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Michigan healthcare freedom community forum
This could become a major political issue because there is a widespread belief that children were not endangered by COVID-19, and this child death data comes from the Biden Administration which insisted the COVID-19 vaccines were safe for children. The leaks thus far also do not disclose how many children were injured, if any. A significant number of injuries to children could increase the adverse public reaction.
Dr. Vinay Prasad, the leader of the FDA Center for Biologics Evaluation and Research (CBER), is a longtime critic of federal COVID-19 policies and a proponent of more stringent vaccine approval standards:
https://thehill.com/policy/healthcare/5626374-fda-vaccine-rules-child-covid-deaths/
FDA to tighten vaccine rules after memo ties COVID-19 shot to child deaths
By Ryan Mancini - November 29, 2025The Food and Drug Administration (FDA) is set to implement stricter vaccine approval guidelines after a memo claimed at least 10 children died “after and because of” receiving a COVID-19 shot.
The guidelines, obtained by The New York Times, could also impact vaccinations for other illnesses and viruses, including the FDA’s standards for annual flu shots and if Americans should receive multiple vaccines at a time. The memo also states that shots for pregnant women could be limited, and manufacturers will be required to conduct larger studies before seeking approval for vaccines.
Vinay Prasad, a top vaccine regulator at FDA, said pneumonia vaccine manufacturers must show that their treatments reduce the infection instead of merely developing antibodies to fight it. The new restrictions would also require drug manufacturers to run larger studies that would slow the process of developing vaccines, according to The Washington Post, which also reviewed the memo.
Prasad, who was reinstated to his post in August after being ousted amid conservative criticism, announced other changes that included a requirement for randomized studies to include all subgroups. He also referred to the annual flu shot framework as a “catastrophe of low-quality evidence,” the Times wrote.
“It’s not like these things are being approved without strong scientific evidence,” Jesse Goodman, the FDA’s former chief scientist, told the Post, noting that guidelines are already “quite strict.”
“They’re being approved with strong scientific evidence,” Goodman added.
The memo does not go into detail about the alleged COVID vaccine-related child deaths.
Prasad called the finding “a profound revelation,” according to the Post.
“For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children,” he said.
The Hill has reached out to the FDA for comment.
FDA Commissioner Marty Makary told Fox News on Saturday that the data on the vaccine-linked child deaths were “accumulated during the Biden administration,” Reuters reported.
The stricter guidelines fit with Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s skepticism of vaccines. Kennedy earlier this year resurrected the long-defunct task force on the safety of childhood vaccines.
Critics said that bringing the panel back would further undermine public confidence in vaccines.
“It’s another politically-controlled forum that can be used for bad messaging and to make investment in and production of vaccines less viable,” Dorit Reiss, a law professor at University of California Law San Francisco, previously told The Hill. “Secretary Kennedy has worked to undermine vaccines for 20 years; this likely seems to him like another tool to make vaccines less accessible.”
In August, the FDA said it was considering revoking the emergency use authorization of Pfizer’s COVID-19 vaccine for healthy children younger than 5 years old. The agency also approved the use of updated vaccines for “high risk” people.
Routine COVID-19 shots are no longer recommended for healthy children and pregnant women.
He also referred to the annual flu shot framework as a “catastrophe of low-quality evidence,” the Times wrote.
Well said, Dr. Prasad.
Predictable hyperventilation from bureaucracies and industry in response. The experts are afraid their house of cards will tumble without the force of law to prop it up. (MedPage)
https://www.medpagetoday.com/pediatrics/generalpediatrics/118755
FDA Memo Claims to Link 10 Kid Deaths to COVID Shots
— Expert calls report without proper scientific review "dangerous and irresponsible"
Kristina Fiore November 29, 2025
Vinay Prasad, MD, MPH, director of FDA Center for Biologics Evaluation and Research, suggested the deaths were related to myocarditis, reports said.
The memo had no details on the ages of the children, whether they had comorbidities, how the agency determined the link, and no information on vaccine manufacturers, the New York Times reported.
