If you wanted to get a COVID vaccine during pregnancy, to protect yourself and your future baby from the virus, that may soon be difficult to impossible. According to a short video posted on X, U.S. Department of Health and Human Services secretary Robert F. Kennedy, Jr, who is also a noted anti-vaccine activist, said that the COVID-19 vaccine “has been removed” from the list of vaccines recommended in pregnancy, as well as the list of vaccines recommended for healthy children. This announcement sidesteps the usual regulatory process, and it’s not clear exactly what will happen next—but here’s what we know. The announcement may not be entirely validRFK, Jr made the announcement in a video where he stood alongside the NIH director Jay Bhattacharya and FDA commissioner Marty Makary. Notably, nobody from the CDC was present. The FDA approves vaccines, but it’s the CDC that is in charge of recommendations. Normally, the CDC has an advisory panel called ACIPthat reviews scientific evidence to make recommendations for vaccines. They’ll vote on whether a given vaccine should be recommended for everybody in a group of people. Their decisions are then passed to CDC leadership, who make the final call as to whether the vaccine gets officially recommended for that group. Vaccines are not usually added or removed to the recommended list by the CDC without consulting with ACIP, and they definitely aren’t usually added or removed by tweeting a video. Dorit Reiss, a law professor who specializes in vaccine policy, posted on LinkedIn that the announcement may not be legally valid if it’s not immediately followed by supporting documentation. She says: “Under administrative law, to avoid being found arbitrary and capricious, an agency's decision has to meet certain criteria, including explaining the agency's fact finding, a connection between the facts and the decisions, etc. A one minute video on Twitter doesn't quite get you there.” So far, the CDC’s web page on vaccines recommended in pregnancy still says that “A pregnant woman should get vaccinated against whooping cough, flu, COVID-19, and respiratory syncytial virus.” The adult and child vaccine schedules still include COVID vaccines.Strangely, this move on behalf of the CDC contradicts the one we reported about recently from the FDA. The FDA plans to require extra stepsto approve new COVID vaccines for healthy children and adults. But these steps don’t apply to people who are at high risk for complications of COVID. The FDA’s policy announcement included a list of those high risk health conditions—which includes pregnancy.Why it matters which vaccines are “recommended”Recommending a vaccine doesn’t just mean expressing an opinion; the Affordable Care Act requires that vaccines recommended by ACIP must be covered by most private insurance and Medicaid expansion plans without any cost sharing. That means no deductible and no copay—so these vaccines must be free to you out of pocket if you fall into a group of people for whom they are recommended. The recommended vaccines include all the standard childhood vaccines, plus your seasonal flu shot, and other vaccines that are recommended for adults, for people who are pregnant, and so on. The full schedules are here. If you’ve gotten a COVID shot, a flu shot, a tetanus shot, a shingles shot—the shot’s inclusion on this list is why you were able toget it for free.So taking a vaccine off the recommended list means that it could be prohibitively expensive. GoodRX, which keeps tabs on pharmacy prices, reports that COVID shots may cost or more out of pocket, plus any applicable administration fee that the provider might charge.Taking a vaccine off the recommended list may also mean it won’t be covered by the Vaccines for Children program, which provides free vaccines to children who don’t have coverage for them through health insurance.Whether or not the vaccine actually gets taken off the list, the recent HHS announcement has another impact: The American College of Obstetricians and Gynecologists said in a statement that “Following this announcement, we are worried about our patients in the future, who may be less likely to choose vaccination during pregnancy despite the clear and definitive evidence demonstrating its benefit.” The ACOG statement also pointed out a few ways in which removing the vaccines from the recommended list is not “common sense and good science,” as the HHS announcement claimed. ACOG writes: “As ob-gyns who treat patients every day, we have seen firsthand how dangerous COVID infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection. We also understand that despite the change in recommendations from HHS, the science has not changed. It is very clear that COVID infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families.” #what #know #about #rfks #announcement

