The Food and Drug Administration has refused to review Moderna's application for an mRNA flu vaccine, the company revealed Tuesday.

While the move came as a surprise to the high-profile vaccine maker, it is just the latest hostility toward vaccines—and mRNA vaccines in particular—from an agency overseen by the fervent anti-vaccine activist Robert F. Kennedy Jr. In his first year in office, Kennedy has already dramatically slashed childhood vaccine recommendations and canceled $500 million in research funding for mRNA vaccines against potential pandemic threats.

In a news release late Tuesday, Moderna said it was blindsided by the FDA's refusal, which the FDA cited as being due to the design of the company's Phase 3 trial for its mRNA flu vaccine, dubbed mRNA-1010. Specifically, the FDA's rejection was over the comparator vaccine Moderna used.

In the trial, which enrolled nearly 41,000 participants and cost hundreds of millions of dollars, Moderna compared the safety and efficacy of mRNA-1010 to licensed standard-dose influenza vaccines, including Fluarix, made by GlaxoSmithKline. The trial found that mRNA-1010 was superior to the comparators.

Moderna said the FDA reviewed and accepted its trial design on at least two occasions (in April 2024 and again in August 2025) before it applied for approval of mRNA-1010. It also noted that Fluarix has been used as a comparator vaccine in previous flu vaccine trials, which tested vaccines that went on to earn approval.

But in a letter dated February 3, Vinay Prasad, the FDA's top vaccine regulator under the Trump administration, informed Moderna that the agency does not consider the trial "adequate and well-controlled" because the comparator vaccine "does not reflect the best-available standard of care."

In its news release, Moderna noted that neither the FDA's regulation nor its guidance to industry makes any reference to a requirement of the "best-available standard of care" in comparators.

"This decision by [the FDA's Center for Biologics Evaluation and Research], which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines," Moderna CEO Stéphane Bancel said in the release. "It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting."

Moderna said it has requested a meeting with the FDA to understand the basis of the refusal. "We look forward to engaging with CBER to understand the path forward as quickly as possible so that America's seniors, and those with underlying conditions, continue to have access to American-made innovations."

The company noted that mRNA-1010 has already been accepted for review in the European Union, Canada, and Australia.

Read full article

Comments

Would you believe that I also completed another book since yesterday? This one is Couch Cinema: Comfort Watches from The Godfather to K-Pop Demon Hunters, a non-fiction collection of essays. No, I didn’t use “AI” or anything, I would never do that, you deserve better as readers. It’s a collection of my December Comfort Watches essays from December of 2023 and 2025, collected up in a nice single volume. I put them all together, did a light edit, added an intro, and sent it off to my agent.

As it happens, this is the first book I’ve done in years that isn’t already spoken for contractually, so we’ll see if we get any nibbles for it. If not, hey, Scalzi Enterprises was designed for just this sort of project in mind, and I wouldn’t have a problem using it as a test case to see if boutique publishing is something we have the bandwidth for. I would have to come up with a name for the imprint. We’ll find out!

Anyway. Two books in, and it’s only February. I can take the rest of the year off, right? Right?!?

— JS

As more than 120 million people tuned in to the Super Bowl for kickoff on Sunday evening, SpaceX founder Elon Musk turned instead to his social network. There, he tapped out an extended message in which he revealed that SpaceX is pivoting from the settlement of Mars to building a "self-growing" city on the Moon.

"For those unaware, SpaceX has already shifted focus to building a self-growing city on the Moon, as we can potentially achieve that in less than 10 years, whereas Mars would take 20+ years," Musk wrote, in part.

This is simultaneously a jolting and practical decision coming from Musk.

Why it's a jolting decision

A quarter of a century ago, Musk founded SpaceX with a single-minded goal: settling Mars. One of his longest-tenured employees, SpaceX President and Chief Operating Officer Gwynne Shotwell, described her very first interview with Musk in 2002 to me as borderline messianic.

“He was talking about Mars, his Mars Oasis project,” Shotwell said. “He wanted to do Mars Oasis, because he wanted people to see that life on Mars was doable, and we needed to go there.”

She was not alone in this description of her first interaction with Musk. The vision for SpaceX has not wavered. Even in the company's newest, massive Starship rocket factory at the Starbase facility in South Texas—also known as the Gateway to Mars—there are reminders of the red planet everywhere. For example, the carpet inside Musk's executive conference room is rust red, the same color as the surface of Mars.

In the last 25 years Musk has gone from an obscure, modestly wealthy person to the richest human being ever, from a political moderate to chief supporter of Donald Trump; from a respected entrepreneur to, well, to a lot of things to a lot of people: world's greatest industrialist/super villain/savant/grifter-fraudster.

