The FDA has blocked Moderna’s groundbreaking mRNA flu vaccine from even entering the review process, marking a dramatic shift under the Trump administration’s newly confirmed Health Secretary Robert F. Kennedy Jr., who has openly criticized mRNA technology and slashed over $500 million in federal mRNA research funding.
Story Snapshot
FDA issued rare “refusal-to-file” letter rejecting Moderna’s mRNA flu vaccine application despite 40,000-patient trial showing superior efficacy in adults 50+ Vaccine Director Dr. Vinay Prasad cited control arm concerns, contradicting 2024 Biden-era FDA feedback that approved Moderna’s trial design HHS Secretary Robert F. Kennedy Jr.’s anti-mRNA agenda has eliminated federal mRNA funding, rolled back COVID vaccine recommendations, and removed dissenting FDA advisors
Over a dozen former FDA commissioners condemned the new approval barriers as harmful to U.S. biomedical innovation leadership Moderna plans urgent FDA meeting while pursuing approvals in EU, Canada, and Australia where reviews continue without issue
FDA Rejects Moderna Application After Contradicting Prior Guidance
The FDA delivered a stunning setback to Moderna in early February 2026, refusing to review the company’s mRNA-based seasonal flu vaccine through a “refusal-to-file” letter. Vaccine Director Dr. Vinay Prasad claimed Moderna’s 40,000-participant phase 3 trial failed to use the “best-available standard of care” as a control, arguing the study lacked an “adequate and well-controlled trial.” This reasoning directly contradicts 2024 guidance from the FDA’s Center for Biologics Evaluation and Research, which deemed Moderna’s standard-dose comparator acceptable, though preferring high-dose shots for seniors 65 and older. Moderna proceeded with the agreed protocol and even supplemented data with high-dose comparisons.
RFK Jr.’s HHS Overhaul Targets mRNA Technology Across Federal Agencies
The refusal-to-file letter represents the latest action in Health Secretary Robert F. Kennedy Jr.’s systematic campaign against mRNA vaccines since joining the Trump administration in 2025. HHS terminated over $500 million in federal BARDA funding for mRNA flu research last summer, rolled back COVID-19 vaccine recommendations, mandated new mRNA vaccine warnings, and removed FDA advisors who supported streamlined approval processes. Dr. Prasad’s 2025 internal memo ended decades-old FDA practices allowing flu vaccine approvals based on immunogenicity data rather than full efficacy trials, specifically targeting mRNA products. More than a dozen former FDA commissioners publicly condemned this policy shift as unnecessarily disruptive to established scientific processes that have safely regulated seasonal vaccines for years.
Moderna CEO Stéphane Bancel issued a sharp rebuke, stating the FDA’s decision “does not further America’s leadership in innovative medicines.” The company immediately requested an urgent meeting with FDA officials and took the unprecedented step of publicly releasing the refusal-to-file letter. Bancel emphasized that no regulatory mandate requires the “best standard” control the FDA now demands, and noted the agency raised no safety or efficacy concerns about mRNA-1010’s performance. The trial demonstrated superior protection compared to standard flu shots in adults 50 and older, the very population most vulnerable to seasonal influenza complications. This marks a rare instance of FDA issuing a refusal-to-file letter for a vaccine after extensive pre-submission discussions supposedly aligned the agency and manufacturer on trial design.
International Regulators Proceed While U.S. Stalls Innovation
While the FDA blocks domestic review, regulatory agencies in the European Union, Canada, and Australia continue evaluating Moderna’s mRNA flu vaccine without raising similar objections. The company anticipates potential approvals in these jurisdictions during late 2026 or early 2027, creating the absurd situation where American innovation may reach foreign markets first while U.S. patients face delays. Moderna maintains its 2026 financial guidance remains unchanged despite the U.S. setback, though the company announced plans to pivot research and development resources toward oncology applications. This strategic shift signals declining confidence in navigating the FDA’s evolving mRNA barriers under current leadership, potentially costing American patients access to potentially superior vaccine technology developed by U.S. companies.