Just Dodge Elden Ring Nightreign update offers solo players a helping hand not even 24-hours after launch because cowards cried too loud What happened to the game that I loved, to the spirit of persevering through adversity? Image credit: Bandai Namco News by Connor Makar Staff Writer Published on May 30, 2025 Elden Ring Nightreign hasn't even been out for 24 hours, and already the game has been made easier for solo players. Those tackling solo runs will get one free revive during the Nightlord fight that's part of the run, and will get increased rune aquisition the entire time. A solo run, which is already scaled so that bosses have less health and offers a purchasable revive before the Nightlord fight for a measly 10,000 runes, was added for those who enjoy the challenge of taking on a game intended for group play on their lonesome. Fair play, y'know. It's not how I best enjoyed the game but godspeed captain, take the wheel. For those who were actually excited to take on the game this way with all its struggle and in the name of fufilment through overcoming adversity, however, their dreams have been hampered by the wails and moans of wittle babies who want the solo experience to be easier. To see this content please enable targeting cookies. They want their warm bottle, a little bib, and for the process of actually overcoming the challenge present in Nightreign to be lowered so they don't have to work as hard to succeed. Was I able to solo every boss during the review period? No. I did like four of 'em. Was I looking forward to improving and doing so over the next few weeks? Absolutely. This journey has been stolen from me and likeminded adults by the feeble among us. "But Connor, what if these people are struggling to beat bosses on their own and need help?", you may ask. Here's a hot tip. Go and ask your dad if you can use the internet, shake the gent's hand, then take the on the boss online. Once you've cracked that with the help of other people, and are better at the game, then try it solo. You'll find that it's easier than before. Wow! It's almost as though that playing the game more and with other peoplehelps make these challenges less daunting. It's almost as though that's a major theme of the game itself. You are meant to ride a bike with your hands on the handle bars. You can ride without doing so, but it's harder. If you try riding a bike without touching the handle bars and wipe out on the pavement, you don't ask for stabilizers to be put on, right? You practice riding your bike normally until you can crack it. The worst part isn't even the revive - you can just take your hands off the controller on your first death and welcome the game over if you want a real "deathless run" - it's the rune aquisition boost. In my opinion it taints the whole thing. There are relics that give rune aquisition boosts but you have to earn them. The game gets easier as you play, as in all games like this. I do understand why this change has happened from From Software's perspective - the company wants all the people playing it to have a good time and not bail out after a few too many frustrating losses. Totally get it. But why not leave it a week so the sickos can claim their laurels? Then, provide this olive branch for everyone else. Maybe I'm an jaded 27 year old but I remember a From Software community that would cheer and pop bottles upon hearing that a new game was really hard as a solo player, and would smash their heads against it like rabid animals until they managed to beat it. These people still exist I'm sure, they are likely as disapointed as I am that the game has already had part of it neutered, but it's too late now. At least with Elden Ring: Shadow of the Erdtree regular players had a few days to soldier on before the early hours of it were made easier. Whatever, enjoy your pram. Elden Ring Nightreign is out now, and is doing really well on Steam at the moment. So, there's a solid chance a lot of you playing it right now are having a good time, which is swell. #elden #ring #nightreign #update #offers

Unity The battle to play Borderlands Online continues, as dedicated archivists ask for help in pursuit of the long lost MMO The team working on bringing this game back is now asking for help from experts to get the game playable. Image credit: 2K China News by Connor Makar Staff Writer Published on May 30, 2025 The Borderlands Online archival saga continues, with the small group of people hoping to get the game playable putting out a call-to-action for those with coding experiencein order to break through the game's character selection screen. Previously, we covered YouTuber, game designer, and dataminer EpicNNG managing to get to the game's class selection screen, but it seems he and his small team working on the archival project have hit a brick wall. Not in terms of skill, but in terms of time. They have a version of the game at their finger tips, they just need more hands to get the build working. He states: "Number 1: We know that we have the full game, we have confirmed we have the full game. Number 2: We know that we can get in eventually, it is just a matter of when." To see this content please enable targeting cookies. In this call-to-action, a lengthy video detailing the journey so far, EpicNNG showed the perilous task as his small team went through old Chinese Borderlands Online websites in the search for a way to actually play the game. Doing so, they found ghost links and viruses, so it's worth emphasising here that you should only really help out with this effort if you know what you're doing. The video is covered in statements making it clear that this is purely for archival purposes, and that he nor his team are looking to infringe on 2K's intelectual property as to avoid the possibility of a cease and desist. However, it's made equally clear that this project may be nearing a dead end thanks to the release of Borderlands 4 and the potential actions of 2K's legal team, unless it gets more people on board to help. It's