But one thing that has remained constant across the Muskiverse has been his commitment to "extending the light of human consciousness" and to the belief that the best place to begin humanity's journey toward becoming a multi-planetary species was Mars.

Until Sunday night.

Why it's a practical decision

We cannot know Musk's full rationale for pivoting to the Moon, at least in the near term. Only a year ago he referred to the Moon as a "distraction." But now, apparently, it's not. What we can do is look at what has changed in the last 13 months.

The first change is that the one company with the potential to seriously challenge SpaceX in spaceflight over the next decade, Jeff Bezos' Blue Origin, has finally started to deliver. The company has now flown, and landed, its New Glenn rocket. Multiple sources have told Ars that Bezos has told his team to go "all in" on lunar exploration. This includes development of a crew transportation system, Blue Moon Mark 1.5, that does not require orbital refueling. This raises the possibility that Blue Origin might land humans on the Moon before Starship, a threat sources at Starbase say SpaceX is beginning to take seriously.

The other major change is Musk's obsession with artificial intelligence and his view that AI and space are increasingly intertwined in their ambitions. SpaceX and xAI recently merged, and a major focus of Musk going forward will be to construct orbital data centers to provide enormous computing resources for his vision of humanity's online future.

He has also spoken increasingly of becoming a Kardashev-level civilization, a reference to a Soviet astronomer who conceived that humanity would advance by first being able to tap and store all energy sources available on its planet, and then by directly collecting a star's energy through technology like a Dyson sphere. Musk has also made frequent references on social media to building a "mass driver" on the Moon.

All of this may sound like it's straight out of the pages of a science fiction novel, and it pretty much is. But the reality is that the Moon has reliable stores of oxygen and silicon, and building a catapult-like mechanism on the airless world would be an efficient way to move materials into space to build large orbital factories, data centers, solar farms, or even O'Neill cylinders.

In this, Musk is starting to sound a lot more like Bezos when it comes to his vision for human habitation in space, rather than the Mars-first advocate he has always been.

One other sobering thing to think about in terms of a lunar mass-driver: it is potentially an extremely potent weapon to threaten Earth with large projectiles. We cannot know if Musk has had any conversations with US military officials about this, but anyone who has read The Moon Is a Harsh Mistress by Robert Heinlein will understand Luna's position as the ultimate high ground. And the US Space Force is not ignorant of this.

So what does all this mean?

In the short-term, it does not mean a whole lot. To anyone paying attention, SpaceX was not on track to send a Starship to Mars in 2026, and the 2028 window was looking rather unlikely as well. Mars was always in the distance, and now it will remain so.

By focusing on the Moon, Musk is making a decision that benefits NASA and the United States. Because for all of Blue Origin's promise with a slimmed down lunar lander, Starship offers a promising avenue to return humans to the Moon in the near term.

Another advantage of Starship is its enormous payload capacity, able to bring 100 metric tons, or more, of cargo down to the Moon. For anyone seeking to build a commercial business on the Moon, Musk's 180-degree pivot represents an enormous opportunity.

For Mars advocates, however, Musk's turn is a bitter pill to swallow. There have long been many dreamers who spoke of settling Mars, but only Musk actually built the hardware and financial war chest to make such dreams a reality. And it is true that, in the long-term, Mars offers a more favorable (although still inhospitable) environment for human settlement, with a thin atmosphere, water ice both on the surface and beneath the ground, methane, and more.

But those dreams are now deferred as Musk has bowed to a harsh reality: The Moon may be hard, but it is a lot easier to develop than Mars, which is only accessible every 26 months when the planets align.

Read full article

Comments

Toyota and Daihatsu have unveiled their new kei-class EV vans, the e-Hijet and the passenger version called e-Atrai. These vehicles are the first mass-production BEVs from Daihatsu, which has traditionally built small cars, vans, trucks, and 4x4s, and they will also be sold under the Toyota Pixis and Suzuki e-Every brand names. Manufacturing happens at Daihatsu, which has already built this generation of Hijet in gasoline-powered form since 2022.

Daihatsu has specialized in manufacturing tiny work vehicles for decades. It’s great to think of a company that exists to build little guys, sympathetic buddies for people working in different fields, where you need your truck to be as small as possible or your panel van to be as big as it can be on the inside while being tiny on the outside. In other words, Japan.

Daihatsu lists industries including agriculture, forestry, fisheries, construction, and delivery as the fields for which it builds “working partners.”For last-mile logistics, a BEV panel van can make sense in a tight urban environment. Design-wise, they are literally white goods on wheels, which has its own certain charm.

