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On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes. However, healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups. FDA Commissioner Martin Makary and the agencys head of vaccines, Vinay Prasad, described the new framework in an article published in the New England Journal of Medicine and in a public webcast. The Conversation U.S. asked Libby Richards, a nursing professor involved in public health promotion, to explain why the changes were made and what they mean for the general public. Why did the FDA diverge from past practice? Until the May 20 announcement, getting a yearly COVID-19 vaccine was recommended for everyone ages 6 months and older, regardless of their health risk. According to Makary and Prasad, the Food and Drug Administration is moving away from these universal recommendations and instead taking a risk-based approach based on its interpretation of public health trends specifically, the declining COVID-19 booster uptake, a lack of strong evidence that repeated boosters improve health outcomes for healthy people and the fact that natural immunity from past COVID-19 infections is widespread. The FDA states it wants to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups. Was this a controversial decision or a clear consensus? The FDAs decision to adopt a risk-based framework for the COVID-19 vaccine aligns with the expected recommendations from the Advisory Committee on Immunization Practices, an advisory group of vaccine experts offering expert guidance to the Centers for Disease Control and Prevention on vaccine policy, which is scheduled to meet in June 2025. But while this advisory committee was also expected to recommend allowing low-risk people to get annual COVID-19 vaccines if they want to, the FDAs policy will likely make that difficult. Although the FDA states that its new policy aims to promote greater transparency and evidenced-based decision-making, the change is controversial in part because it circumvents the usual process for evaluating vaccine recommendations. The FDA is enacting this policy change by limiting its approval of the vaccine to high-risk groups, and it is doing so without any new data supporting its decision. Usually, however, the FDA broadly approves a vaccine based on whether it is safe and effective, and decisions on who should be eligible to receive it are left to the CDC, which receives research-based guidance from the Advisory Committee on Immunization Practices. Additionally, FDA officials point to Canada, Australia and some European countries that limit vaccine recommendations to older adults and other high-risk people as a model for its revised framework. But vaccine strategies vary widely, and this more conservative approach has not necessarily proven superior. Also, those countries have universal health care systems and have a track record of more equitable access to COVID-19 care and better COVID-19 outcomes. Another question is how health officials positions on COVID-19 vaccines affect public perception. Makary and Prasad noted that COVID-19 vaccination campaigns may have actually eroded public trust in vaccination. But some vaccine experts have expressed concerns that limiting COVID-19 vaccine access might further fuel vaccine hesitancy because any barrier to vaccine access can reduce uptake and hinder efforts to achieve widespread immunity. What conditions count as risk factors? The New England Journal of Medicine article includes a lengthy list of conditions that increase the risk of severe COVID-19 and notes that about 100 million to 200 million people will fall into this category and will thus be eligible to get the vaccine. Pregnancy is included. Some items on the list, however, are unclear. For example, the list includes asthma, but the data that asthma is a risk factor for severe COVID-19 is scant. Also on the list is physical inactivity, which likely applies to a vast swath of Americans and is difficult to define. Studies have found links between regular physical activity and reduced risk of severe COVID-19 infection, but its unclear how health care providers will define and measure physical inactivity when assessing a patients eligibility for COVID-19 vaccines. Most importantly, the list leaves out an important group caregivers and household members of people at high risk of severe illness from COVID-19 infection. This omission leaves high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with. Multiple countries the new framework refers to do include this group. Why is the FDA requiring new clinical trials? According to the FDA, the benefits of multiple doses of COVID-19 vaccines for healthy adults are currently unproven. Its true that studies beyond the fourth vaccine ose are scarce. However, multiple studies have demonstrated that the vaccine is effective at preventing the risk of severe COVID-19 infection, hospitalization and death in low-risk adults and children. Receiving multiple doses of COVID-19 vaccines has also been shown to reduce the risk of long COVID. The FDA is requiring vaccine manufactures to conduct additional large randomized clinical trials to further evaluate the safety and effectiveness of COVID-19 boosters for healthy adults and children. These trials will primarily test whether the vaccines prevent symptomatic infections, and secondarily whether they prevent hospitalization and death. Such trials are more complex, costly and time-consuming than the more common approach of testing for immunological response. This requirement will likely delay both the timeliness and the availability of COVID-19 vaccine boosters and slow public health decision-making. Will low-risk people be able to get a COVID-19 shot? Not automatically. Under the new FDA framework, healthy adults who wish to receive the fall COVID-19 vaccine will face obstacles. Health care providers can administer vaccines off-label, but insurance coverage is widely based on FDA recommendations. The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. The FDAs focus on individual risks and benefits may overlook broader public health benefits. Communities with higher vaccination rates have fewer opportunities to spread the virus. What about vaccines for children? High-risk children age 6 months and older who have conditions that increase the risk of severe COVID-19 are still eligible for the vaccine under the new framework. As of now, healthy children age 6 months and older without underlying medical conditions will not have routine access to COVID-19 vaccines until further clinical trial data is available. Existing vaccines already on the market will remain available, but it is unclear how long they will stay authorized and how the change will affect childhood vaccination overall. Libby Richards is a professor of nursing at Purdue University. This article is republished from The Conversation under a Creative Commons license. Read the original article.