worth noting that this article was only written following an exchange of DMs with EpicNNG, in which he stated that he understood the potential risks of this call-to-action being further publicised and was happy with it being covered nonetheless. In the video, EpicNNG acknowledges that time is of the essence here, pointing to Activision's take down of the H2M Call of Duty mod in fears it would suck attention away from the next Call of Duty. The worry is that, unless the team gets the game working soon, 2K would fear a similar thing with Borderlands 4 and send out a Cease and Desist. This archival project, if successful, would be somewhat of a white whale for the video game archival scene. Not only is archiving any game difficult, Borderlands Online is a Chinese-only MMORPG that has been dead for years. Getting it working is an admirable goal. Here's hoping that folks that can help see it and lend a hand before it's too late. Though, if you're a greenthumb when it comes to Unity or video game software in general, maybe it's best to leave it with the experts and wish them luck. #battle #play #borderlands #online #continues

A Rising Tide The studio behind Atomic Heart is kicking up a publishing arm, looking to help get more "big and bold" games made With Atomic Heart selling over 10 million copies, Mundfish is widening to support other devs achieve similar success. News by Connor Makar Staff Writer Published on May 30, 2025 Mundfish, the studio behind Atomic Heart, has announced it's opening up a publishing arm it's calling Mundfish Powerhouse. This comes alongside the studio's celebratory declaration that Atomic Heart has sold over 10 million copies. Speaking to Analogue Stick Gaming CEO and founder of Mundfish Robert Bagratuni stated, "For quite some time, studios and investors have been approaching us seeking supportWe’ve decided to make this direction official. Powerhouse will only partner with projects where we see great potential to make noise. Not just a handful of indie hits, but big and bold games that can set a new standard for quality and creative risk.” To see this content please enable targeting cookies. According to the article, Mundfish Powerhouse will be offering developers it works with "deep production expertise and high-end tools, a proven, scalable development pipeline, hands-on support from concept to launch and a focus on fewer, bigger, bolder games, built to shake up the industry". As for Atomic Heart's 10 million sales milestone, Bagratuni gave the following statement, "What started as a dream has become a reality beyond anything we imagined. Thanks to our team’s relentless dedication, bold vision, and unwavering focus on quality, we’ve achieved something truly special. We’re incredibly grateful to our players for their passion and support - it’s their enthusiasm that brought Atomic Heart to life". Atomic Heart stands out to me as one of those lesser-talked-about games that launched to its own healthy audience, and has continued trucking away as the months flew by. We've seen a decent chunk of these sorts of games from smaller studios as of late, a sign of changing tides in the industry as massive companies struggle to hit the astronomical targets set for the developers working there, while these smaller studios with clear vision manage to sneak through the gaps. What do you think of this news? Let us know below! #studio #behind #atomic #heart #kicking

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

This week, two new leaders at the US Food and Drug Administration announced plans to limit access to covid vaccines, arguing that there is not much evidence to support the value of annual shots in healthy people. New vaccines will be made available only to the people who are most vulnerable—namely, those over 65 and others with conditions that make them more susceptible to severe disease. Anyone else will have to wait. Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk. The plans have been met with fear and anger in some quarters. But they weren’t all that shocking to me. In the UK, where I live, covid boosters have been offered only to vulnerable groups for a while now. And the immunologists I spoke to agree: The plans make sense. They are still controversial. Covid hasn’t gone away. And while most people are thought to have some level of immunity to the virus, some of us still stand to get very sick if infected. The threat of long covid lingers, too. Given that people respond differently to both the virus and the vaccine, perhaps individuals should be able to choose whether they get a vaccine or not. I should start by saying that covid vaccines have been a remarkable success story. The drugs were developed at record-breaking speed—they were given to people in clinical trials just 69 days after the virus had been identified. They are, on the whole, very safe. And they work remarkably well. They have saved millions of lives. And they rescued many of us from lockdowns. But while many of us have benefited hugely from covid vaccinations in the past, there are questions over how useful continuing annual booster doses might be. That’s the argument being made by FDA head Marty Makary and Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research. Both men have been critical of the FDA in the past. Makary has long been accused of downplaying the benefits of covid vaccines. He made incorrect assumptions about the coronavirus