According to Daihatsu, these two small EVs have been packaged to accommodate as large a battery as possible without compromising interior space. The manufacturer says this has resulted in class-leading loading space for the e-Hijet Cargo, as well as the best WLTC norm range in its class. For these vehicles, it means 257 km or 159 miles out of a 36.6 kWh lithium-ion battery that’s as thin as Toyota and Daihatsu could get it. They are rated for a 770lb payload.

The driven rear axle is dubbed the “e-Axle,” which contains the electric motor, inverter, and reduction gear. In kei vehicles such as this, a low center of gravity also adds much-needed stability, and there’s also enough weight over the driven wheels. EV torque also makes these things presumably quite zippy in city traffic.

36.6 kWh is not a lot, but it’s probably the perfect battery size for a small commercial vehicle. Because we’re talking Japan, these vans use the CHAdeMO charging standard, which you would most often only find on Nissan Leafs elsewhere in the world; in the home market, CCS is rarer. It’s Bizarro world, Jerry!

In any case, the vans fast charge at 50kW tops, meaning a charge to 80% takes 50 minutes or a long lunch break.

Since the vans are pretty much power packs you can drive around, they also feature accessory outlets and V2H (vehicle-to-house) compatibility.

They can provide power during blackouts caused by storms or earthquakes, which can be a vital feature in some regions of Japan. Heck, we had an 18-hour blackout before New Year’s and one of these would have been immensely convenient to run the house.

And if you’re using the accessory power outlet on the dashboard, you can still close the door and window, as the cable can be routed outside the vehicle using an adapter that slots in the driver’s door window. The fancier e-Atrai has powered sliding doors on both sides for convenience, while the Pixis and e-Hijet are trimmed in a more utilitarian fashion. Sales started in Japan from the beginning of February.

Top graphic image: Toyota

The post Toyota’s Tiny New EV Van Is A Fridge On Wheels And I Love It appeared first on The Autopian.

On Wednesday, OpenAI announced ChatGPT Health, a dedicated section of the AI chatbot designed for "health and wellness conversations" intended to connect a user's health and medical records to the chatbot in a secure way.

But mixing generative AI technology like ChatGPT with health advice or analysis of any kind has been a controversial idea since the launch of the service in late 2022. Just days ago, SFGate published an investigation detailing how a 19-year-old California man died of a drug overdose in May 2025 after 18 months of seeking recreational drug advice from ChatGPT. It's a telling example of what can go wrong when chatbot guardrails fail during long conversations and people follow erroneous AI guidance.

Despite the known accuracy issues with AI chatbots, OpenAI's new Health feature will allow users to connect medical records and wellness apps like Apple Health and MyFitnessPal so that ChatGPT can provide personalized health responses like summarizing care instructions, preparing for doctor appointments, and understanding test results.

OpenAI says more than 230 million people ask health questions on ChatGPT each week, making it one of the chatbot's most common use cases. The company worked with more than 260 physicians over two years to develop ChatGPT Health and says conversations in the new section will not be used to train its AI models.

"ChatGPT Health is another step toward turning ChatGPT into a personal super-assistant that can support you with information and tools to achieve your goals across any part of your life," wrote Fidji Simo, OpenAI's CEO of applications, in a blog post.

But despite OpenAI's talk of supporting health goals, the company's terms of service directly state that ChatGPT and other OpenAI services "are not intended for use in the diagnosis or treatment of any health condition."

It appears that policy is not changing with ChatGPT Health. OpenAI writes in its announcement, "Health is designed to support, not replace, medical care. It is not intended for diagnosis or treatment. Instead, it helps you navigate everyday questions and understand patterns over time—not just moments of illness—so you can feel more informed and prepared for important medical conversations."

A cautionary tale

The SFGate report on Sam Nelson's death illustrates why maintaining that disclaimer legally matters. According to chat logs reviewed by the publication, Nelson first asked ChatGPT about recreational drug dosing in November 2023. The AI assistant initially refused and directed him to health care professionals. But over 18 months of conversations, ChatGPT's responses reportedly shifted. Eventually, the chatbot told him things like "Hell yes—let's go full trippy mode" and recommended he double his cough syrup intake. His mother found him dead from an overdose the day after he began addiction treatment.

While Nelson's case did not involve the analysis of doctor-sanctioned health care instructions like the type ChatGPT Health will link to, his case is not unique, as many people have been misled by chatbots that provide inaccurate information or encourage dangerous behavior, as we have covered in the past.