Policy Shift Threatens U.S. Biomedical Leadership and Patient Access
The FDA’s action sends a chilling message to pharmaceutical innovators that mRNA vaccine development faces unpredictable regulatory hurdles regardless of prior agency agreements or clinical trial success. Industry analysts warn this uncertainty will deter investment in mRNA seasonal vaccine research, undermining the very American biomedical leadership Moderna’s CEO referenced. The decision particularly impacts seniors who could benefit from mRNA-1010’s demonstrated superior efficacy compared to standard-dose flu shots currently available. No evidence suggests safety concerns drove the FDA’s refusal; rather, administrative objections to trial design choices the agency previously accepted now block progress. This represents classic government overreach where bureaucratic preferences override scientific evidence, agreements, and patient needs. Former FDA commissioners’ widespread condemnation underscores how far current leadership has strayed from sound regulatory principles in service of an ideological agenda against mRNA technology.
Sources: Moderna says FDA refuses its application for new mRNA flu vaccine – ABC News
Moderna hit with FDA refusal-to-file letter on mRNA flu shot, issues sharp rebuke of agency’s rationale – FierceBiotech
Moderna Statement on FDA Refusal to File Letter for mRNA-1010 – Issuer Direct
When tragedy strikes, society teeters on a knife’s edge. It’s a simple truth, really. The line between order and outright anarchy is thin, and it’s our law enforcement officers who have to walk it. Every second is a battle against the entropy of a crisis, a frantic push to reclaim the truth from the noise.
Yet in these moments, a darker element often emerges. While most Americans are frozen in shock or trying to help, some people see chaos as an opportunity. These individuals thrive on deception, seeking to muddy the waters and divert attention from evil. They are not merely bystanders; they are active agents of disorder, inserting themselves into the heart of a tragedy to serve their own twisted purposes.
From ‘The Daily Wire’:
As Zinn continued to claim he shot Kirk, law enforcement asked Zinn for the murder weapon. Zinn responded: “I am not going to tell you where [the gun] is. I shot him, now shoot me.”
Those were the words shouted by 71-year-old George Zinn in the immediate, critical moments after conservative icon Charlie Kirk was tragically assassinated on a Utah college campus. While police were desperately trying to locate a killer, Zinn launched a calculated performance designed to do one thing: interfere with the investigation and help a murderer escape.
Let’s be clear: this wasn’t some harmless prank or a desperate cry for 15 minutes of fame. This was a malicious assault on the rule of law, plain and simple.
An Attack on Justice Itself Every minute that law enforcement spent dealing with George Zinn was a minute the real killer, Tyler Robinson, had to get away. By falsely claiming responsibility and refusing to produce a weapon, Zinn deliberately orchestrated a pointless charade designed to protect a killer. As one report noted, police believe Zinn’s actions were a conscious “effort to conceal the real identity of the shooter.”
This is obstruction of justice in its most dangerous form. In the golden hour after a crime, the actions of first responders can make or break a case. Zinn chose to poison that critical time with lies. He created a smokescreen for evil, forcing officers to waste precious resources on him while the actual perpetrator slipped further away.
We don’t know if Zinn knew the killer personally, or if he was simply an ideological sympathizer who saw an opportunity to run interference. In the end, it doesn’t matter. His actions were a betrayal of every decent citizen’s duty, and he willingly made himself an accessory to chaos.
The Rot Beneath the Lie When a man is willing to publicly aid the escape of a political assassin, one has to wonder what other darkness lurks within his character. In Zinn’s case, we didn’t have to wonder for long.
During his arrest, police searched his phone and made a sickening discovery: child sexual abuse material. The man who tried to derail a murder investigation in public was privately consuming the most depraved content imaginable. And his excuse in court? You almost have to laugh at the audacity. He claimed the images were from some “‘chatroom dialogue with photos that are public access,’” as if that makes it any better. This is the kind of pathetic, predictable excuse you get from a man with no moral compass.
This is the face of moral decay. The same man who felt no shame in obstructing justice for a murdered conservative feels no remorse for his vile appetites. The public lie and the private sickness spring from the same poisoned well of moral bankruptcy.
A Reckoning for Deception Thankfully, Zinn’s despicable actions did not go unpunished. A judge has sentenced him to prison for up to 15 years for both his obstruction of justice and the sexual exploitation charges. While the wheels of justice continue to turn for Charlie Kirk’s actual killer, this sentence is a crucial victory for accountability.
It sends a clear and unequivocal message: if you interfere with law enforcement, if you provide cover for murderers, and if you work to subvert the foundations of our justice system, you will face consequences. Zinn’s lies could have allowed a killer to walk free, but instead, they have landed him exactly where he belongs: behind bars.
In the ongoing battle between order and anarchy, this is a firm point for order. While the pain of Charlie Kirk’s loss remains, we can take solace in knowing that at least one of the men who contributed to that day’s evil has been brought to justice. It is a reminder that truth, however besieged, will ultimately prevail.