Paul Offit, MD, of Children's Hospital of Philadelphia, who reviewed the memo, called it a "dangerous and irresponsible thing to do."
"He [Prasad] says he has evidence that this vaccine killed 10 children, but that's not the way it works," Offit told MedPage Today. "If you think you have an extraordinary claim, you should back it up with extraordinary evidence."
"He should have submitted it to an excellent journal where it can be reviewed by subject matter experts who can say 'Yes, this is clear evidence,' then it can be published," Offit said. "That's the way it works."
The analysis was led by FDA senior adviser Tracy Beth Høeg, MD, PhD, and reviewed by a team at the agency. Prasad requested an analysis of 96 deaths between 2021 and 2024, the Washington Post reported, which concluded that "no fewer" than 10 are related.
The reports originate in the FDA Vaccine Adverse Events Reporting System (VAERS), according to the Washington Post.
In September, reports surfaced that the CDC Advisory Committee on Immunization Practices (ACIP) was expected to claim a link between 25 pediatric deaths and COVID shots.
In his current memo, Prasad called the latest findings a "profound revelation. For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children."
But experts cautioned about the findings being taken out of context.
"With almost one billion COVID immunizations administered to Americans during the pandemic, and perhaps close to 100 million for children and adolescents, it is conceivable that such a one in 10 million or 100 million event occurred," Peter Hotez, MD, PhD, of Baylor College of Medicine in Houston, told the Post.
Hotez noted that "given the public health implications, this is not something one casually blurts out in an email."
Kathryn Edwards, MD, a vaccine expert and professor emeritus at Vanderbilt University in Nashville, Tennessee, cautioned that the "determination of the cause of death in cases that are temporally related to vaccine administration is a very difficult task."
"Saying definitively that a vaccine caused a death requires careful assessment, best done with an autopsy examination, and ruling out other causes of death," Edwards told MedPage Today. "That COVID vaccine might have caused a death related to myocarditis may indeed be the case. But [we] would need to see the details."
She said such details would "best be presented in a peer reviewed manuscript where experts could review the details."
"We also need to remember that COVID disease caused deaths [in kids], many more than 10," she noted. "I spent the entire pandemic reviewing cases of adverse events, I would be delighted to review these cases and assess the evidence that they have to say that they are vaccine caused."
Prasad's memo also announced changes to vaccine oversight and approval, including a requirement for randomized studies to include all subgroups such as pregnant women. It also said the annual framework for choosing the flu vaccine would be re-examined, according to the Times. In addition, Prasad wrote that pneumonia vaccines must show that they reduce pneumonia, rather than just generating antibodies against the bacteria, the Post reported.
Prasad wrote that he is "open to vigorous discussions and debate," according to the Post, but he also added that staff who didn't agree with his approach should resign.
The review comes ahead of the next ACIP meeting, where the childhood immunization schedule will be discussed.
The next ACIP meeting on the childhood vaccine schedule has more to consider.
As posted on X and transcribed by the Lenawee 9-12
https://x.com/NicHulscher/status/1982895909668302992
The Most Comprehensive Analysis Ever Conducted on the Causes of Autism Finds Vaccination Is the DOMINANT Risk Factor
Nicolas Hulscher, MPH | October 27, 2025 X
After decades of censorship and denial, the McCullough Foundation’s Landmark Report of over 300 studies finally delivers the verdict:
Autism’s rise is multifactorial—but vaccination is the MOST significant, preventable driver.
We found potential determinants of new-onset autism before age 9 to include:
- Older parents (>35 years mother, >40 years father);
- Premature delivery (<37 weeks);
- Common genetic variants;
- Siblings with autism;
- Maternal immune activation;
- In utero drug exposure;
- Environmental toxicants;
- Gut–brain axis alterations;
- And combination routine childhood vaccination.Of 136 studies evaluating vaccines or their components:
- 107 (79%) found evidence consistent with a vaccine–autism link
- 29 claimed “no association,” yet lacked truly unvaccinated controls
- 12 studies comparing fully vaccinated vs. unvaccinated children found every time that the unvaccinated had far better overall health and dramatically lower autism risk.Biologic mechanisms converged on shared pathways—immune dysregulation, mitochondrial dysfunction, and neuroinflammation—triggered by clustered and early-timed vaccination during critical windows of brain development.
