May 23, 20257 min readWhat FDA’s Planned Limits on COVID Vaccinations Mean for HealthDespite the fact that vaccines against COVID have already undergone strict safety reviews and that people continue to die from the disease, Trump’s FDA is moving to reduce access to annual COVID boosters for healthy AmericansBy Stephanie Armour & KFF Health News aire images/Getty ImagesLarry Saltzman has blood cancer. He’s also a retired doctor, so he knows getting covid-19 could be dangerous for him — his underlying illness puts him at high risk of serious complications and death. To avoid getting sick, he stays away from large gatherings, and he’s comforted knowing healthy people who get boosters protect him by reducing his exposure to the virus.Until now, that is.Vaccine opponents and skeptics in charge of federal health agencies — starting at the top with Health and Human Services Secretary Robert F. Kennedy Jr. — are restricting access to covid shots that were a signature accomplishment of President Donald Trump’s first term and cost taxpayers about billion to develop, produce, and distribute. The agencies are narrowing vaccination recommendations, pushing drugmakers to perform costly clinical studies, and taking other steps that will result in fewer people getting protection from a virus that still kills hundreds each week in the U.S.On supporting science journalismIf you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today.“There are hundreds of thousands of people who rely on these vaccines,” said Saltzman, 71, of Sacramento, California. “For people who are immunocompromised, if there aren’t enough people vaccinated, we lose the ring that’s protecting us. We’re totally vulnerable.”The Trump administration on May 20 rolled out tougher approval requirements for covid shots, described as a covid-19 “vaccination regulatory framework,” that could leave millions of Americans who want boosters unable to get them.The FDA will encourage new clinical trials on the widely used vaccines before approving them for children and healthy adults. The requirements could cost drugmakers tens of millions of dollars and are likely to leave boosters largely out of reach for hundreds of millions of Americans this fall.Under the new guidance, vaccines will be available for high-risk individuals and seniors. But the FDA will encourage drugmakers to commit to conducting post-marketing clinical trials in healthy adults when the agency approves covid vaccines for those populations.For the past five years, the shots have been recommended by the Centers for Disease Control and Prevention for everyone 6 months and older. They have been available each fall after being updated to reflect circulating strains of the virus, and the vaccines have been shown to be safe and effective in clinical trials.Vinay Prasad, who leads the FDA’s division overseeing vaccines, cited “distrust of the American public” as he announced the new guidelines at a May 20 briefing.“We have launched down this multiyear campaign of booster after booster after booster,” he said, adding that “we do not have gold-standard science to support this for average-risk, low-risk Americans.”The details were outlined in a May 20 article in The New England Journal of Medicine, written by FDA Commissioner Marty Makary. He and Prasad later followed up with the briefing, which appeared the same day on YouTube.The added limits on access aren’t the result of any recent data showing there are new health risks from the covid vaccines. Instead, they reflect a different regulatory stance from Kennedy, who has a history of anti-vaccine activism, and Makary, who has questioned the safety data on covid mRNA shots.Announcing a major regulatory change in a medical journal and YouTube video is a highly unusual approach that still leaves many questions about implementation unanswered. It remains unclear when the changes will go into effect or whether there will be any public comment period. The changes were announced by the administration before an FDA advisory committee meeting on May 22 to consider the 2026 covid vaccine formula.It’s a sharp reversal from the first Trump administration, which launched Operation Warp Speed — the effort that led to the development of the covid shots. Trump called the vaccines the “gold standard” and a “monumental national achievement.”Concerns About Higher TransmissionThe announcement is rattling some patient advocacy groups, doctors, nursing home leaders, and researchers who worry about the ramifications. They say higher-risk individuals will be more likely to get covid if people who aren’t at risk don’t get boosters that can help reduce transmission. And they say the FDA’s restrictions go too far, because they don’t provide exceptions for healthy individuals who work in high-risk settings, such as hospitals, who may want a covid booster for protection.The limits will also make it harder to get insurance coverage for the vaccines. And the FDA’s new stance could also increase vaccine hesitancy by undermining confidence in covid vaccines that have already been subject to rigorous safety review, said Kate Broderick, chief innovation officer at Maravai Life Sciences, which makes mRNA products for use in vaccine development.