That's because AI language models can easily confabulate, generating plausible but false information in a way that makes it difficult for some users to distinguish fact from fiction. The AI models that services like ChatGPT use statistical relationships in training data (like the text from books, YouTube transcripts, and websites) to produce plausible responses rather than necessarily accurate ones. Moreover, ChatGPT's outputs can vary widely depending on who is using the chatbot and what has previously taken place in the user's chat history (including notes about previous chats).

Then there's the issue of unreliable training data, which companies like OpenAI use to create the models. Fundamentally, all major AI language models rely on information pulled from sources of information collected online. Rob Eleveld of the AI regulatory watchdog Transparency Coalition told SFGate: "There is zero chance, zero chance, that the foundational models can ever be safe on this stuff. Because what they sucked in there is everything on the Internet. And everything on the Internet is all sorts of completely false crap."

So when summarizing a medical report or analyzing a test result, ChatGPT could make a mistake that the user, not being trained in medicine, would not be able to spot.

Even with these hazards, it's likely that the quality of health-related chats with the AI bot can vary dramatically between users because ChatGPT's output partially mirrors the style and tone of what users feed into the system. For example, anecdotally, some users claim to find ChatGPT useful for medical issues, though some successes for a few users who know how to navigate the bot's hazards do not necessarily mean that relying on a chatbot for medical analysis is wise for the general public. That's doubly true in the absence of government regulation and safety testing.

In a statement to SFGate, OpenAI spokesperson Kayla Wood called Nelson's death "a heartbreaking situation" and said the company's models are designed to respond to sensitive questions "with care."

ChatGPT Health is rolling out to a waitlist of US users, with broader access planned in the coming weeks.

Read full article

Comments

Make peace (and progress) with incomplete knowledge

You are always working with incomplete knowledge. If you’re working on something for the first time, there will come a point in future — perhaps tomorrow, perhaps next year — when you find a better way. You may decide against the workaround you’re putting in place now. You may find a simpler way to code something. You may know exactly where to find the problem you’re hunting down. In short, in the future, you know more.

That horizon makes it sound like we can never do anything — or at least anything good — in the present. It sounds like an invitation to overthink, procrastinate or give up in despair. But this breach is where humans excel. We are always working with incomplete knowledge. We start the day without knowing what the day will truly bring — knowledge we won’t have until the hindsight of day’s end — and we get through. Although far from perfect, we’re surprisingly good at it. The issue is not so much that we don’t know everything we need to know, but that we don’t realise it — or that we fool ourselves into believing we do.

It is impossible for one to learn that which one already thinks one knows.

— Epictetus

You can always make progress by trying something out. By trying things out you learn something, you acquire knowledge. By trying things out, you might avoid dead ends, needless detours and treacherous routes. By trying things out you might have something that works for now and, in future, can be improved, built on or replaced based on understanding rather than guesswork or panic.

But don’t forget to come back to it in future. Legacy codebases are mired in the regret of unapplied knowledge. Deferment to the future is a form of commitment rather than one of abandonment, as is so commonly practised.

We should be inspired by compassion rather than blame when we find ourselves frustrated by legacy code. The authors of the code — yourself included — most likely lacked many insights from their future we now have in our present. The inevitability of imperfection doesn’t make whatever problem we’re dealing with go away, but it should temper our frustration and make us less ready to misattribute intention.

There are more things in Heaven and Earth, Horatio, than are dreamt of in your philosophy.

— William Shakespeare

Although we might identify technical debt as being the defining problem of legacy, a simple but significant omission makes this characterisation misleading: technical debt is not intrinsically a problem; unmanaged technical debt, however, is. If you’re managing it, well done! A debt is an obligation to repay and, if you’re fulfilling that obligation, that code is probably not considered with the negativity ‘legacy’ often entails.

So, if your debt is unmanaged, ask yourself why is it unmanaged? Characterising a problem simply as technical debt misses not only an important nuance — managed versus unmanaged — but also the distinction between cause and effect. Technical debt is often blamed, but is an effect rather than a cause. The question to ask is “What caused this?” The answer is typically technical neglect.

The causality of neglect is hard to see because it is an absence of a thing — care, attention, remediation, work — rather than a thing that is easily observed. Inaction lacks the visibility of action. Searching for improvement becomes more a question of “What are we not doing?” than “What are we doing wrong?”

And questions are important—often more so than answers. They help us interrogate what we know, what we believe and what we want — and to distinguish between knowledge, belief and desire. The knowledge you have at the moment is incomplete and imperfect — and, for any given moment, always will be — but your ability to acquire knowledge and put it into practice is ever-present.

None of our beliefs are quite true; all have at least a penumbra of vagueness and error.

— Bertrand Russell

Software development (and life) is far from being a game of complete or perfect information, but that doesn’t mean you can’t play — or that you can’t play well.