As a Former Pharma Insider, Senator Ron Johnson’s Questions About COVID Vaccine Accountability Hit Close to Home
Before I became a part of the Heartland Post, I spent a decade working inside the pharmaceutical industry. My customers included some of the largest generic drug manufacturers in the world, where every day revolved around FDA regulatory compliance, quality systems, manufacturing standards, and patient safety. In that world, compliance wasn’t merely a corporate objective — it was the foundation upon which everything else was built. That background gave me a unique perspective during my recent conversation with Wisconsin Senator Ron Johnson.
As Senator Johnson detailed allegations of ignored safety warnings, regulatory failures, legal immunity protections, and unanswered questions surrounding the COVID-19 vaccine rollout, I found myself listening not only as a writer, but as someone who spent years navigating the very compliance systems at the center of this controversy.
The questions raised during our conversation go far beyond politics. They strike at the heart of how the pharmaceutical industry operates, how FDA oversight is supposed to function, and what happened when an experienced scientist and regulator raised concerns that challenged the official COVID narrative. What Senator Johnson described paints a troubling picture of a massive cover up and a broken public health system that many Americans no longer trust.
Understanding the FDA’s Two Worlds
One detail often overlooked in discussions surrounding the COVID vaccines is that not all FDA divisions serve the same function.
For my entire pharmaceutical career, I worked around products regulated by the FDA’s Center for Drug Evaluation and Research (CDER). CDER is the largest division within the FDA, regulating traditional pharmaceutical drugs, including generic medications, and has long-established systems for evaluating safety, efficacy, manufacturing quality, and post-market surveillance.
The COVID mRNA vaccines, however, fell under a different regulatory branch of the FDA — the Center for Biologics Evaluation and Research (CBER). CBER regulates vaccines, blood products, gene therapies, and other advanced biological products.
That distinction became critically important in March 2021 when a veteran FDA scientist from the CDER side of the agency reportedly warned officials at CBER that the safety monitoring system being used for the COVID vaccines had a serious flaw.
According to Senator Johnson, that warning was completely ignored.
The FDA Scientist Who Raised the Alarm
One of the most revealing parts of my conversation with Senator Johnson centered on Dr. Ana Szarfman, a senior FDA medical officer and safety data-mining expert who worked within CDER.
To understand the significance of Szarfman’s warning, it is important to understand the system she was evaluating. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program jointly administered by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). VAERS collects and analyzes reports of adverse events following vaccination and serves as an early warning system designed to identify potential safety concerns that may warrant further investigation. While VAERS reports alone do not establish causation, the system plays a critical role in detecting unusual patterns and safety signals that could indicate previously unrecognized risks.
Johnson described how Szarfman warned FDA leadership, including Dr. Peter Marks — the longtime CBER director who oversaw the authorization and approval process for the mRNA vaccine rollout — that the agency’s standard data-mining algorithm used to analyze vaccine adverse-event reports suffered from a known problem called “masking,” a flaw that could hide important safety signals instead of revealing them.
At this point, Szarfman had already developed a better algorithm designed to correct the problem.
“On March 1st (2021), you get warned that the algorithm you’re using to analyze all those data reports is gonna mask and hide signals,” Johnson told me. “Then 26 days later, she comes up with the data from the new algorithm.”
According to Johnson, her updated algorithm revealed dozens of statistically significant safety signals for serious adverse events — including sudden cardiac death, pulmonary infarction, Bell’s palsy and other neurological conditions, and various strokes. These safety signals had previously been obscured.
Internal records and testimony indicate that senior FDA officials, including Dr. Marks at CBER, were made aware of Szarfman’s improved methodology and its findings. According to Johnson, however, the agency chose not to implement it. He contends that rather than fully exploring Szarfman’s concerns, FDA leadership sidelined both her and her improved algorithm.
The timing of that warning became even more significant because, according to Johnson, FDA officials were already being inundated with adverse-event reports unlike anything the agency had ever experienced.
As head of CBER, Dr. Marks oversaw the authorization process for the mRNA vaccines during one of the most politically and socially pressured periods in modern American history. Johnson acknowledged the immense pressure regulators faced.
“You’re under a great deal of pressure from the administration and the public,” he said. “‘We want something to protect us. We want to end this pandemic.'”
But shortly after the Emergency Use Authorizations were granted under Operation Warp Speed, Johnson says the system was overwhelmed by reports of adverse events. According to him, the contractor responsible for processing those reports had to hire approximately 280 additional employees simply to address the growing backlog.
The volume alone, Johnson argued, should have triggered concern.
“Even though the deluge of reports is a screaming safety signal in and of itself,” Johnson said, officials continued relying on the same analytical approach.
The senator highlighted another statistic that he believes deserves scrutiny.
“Since the start of VAERS, on average, about 280 deaths are reported associated with a vaccine every year,” Johnson said. “In 2021, there were 21,000 deaths reported worldwide.”
Johnson was careful to note that VAERS does not establish causation. Still, he pointed to data showing a significant percentage of reports occurred within one to two days of injection.
“I know VAERS doesn’t prove causation,” he said. “But that’s a correlation that you have to be concerned about.”
Johnson suggested that FDA officials may have been reluctant to revisit decisions made during the height of the pandemic, when regulators faced extraordinary pressure to authorize products viewed as critical to ending the public health emergency.