responsible for covid-19 and predicted that the disease would be “mostly gone” by April 2021. Most recently, he also testified in Congress that the theory that the virus came from a lab in China was a “no-brainer.”Prasad has said “the FDA is a failure” and has called annual covid boosters “a public health disaster the likes of which we’ve never seen before,” because of a perceived lack of clinical evidence to support their use. Makary and Prasad’s plans, which were outlined in the New England Journal of Medicine on Tuesday, don’t include such inflammatory language or unfounded claims, thankfully. In fact, they seem pretty measured: Annual covid booster shots will continue to be approved for vulnerable people but will have to be shown to benefit others before people outside the approved groups can access them. There are still concerns being raised, though. Let’s address a few of the biggest ones. Shouldn’t I get an annual covid booster alongside my flu vaccine? At the moment, a lot of people in the US opt to get a covid vaccination around the time they get their annual flu jab. Each year, a flu vaccine is developed to protect against what scientists predict will be the dominant strain of virus circulating come flu season, which tends to run from October through March. But covid doesn’t seem to stick to the same seasonal patterns, says Susanna Dunachie, a clinical doctor and professor of infectious diseases at the University of Oxford in the UK. “We seem to be getting waves of covid year-round,” she says. And an annual shot might not offer the best protection against covid anyway, says Fikadu Tafesse, an immunologist and virologist at Oregon Health & Science University in Portland. His own research suggests that leaving more than a year between booster doses could enhance their effectiveness. “One year is really a random time,” he says. It might be better to wait five or 10 years between doses instead, he adds. “If you are at riskyou may actually needevery six months,” says Tafesse. “But for healthy individuals, it’s a very different conversation.” What about children—shouldn’t we be protecting them? There are reports that pediatricians are concerned about the impact on children, some of whom can develop serious cases of covid. “If we have safe and effective vaccines that prevent illness, we think they should be available,” James Campbell, vice chair of the committee on infectious diseases at the American Academy of Pediatrics, told STAT. This question has been on my mind for a while. My two young children, who were born in the UK, have never been eligible for a covid vaccine in this country. I found this incredibly distressing when the virus started tearing through child-care centers—especially given that at the time, the US was vaccinating babies from the age of six months. My kids were eventually offered a vaccine in the US, when we temporarily moved there a couple of years ago. But by that point, the equation had changed. They’d both had covid by then. I had a better idea of the general risks of the virus to children. I turned it down. I was relieved to hear that Tafesse had made the same decision for his own children. “There are always exceptions, but in general,is not severe in kids,” he says. The UK’s Joint Committee on Vaccination and Immunology found that the benefits of vaccination are much smaller for children than they are for adults. “Of course there are children with health problems who should definitely have it,” says Dunachie. “But for healthy children in healthy households, the benefits probably are quite marginal.” Shouldn’t healthy people get vaccinated to help protect more vulnerable members of society? It’s a good argument, says Tafesse. Research suggests that people who are vaccinated against covid-19 are less likely to end up transmitting the infection to the people around them. The degree of protection is not entirely clear, particularly with less-studied—and more contagious—variants of the virus and targeted vaccines. The safest approach is to encourage those at high risk to get the vaccine themselves, says Tafesse. If the vaccines are safe, shouldn’t I be able to choose to get one? Tafesse doesn’t buy this argument. “I know they are safe, but even if they’re safe, why do I need to get one?” People should know if they are likely to benefit from a drug they are taking, he says. Having said that, the cost-benefit calculation will differ between individuals. Even a “mild” covid infection can leave some people bed-bound for a week. For them, it might make total sense to get the vaccine. Dunachie thinks people should be able to make their own decisions. “Giving people a top-up whether they need it or not is a safe thing to do,” she says. It is still not entirely clear who will be able to access covid vaccinations under the new plans, and how. Makary and Prasad’s piece includes a list of “medical conditions that increase a person’s risk of severe covid-19,” which includes several disorders, pregnancy, and “physical inactivity.” It covers a lot of people; research suggests that around 25% of Americans are physically inactive. But I find myself agreeing with Dunachie. Yes, we need up-to-date evidence to support the use of any drugs. But taking vaccines away from people who have experience with them and feel they could benefit from them doesn’t feel like the ideal way to go about it. This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here. #fda #plans #limit #access #covid

