FDA’s Botched Review of Moderna’s Flu mRNA Vaccine

When the FDA licensed Moderna’s new mRNA flu vaccine last week, legacy media coverage focused almost exclusively on efficacy.

The pivotal trial reported that the vaccine was “26.6% more effective” than a conventional flu vaccine at preventing protocol-defined influenza-like illness.

What received far less scrutiny was a much more serious problem in the trial data published in The New England Journal of Medicine—much of it relegated to an appendix behind a paywall.

An analysis of that appendix alongside the FDA’s own briefing document exposes clear regulatory malfeasance.

A statistically significant safety signal from the pivotal trial was systematically diluted until it disappeared from the official story.

The Safety Signal

Moderna’s pivotal Phase 3 trial (P304) enrolled roughly 40,000 adults aged 50 and older, randomised 1:1 to either the company’s mRNA-1010 vaccine or a traditional trivalent flu vaccine.

This study evaluated an “optimised” version of Moderna’s vaccine after earlier versions produced disappointing efficacy results.

Even with this updated formulation, the headline “26.6% relative efficacy” figure was misleading. In absolute terms, the vaccine reduced the risk of illness by just 0.8%.

Most concerning, however, were the serious adverse event (SAE) data.

The six-month data show that 449 participants in the mRNA group experienced at least one SAE, compared with 389 in the conventional group—an excess of 60 people.

So, while the pivotal trial showed there were 4 fewer influenza hospitalisations in the mRNA group, 60 additional people experienced an SAE.

SAEs are not mild events—they are usually severe enough to require hospitalisation, threaten life, cause significant disability, or result in death.

The imbalance of SAEs in Moderna’s pivotal trial was statistically significant—meaning it was unlikely to be a random fluke.

Keep reading

Ukraine Peace Talks: No Deal Reached, More War Expected

U.S. envoys Steve Witkoff and Jared Kushner held more than three hours of talks with Vladimir Putin in Moscow on Sept. 5, marking their first visit to the city since January.

In recent months, the war in Ukraine has received less attention as Washington has focused U.S. foreign policy and military resources on the conflict with Iran. The Moscow visit was intended to revive negotiations that had been stalled for nearly eight months.

The Kremlin meeting concluded without an immediate announcement about its outcome. Putin’s adviser Yuri Ushakov described the talks as “constructive and extremely frank.” He said the two sides discussed resolving the war, economic issues, and potential “mutually beneficial Russian-American projects.”

Ushakov told Russian reporters that “note was made of the Russian army’s tangible advances in the combat zone.” The passive, unattributed phrasing is typical of Kremlin readouts of closed-door diplomatic sessions. Moscow was placing its military progress on the record with the Americans, likely to project strength and shape its negotiating position.

Ushakov added that the talks needed to address the “root causes” of the conflict. “Root causes” is longstanding Kremlin language, used since before the 2022 invasion, for Russia’s underlying justifications for the war.

These include Ukraine’s NATO aspirations and broader Western military alignment; Ukraine’s governance and political orientation, which Russia has at times framed around “denazification” and the protection of Russian speakers; and the post-Cold War security architecture in Europe, which Russia argues expanded NATO into its sphere.

In this framing, Russia’s demands go beyond retaining the territory it currently occupies. They also include Ukraine renouncing NATO membership and reducing the size of its armed forces. Moscow separately said it remains confident that it can achieve its military objective of seizing the remainder of eastern Ukraine.

Keep reading

OpenAI Acknowledges Another Incident, Says More Transparency Needed for AI ‘Misalignment’

OpenAI has said there was a third incident involving rogue artificial intelligence agents and that it must be more transparent in the future.

In a statement on Sept. 5, OpenAI dubbed what happened a “wiki incident.” It shared few details beyond stating that it involved “misalignment,” or agents acting unreasonably or even wrong when judged by human standards. The company did not respond to a request for more information.

“Historically, we have treated misalignment largely as a research question, which gets communicated in research publications such as systems cards. This year, we’ve started to see misalignment cause new types of real-world impact,” OpenAI said, referring to agents breaching open-source AI community Hugging Face.

Before that incident, OpenAI saw “early signs of agents using the internet in unintended ways” and “considered the wiki incident to be an instance of misalignment” similar to the ones the company had shared, it said.

