Latest news with #vaccines
Forbes
8 hours ago
- Health
- Forbes
Subtle Differences Emerge Between FDA And CDC On COVID Vaccine Advice
An illustration picture shows vials with Covid-19 vaccine stickers attached and syringes with the ... More logo of the company Novavax. (Photo by JUSTIN TALLIS / AFP) (Photo by JUSTIN TALLIS/AFP via Getty Images) In a major policy shift last month, Food and Drug Administration officials proposed requiring new clinical trial research with respect to the effectiveness of COVID-19 vaccines in healthy people under 65, including pregnant women, before issuing an updated approval for a broader population. At the same time, in an update to its immunization schedule posted May 29th, the Centers for Disease Control and Prevention include the option of COVID-19 vaccines for healthy children and pregnant women. Based on the language used by CDC, it suggests the agency aims for a shared decision-making approach in which individuals consult with their doctor prior to getting a shot. We witnessed a preview of the new FDA approach when the agency made an unusual decision to limit the approval of the nation's only non-mRNA coronavirus vaccine, Novavax's nuvaxovid, for use only in adults 65 and older or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. To be indicated for a broader population, the FDA plans to require that vaccine makers conduct booster trials to demonstrate effectiveness in people under 65 or without certain risks. These trials could take a year to complete, according to a STAT report. As such, it's not something that can be accomplished prior to the autumn, even if Novavax, Pfizer, or Moderna, wished to pursue this pathway. Similar to annual flu shots, which adapt to new strains, COVID-19 boosters update immunity to target evolving variants. Data from several years of booster campaigns show lower hospitalization and death rates for boosted individuals compared to unvaccinated people or those who haven't gotten boosters. This particularly applies to the vulnerable subpopulations, stratified by age and underlying health conditions. The COVID-19 vaccines, both mRNA and non-mRNA, are recommended for anyone who is over 65 or who has a medical condition that can increase the risk of severe illness or death. Underlying conditions include, among other things, obesity, 'physical inactivity,' diabetes, clinical depression and being immunocompromised. It's estimated that between 100 and 200 million Americans will still be eligible for vaccination due to having such health issues. Nevertheless, this raises questions for people who don't have underlying health conditions and are under 65 but would like to get a COVID-19 shot this fall. The FDA and CDC appear to differ subtly in terms of their current advice for healthy individuals under 65. Is it possible for these folks to obtain a jab at the pharmacy with no questions asked? Or will they have to go to their doctor and be granted de facto permission to get the shot? Perhaps equally important, will their insurer pay for it? As the New York Times explains, insurance companies may serve as the 'gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.' The out-of-pocket cost to patients could be as much $140 a shot. Top FDA officials Prasad and Makary advocate an 'evidence-based' approach to COVID-19 vaccination. They also write of aligning policy with Europe. Indeed, in most instances, European public health authorities have adopted a targeted approach that aims at ensuring the elderly and those with underlying health conditions get boosted. This means that outreach campaigns in European countries only target subpopulations for which the vaccine is recommended by the respective public health authority. This is unlike the universal recommendations previously issued by the CDC that didn't differentiate by age or risk factors. However, the European agencies in charge of vaccine approval, the EMA and MHRA, haven't suggested marketing authorization changes, such as narrowing the indication based on age, for any of the approved COVID-19 vaccines.