By evaluating all known risk factors side by side, this analysis uniquely clarifies the relative contribution of vaccination compared to genetic and environmental domains. No prior review has attempted this integrative scope without excluding positive vaccine-association studies or unvaccinated controls—an essential step in determining whether vaccines truly play a role in autism risk, and if so, how significant that role is within the broader causal landscape.
Our report represents a major breakthrough through the iron grip of censorship imposed by the Bio-Pharmaceutical Complex on the issue of vaccination and autism. It also marks Dr. Andrew Wakefield’s first major return to the scientific literature in years—after enduring years of irrational attacks from the vaccine cartel.
Thanks to the tireless work of the McCullough Foundation team: Nicolas Hulscher, MPH; John S. Leake, MA; Simon Troupe, MPH; Claire Rogers, MSPAS, PA-C; Kirstin Cosgrove, BM, CCRA; M. Nathaniel Mead, MSc, PhD; Bre Craven, PA-C; Mila Radetich; Andrew Wakefield, MBBS; and Peter A. McCullough, MD, MPH — and support from the Bia-Echo Foundation — this historic effort was made possible.
CONCLUSION
The totality of evidence supports a multifactorial model of ASD [Autism Spectrum Disorder] in which genetic predisposition, neuroimmune biology, environmental toxicants, perinatal stressors, and iatrogenic exposures converge to produce the phenotype of a post-encephalitic state. Combination and early-timed routine childhood vaccination constitutes the most significant modifiable risk factor for ASD, supported by convergent mechanistic, clinical, and epidemiologic findings, and characterized by intensified use, the clustering of multiple doses during critical neurodevelopmental windows, and the lack of research on the cumulative safety of the full pediatric schedule.
Vaccine stocks tanked today as the import of the Prasad memo reached Wall Street:
Vaccine Stocks Drop After FDA Memo Links COVID Shots To Child Deaths
By Tyler Durden - December 01, 2025Vaccine stocks slumped Monday after an explosive memo from FDA vaccine chief Vinay Prasad surfaced late Friday, signaling the agency is preparing to roll out tough restrictions on new vaccines for children. Prasad described a "profound revelation" linking Covid shots to at least ten deaths in children.
By late morning, Vaccine makers dropped on the memo: Moderna -6%, BioNTech -4.3%, Novavax -4%, Vaxcyte -6.6%.
"This is a profound revelation," Prasad wrote in the memo. "For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children."
He added, "It is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection."
Wall Street analysts weighed in on the memo, and all agreed it introduces a new regulatory overhang for vaccine stocks.
