Federal health agencies leaned on a safety tool they had been warned was missing signals. Over the same stretch, the two mRNA makers posted the most lucrative years in their history.
Days after calling for congressional and Justice Department investigations into CDC and FDA vaccine safety surveillance, the Independent Medical Alliance (IMA), a national coalition of independent physicians, researchers and clinicians, today turned to the money.
The BMJ (formerly British Medical Journal) investigation published last week documented that CDC and FDA officials relied on a data mining method they had been told could not flag myocarditis and other serious events from the two mRNA shots. Officials then pointed to the lack of alerts as evidence the products were safe. That “no signal” message went out during the two most lucrative years Pfizer and Moderna have ever had.
“They told the country the safety alarm hadn’t gone off, so there was nothing to worry about,” said Dr. Joseph Varon, President and Chief Medical Officer of the Independent Medical Alliance. “The FDA had been warned the alarm was missing signals. Meanwhile, Pfizer and Moderna were booking tens of billions of dollars in COVID shot revenue. I’ll let the public decide whether that’s a coincidence.”
What The BMJ found
The CDC promoted VAERS as the nation’s early warning system and promised two methods of analysis. It did not run one of them, PRR, until 2022. In the weekly FDA reports The BMJ reviewed, the method both agencies “chose to rely” on never signaled for myocarditis, pericarditis, or tinnitus.
In February 2021, FDA medical officer Ana Szarfman, working with statistician William DuMouchel, warned FDA leadership about the flaw and brought an updated method to fix it. Peter Marks, then head of the FDA’s biologics center, kept the existing tool.
On April 27, 2021, after Israel and the Pentagon had already raised myocarditis concerns with a CDC safety committee, CDC Director Rochelle Walensky told reporters, “We have not seen a signal,” and said the agency had looked for one across more than 200 million doses.
On May 7, 2021, FDA official Craig Zinderman asked Szarfman to stop sending analyses. He argued the surveillance method should stay “standard, predictable, and road tested” and warned that changing it could have “unintended consequences (eg, regarding vaccine confidence).”
In a September 2022 letter, Walensky acknowledged the CDC had not run its promised PRR analyses until 2022. When it finally did, myocarditis, pericarditis, Bell’s palsy and tinnitus met the agency’s own signal criteria in 13 straight weekly reports. Walensky still described the results as showing “no additional unexpected safety signals.”
What the ‘all-clear’ was worth
Pfizer’s COVID vaccine, Comirnaty, brought in about $37 billion in 2021 and nearly $38 billion in 2022. Pfizer’s COVID pill, Paxlovid, added almost $19 billion in 2022. That year Pfizer’s total revenue topped $100 billion, a first for any drug company.
Moderna went from $803 million in revenue in 2020 to more than $18 billion in 2021 and about $19 billion in 2022, almost all of it from its COVID shot, Spikevax.
The federal government was at the center of both windfalls. It regulated the shots, bought the most, and granted manufacturers immunity from liability. With Moderna, it was also a development partner: the National Institutes of Health co-developed the mRNA shot.
Had the government’s own tool flagged a safety signal in early 2021, the resulting questions would have slowed the pace of pediatric authorizations, boosters, and seasonal shots that followed.
“Why did FDA officials cite ‘vaccine confidence’ as a reason not to fix the detection problem?” asked Varon. “This demands reform that stops the industries being regulated from picking their regulators and shaping their rules.”
The revolving door
Peter Marks met with Szarfman, kept the flawed method in place, and later wrote that her work could “feed into anti-vaccination rhetoric.” After leaving the FDA in 2025, he joined Eli Lilly as a senior vice president.
Doran Fink, a senior FDA vaccines official who took part in the decision to license the Pfizer and Moderna shots, left the agency in December 2022 and was working at Moderna two months later.
Patrizia Cavazzoni, who led the FDA’s drug center, the division that authorized and approved Paxlovid, left the agency in January 2025 and became Pfizer’s chief medical officer weeks later.
Former FDA Commissioner Scott Gottlieb joined Pfizer’s board in 2019, three months after leaving the agency, and served on it throughout the pandemic.
The BMJ investigation is available at bmj.com. IMA’s analyses are available at IMAhealth.org. To arrange an interview with one of our doctors, contact Lynne@imahealth.org.
About Dr. Joseph Varon
Dr. Joseph Varon is a critical care physician, professor, and president and chief medical officer of the Independent Medical Alliance. He has authored over 1000 peer-reviewed publications and serves as editor-in-chief of the Journal of Independent Medicine. You can read more of Dr. Varon’s IMA posts here.
The most PERFECT crime and con in the history of time all things considered with not ONE person who planned or executed the entire 2020 plandemic held remotely accountable...not ONE! Now we slow roll into 2027 the CDC and FDA fully back the mRNA gene therapy medication injections STILL.
Yet none are held accountable