The Independent
15 hours ago
- Business
- The Independent
Elon Musk has gone – but there is an even bigger danger in the White House now
Before he set foot in 200 Independence Avenue, Washington DC, Robert F Kennedy Jr, US president Donald Trump 's secretary of health and human services, had raised more than a few eyebrows from America's medical establishment. Around 17,000, to be precise – that's how many doctors signed a letter from the Committee to Protect Health Care urging senators to reject his nomination, saying he was 'unqualified to lead' and was 'actively dangerous'. Their petition failed. Today, Kennedy Jr, better known as RFK, is head of an agency with an almost two trillion-dollar budget and a little over 80,000 employees. Last week, Trump unveiled The Maha Report, the administration's blueprint for 'making our children healthy again'. This report reflected Kennedy's most contentious views on vaccines, pesticides, prescription drugs, and a description of America's children as overmedicated and undernourished. 'Never in American history has the federal government taken a position on public health like this,' Kennedy told a group of supporters. The Washington Post reported that medical experts said some of its suggestions 'stretched the limits of science'. In an interview to coincide with its release, Kennedy said parents should be sceptical of 'any medical advice' and should 'do their own research' – something Kennedy critics say amounts to a dangerous rejection of scientific consensus; a call for Americans to replace peer-reviewed evidence with internet rabbit holes. As one critic noted, researching a vaccine isn't like shopping for a toaster. But in Kennedy's world, health policy becomes a choose-your-own-adventure, and critics say the consequences for public trust and child health are real. The mission of Kennedy's Department of Health and Human Services is to 'enhance the health and wellbeing of all Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services'. Yet Kennedy is one of America's leading vaccine conspiracy theorists, even campaigning against the Covid shot designed to help stem the tide of a disease that has killed more than seven million worldwide. In 2021, Instagram disabled his account for repeatedly sharing debunked claims about the vaccine. Since releasing the report, which cited hundreds of studies, critics have found that some of those studies did not actually exist, something which has now been acknowledged by White House press secretary Karoline Leavitt. However, while she told reporters this week that the report will be updated, she doubled in her defence of RFK's vision, saying: 'It does not negate the substance of the report, which, as you know, is one of the most transformative health reports that has ever been released by the federal government.' The rise of the so-called Maha movement within the Trump administration is, according to its some, a chilling embrace of figures and ideologies that undermine established public health principles. Earlier this month, Trump announced his nominee for surgeon general: Casey Means, a medical doctor who dropped out of her surgical residency due to disillusionment with healthcare and who subsequently chose to practise functional medicine, a form of alternative medicine, and is now known for her 'wellness' advocacy. Among Kennedy's many claims: that vaccines cause autism; that psychiatric drugs cause mass shootings; that HIV is not the cause of Aids and instead it's due to recreational drug use. He has said Covid was 'targeted to attack caucasians and Black people' and argued that exposure to pesticides is a cause of gender dysphoria. In early May, during a televised town hall, he claimed, without evidence, that Darpa, the US Defence Department's research and development arm, is spraying Americans with chemicals via jet fuel, reviving long-debunked 'chemtrail' conspiracy theories. He has also made controversial statements about raw milk and fluoride in drinking water (Florida governor Ron DeSantis just signed a bill banning the addition of fluoride to public water supplies, making Florida only the second state to outlaw a practice long considered a cornerstone of public health). Since taking office, Kennedy has fired 10,000 staffers – before admitting some programmes were mistakenly cut and would be reinstated. A couple of weeks back, he appeared before Congress to ask for less money for the agency, planning drastic cuts in line with Trump's agenda. Like Kennedy, Casey Means is sceptical about vaccine safety and calls for more research on their cumulative effects, despite there being no evidence that the current Centres for Disease Control and Prevention (CDC) schedule is unsafe. Timothy Caulfield is a health law and science policy professor at the University of Alberta in Canada, and an expert in debunking pseudoscience in wellness culture. He is convinced the Maha movement at the centre of the US government will do harm for generations to come. 'Their erosion in trust in scientific institutions is tremendously damaging,' Caulfield says. Following the disruption of the Trump administration, it was reported that 75 per cent of scientists who responded to a survey in Nature were planning to leave the country, with Europe and Canada among the top choices for relocation. 