This week, two new leaders at the US Food and Drug Administration announced plans to limit access to covid vaccines, arguing that there is not much evidence to support the value of annual shots in healthy people. New vaccines will be made available only to the people who are most vulnerable—namely, those over 65 and others with conditions that make them more susceptible to severe disease. Anyone else will have to wait. Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk. The plans have been met with fear and anger in some quarters. But they weren’t all that shocking to me. In the UK, where I live, covid boosters have been offered only to vulnerable groups for a while now. And the immunologists I spoke to agree: The plans make sense. They are still controversial. Covid hasn’t gone away. And while most people are thought to have some level of immunity to the virus, some of us still stand to get very sick if infected. The threat of long covid lingers, too. Given that people respond differently to both the virus and the vaccine, perhaps individuals should be able to choose whether they get a vaccine or not. I should start by saying that covid vaccines have been a remarkable success story. The drugs were developed at record-breaking speed—they were given to people in clinical trials just 69 days after the virus had been identified. They are, on the whole, very safe. And they work remarkably well. They have saved millions of lives. And they rescued many of us from lockdowns. But while many of us have benefited hugely from covid vaccinations in the past, there are questions over how useful continuing annual booster doses might be. That’s the argument being made by FDA head Marty Makary and Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research. Both men have been critical of the FDA in the past. Makary has long been accused of downplaying the benefits of covid vaccines. He made incorrect assumptions about the coronavirus responsible for covid-19 and predicted that the disease would be “mostly gone” by April 2021. Most recently, he also testified in Congress that the theory that the virus came from a lab in China was a “no-brainer.”Prasad has said “the FDA is a failure” and has called annual covid boosters “a public health disaster the likes of which we’ve never seen before,” because of a perceived lack of clinical evidence to support their use. Makary and Prasad’s plans, which were outlined in the New England Journal of Medicine on Tuesday, don’t include such inflammatory language or unfounded claims, thankfully. In fact, they seem pretty measured: Annual covid booster shots will continue to be approved for vulnerable people but will have to be shown to benefit others before people outside the approved groups can access them. There are still concerns being raised, though. Let’s address a few of the biggest ones. Shouldn’t I get an annual covid booster alongside my flu vaccine? At the moment, a lot of people in the US opt to get a covid vaccination around the time they get their annual flu jab. Each year, a flu vaccine is developed to protect against what scientists predict will be the dominant strain of virus circulating come flu season, which tends to run from October through March. But covid doesn’t seem to stick to the same seasonal patterns, says Susanna Dunachie, a clinical doctor and professor of infectious diseases at the University of Oxford in the UK. “We seem to be getting waves of covid year-round,” she says. And an annual shot might not offer the best protection against covid anyway, says Fikadu Tafesse, an immunologist and virologist at Oregon Health & Science University in Portland. His own research suggests that leaving more than a year between booster doses could enhance their effectiveness. “One year is really a random time,” he says. It might be better to wait five or 10 years between doses instead, he adds. “If you are at riskyou may actually needevery six months,” says Tafesse. “But for healthy individuals, it’s a very different conversation.” What about children—shouldn’t we be protecting them? There are reports that pediatricians are concerned about the impact on children, some of whom can develop serious cases of covid. “If we have safe and effective vaccines that prevent illness, we think they should be available,” James Campbell, vice chair of the committee on infectious diseases at the American Academy of Pediatrics, told STAT. This question has been on my mind for a while. My two young children, who were born in the UK, have never been eligible for a covid vaccine in this country. I found this incredibly distressing when the virus started tearing through child-care centers—especially given that at the time, the US was vaccinating babies from the age of six months. My kids were eventually offered a vaccine in the US, when we temporarily moved there a couple of years ago. But by that point, the equation had changed. They’d both had covid by then. I had a better idea of the general risks of the virus to children. I turned it down. I was relieved to hear that Tafesse had made the same decision for his own children. “There are always exceptions, but in general,is not severe in kids,” he says. The UK’s Joint Committee on Vaccination and Immunology found that the benefits of vaccination are much smaller for children than they are for adults. “Of course there are children with health problems