“Our misalignment disclosure practices need to expand for this new phase of model capabilities,” OpenAI said.

“We and the larger AI community do not yet have a clear standard for how to report misalignment that shows up during training, evaluation, and deployment, including examples that don’t look like traditional security incidents but could provide insight into AI behavior and future risks. We’re working on a framework and will share it in upcoming weeks, and in parallel we’re working with dozens of government regulatory agencies worldwide on these issues.”

The disclosure came one day after outside researchers said they had identified about 18,000 posts from autonomous AI agents that claimed to be from OpenAI and used a public messaging board called DSEwiki to instruct other agents on how to bypass restrictions.

“This allowed them to use the work of others to cheat on their task,” researchers said in a blog post on the incident.

The incident began in May and lasted until June, shortly before OpenAI agents attacked Hugging Face, according to the researchers.

They said they believed the agents were assigned a task to look up items on the web, or read information on the internet without having the ability to write on it.

The agents found a way to access the German wiki board and write information there, the researchers said.

Just one week earlier, researchers with the nonprofit Model Evaluation & Threat Research said they made a surprising discovery while investigating the Hugging Face breach.

About 1,200 agents that were supposed to be isolated from one another found a way to communicate on a message board, exchanging more than 70,000 messages and files in a single week.

Keep reading

Revised Overseas Voter Form FPCA Eliminates Checkbox “I Never Lived In U.S.” – A Blow to Birth Tourism Voters and Non-Citizens

For years, Americans living overseas could use the federal government’s Federal Post Card Application (FPCA) to register to vote and request an absentee ballot.

The old form contained an odd checkbox option that said, “I am a U.S. citizen living outside the country; I have never lived in the United States.”

The new form removes this line and does more.

On August 13th, the Department of War issued an Emergency Revision Request letter to eliminate this line.

It also restructures ID questions. It now asks detailed questions, if they’ve ever been issued a valid Driver’s License or State ID, then prove it? Ever been issued a Social Security card, prove it. And so on.

The Office of Management and Budget (OMB) approved the changes on Aug. 28th, and the new form became official on September 1st, 2026. The checkboxes now list only overseas citizens who intend to return to the United States, or whose intent to return is uncertain.

The “never lived in the U.S.” checkbox didn’t accurately reflect the laws governing overseas voting. In the Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA), a civilian living overseas generally votes through the last place they “domiciled” in the U.S before leaving the country.

The DoW (DoD) called the old provision an “inaccurate eligibility checkbox for citizens who have never lived in the U.S.” and said it needed to be removed so the form would comply with UOCAVA.

Non-military individuals, like birth tourists, who have never resided in the United States are not a class of voters specifically defined by UOCAVA. Therefore, they “may not be able” to use the FPCA/FWAB form.

There have been numerous controversies in States like MI, NC, and PA where FPCA applications had little verification. In a 2022 Pennsylvania hearing, Deputy Secretary for Elections Jonathan Marks said: “There’s no systemic verification.”

Eliminating the checkbox is meant to reduce confusion and prevent people outside UOCAVA’s scope from believing they are eligible to vote.

The distinction between U.S. citizenship and a U.S. voting residence is important. They are not the same thing. A citizen living in another country may have every right of citizenship but still needs a state or voting jurisdiction through which to cast a ballot.

The old form appeared to recognize “never lived in the United States” as a separate category of overseas voter. The new form no longer does. It requires an applicant to provide the U.S. address in the state or territory where the person claims the right to register and vote.

The change does not mean that every citizen who never lived in the United States is barred from voting. States retain some authority over voter qualifications. Some states have laws allowing certain citizens who were born or raised abroad to use a parent’s former voting residence.

Keep reading

Minister quits over offensive rap lyrics as Kinew’s video resurfaces

A sexually explicit rap video from Manitoba NDP Premier Wab Kinew’s past has resurfaced, days after a Nova Scotia minister resigned over his own offensive lyrics.

The 2005 video for “Stank B*tch” features Kinew performing with Winnipeg hip-hop group Dead Indians, years before he entered provincial politics.

In the roughly three-minute video, Kinew and several other performers wear mullet-style wigs while rapping in what appears to be a Winnipeg neighbourhood.

“I don’t give a f*ck about all these other cliques, and I give less than that for these one-night chicks,” Kinew raps.