'One of my greatest fears is the degree to which they're undermining institutions like the National Institutes of Health and the CDC, which is going to make it more difficult to point to the truth,' Caulfield says. '[Kennedy's] resurrection of the lie around vaccines and autism is a really good example of this because he tries to position himself and his team as being on the high ground.' There have been more measles cases in the US during the first three months of 2025 than in all of 2024, according to the CDC. While Kennedy seems to have made a volte-face on vaccinations, acknowledging recently that they are the best way to avoid spreading measles, he has also downplayed the seriousness of infections, actions experts see as damaging confidence in vaccines. The roots of this scepticism lie with former British doctor Andrew Wakefield. Wakefield was struck off the UK medical register after his 1998 paper suggesting a link between the MMR vaccine and autism sparked a major health scare. I interviewed Wakefield some years ago and he remained defiant, despite his discredited idea that there's an autism-vaccine link. His distrust of the medical establishment has found a new platform in Maha. Caulfield adds that having people who trained as medical doctors can make the movement seem more legitimate. He points to Dr Mehmet Oz, a TV staple of American daytime television, who Trump recently nominated as the administrator for Medicare and Medicaid, government programmes that provide health insurance for pensioners and people on low incomes. 'Dr Oz almost made it noble to open your mind to embracing fringe ideas and disproven ideas,' Caulfield says. Oz has promoted the antimalarial hydroxychloroquine as a cure for Covid. If Kennedy, Means and Dr Oz are the political wing of the Maha movement, the 'crunchy mums' are its foot soldiers. A loosely defined but increasingly vocal group, they're just as likely to be found on Instagram as in a food co-op, posting about raw milk, cloth diapers, or the dangers of seed oils. But what began as a subculture rooted in environmentalism and food equity has morphed into a more politicised movement that blends wellness, parental autonomy, and deep mistrust of mainstream medicine. And Kennedy is their leader. His anti-establishment rhetoric against Big Pharma, food additives, and what he sees as the corrupt medical-industrial complex, has found fertile ground among mothers who feel dismissed or ridiculed by conventional health authorities. For them, it's about reasserting control over their families' health in a system they no longer trust. Kennedy speaks their language and validates their deepest fears. But his critics warn of the real-world consequences of promoting medical misinformation. Jonathan Jarry is a science communicator with McGill University's Office for Science and Society. He says RFK is part of a much larger wellness movement that has, for many years now, told people what they should blame for their health problems. 'Basically, modernity itself has been turned into the bogeyman,' Jarry says. 'Everything that screams modernity, like pesticides and food dyes and even vaccines. Anything that your grandma didn't have access to.' But, Jarry says, there's always a kernel of truth buried inside the messaging from Maha – that's what makes it so effective. Of course, there are issues with ultra-processed foods. And so when people hear RFK and other Maha leaders identify a problem, it often has a ring of truth to it. 'People say, 'Finally he's talking about this thing we knew was bad,'' Jarry says. 'But the problem is that the solution they're offering is completely wrong. That's what happens when you have somebody who says, 'I see your pain and I know what's causing it; I know what we can blame for this, so follow me and together we will enact the right solutions even when those solutions are completely pseudo-scientific.'' Jarry says we know what it takes to be healthy, and none of this is revolutionary. Of course, there's a kernel of truth in the idea that corporations don't necessarily have our best interests at heart. 'But [Kennedy] will demonise the entire pharmaceutical industry and anybody who works in health regulation or vaccine development. And that can be appealing to people looking at these giant institutions that are raking in millions and millions of dollars, thinking there's something wrong there.' Dr Peter Hotez, dean of the National School of Tropical Medicine and an expert on vaccines, told Mother Jones magazine that he was deeply concerned that the vaccine ecosystem 'could collapse and we could see polio in the wastewater and the return of regular measles and pertussis outbreaks'. Jarry says he shares Hotez's fear. 'I think that it is very likely that we're going to see a resurgence of vaccine-preventable illnesses. We're already seeing what's happening with measles and there's going to be more. And unfortunately, these diseases don't stop at the border. And so there will be ripple effects on other countries throughout the world. 'Add to that the complete evisceration of the biomedical research funding apparatus in the United States … and [I think] we're going to go backwards to a time when these infections were spreading routinely and people are going to suffer and die for no good reason. And this is what's really horrifying.'
Yahoo
a day ago
- General
- Yahoo
U.S. just radically changed its COVID vaccine recommendations: How will it affect you?
