The effort to promote COVID vaccines to the general public took many forms. Experts like Anthony Fauci downplayed the extreme difference in risk between age groups, asserting that everyone should be vaccinated, regardless of youth or a lack of other health-related risk factors.
The former CDC director, Rochelle Walensky, made the completely unsupported claim that “vaccinated people don’t carry the virus” and “don’t get sick,” promises that were false at the time and proved humiliating later.
Former President Joe Biden said that unvaccinated people should prepare for a “winter of severe illness and death” in 2021-2022. He also tried to force all private businesses with more than 100 employees to enforce vaccine mandates. There were vaccine passports, university mandates, and of course, the pinnacle, or nadir, or COVID absurdity, Stephen Colbert’s “The Vax-scene.”
But the other side of the incessant push for more COVID vaccine uptake was the purposeful downplaying or denying of potential side effects and their impact on the risk-benefit calculation.
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One of the tools for measuring those side effects is the VAERS, or Vaccine Adverse Event Reporting System. And Sen. Ron Johnson (R-Wis.) has released a new report on how that system may have been purposefully ignored by a Biden administration desperate to promote uptake.
President Joe Biden receives a third dose of the Pfizer-BioNTech COVID-19 vaccine in the South Court Auditorium at the White House in Washington, D.C., on Sept. 27, 2021. (Anna Moneymaker/Getty Images)
VAERS safety signals may have been ignored by Biden administration
Johnson’s new report, released last week, contains some potential bombshell revelations about Biden administration health officials’ conduct regarding potential safety signals.
The report came from an investigation by the Permanent Subcommittee on Investigations, which requested documents from the Department of Health and Human Services on the VAERS system at the height of the pandemic in early 2021.
Some of the submitted documents covered Dr. Ana Szarfman, described as a “senior medical officer and safety data mining developer at the Food and Drug Administration. Szarfman, Johnson says, “used an updated data analysis technique that identified dozens of statistically significant safety signals for adverse events associated with the COVID-19 vaccines.”
The report says she “immediately shared her findings with other FDA officials,” particularly those “responsible for COVID-19 vaccine safety surveillance.”
Surely, there would be some interest at the FDA in further investigating safety signals, particularly knowing that recommendations from other experts would rely on their findings. Well, instead, the report says those officials “largely ignored her and eventually told her to stop her data analyses.”
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Not what you want to hear. But what did Szarfman actually find?
Well, Johnson’s report says that she found in her data analysis that there were nearly 50 examples of “extreme masking.” Essentially, masking means that one very common signal in data makes others harder to find. Szarfman and Dr. William DuMouchel, then chief statistician at Oracle and the inventor of the data mining algorithm in effect at the FDA, found that the “extreme masking” had covered up roughly 20-25 examples of “statistically significant” safety signals for adverse effects. Those adverse effects had not been “previously detected” by the FDA and included “sudden cardiac death, Bell’s palsy, and pulmonary infarction.”
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, delivers an opening statement during a Senate Health, Education, Labor and Pensions Committee hearing on the federal response to COVID-19 in Washington, D.C., on May 11, 2021. (Greg Nash-Pool/Getty Images)
Dr. Szarfman, Johnson says, continued sharing updated findings of similar safety signals several times throughout the early part of 2021 as vaccine policies and recommendations were rolling out.
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Instead of taking these findings seriously and looking into them further, the Biden-FDA wanted her to stop looking. The report says that “one senior FDA official wrote to his colleagues, ‘[b]efore we potentially reach out to Ana, we should meet internally — many considerations not suited to email.’”
Another expert, Dr. Peter Marks, warned that the data mining “create erroneous conflicts that feed in to anti-vaccination rhetoric.”
By June 2021, Dr. Szarfman had emailed another FDA employee about conversations between the FDA and CDC about the potential “myocardial events” associated with COVID-19. She attached a data analysis showing “higher statistically significant safety signals for acute myocardial infarction,” and added that they’d “detected clear signals for other similar events.”
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What did the FDA do with this information? Well, basically nothing. Sounds about right.
VAERS has limitations, being a reporting system rather than controlled scientific study. It’s subject to bias and can be misleading. However, with an all-important question like this, and known limitations regarding masked data, it seems absurd that there was so little interest in further investigating.
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It would be absurd, if it didn’t fit perfectly into the pattern of behavior from the FDA and other experts at the time. They downplayed the risk of myocarditis or other health-related side effects, particularly for young men, leading to unnecessary risks being taken by say, college students or others in that age group to whom COVID posed vanishingly small possibility of severe illness.
They ignored that it had become clear, almost immediately, that the vaccines had little-to-no efficacy against infection. Choosing instead to continue pushing for mandates and passports based on their false assumptions.
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Dr. Anthony Fauci, White House chief medical advisor and NIAID director, and Dr. Rochelle Walensky, CDC director, arrive for a White House COVID-19 Response Team call with the National Governors Association in the South Court Auditorium of the Eisenhower Executive Office Building on the White House campus in Washington on Dec. 27, 2021. (Carolyn Kaster/AP)
There was no interest in further examining safety signal data because it would have undermined their desire to push for universal uptake. Even if that investigation had found that the potentially elevated safety signals were overblown. It simply wasn’t a priority, because it could have fed into “anti-vax” sentiment. That’s what concerned them, not finding the truth.
You don’t need to be “anti-vax” to want to have all available information. And concerns about COVID vaccines in particular should not be conflated with skepticism or distrust of all vaccines. But the more stories and reports of this nature emerge in the post-pandemic period, showing just how disinterested many officials were, the more they encourage that type of thinking. It’s their own fault, and they refuse to acknowledge it.