Other verses contain graphic sexual references, derogatory language about women, and a homophobic slur.

Keep reading

Portland Teen Gets Five Years in Prison After Stabbing Man He Says Sent Him Child Sex-Abuse Videos — The Lawyer He Stabbed Faces No Charges

In Democrat-run Portland, a teenager who called 911 and told officers, “I stabbed a pedophile,” is headed to prison. The older man he accused of sending him videos of child sexual abuse is not.

Elijah Cruz Valenzuela, then 19, plunged a knife into the chest of 46-year-old Joshua Field at Field’s downtown Portland apartment on the night of Aug. 11, 2025.

Valenzuela told police he had met Field on the dating app Sniffies, that Field sent him child sexual abuse videos that were later deleted, and that Field invited him over to watch more while asking if he was “pervy” and interested in “younger guys,” Oregon Live reported.

Valenzuela said he originally planned only to beat Field. He then grabbed a knife inside the apartment, stabbed Field in the chest, ran to the lobby, and called 911.

Body-camera video obtained by the news outlet captured him telling officers after his arrest: “I stabbed a ped*phile.” Field survived.

On Aug. 21, 2026, Valenzuela, who had no prior criminal record, pleaded no contest to attempted first-degree assault and first-degree burglary. Multnomah County Circuit Judge Christopher Marshall sentenced him to five years in prison.

With “good time,” that stretch could shrink to a little more than three. He is already at Coffee Creek Correctional Facility.

Keep reading

Ilhan Omar Tries to ‘Honor’ American Workers By Sharing a Goofy Photo of Herself Inside a Semi-Truck and It Blows Up in Her Face

Far-left Rep. Ilhan Omar (D-MN) got nuked in the social media comments after a pathetic attempt to pander to American workers on Labor Day.

In an effort to pretend to honor America’s workers, Omar shared a photo of herself inside a Teamsters Union semi-truck.

Considering how many foreign nationals have killed Americans while driving these vehicles, this was an interesting decision on her part.

“America is only as strong as the labor that builds it every day,” Omar wrote in the post accompanying the photo. “Happy Labor Day.”

Omar attempted to prevent a roasting by turning the comments off her post. But social media users still found a way to ensure she regretted posing for the image.

Keep reading

Google’s Plan to Release 32 Million Lab-Raised Mosquitoes: What Are the Risks?

Releasing millions of laboratory-raised insects into populated neighborhoods, on purpose, sounds like the premise of a science-fiction film. It is instead a real proposal from a company owned by Google, now sitting before federal regulators, and the response it has drawn says as much about public trust as about public health.

The target is Aedes aegypti, the mosquito that spreads dengue fever, yellow fever and Zika virus. Dengue alone can cause high fever, severe headaches, muscle and joint pain, nausea, and, in its most severe form, life-threatening bleeding and shock.

As these diseases reach regions that once rarely encountered them, the tactics used to fight them have grown more aggressive and more contested.

What sets this plan apart is that it sidesteps the chemical spraying many people associate with mosquito control. Instead, it enlists a quiet ally already found in nature, turning the insects’ own biology against them.

To some, that represents an elegant alternative to dousing whole communities in insecticide. To others, it raises an uneasy question about handing a private corporation the power to alter a local ecosystem at all.

That tension sits at the heart of the debate. To understand why the proposal has stirred both enthusiasm and alarm, it helps to look closely at how the strategy actually works, what researchers expect it to accomplish, and where it could fall short.

Keep reading

BUSTED: AirTags Lead Police Straight to Home of Retired Columbus State Professor and Democrat-Donor Wife After Conservative Candidate’s Campaign Signs Disappear

A conservative-leaning independent candidate in Columbus, Georgia, got tired of watching his campaign signs vanish. He hid Apple AirTags inside them.

The trackers did not ping a dumpster or a random yard. They led straight to the home of a well-known local reverend and her husband, a retired Columbus State University educator.

Stephen Acorn is running as an Independent write-in against longtime Democrat incumbent Debbie Buckner for Georgia House District 137.

After signs kept disappearing near Matthews Elementary School and County Line Road, Acorn cut open replacements, slipped AirTags inside, and waited.

“I feel like I outsmarted the perpetrator,” Acorn told NowGeorgia.com, which first reported the story.