Here's what the research desks told clients:
William Blair, Myles R. Minter (rates the MRNA market perform)
- "Our interpretation of the memo is that CBER will focus its efforts on the younger 12- to 24-year-old male population for newly approved Covid-19 vaccines where the myocarditis risk is highest"
- If new regulatory restrictions were to be implemented in the higher myocarditis risk population, analysts see further headwinds toward Moderna's declining Covid-19 franchise "alongside further negative sentiment that this memo and subsequent actions may generate"
- Analyst says Pfizer, BioNTech, Novavax and Sanofi could also be impacted
- "The memo also indicates several upcoming reforms to the CBER vaccine regulatory pathway, most notably the "demand" for pre- market randomized trials assessing clinical endpoints, not just immunogenicity, for most new vaccine products"
Mizuho, Salim Syed (rates PCVX outperform)
- Says the memo notes "pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post- market setting), and not merely generate antibody titers"
- However, "what investors are missing here is this is already in-line with the current standard" and poses no material change to Vaxcyte
Cantor, Carter Gould (rates PCVX overweight)
- Says not surprised to see selloff in PCVX shares "on the back of the return of perceived regulatory risk after a period of relative calm, particularly with key data weighted to late 2026"
- However, analyst says there wasn't much in the actual memo language on pneumococcal vaccines (PCVs) that's concerning
- Reminds investors that "this all needs to continue to be viewed in the context of the likely timelines for VAX-31 adult and infants efforts against the backdrop of the time remaining in the current administration's term"
- "We appreciate that there's plenty within the memo that's controversial or worrisome regarding Covid-19 vaccine policy, but the actual language on PCVs shows little evolution vs. prior guidance"
Leerink Partners, Mani Foroohar (rates MRNA underperform)
- Says the memo's inflammatory tone highlights how agency policy/communications continue to contribute to vaccine skepticism and US vaccination rate decline
- "We view this as a continued negative for mRNA vaccine manufacturers in our coverage– especially as it relates to Moderna's recently updated short-to-mid-term revenue guidance"
The memo comes months after the Trump administration signaled it would link Covid shots to children's deaths. Remember, anyone who questioned the vaccines in the early days of the pandemic was demonized by Democrats and "trust the science" regime, which unleashed big-tech and state-sponsored censorship cartel against anyone asking questions.
Former FDA Commissioners strike back. Dr. Prasad has hit a nerve:
https://www.statnews.com/2025/12/03/fda-former-commissioners-vaccine-policy/
A dozen former FDA commissioners decry Prasad memo on vaccine regulation
Ex-officials stretching back decades say plans would ‘upend core policies governing vaccine development’
By Matthew Herper - December 3, 2025Changes to the ways in which the Food and Drug Administration plans to regulate vaccines represent a threat to effective and available vaccines and public health, 12 former commissioners wrote Wednesday in the New England Journal of Medicine.
The changes, as described in a leaked memo by Vinay Prasad, the agency’s top regulator of vaccines, “will upend core policies governing vaccine development and updates,” the former commissioners wrote in the piece, a striking show of unanimity among those who have served in both Republican and Democratic administrations.
“If the goal is to rebuild confidence, the answer is not to toss aside the basic rules of science, stifle argument and oversight, or supplant expert scientific inquiry for the unilateral decision making of a few individuals,” the former commissioners wrote. “It is to insist on open deliberation, solid evidence, and procedures the public can see and trust.”
The article was co-written by almost every FDA commissioner who has served in the role since 1990, during the administration of George H. W. Bush.
On Nov. 28, Prasad, who is head of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, blood products, and gene therapies, sent a memo to the entire staff of his center saying that agency scientists had identified 10 cases in which the deaths of children were tied to the Covid vaccines made by Pfizer and Moderna. In the same memo, he stated that the FDA would be making sweeping changes to vaccine policy more broadly.
In NEJM, the former commissioners wrote that the FDA staff had previously “carefully reviewed” many if not all cases and drew different conclusions. “The memo offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation,” the commissioners said.
They wrote that the Vaccine Adverse Event Reporting System (VAERS), from which the 10 cases are drawn, passively collects reports of problems after vaccination and “cannot be used to determine whether a vaccine caused a particular event.” They also wrote that “substantial evidence shows that vaccination can reduce the risk of severe disease and hospitalization in many children and adolescents.”
But their bigger point was that the Covid experience should not change the way the FDA handles the regulation of other vaccines that are safe and well-characterized.
The former commissioners pointed to one change outlined by Prasad in the memo that they think is particularly misguided and that relates to how vaccines are updated to deal with mutations in pathogens, or changes in exactly what infectious variant is circulating. (These are key for influenza vaccines, which must be updated annually, but also for pneumococcal and, of course, Covid shots.)
Prasad seems to want to cease the practice of using antibody levels generated by a new version of an existing vaccine to determine whether the vaccine is effective. This change, the commissioners write, “would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes.”
Separately, the former FDA commissioners expressed concerns about the agency’s current thinking on the use of outside advisers in reaching its decisions. Previous FDA officials frequently turned to expert committees of outside advisers in the past, particularly in cases seen as controversial, but the agency has more recently suggested it will break with that practice.