“For the public, it raises questions,” she said. “If someone has concerns, I’d like them to know that of all the vaccines, the ones with the most understood safety profile are probably covid-19 vaccines. There is an incredible body of data and over 10 billion doses given.”Some doctors and epidemiologists say it could leave healthy people especially vulnerable if more virulent strains of covid emerge and they can’t access covid shots.“It’s not based on science,” said Rob Davidson, an emergency room doctor in Michigan and executive director of the Committee to Protect Health Care, which works to expand health care access. “It’s what we were all worried would happen. It risks peoples’ lives.”Current federal regulators say there is no high-quality evidence showing that vaccinating healthy people, including health workers who are near or around immunocompromised people, provides an additional benefit.“It is possible, actually, that such approvals and strategies provide false reassurance and lead to increased harms,” Prasad said.The covid vaccines underwent clinical trials to assess safety, and they have been subject to ongoing surveillance and monitoring since they obtained emergency use authorization from the FDA amid the pandemic. Heart issues and allergic reactions can occur but are rare, according to the CDC.On a separate track, the FDA on May 21 posted letters sent in April to makers of the mRNA covid vaccines to add information about possible heart injury on warning labels, a move that one former agency official described as overkill. The action came after the Permanent Subcommittee on Investigations, a panel of the Senate Homeland Security and Governmental Affairs Committee, held a hearing on alleged adverse events associated with covid vaccines.Limiting boosters to healthy people goes against guidance from some medical groups.“The COVID-19 vaccine is safe, effective, and the best way to protect children,” Sean O’Leary, chair of the Committee on Infectious Diseases at the American Academy of Pediatrics, said in an email. “Young children under 5 continue to be at the highest risk, with that risk decreasing as they get older.”Unsupported Claims About mRNA VaccinesThe covid booster clampdown is supported by many adherents of the “Make America Healthy Again” movement, which casts suspicion on traditional medicine. Some opponents of covid mRNA vaccines say without evidence that the shots cause “turbo” cancer, are genetic bioweapons, and cause more heart damage than the covid virus.There is no evidence the shots lead to rapid and aggressive cancers. Cancer rates decreased an average of 1.7% per year for men and 1.3% for women from 2018 to 2022, according to the National Institutes of Health. The covid vaccines debuted in 2021.Federal regulators say narrowing who can get the boosters will align the U.S. with policies of European nations. But other countries have vastly different economic structures for health care and approaches to preventive care. Many European countries, for example, don’t recommend flu shots for the entire population. The U.S. does in part because of the financial drain attributed to lost productivity when people are sick.They also want more information. “I think there’s a void of data,” Makary told CBS News on April 29. “And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”A massive five-year study on covid vaccine safety by the Global Vaccine Data Network, involving millions of people, was underway, with about a year left before completion. The Trump administration terminated funding for the project as part of cuts directed by the president’s Department of Government Efficiency, and work on the study has stopped for now.There are a multitude of studies, however, on the vaccines’ effectiveness in preventing severe illness, hospitalization, and death.Limiting boosters for healthy people can be risky, some doctors say, because people don’t always know when they fall into higher-risk categories, such as individuals who are prediabetic or have high blood pressure. The covid vaccine restrictions could deter them from getting boosted, and they might experience worse complications from the virus as a result. For example, about 40% of people with hepatitis C are unaware of their condition, according to a study published in 2023.The number of people getting covid vaccines has already dropped significantly since the height of the crisis. More than half of the more than 258 million adults in the U.S. had gotten a covid vaccination as of May 2021, according to the CDC. In each of the past two seasons, less than 25% of Americans received