwards of 3,000, citing VAERS data. That’s technically accurate yet deeply misleading.

The reports he’s citing are unverified. U.S. officials and experts make a point of saying the VAERS data should not be used to draw inferences about the risks of vaccination. The coronavirus vaccinations were first concentrated among vulnerable groups such as nursing-home residents with prior illnesses. And the CDC says it has no evidence to establish coronavirus vaccination as the cause of any death.

Johnson also said, “I’m talking to doctors who have since Day One been concerned about vaccines [for] people who have already had covid, because you die not of covid, you die of the immune-system overreaction to covid.” He gets in trouble by using the word “because.”

The body’s immune response may aggravate the health problems of patients afflicted by covid, but no study or case has established that the vaccine itself could trigger a lethal immune response in people who recovered from covid-19 and waited to get the shot. As we keep saying, the burden of proof is on the speaker.

All in all, Three Pinocchios.

Three Pinocchios

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