“FDA Commissioner Martin Makary’s leadership team has said they intend to forgo advisory committee meetings for many major decisions, since they view these committees, which were established by bipartisan agreement in Congress decades ago, as a needlessly costly and burdensome check on their decision making,” the former commissioners wrote.
That, they said, would be to the detriment of public transparency, since the meetings of outside advisers are open to the public, and eliminate an important venue for any disagreements.
The commissioners also disagreed strongly with Prasad’s assertion in his memo that FDA staff who do not believe in his “core principles” should submit their resignations.
“Americans’ safety depends on a culture in which evidence is reviewed openly and staff can surface concerns, challenge leadership, and engage with external scientists without fear of reprisal,” they wrote.
The co-authors include commissioners who were confirmed by the Senate and acting commissioners who were not. Among them were Mark McClellan and Andrew von Eschenbach, who served in the administration of Republican George W. Bush, and Brett Giroir, who served a brief term as acting FDA commissioner and in several other roles during the first Trump administration, including as a key point person on Covid.
The other authors were: Robert Califf, FDA commissioner under Presidents Barack Obama and Joe Biden; Michael Friedman, an acting commissioner under Bill Clinton; Scott Gottlieb, an FDA commissioner in the first Trump administration who has raised alarms about the new Trump administration’s vaccine policy; Margaret Hamburg, who served six years under Obama; Jane Henney, who served under Clinton; David Kessler, who served under the first President Bush and Clinton; Stephen Ostroff, who was an acting commissioner under Obama and Trump; and Norman Sharpless and Janet Woodcock, who were acting commissioners during the first Trump administration.
Stephen Hahn, who was FDA commissioner at the end of the first Trump administration, did not sign the article.
DoJ Attempts To Quash Pfizer Clinical Trials False Claims Lawsuit
DoJ lawyer Nicole Smith told a 5th U.S. Circuit Court of Appeals Court (Louisiana & Texas districts) hearing Wednesday that the discovery of false data submissions would not change the FDA approval of Pfizer's COVID vaccine:
DOJ tries to shut down Pfizer clinical trial whistleblower after FDA admits COVID vax killed kids
Government lawyer ignores leaked memo from FDA vaccines chief as she tries to convince appeals court to block Brook Jackson from refiling her False Claims Act case with new information such as vaccine injury records.
By Greg Piper - December 4, 2025Last week, the Food and Drug Administration's top vaccine regulator told staff that "at least" 10 children died "after and because of" COVID-19 vaccinations and that the agency was preparing to raise the safety hurdles for vaccine approvals.
This week the Department of Justice acted as if that didn't happen.
DOJ lawyer Nicole Smith didn't mention the leaked memo from Center for Biologics Evaluation and Research Director Vinay Prasad at an appeals court hearing Wednesday on whether to reinstate a False Claims Act case against Pfizer and a contractor who ran some of its COVID vaccine trials, arguing nothing would change the feds' minds about Pfizer's vaccine.
The feds are unabashedly asking for a license to shut down whistle-blowers when regulators are in cahoots with fraudsters, lawyer Warner Mendenhall told the 5th U.S. Circuit Court of Appeals, representing whistle-blower Brook Jackson.
"The government really sort of made our case for us" that DOJ treats the phrase "good cause" in the FCA as authorizing its "mere desire to dismiss" a whistle-blower case to recover federal taxpayer money and share in the refund, Mendenhall said in rebuttal to DOJ's Smith.
Yet the administration "actually is changing its policies" in real time on vaccines, and there will be "hundreds more deaths in children that the government's going to recognize" after the 10 cited by Prasad, Mendenhall predicted.
Fired six hours after she notified the FDA in September 2020 about concern regarding the Phase 3 trials she oversaw in Texas as a regional director for Ventavia, Jackson filed the FCA case in 2021 as a "relator" on behalf of the federal government, arguing Pfizer wrongly secured emergency use authorization and a related massive payout from taxpayers.