In his view, acknowledging flaws in the safety-monitoring process would have raised difficult questions about decisions already made, and could have undermined public confidence in the agency — which is possibly why the FDA chose not to investigate this matter.
“I don’t have the proof. I don’t have the documentation,” Johnson acknowledged during our conversation. “But it’s pretty easy to do that mind game and realize it’s probably just what these guys are thinking.”
This allegation immediately stood out to me. When a subject-matter expert identifies a flaw in a safety-monitoring system, the expectation is that regulators investigate aggressively. The entire purpose of post-market surveillance is to identify emerging risks before they become larger problems.
At the center of this revelation remains a fundamental question: Why was a senior FDA safety expert’s warning about potential flaws in the agency’s analytical methods not given greater consideration at a time when unprecedented numbers of adverse-event reports were pouring into the system?
Johnson believes the timing and circumstances raise serious questions, describing the controversy surrounding the FDA’s handling of these warnings as “the biggest scandal of his lifetime.”
The Questions Nobody Wanted to Ask
Listening to Johnson describe what occurred inside the FDA brought back memories from inside the pharmaceutical industry during the pandemic.
Among many professionals I knew, there was an unspoken protocol.
We were never required to disclose whether we had received a COVID vaccine. We were never asked. We were never pressured to reveal our status.
It was essentially a “don’t ask, don’t tell” environment.
Looking back, many of us had concerns from the very beginning.
I remember conversations with colleagues who worked throughout the industry. One friend working for Pfizer in Chicago told me in September 2021 that he had never seen such a volume of VAERS reports surrounding a pharmaceutical product.
While anecdotal observations are not scientific evidence, they reflected a growing unease among many professionals who understood how pharmaceutical safety monitoring normally works.
The questions simply weren’t being asked publicly.
Following the Money and the Immunity
Pfizer’s COVID-19 vaccine generated roughly $90–95 billion in revenue between 2021 and 2024, while Moderna’s vaccine generated approximately $46–50 billion over the same period, making the mRNA vaccine rollout one of the most financially lucrative pharmaceutical product launches in history.
Our conversation eventually turned toward accountability.
I asked Johnson about the sweeping liability protections granted to vaccine manufacturers under the PREP Act and whether states might eventually find ways to investigate pharmaceutical companies despite federal protections.
I pointed to a simple question many Americans continue asking: “Why do these companies need full immunity if the product is safe and effective?” Johnson agreed.
“It’s just interesting,” he responded, “if these things are so safe and effective, you wouldn’t need immunity, would you?”
Johnson revealed that his office continues seeking documents from the Department of Health and Human Services related to the Biden administration’s decision to extend PREP Act protections.
“A group of documents that we’re getting stonewalled to this day from (Biden’s) HHS has relevant information and communications regarding Joe Biden’s extension of the PREP Act immunity,” Johnson said.
Those documents, he believes, could help explain the rationale behind continuing legal protections for manufacturers despite mounting questions about safety and efficacy.
The Revolving Door
Another topic that drew scrutiny was the relationship between regulators and the pharmaceutical industry.
I brought up the fact that Dr. Peter Marks later joined Eli Lilly after overseeing CBER during the vaccine rollout.
The move reignited longstanding concerns about the revolving door between federal regulators and the industries they regulate. (Another prominent example: former FDA Commissioner Dr. Scott Gottlieb, who served as the 23rd FDA Commissioner from 2017 to 2019, subsequently joined Pfizer’s Board of Directors after leaving the FDA).
“The incestuous relationship between pharma and the FDA is rampant, to say the least,” I told Johnson.
While no evidence has emerged suggesting wrongdoing related to Marks’ employment transition, such moves contribute to public skepticism and undermine confidence in regulatory independence.
A Reckoning That Has Yet to Begin
Toward the end of our discussion, Johnson expressed hope that lawsuits and state-level investigations will eventually provide answers – even if the suit simply triggers the discovery phase, prompting further investigation.
Note: When you file a formal complaint or lawsuit, you legally trigger the discovery phase. In this mandatory pre-trial process, both sides are required to exchange relevant evidence, documents, and witness information. You cannot hide damaging facts; all non-privileged information must be disclosed.
“I hope somebody does engage in some kind of lawsuit against the whole COVID cartel,” he told me. “I think they’re all culpable from my standpoint.”
Whether those legal challenges ultimately materialize remains to be seen.
What is clear is that many questions remain unanswered.
I understand both the importance of innovation and the necessity of accountability. Public trust depends on transparency. It depends on regulators following the data wherever it leads. And it depends on asking difficult questions even when the answers may be harmful to the reputation of the industry. Senator Johnson has spent years pursuing those questions.
“There’s not one thing that I’ve said during COVID that’s been proven wrong” says Johnson. “I’m not going to give up.”
As a relentless truth-seeker, his unwavering commitment to forcing investigations, federal oversight and demanding accountability is appreciated more than he realizes. For years, Senator Johnson has endured unrelenting criticism, media scorn, and resistance from powerful institutions while continuing to ask difficult questions that many others were unwilling to ask. Regardless of where one stands on the COVID vaccines, his commitment to transparency, investigation, and following the facts wherever they lead reflects the kind of public service America deserves.
For the millions of Americans whose lives were negatively affected by pandemic-era policies, the search for answers is far from over.
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