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E-Commerce
Early this morning, the House voted 215214 to pass a sweeping budget reconciliation bill with provisions that include a cancellation or phaseout for just about everything that was in the Inflation Reduction Act. The measure, which now heads to the Senate, is being described by clean energy and environmental groups as a monumental betrayal of the country that will cost jobs and increase electricity bills. But during the floor debate overnight, the energy parts of the bill were an afterthought to higher priority issues for members of both parties, such as tax cuts, revisions to Medicaid, and a desire to support or oppose the agenda of President Donald Trump. Two months ago, 21 House Republicans sent a letter to the chair of the House Ways & Means Committee about the need to preserve the IRA tax credits, warning against premature credit phase outs or additional restrictive mechanisms. House leadership was able to assuage some of those concerns when the draft of the bill showed that tax credits for biofuels would be preserved, among other changes. But some House Republicans still objected. Last week, 14 of the signers of the previous letter issued a joint statement affirming their support for the credits. This was a smaller number than the March letter, but it was more than enough to sink the bill if even a few of them held firm. So how many of them ended up voting against the bill? Zero. Rep. Andrew Garbarino (R-N.Y.) missed the vote, but had intended to vote for the bill. The other 13 people who issued the statement last week all voted yes. Before the vote, I spoke with David Spence, a professor at the University of Texas at Austin, to try to get a sense of the factors that were most likely to influence each member. Theyre feeling pressure to go along with whatever Trump wants and whatever the leadership wants, he said. Whats putting counterpressure on them is that for some of them that means giving up a lot of jobs and money that came from the IRA. And for others, its about how far they can be pushed away from their principles. The counterpressure turned out to be weak. Spence is the author of Climate of Contempt: How to Rescue the U.S. Energy Transition from Voter Partisanship, a 2024 book that I wrote about last summer. He wrote a blog post this month describing the factors influencing how Congress may vote on IRA-related measures. He was paying close attention to a debate within the debate between 38 Republicans who had signed a letter this month attesting to the urgent need to fully repeal the Inflation Reduction Act, and also the 21later 14who said they wanted at least some parts of the law to be preserved. A brief aside about the merits of the bill: Energy researchers are describing it as an economic and environmental disaster. The think tank Energy Innovation said this week that the bill would lead to the loss of 830,000 jobs by 2030 and increase consumer energy costs by $16 billion in 2030. Any discussion of who voted for it in the House and who might in the Senate may sound like a parlor game, but the stakes are incredibly high when it comes to shaping the world of future generations. Spence made a chart showing each of the members who signed the two letters, along with factors that may shape their views, such as the partisan lean of their districts and the extent of IRA projects there. Of the 38 people calling for a full repeal, 28 represent districts with a Republican lean of at least 10 points, which means their district favored the GOP by at least 10 percentage points more than the country as a whole did in the 2024 general election, according to Cook Political Report. These members have a much higher risk of losing in a primary challenge from another Republican than of losing in a general election. Among the 38 are some of the Houses most outspoken budget hawks, who are so committed to their ideology that they have been willing to go against the House leadership and the Trump administration on issues related to spending. Examples include Reps. Josh Brecheen of Oklahoma, Andrew Clyde of Georgia, and Ralph Norman of South Carolina. Only 10 of the 38 have IRA-funded projects in their districts, based on data from E2, a clean energy business group. Among them is Norman, whose district has six such projects that have led to commitments for 1,933 jobs. One of those projects, a solar panel plant planned by Silfab Solar of Canada, has been controversial. Some residents have said they are alarmed about chemicals that would be used to make solar equipment. Norman said on Wednesday that his main concern is that he doesnt like subsidies. Embracing an all-of-the-above energy strategy is crucial, and solar plays a role in that mix, Norman said in a statement. But let me be clearthat does not mean we support endless subsidies. The real value of energy production lies in strengthening our infrastructure, streamlining permitting, and reducing our dependence on foreign suppliers. We need to rely on what works where it works, without burdening taxpayers to prop up any one industry. Based on the outcome, the House members who really hate the IRA were able to win the internal debate over those who wanted to preserve some parts of the lawand it wasnt even close. The final negotiations were more about making the bill palatable to budget hardliners, which involved making the IRA provisions even more onerous for energy companies and implementing faster phaseouts. Among the potential holdouts that voted for the bill