boosters, CDC data shows.While deaths from the virus have dropped, covid remains a risk, especially when cases peak in December and January. Weekly covid deaths topped 2,580 as recently as January 2024, according to CDC data.Some high-risk individuals are worried that the new restrictions are just the first salvo in halting all access to mRNA shots. “The HHS motivation really is hidden, and it’s to dismiss all mRNA technology,” said Michael Osterholm, an epidemiologist at the University of Minnesota.Officials at the NIH have told scientists to remove references to mRNA in grant applications. HHS also announced plans in May to develop new vaccines without mRNA technology, which uses messenger RNA to instruct cells to make proteins that trigger an immune response.Rose Keller, 23, is concerned about future access to covid shots. She would be eligible under the current announcement — she has cystic fibrosis, a progressive genetic condition that makes the mucus in her lungs thick and sticky, so covid could land her in the hospital. But she is concerned the Trump administration may go further and restrict access to the vaccines as part of a broader opposition to mRNA technology.“I’ve had every booster that’s available to me,” said Keller, a government employee in Augusta, Maine. “It’s a real worry if I don’t have the protection of a covid booster.”KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. #covid #vaccines #face #potential #new

As part of proposals outlined by Keir Starmer on Monday, tougher entry requirements for students and workers would be introduced to reduce immigration. The immigration bill would raise entry requirements to degree level for workers entering the UK, introduce tougher English language requirements, and extend the period for claiming settled status from five to ten years. Universities will, meanwhile, have to score five percentage points moreon the Basic Compliance Assessment, which the home office uses to assess compliance with the immigration system. This could reduce the number of places on offer to overseas students.Advertisement Responding to the proposals, RIBA president Muyiwa Oki said immigration into the UK was crucial for filling the current skills gap in the housing sector given the government’s target to build 1.5 million homes in this parliament. He said: ‘The government’s decision to reduce the number of international workers and students comes at a time when they have ambitious plans to drive growth, including delivering 1.5 million new homes. ‘Architects are vital to achieving this, but the sector has a significant skills shortage. We need an immigration system that helps plug these gaps.’ The government’s reforms would abolish the immigration salary list, which put the minimum salary for a foreign worker visa at 80 per cent of the going rate for that profession. Architects were, controversially, among the sectors removed from the list designed to combat occupational shortages through worker visas. Until last year, the list had allowed firms to hire foreign workers in particular sectors on salaries 20 per cent less than the going rate. Oki added that, following the government’s drive to reduce immigration, more investment was needed in apprenticeships and non-traditional routes into the profession.Advertisement The RIBA has previously called on the government not to implement changes that could see practices pay more towards training Level 7 apprenticeships – the equivalent to a master’s degree. Oki commented: ‘We welcome the desire to nurture homegrown talent, and we continue to champion new and accessible routes into the profession, such as apprenticeships. But the potential of defunding Level 7 apprenticeships puts this at risk. We continue to work with the government to ensure a pipeline of talent in the architecture sector and drive growth across the country.’ The Chartered Institute of Architectural Technologistsechoed the RIBA’s calls for investment in apprenticeships. CIAT president Eddie Weir said: ‘The UK’s built environment sector faces significant pressures at all levels. If we are to deliver the 1.5 million new homes that our communities need and ensure that our existing homes and buildings are healthy, sustainable and fit for the future, these pressures must be relieved.’ Weir warned the government not to limit skilled professionals where there are gaps in the market and added: ‘Government must also move ahead with reforming the apprenticeships system … At the same time, the industry still needs a steady supply of highly skilled professionals, particularly in building design and project management.’ Meanwhile, Building Cost Information Servicechief economist David Crosthwaite compared the construction and health industries. He said both needed migrant workers when domestic supply fell short. ‘If the government is serious about delivering 1.5 million homes and boosting national infrastructure delivery, they must seek both short-term and long-term solutions,' he said. ‘In the meantime, it is critical that we can access migrant workers where there’s a clear economic need, or else risk stalling growth and delivery even further.’ The BCIS chief also called for a transitional arrangement before the introduction of the new immigration rules, and warned: ‘Tightening migration rules could increase costs, delay projects, and make it even harder to meet ambitious targets. Workforce decisions need to be grounded in long-term strategy, not short-term political pressure.’ Comment Paul Chappell, director, 9B Careers A government crackdown on immigration could seriously disrupt the architecture profession, affecting talent pipelines, creativity, and salary dynamics. The sector relies heavily on a diverse international workforce that brings essential skills in areas such as sustainable design, digital technologies and cultural placemaking. Tighter immigration controls risk shrinking the talent pool, making it harder for practices to fill key roles, and undermining the UK’s position as a global design hub, just as the industry appears to be recovering from a prolonged downturn. We've just experienced one of our busiest quarters in a decade, and many practices are urgently trying to recruit large teams without the time or capacity to sponsor visas. In this climate, reduced access to international talent is already driving up salaries, particularly for specialist and mid-level roles where skills shortages are acute. The days of receiving 500 applications for a single job are gone. Most of our time is now spent headhunting, which inevitably requires higher salary offers to entice candidates from secure positions. But this wage inflation is not sustainable, especially for smaller firms operating within tight fee constraints. Over time, we may see widening regional disparities, increased outsourcing and fewer opportunities for Part 1 graduates, who are already struggling to find meaningful year-out placements. Studios, sadly, often no longer have the time or money to support the next generation coming through. Restricting international students and early-career professionals also threatens the long-term health of the profession. Architecture thrives on openness, diversity, and the free exchange of ideas. Without that, we risk weakening both the profession and the quality of the built environment it shapes. Charlie Edmonds, Future Architects FrontStarmer's logic that we can replace international workers with greater investment in training for British nationals is, at best, naive and, at worst, intentionally furthering the managed decline of the social and physical infrastructure of the UK. The decision to massively restrict worker visas undermines Labour's promises to support the NHS and to bolter UK construction. Simultaneously, pay in these roles is notoriously low, public investment into these sectors is insufficient, and Labour seems to have to immediate intention of changing this. So the only result will be the increase of vacancies in vital sectors from care to construction. If Starmer was serious about the wellbeing of people living in the UK, regardless of nationality, the Labour party would be supporting dignified routes for immigration while simultaneously investing in UK skills and sectors — setting these outcomes in opposition to one another is not only a false dichotomy but lays the groundwork for continued destitution in the UK. #riba #says #governments #immigration #clampdown

The Department of Commercehas slammed the brakes on the sweeping “AI Diffusion Rule,” yanking it just a day before it was due to bite. Meanwhile, officials have laid down the gauntlet with stricter measures to control semiconductor exports.The AI Diffusion Rule, a piece of regulation cooked up under the Biden administration, was staring down a compliance deadline of May 15th. According to the folks at the DOC, letting this rule roll out would have been like throwing a spanner in the works of American innovation.DOC officials argue the rule would have saddled tech firms with “burdensome new regulatory requirements” and, perhaps more surprisingly, risked souring America’s relationships on the world stage by effectively “downgrading” dozens of countries “to second-tier status.”The nuts and bolts of this reversal will see the Bureau of Industry and Security, part of the DOC, publishing a notice in the Federal Register to make the rescission official. While this particular rule is heading for the shredder, the official line is that a replacement isn’t off the table; one will be cooked up and served “in the future.”Jeffery Kessler, the Under Secretary of Commerce for Industry and Security, has told BIS enforcement teams to stand down on anything concerning the now-canned AI Diffusion Rule.