who should definitely have it,” says Dunachie. “But for healthy children in healthy households, the benefits probably are quite marginal.” Shouldn’t healthy people get vaccinated to help protect more vulnerable members of society? It’s a good argument, says Tafesse. Research suggests that people who are vaccinated against covid-19 are less likely to end up transmitting the infection to the people around them. The degree of protection is not entirely clear, particularly with less-studied—and more contagious—variants of the virus and targeted vaccines. The safest approach is to encourage those at high risk to get the vaccine themselves, says Tafesse. If the vaccines are safe, shouldn’t I be able to choose to get one? Tafesse doesn’t buy this argument. “I know they are safe, but even if they’re safe, why do I need to get one?” People should know if they are likely to benefit from a drug they are taking, he says. Having said that, the cost-benefit calculation will differ between individuals. Even a “mild” covid infection can leave some people bed-bound for a week. For them, it might make total sense to get the vaccine. Dunachie thinks people should be able to make their own decisions. “Giving people a top-up whether they need it or not is a safe thing to do,” she says. It is still not entirely clear who will be able to access covid vaccinations under the new plans, and how. Makary and Prasad’s piece includes a list of “medical conditions that increase a person’s risk of severe covid-19,” which includes several disorders, pregnancy, and “physical inactivity.” It covers a lot of people; research suggests that around 25% of Americans are physically inactive. But I find myself agreeing with Dunachie. Yes, we need up-to-date evidence to support the use of any drugs. But taking vaccines away from people who have experience with them and feel they could benefit from them doesn’t feel like the ideal way to go about it. This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here. #fda #plans #limit #access #covid

Court Dismissed The FTC has dropped its lawsuit against Microsoft following the Activision Blizzard acquisition, letting the tech giant loose After years of legal debate and courthouse clashes, the FTC x Microsoft saga is at an end. Image credit: Activision, Treyarch, Raven. News by Connor Makar Staff Writer Published on May 23, 2025 The FTC has officially dropped its legal case against Microsoft following the American tech giant's aquisition of Activision Blizzard in 2023. Microsoft is now free from scrutiny, and can now proceed with all manner of business shenanigans with Activision Blizzard in tow without worrying about the courts. This legal battle, which has been raging for roughly the past two years, concluded as the FTC filed an order to dismiss its case. This comes now as the FTC recently had its appeal for an injunction on the aquisition declined, meaning in simple terms the FTC didn't really have any more cards left to play. To see this content please enable targeting cookies. Brad Smith, Microsoft Vice Chair, responded to the announcement gleefully in social media, posting: "Today’s decision is a victory for players across the country and for common sense in Washington, D.C. We are grateful to the FTC for today’s announcement." The FTC, in its filing to withdraw from this legal battle, conceeding the clash with the following statement: "The Commission has determined that the public interest is best served by dismissing the administrative litigation in this case. Accordingly, IT IS HEREBY ORDERED that the Complaint in this matter be, and it hereby is, DISMISSED." So that's that. The end of a saga of great legal consequence for the video game industry. Now, Microsoft is free to spread the wings it has recently bought and strapped on, and fly out in pursuit of large sums of money unimpeded. Whether or not the FTC's fears were well placed, and Microsoft will start leaning on the large market share it now has, is something video game fans will have to keep an eye out for. How do you feel about this conclusion? Happy, or bummed out? Let us know below! #ftc #has #dropped #its #lawsuit

This week, two new leaders at the US Food and Drug Administration announced plans to limit access to covid vaccines, arguing that there is not much evidence to support the value of annual shots in healthy people. New vaccines will be made available only to the people who are most vulnerable—namely, those over 65 and others with conditions that make them more susceptible to severe disease. Anyone else will have to wait. Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk. The plans have been met with fear and anger in some quarters. But they weren’t all that shocking to me. In the UK, where I live, covid boosters have been offered only to vulnerable groups for a while now. And the immunologists I spoke to agree: The plans make sense. They are still controversial. Covid hasn’t gone away. And while most people are thought to have some level of immunity to the virus, some of us still stand to get very sick if infected. The threat of long covid lingers, too. Given that people respond differently to both the virus and the vaccine, perhaps individuals should be able to choose whether they get a vaccine or not. I should start by saying that covid vaccines have been a remarkable success story. The drugs were developed at record-breaking speed—they were given to people in clinical