As promised, federal health officials have dropped longstanding recommendations that healthy children and healthy pregnant women should get the COVID-19 vaccines. "The COVID-19 vaccine schedule is very clear. The vaccine is not recommended for pregnant women. The vaccine is not recommended for healthy children," the U.S. Department of Health and Human Services said in a post on X on Friday. In formal documents, health officials offer "no guidance" on whether pregnant women should get the vaccine, and ask that parents talk with a healthcare provider before getting the vaccine for their children. The decision was done in a way that is still expected to require insurers to pay for COVID-19 vaccines for children should their parents still want the shots for them. The new vaccine guidelines were posted to the website of the U.S. Centers for Disease Control and Prevention late Thursday. It wasn't immediately clear whether insurers will still be required under federal law to pay for vaccinations for pregnant women. The Trump administration's decision came amid criticism from officials at the nation's leading organizations for pediatricians and obstetricians. Some doctors said there is no new evidence to support removing the recommendation that healthy pregnant women and healthy children should get the COVID vaccine. "This situation continues to make things unclear and creates confusion for patients, providers and payers," the American College of Obstetricians and Gynecologists said in a statement Friday. Earlier in the week, the group's president, Dr. Steven Fleischman, said the science hasn't changed, and that the COVID-19 vaccine is safe during pregnancy, and protects both the mom-to-be and their infants after birth. "It is very clear that COVID-19 infection during pregnancy can be catastrophic," Fleischman said in a statement. Dr. Susan Kressly, president of the American Academy of Pediatrics, criticized the recommendation change as being rolled out in a "conflicting, confusing" manner, with "no explanation of the evidence used to reach their conclusions." "For many families, the COVID vaccine will remain an important way they protect their child and family from this disease and its complications, including long COVID," Kressly said in a statement. Some experts said the Trump administration should have waited to hear recommendations from a committee of doctors and scientists that typically advises the U.S. Centers for Disease Control and Prevention on immunization recommendations, which is set to meet in late June. The California Department of Public Health on Thursday said it supported the longstanding recommendation that "COVID-19 vaccines be available for all persons aged 6 months and older who wish to be vaccinated." The changes come as the CDC has faced an exodus of senior leaders and has lacked an acting director. Typically, as was the case during the first Trump administration and in the Biden administration, it is the CDC director who makes final decisions on vaccine recommendations. The CDC director has traditionally accepted the consensus viewpoint of the CDC's panel of doctors and scientists serving on the Advisory Committee on Immunization Practices. Even with the longstanding recommendations, vaccination rates were relatively low for children and pregnant women. As of late April, 13% of children, and 14.4% of pregnant women, had received the latest updated COVID-19 vaccine, according to the CDC. About 23% of adults overall received the updated vaccine, as did 27.8% of seniors age 65 and over. The CDC estimates that since October, there have been 31,000 to 50,000 COVID deaths and between 270,000 and 430,000 COVID hospitalizations. Here are some key points about the CDC's decision: Previously, the CDC's guidance was simple: everyone ages 6 months and up should get an updated COVID vaccination. The most recent version was unveiled in September, and is officially known as the 2024-25 COVID-19 vaccine. As of Thursday, the CDC, on its pediatric immunization schedule page, says that for healthy children — those age 6 months to 17 years — decisions about COVID vaccination should come from "shared clinical decision-making," which is "informed by a decision process between the healthcare provider and the patient or parent/guardian." "Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," the CDC says. The vaccine-skeptic secretary of Health and Human Services, Robert F. Kennedy Jr., contended in a video posted on Tuesday there was a "lack of any clinical data to support the repeat booster strategy in children." However, an earlier presentation by CDC staff said that, in general, getting an updated vaccine provides both children and adults additional protection from COVID-related emergency room and urgent care visits. Dr. Peter Chin-Hong, a UC San Francisco infectious diseases expert, said he would have preferred the CDC retain its broader recommendation that everyone age 6 months