“The Trump Administration will pursue a bold, inclusive strategy to American AI technology with trusted foreign countries around the world, while keeping the technology out of the hands of our adversaries,” said Kessler.“At the same time, we reject the Biden Administration’s attempt to impose its own ill-conceived and counterproductive AI policies on the American people.”What was this ‘AI Diffusion Rule’ anyway?You might be wondering what this “AI Diffusion Rule” actually was, and why it’s causing such a stir. The rule wasn’t just a minor tweak; it was the Biden administration’s bid to get a tight grip on how advanced American tech – everything from the AI chips themselves to cloud computing access and even the crucial AI ‘model weights’ – flowed out of the US to the rest of the world.The idea, at least on paper, was to walk a tightrope: keep the US at the front of the AI pack, protect national security, and still champion American tech exports.But how did it plan to do this? The rule laid out a fairly complex playbook:A tiered system for nations: Imagine a global league table for AI access. Countries were split into three groups. Tier 1 nations, America’s closest allies like Japan and South Korea, would have seen hardly any new restrictions. Tier 3, unsurprisingly, included countries already under arms embargoes – like China and Russia – who were already largely banned from getting US chips and would face the toughest controls imaginable.The squeezed middle: This is where things got sticky. A large swathe of countries, including nations like Mexico, Portugal, India, and even Switzerland, found themselves in Tier 2. For them, the rule meant new limits on how many advanced AI chips they could import, especially if they were looking to build those super-powerful, large computing clusters essential for AI development.Caps and close scrutiny: Beyond the tiers, the rule introduced actual caps on the quantity of high-performance AI chips most countries could get their hands on. If anyone wanted to bring in chips above certain levels, particularly for building massive AI data centres, they’d have faced incredibly strict security checks and reporting duties.Controlling the ‘brains’: It wasn’t just about the hardware. The rule also aimed to regulate the storage and export of advanced AI model weights – essentially the core programming and learned knowledge of an AI system. There were strict rules about not storing these in arms-embargoed countries and only allowing their export to favoured allies, and even then, only under tight conditions.Tech as a bargaining chip: Underneath it all, the framework was also a bit of a power play. The US aimed to use access to its coveted AI technology as a carrot, encouraging other nations to sign up to American standards and safeguards if they wanted to keep the American chips and software flowing.The Biden administration had a clear rationale for these moves. They wanted to stop adversaries, with China being the primary concern, from getting their hands on advanced AI that could be turned against US interests or used for military purposes. It was also about cementing US leadership in AI, making sure the most potent AI systems and the infrastructure to run them stayed within the US and its closest circle of allies, all while trying to keep US tech exports competitive.However, the AI Diffusion Rule and broader plan didn’t exactly get a standing ovation. Far from it.Major US tech players – including giants like Nvidia, Microsoft, and Oracle – voiced strong concerns. They argued that the rule, instead of protecting US interests, would stifle innovation, bog businesses down in red tape, and ultimately hurt the competitiveness of American companies on the global stage. Crucially, they also doubted it would effectively stop China from accessing advanced AI chips through other means.And it wasn’t just industry. Many countries weren’t thrilled about being labelled “second-tier,” a status they felt was not only insulting but also risked undermining diplomatic ties. There was a real fear it could push them to look for AI technology elsewhere, potentially even from China, which was hardly the intended outcome.This widespread pushback and the concerns about hampering innovation and international relations are exactly what the current Department of Commerce is pointing to as reasons for today’s decisive action to scrap the rule.Fresh clampdown on AI chip exportsIt wasn’t just about scrapping old rules, though. The BIS also rolled out a new playbook to tighten America’s grip on AI chip exports, showing they’re serious about guarding the nation’s tech crown jewels. The latest clampdown includes:A spotlight on Huawei Ascend chips: New guidance makes it crystal clear: using Huawei Ascend chips anywhere on the planet is now a no-go under US export controls. This takes direct aim at one of China’s big players in the AI hardware game.Heads-up on Chinese AI model training: A stark warning has gone out to the public and the industry about the