The Biden administration initially declined to exercise its power to dismiss the qui tam lawsuit in early 2022, then sided with Pfizer several months later by claiming its vaccine would have been approved even if Jackson was right that 3% of trial data were fraudulent, but didn't actually move to intervene and dismiss until last year.
As it has done repeatedly in less than a year, the second Trump administration stuck with its predecessor's legal arguments, defending a trial court's order that dismissed the suit with prejudice so it can't be refiled, even though a senior Trump DOJ official was simultaneously prosecuting asthma trial fraud.
Warning to whistleblowers: avoid "government complicity"
Chief Judge Jennifer Walker Elrod did nearly all of the questioning at Wednesday's hearing, which the 5th Circuit itself has not posted as of Thursday but was recorded and posted by Texas medical freedom activist and physician Mary Talley Bowden.
In its combined motion to intervene and dismiss, DOJ first argued it didn't have to give a specific reason to intervene, then argued for dismissal based on "secondary issues" such as the costs of prosecuting the case, which U.S. District Judge Michael Truncale improperly "confounded" to permanently dismiss the case, Mendenhall told Elrod.
The appeals court must require the feds to prove that her case is truly at odds with "public health policies in the United States," since the 1986 amendments to the FCA make clear that "relators themselves have this role as a check on a government that may actually be complicit with the defendant" in healthcare fraud, he told Judge Priscilla Richman.
Unlike every previous FCA case cited by DOJ, where the government had good cause to intervene, Jackson's alleged "facts are extensively supported" by affidavits and documents and DOJ has already recognized her theory as "cognizable" – that inducing the FDA to issue an EUA through fraud violates the law, Mendenhall said.
Its documentation shows "millions of disabled people now due to these COVID-19 shots," including from the myocarditis flagged by Prasad, "neurological disease or otherwise," while Pfizer made an initial $1.9 billion for 100 million doses paid for by taxpayers and now $30 billion worldwide, he said.
The government has presented no evidence or analysis to stop Jackson's suit, or explained its theory that FCA cases are exempt from a provision of the Federal Rules of Civil Procedure on intervention protocol, he said.
The Biden administration blew its chance to invoke its "pretty much unfettered right to dismiss" the suit by waiting until the case was unsealed, and now must face a "much higher bar" for such a late intervention, according to Mendenhall.
Though the case hasn't moved into legal discovery, it is "unique" because of "a vast army of citizen-researchers and scientists" who spent hundreds if not thousands of hours reviewing Pfizer documents from Freedom of Information Act requests, which confirmed that "more people died in the vaccine arm" than the placebo arm, he said.
Asked why the government isn't allowed to invoke a political justification to intervene, Mendenhall told Elrod that the feds are suppressing Jackson's "First Amendment right to access the courts, to vindicate what she learned" in Pfizer's trials. It "certainly is possible" that bureaucrats "know about the fraud that Pfizer committed," he said.
If the 5th Circuit lets Jackson refile the case, she "may be able to bring a very different case along the same lines, but with the additional information" to prove fraud, but if not, the message to whistle-blowers is "if fraud involves government complicity, don't bother reporting it," Mendenhall said.
"Why is it called 'good cause'" if you don't need any reason?
DOJ's Smith framed the FCA in black-and-white terms and the government's power to dismiss whistle-blower cases as absolute.
Judge Truncale was right that "the government's desire to dismiss itself constitutes good cause" because DOJ determined "its interest would not be served" and the defendants haven't filed an answer, so "the court has no adjudicatory role," Smith said.
She argued with Judge Elrod over whether FRCP Rule 41 requires trial judges by default to dismiss without prejudice, letting plaintiffs refile their cases, with Smith claiming the rule only assumes dismissals are without prejudice unless otherwise stated.
The 5th Circuit wouldn't have jurisdiction to review if Jackson could keep refiling and Judge Truncale kept dismissing the case, Smith said.