was Rep. Don Bacon (R-Neb.), who was re-elected despite his district favoring Democrats by a narrow margin in the presidential election. He was part of both the letter and the joint statement calling for tax credits to be maintained. Others who said they supported tax credits come from heavily Republican districts that have major projects funded in part by the IRA. This includes Rep. Buddy Carter of Georgia, who has seven projects and 4,462 jobs in his district related to the law, and still voted for the bill. This is a once-in-a-generation bill that will unlock President Trumps full domestic agenda, which Georgians voted for overwhelmingly back in November, Carter said in a statement after the vote. With the One, Big, Beautiful Bill Act we are unleashing our nations energy dominance, securing the border, putting more money back into hardworking Americans wallets, kicking illegal immigrans off Medicaid so that it is available for those who need it, and ending the waste, fraud, and abuse that risks sending our country into economic ruin. The larger lesson was that the power of partisanship overwhelmed just about everything else. This gives credence to a view I hear a lot from grassroots environmental advocates: The only way to pass and maintain strong climate and energy policies is to elect Democrats because even the Republicans who care about those topics will be marginalized and ultimately run over by their leadership. But this isnt over yet. Four Senate Republicans have raised concerns about the phaseout of energy tax credits. If the Senate makes any changes, the House will need to vote again. In the meantime, entire industriesincluding solar, wind, batteries, EVs, and energy efficiencymay need to throw out their business plans, scrap investments, and prepare for a challenging near future. This article originally appeared on Inside Climate News. It is republished with permission. Sign up for their newsletter here.
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Welcome to AI Decoded, Fast Companys weekly newsletter that breaks down the most important news in the world of AI. You can sign up to receive this newsletter every week here. OpenAI will acquire the AI device startup co-founded by Apple veteran Jony Ive and Sam Altman, called io, for nearly $6.5 billion, Bloomberg reported Wednesday. This almost certainly will put OpenAI in the consumer hardware business, and it seems like it will soon release a dedicated personal AI device. Ive is a pedigreed design guru with a track record of creating iconic tech products like the iPhone and the Apple Watch. Ive, a close friend of Steve Jobs, left Apple in 2019. I have a growing sense that everything Ive learned over the last 30 years has led me to this place and to this moment, Ive told Bloomberg. Coming from the worlds best device designer, thats saying a lot. OpenAI brings a lot to the table, too. After setting off the AI boom with the late 2022 release of ChatGPT, the startup has quickly built its chatbot into a mass market AI app and a household name. More than 400 million people around the world now use ChatGPT every week, OpenAI COO Brad Lightcap recently told CNBC. (For comparison, longtime Apple analyst Gene Munster estimates that there are 1.7 billion Apple device users and 2.35 billion active devices worldwide.) OpenAI has all of the core leadership and the best-in-class models, as well as some of the most widely used interfaces, says Gartner analyst Chirag Dekate. ChatGPT has defined and set the bar for what early experiences of generative AI ought to look like, Dekate says. Ive helped Apple set such standards for smartphones and smartwatches. Apples traditional power was its mastery of the user interfacethe technology that mediates between a human user and their digital tools and content. But iOS devices evolved from roots in traditional computing. AI models operate in a fundamentally different way, and may require a fundamentally different UX. (Apple, which has struggled to empower its devices with new generative AI capabilities, saw its stock price drop as much as 2.3% on news of the io deal Wednesday.) OpenAI will now get an opportunity to define the ideal software-hardware fusion for the new computing paradigm it helped usher inafter high-profile flops like Humanes AI pin. AI is such a big leap forward in terms of what people can do that it needs a new kind of computing form factor to get the maximum potential out of it, OpenAI CEO Sam Altman told Bloomberg. Ives and Altmans design firm has so far given the world no clue of its vision for a personal AI device. But whatever it buildsa pendant or a bracelet or some kind of glasseswill very likely provide an influential blueprint for how a vehicle for personal AI should look in the future. Jony Ive and io joining OpenAI is so important: It calls out the fact that in order to truly diffuse generative AI across society, we need to build new hardware experiences, Dekate says. The QWERTY keyboard may not be the best way to experience generative AI. Google got its AI mojo back Google looks like a company thats got its mojo back. Yes, yes, I know . . . the company still faces some very big problemsantitrust actions, changes in its core search business, etc.but it also seems to have fully woken up to the AI revolution it helped start, and seems to be navigating it with level-headedness and even a sense of fun. The companys two-hour keynote at its developer event in Mountain View Tuesday was all about AI, a showcase for a comprehensive strategy of applying