Key Takeaways Obstructing a murder investigation is a direct and serious attack on law and order. The perpetrator’s private depravity reveals the moral rot behind his public deception. Accountability is paramount; justice was served to a man who tried to help a killer. Deception in moments of crisis is not a prank, but a dangerous act of societal betrayal.
by Michael Nevradakis, Ph.D.Brenda Baletti, Ph.D. January 21, 2026
In a lawsuit filed today in federal court, Children’s Health Defense (CHD) and five other plaintiffs accused the American Academy of Pediatrics (AAP) of running a decades-long racketeering scheme to defraud American families about the safety of the childhood vaccine schedule.
The suit alleges that the AAP violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by making “false and fraudulent” claims about the safety of the Centers for Disease Control and Prevention’s (CDC) childhood immunization schedule — while receiving funding from vaccine manufacturers and providing financial incentives to pediatricians who achieve high vaccination rates.
“For too long, the AAP has been held up on a pedestal, as if it were a font of science and integrity,” said CHD CEO Mary Holland. “Sadly, that’s not the case.”
Instead, Holland said, the AAP “is a front operation in a racketeering scheme involving Big Pharma, Big Medicine and Big Media, ready at every turn to put profits above children’s health. It’s time to face facts and see what the AAP is really about,” Holland said.
According to the complaint, the AAP has worked to conceal the findings of studies that the Institute of Medicine (IOM) — now known as the National Academy of Medicine — published in 2002 and 2013.
The IOM called for more research after concluding that no studies had ever been conducted to compare the health outcomes of vaccinated and unvaccinated children.
The AAP’s conduct constitutes a pattern of fraud under RICO, a statute often used to prosecute organized crime, said Rick Jaffe, attorney for the plaintiffs.
Jaffe told The Defender that while previous lawsuits “challenged individual vaccines or sought compensation for individual injuries,” this “is a fraud case following the playbook that took down Big Tobacco.”
“The AAP’s actions parallel those of Big Tobacco, which misled the public regarding the safety of its products,” Jaffe said. “Tobacco created false uncertainty to manufacture doubt. The AAP did the inverse — it created false certainty to foreclose questions. Both used the trappings of science to prevent actual science.”
CHD General Counsel Kim Mack Rosenberg said the lawsuit shows “the close ties between entities and individuals who work toward the same purpose — propping up the vaccine industry and those who profit from it.”
The AAP is the largest pediatric trade group in the U.S., with 67,000 members.
The lawsuit, filed in the U.S. District Court for the District of Columbia, seeks financial damages for the individual plaintiffs. It also asks the court to require the AAP to disclose the “lack of comprehensive safety testing” of vaccines, and bar the AAP from making “further unqualified safety claims” about vaccines.
Drs. Paul Thomas and Kenneth Stoller — physicians whose professional reputations were harmed for opposing AAP’s guidelines, and the parents of four children who died or were injured after receiving routine childhood vaccinations, are among the plaintiffs.
Lawsuit: AAP’s childhood vaccine safety claims based on ‘foundational fraud’
According to the lawsuit, the AAP’s claims about vaccine safety rest on a “foundational fraud” — namely, a 2002 article by pediatrician Dr. Paul Offit, published in the journal Pediatrics. The article claims that infants can “theoretically” receive up to 10,000 vaccines at once without posing a health risk.
The AAP “deployed this theoretical reassurance” to block the IOM studies and questions about the safety of the childhood schedule, to assure parents, doctors and policymakers that the vaccine schedule was thoroughly tested, the complaint states.
The AAP incorporated Offit’s claims into its flagship Red Book — its guide to the prevention, management and control of pediatric diseases. “Pediatricians learned to cite the 10,000 vaccines figure when parents expressed concern,” the complaint states.
“The Red Book is their Bible. When AAP says the schedule is safe, that’s what parents hear in examination rooms across America,” Jaffe said.
“Offit’s theoretical PR article did not study, and could not prove, the safety of the cumulative schedule,” according to the complaint. Yet the pediatricians who deviate from this standard of care have faced professional and personal consequences.
‘AAP turned pediatricians into vaccine delivery systems’
Thomas and Stoller, the two pediatricians who are suing the AAP, said they suffered professional and economic harm after questioning vaccine safety claims.