serious consequences if US AI chips are used to train or run Chinese AI models. The worry? That American tech could inadvertently supercharge AI systems that might not have US interests at heart.Guidance on shoring up supply chains: US firms are getting a fresh batch of advice on how to batten down the hatches on their supply chains to stop controlled tech from being siphoned off to unapproved destinations or users.The Department of Commerce is selling today’s double-whammy – axing the rule and beefing up export controls – as essential to “ensure that the United States will remain at the forefront of AI innovation and maintain global AI dominance.” It’s a strategy that looks to clear the runway for domestic tech growth while building higher fences around critical AI technologies, especially advanced semiconductors.This policy pivot will likely get a thumbs-up from some quarters in the US tech scene, particularly those who were getting sweaty palms about the AI Diffusion Rule and the red tape it threatened. On the flip side, the even tougher export controls – especially those zeroing in on China and firms like Huawei – show that trade policy is still very much a frontline tool in the high-stakes global chess game over who leads in tech.The whisper of a “replacement rule” down the line means this isn’t the final chapter in the saga of how to manage the AI revolution. For now, it seems the game plan is to clear the path for homegrown innovation and be much more careful about who gets to play with America’s latest breakthroughs.Want to learn more about AI and big data from industry leaders? Check out AI & Big Data Expo taking place in Amsterdam, California, and London. The comprehensive event is co-located with other leading events including Intelligent Automation Conference, BlockX, Digital Transformation Week, and Cyber Security & Cloud Expo.Explore other upcoming enterprise technology events and webinars powered by TechForge here. #slams #brakes #diffusion #rule #hardens

Nvidia’s efforts to suck up to the Trump administration have seemingly paid off, with the US now lifting export limits on US-made AI chips and cracking down on anyone using Huawei’s emerging alternatives. The announcements come as Nvidia CEO Jensen Huang joined President Trump in Saudi Arabia this week to solicit AI investments for US companies.The US Department of Commerce (DOC) announced on Monday that it has rescinded the Artificial Intelligence Diffusion Rule, due to take effect on May 15th, that aimed to restrict how many US-made AI chips could be sent to international markets without special government approval. The DOC said that a replacement rule for protecting US AI technology will be issued “in the future,” but provided no specific details.“These new requirements would have stifled American innovation and saddled companies with burdensome new regulatory requirements,” The DOC said in a statement. “The AI Diffusion Rule also would have undermined US diplomatic relations with dozens of countries by downgrading them to second-tier status.”Trump’s favorite government meddler Elon Musk was also rubbing shoulders with Huang and the Saudi prince at the investment forum. Image: Brendan Smialowski / Getty ImagesWhile the goal was to prevent countries already subject to chip restrictions, such as Russia and China, from accessing or building AI tech, it also placed Nvidia’s estimated 90 percent share of the AI chip market in jeopardy. Shortly after the Diffusion Rule was introduced by former President Joe Biden in January, Nvidia issued a statement calling it “misguided,” while anticipating a return to Trump’s first term policies “that strengthen American leadership, bolster our economy and preserve our competitive edge in AI and beyond.”The DOC also warned companies that using Huawei’s Ascend AI chipset “anywhere in the world” would violate US export control agreements. Huawei’s home-grown Ascend processors are seen as China’s best answer to Nvidia’s powerful AI chips. Nvidia CEO Jensen Huang was notably one of the only US tech leaders to not attend Donald Trump’s inauguration. His absence doesn’t appear to have soured the relationship between them, however, with Huang spotted cosying up to Trump at a US-Saudi investment summit in Riyadh on Tuesday, alongside other tech leaders like Elon Musk, AMD’s Lisa Su, OpenAI’s Sam Altman, and Epic CEO Tim Sweeney.The Washington Post reports that Trump was far from subtle about what the US wanted from the gathering. “As you know, we have the biggest business leaders in the world here,” he told Saudi Crown Prince Mohammed bin Salman. “They’re going to walk away with a lot of checks for a lot of things that you’re going to provide.”See More: Source: https://www.theverge.com/news/666605/nvidias-flattery-of-trump-wins-reversal-of-ai-chip-limits-and-a-huawei-clampdown #nvidiaampamp8217s #flattery #trump #wins #reversal #chip #limits #and #huawei #clampdown