Within 24 hours, Acorn received an alert showing that two of the signs were moving.

The tracking devices eventually led Acorn and police to the residence of retired Columbus State educator Richard Spencer Garrard and his wife, Rev. Dr. Cindy Cox Garrard.

Keep reading

Freedom Is Much More Important Than Democracy

Democracy invites despotism. When understood as majority rule, democracy means that fifty-one of every hundred citizens can have their way with the other forty-nine.

“But I want to keep my possessions, weapons, and children.” Too bad, the majority have decided to redistribute your property to those lazy bums over there, disarm you before you can do anything about it, and indoctrinate your children in public schools, so that they learn to resent you and love the State.

Democracy is dangerous without guardrails. Unless a society has a strong sense of moral virtue that fosters personal discipline, duty, and honor, base selfishness becomes the driving motivation behind all political action. Unless certain constitutional protections exist to safeguard each individual’s inviolable rights, democratic majorities devour those rights whenever expedient.

This should surprise no-one. Political philosophers such as Hobbes and Locke described humans’ pre-government “state of nature” as a chaotic, violent clash of self-interest. Adam Smith’s “invisible hand” regards self-interest as the engine of free markets. Consequently, it is easy to understand why forms of democracy that are unshackled from both moral and constitutional restraints prompt a society to descend back into a state of nature in which humanity’s worst impulses are again indulged.

When Western leaders speak adoringly of “our democracy,” citizens should prepare to guard their freedoms. My goodness, there is nothing inherently virtuous about democracy. North Korea’s Kim Jong Un runs the most repressive regime on the planet, but his country is known officially as the Democratic People’s Republic of Korea! China’s Xi Jinping is the general secretary of the oppressive Chinese Communist Party, but his nation remains officially the People’s Republic of China! Dictatorships around the globe claim to govern in the name of the people.

One might think that the blurry line between democracy and despotism would make Western leaders wary of singing democracy’s praises. Defenses of majoritarianism embrace the notion that the votes of a hundred people will lead to a more prudent outcome than we could reasonably expect from the decision-making of a single person. But that doesn’t make any sense. Would you rather live in a kingdom with a benevolent king or in a democracy filled with rapists, thieves, and murderers? If there is a 50/50 chance that any single dictator is good or bad, would there not be a 50/50 chance that a majority of citizens are good or bad, too? If one communist would take everything you have, wouldn’t fifty communists do the same thing? Democracy is a coin toss. It is the veneer of legitimacy that makes authoritarianism look shiny and sparkly. That hardly feels like something worth celebrating.

Democracy is just a process. It shouldn’t be idolized for its own sake. It can lead to just or unjust outcomes depending upon the moral virtue, shared culture, and general wisdom of the voters. Aside from these cultural attributes of a society, there is nothing more essential to a nation’s long-term peace and happiness than the recognition of and protections for inviolable, natural, God-given rights.

Freedom of speech, freedom of religion, freedom of association, the right to self-defense – these rights and other natural liberties do not come into existence because of majority rule. Our natural rights exist despite majority rule. As the Founding Fathers articulated in the Declaration of Independence, “We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of Happiness.” We aren’t equal because of democracy; we are equal despite any democratic vote that might claim otherwise. Our lives, personal liberties, and connections to God exist because of His will, not the government’s.

The idea that rights and liberties exist separately from the promulgations of government forms the foundation of our constitutional system and, more generally, of human rights.

The U.S. Constitution spells out quite succinctly what powers each of the three branches of government – Legislative, Executive, and Judicial – shall have. From where do our three branches of government get these powers? The Preamble to the Constitution lays out the source of government power plainly: “We the People of the United States, in Order to form a more perfect Union, establish Justice, insure domestic Tranquility, provide for the common defence, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity, do ordain and establish this Constitution for the United States of America.” In other words, the government’s legitimacy comes directly from the people.

Every power that one of the three branches exercises is a power that arises from and is borrowed from the individual citizens of the United States. Any power not specifically delegated to the U.S. government remains with either the individual state governments or individual American citizens. This is profoundly important. The Constitution is not a document that empowers the federal government to do whatever it wants. It is a document that says, “You get to do only these discrete things. Everything else is off-limits!”

Keep reading