and up get the updated vaccine. "It's simpler," Chin-Hong said. He added there's no new data out there that to him suggests children shouldn't be getting the updated COVID vaccine. A guideline that involves "shared decision-making," Chin-Hong said, "is a very nebulous recommendation, and it doesn't result in a lot of people getting vaccines." Kressly, of the American Academy of Pediatrics, said the shared clinical decision-making model is challenging to implement "because it lacks clear guidance for the conversations between a doctor and a family. Doctors and families need straightforward, evidence-based guidance, not vague, impractical frameworks." Some experts had been worried that the CDC would make a decision that would've ended the federal requirement that insurers cover the cost of COVID-19 vaccines for children. The out-of-pocket cost for a COVID-19 vaccine can reach around $200. In its adult immunization schedule for people who have medical conditions, the CDC now says it has "no guidance" on whether pregnant women should get the COVID-19 vaccine. In his 58-second video on Tuesday, Kennedy did not explain why he thought pregnant women should not be recommended to get vaccinated against COVID-19. Chin-Hong, of UCSF, called the decision to drop the vaccination recommendation for pregnant women "100%" wrong. Pregnancy brings with it a relatively compromised immune system. Pregnant women have "a high chance of getting infections, and they get more serious disease — including COVID," Chin-Hong said. A pregnant woman getting vaccinated also protects the newborn. "You really need the antibodies in the pregnant person to go across the placenta to protect the newborn," Chin-Hong said. It's especially important, Chin-Hong and others say, because infants under 6 months of age can't be vaccinated against COVID-19, and they have as high a risk of severe complications as do seniors age 65 and over. There are some questions that don't have immediate answers. Will some vaccine providers start requiring doctor's notes in order for healthy children and healthy pregnant women to get vaccinated? Will it be harder for children and pregnant women to get vaccinated at a pharmacy? In a statement, CVS Pharmacy said it "follows federal guidance and state law regarding vaccine administration and are monitoring any changes that the government may make regarding vaccine eligibility." The insurer Aetna, which is owned by CVS, is also monitoring any changes federal officials make to COVID-19 vaccine eligibility "and will evaluate whether coverage adjustments are needed." Blue Shield of California said it will not change its practices on covering COVID-19 vaccines. "Despite the recent federal policy change on COVID-19 vaccinations for healthy children and pregnant women, Blue Shield of California will continue to cover COVID-19 vaccines for all eligible members," the insurer said in a statement. "The decision on whether to receive a COVID-19 vaccine is between our member and their provider. Blue Shield does not require prior authorization for COVID-19 vaccines." Under California law, health plans regulated by the state Department of Managed Health Care must cover COVID-19 vaccines without requiring prior authorization, the agency said Friday. "If consumers access these services from a provider in their health plan's network, they will not need to pay anything for these services," the statement said. Sign up for Essential California for news, features and recommendations from the L.A. Times and beyond in your inbox six days a week. This story originally appeared in Los Angeles Times.
Yahoo
a day ago
- Entertainment
- Yahoo
Caitlin Clark's quads, Trump-Musk bromance and 'Duck Dynasty': Your week in review
COVID-19 vaccines will no longer be part of the Centers for Disease Control and Prevention's recommended immunization schedule for healthy children and pregnant women, Health and Human Services Secretary Robert F. Kennedy Jr. announced. National Institutes of Health Director Jay Bhattacharya, joining Kennedy for the announcement posted in a video on X, called the change 'common sense and good science." Traditionally, immunization guidance is voted on by a CDC advisory committee; then the CDC director makes the final call. The CDC panel has not voted on Kennedy's change. COVID-19 protocols: Changes are happening. Here's what to know Could there be some cooling in the Trump-Musk bromance? The president's crusade to pass his "big, beautiful" tax and spending bill through Congress took some flak from his former right-hand man, who said he was "disappointed" with the cost of the bill and complained that it "undermines the work the DOGE team is doing." (Musk has also criticized Trump's tariffs.) Asked about Musk's remarks on the spending bill, Trump cited politics: "I'm not happy about certain aspects of it, but I'm thrilled by other aspects of it. … It's got a way to go." At least one break is official, however: