‘Painful Truths’: Florida Grand Jury Finds ‘Profound and Serious’ Issues With Vaccine Development and Safety in U.S.
A Florida grand jury found “profound and serious issues involving the process of vaccine development and safety surveillance in the United States,” according to a report unsealed on Tuesday.
Gov. Ron DeSantis convened the grand jury in December 2022 to investigate “any and all wrongdoing” concerning COVID-19 vaccines. Jury members reviewed documents and interviewed witnesses involved in the COVID-19 production process.
“While we did not find criminal activity,” they wrote in their 140-page report, “we did find a pattern of deceptive and obfuscatory behavior on the part of sponsors and regulators that often straddled the line between ethical and unethical conduct.”
They added:
“More importantly, however, not finding any indictable criminal activity does not mean we did not find any problems. On the contrary, there are profound and serious issues involving the process of vaccine development and safety surveillance in the United States.
“Some of those are acute, COVID-19-era problems that are unlikely to occur outside the context of another once-in-a-hundred-year pandemic. Others, however, are systemic; they will occur over and over until someone fixes them.”
Commenting on the jury’s conclusion, Peter Doshi, Ph.D., told The Defender, “It strikes me as a sober and honest appraisal of the situation.”
Doshi is a senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. In July 2024, he published a BMJ investigation on the “revolving door” between the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry.
The investigation revealed that departing FDA staff who take industry jobs are allowed to influence the FDA “behind the scenes.”
An Associated Press (AP) story — picked up by multiple news outlets including CBS News and MedPage Today — ran with a headline focused on “no evidence of criminal activity.”
However, those headlines contrasted with what DeSantis said on X about the jury’s findings.
This morning, the Twenty-Second Statewide Grand Jury released its final report. This Grand Jury was tasked with investigating vaccine manufacturers and their production process for vaccines following the COVID-19 pandemic.
While we are still reading through the report and its…
— Ron DeSantis (@GovRonDeSantis) January 7, 2025
DeSantis said that not only does the report reveal Big Pharma’s pattern of deception and obfuscation, it “also details the frustrations of many, stating, ‘these sponsors have taken in billions of taxpayer dollars for creating and selling their vaccines; they cannot be sued if something goes wrong with them; they have access to critical information about deaths related to a side effect of their products; and the public does not have access to that information.’”
“The status quo cannot continue,” DeSantis said. “The American people deserve transparency on how Big Pharma is using their federal tax dollars, and they deserve regulating entities that operate as watchdogs, not cheerleaders.”
‘Painful truths’ about pharma and U.S. vaccine regulatory process
The grand jury report highlighted “some painful truths about the COVID-19 pandemic, the pharmaceutical industry and our system of vaccine approval and licensing.”
For instance, Pfizer initially failed to publicly disclose information about adverse events that occurred among pregnant women in one of its main clinical trials.
“These adverse events somehow did not make it into any of the articles published in the NEJM [New England Journal of Medicine] regarding the safety and efficacy of BNT162b2,” the report stated. “The public only knows about them at all because, legally, Pfizer was required to eventually publish the results of the 1001 trial on ClinicalTrials.gov.”
Also, the FDA did not enforce marketing limitations on vaccine companies as long as the advertisement promoted vaccination in general, rather than a specific vaccine.
For example, Moderna in August 2021 ran an ad featuring a former athlete saying, “What’s our Number 1 rule? Always protect the team … with the vaccines here to help millions, we can take steps towards life as we knew it.”
Based on their findings, the jury made recommendations on how the U.S. vaccine production and regulation process should change, including:
- The public must address the “revolving door” problem between the pharmaceutical industry and government agencies such as the FDA and Centers for Disease Control and Prevention.
- Vaccine makers must publicly disclose safety signals as soon as they are found and verified, rather than waiting until the signal has been investigated and confirmed. “It is infantilizing and paternalistic for sponsors and regulators to assume that the public cannot distinguish between ‘we are investigating this potential problem’ and ‘we have investigated, and this is a problem,’” the jury said.
- Conduct updated clinical trials for Pfizer and Moderna’s COVID-19 shots.
- Ban direct-to-consumer marketing of pharmaceutical products.
- Require vaccine makers to publish anonymized individual patient data from safety and efficacy studies swiftly after receiving FDA licensure.
- Remove vaccine maker’s legal immunity if they fail to comply with data transparency requirements.
‘A real call for systemic change and rebalancing’
The jury report authors said they don’t want to take sides in the “ideological war that has been waged in public health, popular culture and the media” over the safety and efficacy of COVID-19 vaccines.
Some people call the vaccines “a triumph of science, technology and public health that saved countless lives,” while others say they “were heedlessly licensed, excessively recommended, and even mandated to broad swathes of people that did not need them, placing their health — and sometimes their lives — at unnecessary risk.”
Both claims hold some truth, they said.
Their report isn’t “another entry in an ideological war, but a real call for systemic change and rebalancing,” they wrote.
“If this Final Report accomplishes nothing else, we are optimistic that it can elevate the debate around the many nuanced and specific issues involving these pharmaceuticals by clearly describing and contextualizing them.”
Their findings and recommendations can serve as a “blueprint for a larger reckoning regarding the balance of power between federal regulators, public health officials, pharmaceutical sponsors and the citizens of the United States.”
The Defender reached out to Dr. Marty Makary, nominated to head the FDA by incoming President Donald Trump, for comment on the jury’s report but did not receive a response by the deadline.
See more here The Defender
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