the companys Gemini AI models broadly across its product portfolioto everything from search tools to coding agents to video generators to smart glasses. Remember that Google is a company that entered the AI race only reluctantly in 2023, in the wake of the ChatGPT launch. Even though it was Google researchers who figured out how to architect and train the type of large language models that power ChatGPT, the company was, for legal and safety reasons, deeply conflicted about exposing such models to the public. But after OpenAI, Microsoft, and others hurried to apply and commercialize LLMs, Google found itself on the back foot, punished by Wall Street for not leading the race: a lackluster February 2023 demo of the Bard chatbot caused an 8% drop in Alphabet stock. Googles biggest announcement Tuesday may mark the moment when it retook the leadwith a new AI product that could remake its core search business. AI Mode, a chatbot-format AI search tool that will compete directly against ChatGPT and Perplexity, went from being an experimental product to being available to all users. Its powered by Googles best model, Gemini 2.5 Pro. In AI Mode, rather than entering a search term or phrase, users can describe in detail what theyre looking for (often a solution to a problem rather than just some facts) and then work with Geminis reasoning abilities to get to a fully responsive package of custom information. Features from the companys Project Astra work will increasingly let the AI gather information about objects (or problems) it sees (through a phone camera or smart glasses) in the real world around the user. Its work in Project Mariner will give AI more and more power to operate the users device and call on various web tools (mapping, live weather, etc.) on the users behalf. This summer AI Mode will be able to book appointments on the users behalf, do deep research projects and data visualization, and help people shop for clothing and other products. The Gemini Live mode in the Gemini app leverages some of the same technologies. Googles Demis Hassabis described the experimental project as a universal AI assistant powered by a world model that understands the context in which the user is moving, and understands a certain amount about how the physics of the world works, and can plan and take action on behalf of the user. In the demo video during I/O, a young man talks to the assistant while fixing a bicycle. Through the phone camera, the Gemini Live identifies problems and replacement parts, places a phone call to order a part, looks up schematics on the web, and makes suggestions. It can also control a users device, analyze video, share its screen, and remember everything it sees or discusses in a session. Google ha always been a medium between humans and all the data and intelligence that resides on the public web. No other company has as much experience accessing, parsing, organizing, and packaging all that information. Google believes that AI can make that medium a lot smarter, proactive, and personalized. And the power of Gemini goes well beyond search to best-in-class video/audio generation tools (Veo 3, Flow) to coding assistants (Jules) and to wearables (Android XR glasses). Anthropic debuts new generation of Claude models Anthropic on Thursday debuted the fourth generation of its AI models with Claude Opus 4 and Claude Sonnet 4, which the company says push the state of the art for coding, advanced reasoning, and AI agents. Both can use tools, such as web search. The company says Claude Opus 4 is its best model and the best coding model in the world. The model can work for several hours straight on complex, long-running tasks that involve thousands of steps, Anthropic says, and significantly expands what AI agents can accomplish. Claude Sonnet 4 replaces Anthropics previous best effort, Claude 3.7 Sonnet. The company says the new model does everything 3.7 did, but pushes the envelope further on coding, reasoning, and precise instruction following. Claude Opus 4 and Sonnet 4 are hybrid models offering two modes: near-instant responses and extended thinking for deeper reasoning. Both models are available on the Anthropic API, Amazon Bedrock, and Google Cloud’s Vertex AI. Claude Sonnet 4 is also available in the free version of the Claude chatbot. The new models use chain-of-thought processing, as Claude 3.7 Sonnet did. But instead of displaying the models raw thought process to users, Anthropic now shows summaries of the models reasoning steps. Anthropic says it made this change to preserve visibility for users while better securing our models. Anthropics competitors could potentially use the raw chain-of-thought output to train their own models. While Anthropics models are used to power a number of commercial coding assistants, the company has its own assistant, Claude Code, which it released as a research preview earlier this year. The assistant is now generally available. Anthropic says itll start to release model updates more frequently in an effort to continuously refine and enhance its models. More AI coverage from Fast Company: Forget return-to-office. Hybrid now means human plus AI What its like to wear Googles Gemini-powered AI glasses How Google is rethinking search in an AI-filled world Cartwheel uses AI to make 3D animation 100 times faster for creators and studios Want exclusive reporting and trend analysis on technology, business innovation, future of work, and design? Sign up for Fast Company Premium.
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