In 2020, Thomas co-authored research, now retracted, comparing the health outcomes of vaccinated and unvaccinated children. Days later, the Oregon Medical Board suspended Thomas, citing his deviation from AAP protocols and calling him a “threat to public health.”
“I was forced to abandon my patients, something highly illegal,” Thomas said. “There was economic damage in the millions and devastating stress and emotional duress.”
Stoller also faced professional discipline and reputational harm, according to the complaint. He lost his medical license in California and New Mexico after he granted medical exemptions to vaccine mandates.
“AAP turned pediatricians into vaccine delivery systems and destroyed the ones who asked questions,” Jaffe said.
AAP guidelines led to children’s vaccine-related deaths and injuries
The AAP’s “Red Book” vaccine recommendations contributed to the deaths and injuries of three of the plaintiffs’ children, according to the lawsuit.
Idaho resident Andrea Shaw’s two children — fraternal twins Dallas and Tyson Shaw — both died last year, eight days after receiving their 18-month vaccines.
According to the complaint, the Shaw family’s physician dismissed the parents’ warnings about the family’s history of adverse reactions to the flu vaccine. The doctor was following AAP guidance, “which does not generally recognize family history of vaccine reactions.”
A day after their vaccination, Shaw’s children were taken to the emergency room for a series of symptoms documented as “post-immunization reaction, initial encounter.”
A week later, the children died. Local authorities launched a homicide investigation against their mother, based on the suspicion that she caused their deaths. The investigation is still active.
New York resident Shanticia Nelson’s 1-year-old daughter, Sa’Niya Carter, died last year of cardiac arrest after having seizures roughly 12 hours after receiving six “catch-up” injections containing 12 vaccines.
Nelson told doctors she was concerned about giving her daughter so many vaccines at once, because the child was sick at the time. However, healthcare workers told Nelson that the “catch-up” regimen and vaccinating a “mildly ill” child were safe, according to the AAP.
Carter’s death certificate listed “sudden unexpected death in childhood” as the official cause of death. However, the coroner found signs of encephalitis, a condition linked to the DTaP (diphtheria, tetanus and pertussis) vaccine, which Carter had received.
“Shaw and Nelson’s stories show what happens when AAP’s paradigm corrupts medical judgment at the point of care,” the complaint states.
Plaintiff Jane Doe’s daughter, “E,” a high school student in New York, sustained anaphylactic reactions after getting three routine childhood vaccines.
The student later obtained a medical exemption from all further vaccinations. But in 2024, her school’s medical consultant revoked the exemption — and two more exemptions “E” had obtained — citing AAP guidelines.
After school officials said she couldn’t return to school unless she complied with state vaccine mandates, “E” became suicidal — so her parents allowed her to “catch up” on her vaccines.
After getting those shots, “E” had a severe allergic reaction and was diagnosed with arthropathy, a joint disease, requiring surgery and ongoing care. Arthropathy has been linked to the measles-mumps-rubella (MMR) vaccine, which “E” had received.
“Jane Doe’s story shows what happens when treating physicians get it right and the AAP paradigm overrides them,” the complaint states.
Complaint highlights AAP’s conflict of interest with vaccine makers
The AAP maintains financial relationships with vaccine manufacturers, including Pfizer, Merck, GlaxoSmithKline (GSK) and Sanofi Pasteur, and also with the federal government. However, the group doesn’t disclose these relationships in its policy statements and public safety assurances, according to the complaint.
This has led to conflicts of interest, including the formation of an “association-in-fact enterprise,” referring to “individuals or entities that operate together for a common purpose without forming a formal legal entity.”
“The same pharmaceutical conglomerates that serve as enterprise participants in manufacturing childhood vaccines have systematically acquired companies treating the chronic conditions those vaccines cause, creating a closed-loop system that financializes childhood illness,” the complaint states.
The complaint alleges that AAP has subsequently resisted any changes to the childhood vaccination schedule, including those enacted under the leadership of U.S. Health Secretary Robert F. Kennedy Jr.
Last year, the AAP and other medical organizations sued Kennedy and other federal health officials and agencies. The groups seek to roll back the changes the U.S. Department of Health and Human Services (HHS) made to the childhood schedule. Last week, the AAP updated its complaint after HHS reduced the number of recommended childhood vaccines from 17 to 11 earlier this month.
The AAP last year released its own “evidence-based” immunization schedule, identical to the CDC’s childhood immunization schedule as it was before Kennedy became health secretary. Several states have adopted the AAP’s schedule.