trials just 69 days after the virus had been identified. They are, on the whole, very safe. And they work remarkably well. They have saved millions of lives. And they rescued many of us from lockdowns. But while many of us have benefited hugely from covid vaccinations in the past, there are questions over how useful continuing annual booster doses might be. That’s the argument being made by FDA head Marty Makary and Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research. Both men have been critical of the FDA in the past. Makary has long been accused of downplaying the benefits of covid vaccines. He made incorrect assumptions about the coronavirus responsible for covid-19 and predicted that the disease would be “mostly gone” by April 2021. Most recently, he also testified in Congress that the theory that the virus came from a lab in China was a “no-brainer.”Prasad has said “the FDA is a failure” and has called annual covid boosters “a public health disaster the likes of which we’ve never seen before,” because of a perceived lack of clinical evidence to support their use. Makary and Prasad’s plans, which were outlined in the New England Journal of Medicine on Tuesday, don’t include such inflammatory language or unfounded claims, thankfully. In fact, they seem pretty measured: Annual covid booster shots will continue to be approved for vulnerable people but will have to be shown to benefit others before people outside the approved groups can access them. There are still concerns being raised, though. Let’s address a few of the biggest ones. Shouldn’t I get an annual covid booster alongside my flu vaccine? At the moment, a lot of people in the US opt to get a covid vaccination around the time they get their annual flu jab. Each year, a flu vaccine is developed to protect against what scientists predict will be the dominant strain of virus circulating come flu season, which tends to run from October through March. But covid doesn’t seem to stick to the same seasonal patterns, says Susanna Dunachie, a clinical doctor and professor of infectious diseases at the University of Oxford in the UK. “We seem to be getting waves of covid year-round,” she says. And an annual shot might not offer the best protection against covid anyway, says Fikadu Tafesse, an immunologist and virologist at Oregon Health & Science University in Portland. His own research suggests that leaving more than a year between booster doses could enhance their effectiveness. “One year is really a random time,” he says. It might be better to wait five or 10 years between doses instead, he adds. “If you are at riskyou may actually needevery six months,” says Tafesse. “But for healthy individuals, it’s a very different conversation.” What about children—shouldn’t we be protecting them? There are reports that pediatricians are concerned about the impact on children, some of whom can develop serious cases of covid. “If we have safe and effective vaccines that prevent illness, we think they should be available,” James Campbell, vice chair of the committee on infectious diseases at the American Academy of Pediatrics, told STAT. This question has been on my mind for a while. My two young children, who were born in the UK, have never been eligible for a covid vaccine in this country. I found this incredibly distressing when the virus started tearing through child-care centers—especially given that at the time, the US was vaccinating babies from the age of six months. My kids were eventually offered a vaccine in the US, when we temporarily moved there a couple of years ago. But by that point, the equation had changed. They’d both had covid by then. I had a better idea of the general risks of the virus to children. I turned it down. I was relieved to hear that Tafesse had made the same decision for his own children. “There are always exceptions, but in general,is not severe in kids,” he says. The UK’s Joint Committee on Vaccination and Immunology found that the benefits of vaccination are much smaller for children than they are for adults. “Of course there are children with health problems who should definitely have it,” says Dunachie. “But for healthy children in healthy households, the benefits probably are quite marginal.” Shouldn’t healthy people get vaccinated to help protect more vulnerable members of society? It’s a good argument, says Tafesse. Research suggests that people who are vaccinated against covid-19 are less likely to end up transmitting the infection to the people around them. The degree of protection is not entirely clear, particularly with less-studied—and more contagious—variants of the virus and targeted vaccines. The safest approach is to encourage those at high risk to get the vaccine themselves, says Tafesse. If the vaccines are safe, shouldn’t I be able to choose to get one? Tafesse doesn’t buy this argument. “I know they are safe, but even if they’re safe, why do I need to get one?” People should know if they are likely to benefit from a drug they are taking, he says. Having said that, the cost-benefit calculation will differ between individuals. Even a “mild” covid infection can leave some people bed-bound for a week. For them, it might make total sense to get the vaccine. Dunachie thinks people should be able to make their own decisions. “Giving people a top-up whether they need it or not is a safe thing to do,” she says. It is still not entirely clear who will be able to access covid vaccinations under the new plans, and how. Makary and Prasad’s piece includes a list of “medical conditions that increase a person’s risk of severe covid-19,” which includes several disorders, pregnancy, and “physical inactivity.” It covers a lot of people; research suggests that around 25% of Americans are physically inactive. But I find myself agreeing with Dunachie. Yes, we need up-to-date evidence to support the use of any drugs. But taking vaccines away from people who have experience with them and feel they could benefit from them doesn’t feel like the ideal way to go about it. This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here. #fda #plans #limit #access #covid