Elrod wasn't convinced the record shows the case "would be futile" if Jackson could refile, as Smith insists, since Jackson might be able to "plead it better" and the government might change its public health policy, especially following an election.
The judge questioned whether "the government's made up its mind" is a legitimate basis to permanently dismiss a whistle-blower case.
Judge Don Willett asked whether "desire alone" is enough for good cause or "must there always be some articulated reason" for dismissal. Smith responded that "the government doesn't need to convince the court" when it moves to intervene.
"Why is it called 'good cause'?" Elrod retorted. "That sounds like that's a standard where you have to reach a certain goal," but Smith is arguing "it's just the government's prerogative." Elrod asked if Smith was "trying to make some law here in a circuit," chuckling.
"Whistleblowers have a right to gather information"
Ventavia lawyer, Andrew Guthrie, rebutted Jackson's claim that the Pfizer contractor knew she had gone to the FDA when it fired her the same day. "If it's super-duper fast we can say that it could be linked," Elrod responded, but Guthrie insisted Jackson must show the company knew she was engaged in "protected activity."
When Elrod questioned whether her firing could be a "coincidence," Guthrie recounted Ventavia's "issues" with Jackson in 18 days as an employee. "She was finding confidential materials. She was taking pictures."
The FCA does not protect "criticizing business practices," and all Jackson reported internally was "I'm concerned we're not following a clinical trial protocol" and possibly not following FDA rules, Guthrie said. The FCA does not create "an all-purpose anti-retaliation provision."
"Is it categorical or is there any scenario where a quality control complaint in a clinical trial could constitute FCA protected activity?" Willett asked. Only if Jackson had explicitly said Ventavia was defrauding the government through its trial protocol, Guthrie said.
Whistleblowers aren't required to say the exact right words to bring cases, Mendenhall said in rebuttal. "They have no idea" what the FCA is or what "qui tam" means, but Jackson saw her employer lying in a clinical trial, to Pfizer and the FDA, "and suppressing the information about those lies with this relator," which "messes up the entire data set" from the trial.
The FRCP requires the court to read all inferences in Jackson's favor, and given that "there was no disciplinary action before that day" when Ventavia blindsided her with accusations of violating federal health privacy law, the judges should interpret its actions as "papering the file," Mendenhall said. "Whistle-blowers have a right to gather information."
Reuters reports that the FDA is now investigating deaths amongst other age groups which may be attributable to the COVID vaccines:
FDA probes deaths likely related to COVID vaccines across age groups
Reporting by Mariam Sunny and Sahil Pandey in Bengaluru; Editing by Krishna Chandra Eluri
December 9, 2025The U.S. health regulator is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part of a safety review, a spokesperson for the Department of Health and Human Services said on Tuesday.
The HHS did not immediately clarify what age groups will be included in the FDA probe.
The U.S. Food and Drug Administration Commissioner Marty Makary had previously said they were looking at such deaths in young people.
Last month, the agency's chief medical and scientific officer Vinay Prasad had told staffers in a memo that COVID shots probably contributed to the deaths of at least 10 children who died of heart inflammation and announced plans to tighten vaccine oversight.
The memo did not disclose the health conditions of the children, or the vaccine manufacturers involved. The findings, which have not been published in a peer-reviewed medical journal, were based on an initial analysis of 96 deaths between 2021 and 2024.
Moderna (MRNA.O) reiterated its previous statement that there were no new or undisclosed safety concerns in children or in pregnant women related to its mRNA-based COVID shot Spikevax.
Pfizer (PFE.N), which markets another mRNA-based COVID shot with partner BioNTech (22UAy.DE), also reaffirmed its safety and efficacy.
Health Secretary Robert F. Kennedy Jr. has sharply changed government policy on COVID vaccines, limiting access to people 65 and older as well as those with underlying conditions.
Kennedy, a longtime vaccine skeptic, has made far-reaching changes to the U.S. vaccine policy, which include dropping a long-standing recommendation for the hepatitis B birth dose, cutting funding for mRNA vaccines and, contrary to established science, linking vaccines to autism.
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