AAP later rejected the CDC Advisory Committee on Immunization Practices (ACIP) vote to end hepatitis B shots for newborns, claiming children will “die” as a result. HHS removed AAP members from ACIP work groups last year. AAP’s updated lawsuit also asks the court to block ACIP’s next meeting in February.
In a separate lawsuit filed last month, the AAP demanded HHS restore $12 million in research grants that HHS withdrew last year. Last week, a federal judge reinstated the funding. AAP has also called for the prohibition of religious and philosophical exemptions to vaccination.
When HHS “has attempted reform, AAP leads the opposition,” the complaint states.
Mack Rosenberg said the AAP “fails to follow the actual science” in its lawsuits. Instead, the organization relies “only on that which supports its position that the childhood schedule is ‘safe and effective.’”
Plaintiffs compare AAP’s actions to those of Big Tobacco
The complaint draws parallels between AAP’s actions and tobacco companies’ efforts to conceal the dangers of smoking, which the U.S. Department of Justice prosecuted in a landmark RICO case, U.S. v. Philip Morris USA.
In the Philip Morris case, a federal court found that the tobacco industry was liable for denials about the health risks of tobacco spanning several decades.
The complaint states there are parallels between the AAP’s actions and those of Big Tobacco, including “suppression of adverse research, use of ‘independent’ scientific voices to block studies, and coordinated enterprise activity to mislead the public.”
This is the latest in a series of lawsuits CHD has filed. These include lawsuits against:
The federal Countermeasures Injury Compensation Program, which oversees COVID-19 vaccine injury compensation claims. The U.S. Department of Defense over its “sham” religious exemption policies, The state of New York, alleging its prohibition of religious exemptions is unconstitutional.
https://www.thegatewaypundit.com/2026/01/developing-lt-michael-byrd-who-shot-ashli-babbitt/
In one of his autopen’s last acts before Joe Biden left office was to pardon Capt. Mike Byrd, the DC officer who shot and killed January 6 protester Ashli Babbitt in cold blood during the protests on Capitol Hill on January 6, 2021.
As TGP’s Brian Lupo noted, video evidence captured Byrd shooting an unarmed Babbitt without warning as she attempted to climb through a narrow window near a barricaded entryway to the Speaker of the House’s office area in the U.S. Capitol.
Following an investigation, Byrd was cleared of any wrongdoing, although questions remain about the escalation to lethal force without attempts to subdue or detain Babbitt.
In the video, other armed law enforcement officers are visible in the background, appearing available to provide backup if needed.
In addition to Byrd leaving his Glock 22 service weapon in a Visitor’s Center bathroom in February 2019, Byrd also had his police powers revoked on several occasions for failing to meet semi-annual firearms qualifications standards.
Byrd expressed defiance after being pressed about killing Babbitt during an NBC interview months following the killing. He claimed that he saved “countless lives” by killing Babbitt.
He also whined that he has been getting death threats since killing the Air Force veteran. The officer said that it was “disheartening” and that he was simply “doing my job.”
On Tuesday, investigative journalist Paul Sperry discovered and posted that Former Lt., now Captain Mike Byrd, and his wife, Kaleska Byrd, have operated a home-based day care called Byrd’s Family Day Care from their residence in Brandywine, Maryland, since 2008. That is nearly 17 years!
Public records and listings on sites like CareLuLu confirm the existence of this licensed family child care provider, operating under Kaleska Byrd’s name (Maryland license #255727) and located in Brandywine, MD, year-round.
The daycare is registered and licensed by the Maryland State Department of Education’s Office of Child Care, meeting the basic state requirements for operation. However, it does not appear on Maryland’s list of accredited family child care providers (e.g., those meeting higher standards from organizations like NAEYC).
According to Townhall, “accreditation is optional and merely a sign that a daycare has demonstrated “high quality,” but it is not a requirement for federal funding.”
Sperry alleged that the daycare received $190 million in HHS funds. However, according to the Maryland State Department of Education, $193 million is the total allocation to Maryland, distributed across thousands of childcare providers.
more: https://www.thegatewaypundit.com/2026/01/developing-lt-michael-byrd-who-shot-ashli-babbitt/enter text
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This one is actually interactive. Data Center Map: https://www.datacentermap.com/
FBI Director Kash Patel ended his update Friday on the arrest of Tyler Robinson, the suspect accused in the fatal shooting of conservative influencer Charlie Kirk, with a curious message to Kirk: “Rest now, brother. We have the watch, and I’ll see you in Valhalla.”