The U.S. government has not yet made its official recommendations for who should be able to get COVID booster shots this fall, but FDA officials published a policy position in the New England Journal of Medicine announcing that it intends to make some drastic policy changes. The changes could result in healthy people under age 65 losing access to COVID vaccines, according to vaccine experts who have spoken about the policies. Here’s what we know so far, and why the announced policy could be a problem. How COVID vaccines are currently approvedScientists have changed the formulation of COVID vaccines a few times over the years, because the COVID virus itself tends to mutate. Vaccines are updated to better match the strains that are circulating, and this has happened roughly once a year—similar to how flu shots are updated each year. Instead of designing new vaccine trials from scratch for each small change in the COVID vaccine, manufacturers conduct studies to show that the immunity people get from the new vaccine is equivalent to what people got from the old vaccine. After approval from the FDA, the CDC then issues a recommendation for who should get the vaccine. Currently, everyone aged 6 months and up is recommended to get a COVID vaccine. What might be changingThe new policy, according to the NEJM article, would be to accept those immunobridging studies only to approve vaccines for people aged 65 and up, and people above the age of 6 months who have one of the high-risk conditions on a list maintained by the CDC. For healthy people under 65, the FDA’s policy wouldn’t approve new COVID vaccines unless they were tested against a placebo. The FDA doesn’t have the authority to change the recommendations on who should get vaccines that are already approved, but it is in charge of approving vaccines and can approve them only for specific populations. Why placebo-controlled trials are an absolutely wild idea for COVID vaccinesPublic health experts are, to put it mildly, not happy with this plan. That’s because we already have COVID vaccines that work. Doing a placebo-controlled trial would require withholding COVID vaccines from people in the control group; they would get saline instead of a functional vaccine. The normal way to do this type of trialis to compare the new vaccine or medication against one that is already considered effective. To use an extreme analogy, you wouldn’t test a new design of seatbelt by randomizing people to ride around without using any seatbelts at all. Vaccine scientist Peter Hotez told CNN that the FDA’s announced approach “essentially denies access to vaccines,” since such trials are not practical for companies to do. In a post on Bluesky, toxicologist Ryan Marino said that it amounts to “scientific misconduct.” Vaccine expert Paul Offit told NPR “I don't think it's ethical, given that we have a vaccine that works, given that we know that SARS-CoV2continues to circulate and cause hospitalizations and death, and there's no group that has no risk.”More vaccine chaos may be comingThe new policy isn’t official yet, but it’s hard to imagine the FDA and CDC being allowed to approve and recommend vaccines the way it always has in the current political climate. Biologics director Vinay Prasad and FDA Commissioner Marty Makary, whose names appear on the FDA’s policy statement, have a history of arguing against COVID vaccine access for children. And both agencies are under the umbrella of HHS, the department of Health and Human Services, which is headed by Robert F. Kennedy, Jr—the same person whose anti-vaccine organization financed the movie Plandemic. If you don’t recall the details of that movie circulating in the early pandemic days, it implied both that COVID wasn’t real and that it was a bioweapon created by the government; the logic didn’t hold together but ultimately the point was that we should be suspicious of vaccines. RFK, Jr has said a lot of bananas stuff about vaccines. He has compared childhood vaccines to the holocaust, claimed that Bill Gates put microchips in vaccines, and loudly questioned whether vaccines cause autism. How this man got put in charge of a health agency, I will never understand. Recent and future vaccine approvals may be at risk in this environment. Moderna had planned to submit a combined flu/COVID vaccine for approval; it has since withdrawn its application.Novavax’s recent vaccine was approved recently, but only after a delay and only for older adults and for people with high-risk health conditions. Kennedy released a report today that questions the childhood vaccine schedule and implies that vaccines are part of the “stark reality of American children's declining health.”  #how #fda #might #make #harder