Musk's turbulent 130-day run as a "special government employee" is now over. It's the end of the line for free checked bags on Southwest. For the first time, the airline is now charging for the service: $35 for a first checked bag and $45 for a second bag (overweight and oversized baggage costs more). Tickets booked or changed on or before May 28 don't apply, and for some customers, new fare categories and membership perks will still earn them free checked bags. The new fees are the latest major change for Dallas-based Southwest, including a farewell to its open seating policy of more than 50 years. In a news release, the airline acknowledged that "preferences have evolved." Phil Robertson, the bushy-bearded and plainspoken patriarch of the colorful Louisiana family featured on A&E Network's 'Duck Dynasty," has died. He was 79 and had battled Alzheimer's disease and other health problems, his family said. His family-run hunting products business, Duck Commander, was the epicenter of "Duck Dynasty," which ran from 2012 to 2017 on the back of the clan's three core tenets: "faith, family and ducks.' The duck call will not go silent, however; a spinoff, "Duck Dynasty: The Revival," premieres June 1. Call it the Caitlin Clark effect − in reverse. The Indiana Fever's star guard is out for at least two weeks after she strained her left quad in a loss to the New York Liberty, which meant she would be sidelined for at least the next four games. The WNBA is feeling the pain, too: Ticket prices have plunged since news of Clark's injury. It's especially disappointing for the Fever's road game June 7 against the Chicago Sky − the latest Clark vs. Angel Reese clash − which had been moved to the 23,000-plus-seat United Center to meet demand for tickets. − Compiled by Robert Abitbol, USA TODAY copy chief This article originally appeared on USA TODAY: Caitlin Clark's quads, Trump-Musk and 'Duck Dynasty': Week in review
Yahoo
2 days ago
- Health
- Yahoo
RFK Jr. Changes Guidance for This Common Vaccine
The Center for Disease Control and Prevention (CDC) will no longer recommend COVID-19 vaccines to healthy children and healthy pregnant women, the change being justified as 'common sense.' Secretary of Health and Human Services Robert F. Kennedy Jr. made the announcement on X Tuesday in a video message with the Director of the National Institutes of Health (NIH) Dr. Jay Bhattacharya and Federal Drug Administration (FDA) Commissioner Marty Makary. 'I couldn't be more pleased to announce that, as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,' Kennedy said. He accused the Biden administration of urging healthy children to get 'yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.' 'That ends today. It's common sense and it's good science,' chirped Bhattacharya. 'There's no evidence healthy kids need it today, and most countries have stopped recommending it for children,' added Makary. 'We're now one step closer to realizing President Trump's promise to Make America Healthy Again,' Kennedy concluded. Both Kennedy and Makary teased this new development last week, Makary hinting that annual shots for healthy adults and children might not be regularly approved anymore, and Kennedy placing new restrictions on the Novavax COVID-19 vaccine. This marks a drastic shift from the CDC's previous stance on the COVID vaccine, the agency saying two weeks prior to Trump's second inauguration that they recommend that 'everyone ages 6 months and older should get a 2024–2025 COVID-19 vaccine.' But Kennedy's announcement comes before the CDC's Advisory Committee on Immunization Practices has completed its deliberations on whether or not pregnant women should remain eligible for the COVID-19 vaccine. The Committee was set to vote on the issue, among others, in June. Multiple studies have stated that pregnant women are at an increased risk from COVID, going against Kennedy's 'common sense' claim that they don't require vaccination. One study conducted by researchers at Brown University School of Public Health showed that maternal mortality spiked at the peak of COVID in 2021. Even Elon Musk's AI chatbot on X, Grok, couldn't believe its digital ears, writing that the trio's statement 'cited 'lack of clinical data' but provided no specific scientific papers.' 'A 2022 Lancet study supports vaccine safety in pregnancy, showing no adverse outcomes,' it wrote. 'Critics cite 2023 ACIP data indicating benefits across groups. Without direct HHS citations, the decision's basis remains unclear.' Leaving out healthy children and pregnant women from the CDC's recommended immunization schedule could also significantly alter existing insurance guidelines. The immunization schedule provides a guide for doctors and insurance coverage for Medicaid expansion programs and a majority of private insurance plans. All three men have been outspoken about their vaccine criticism, Makary previously claiming that the FDA and CDC 'lied to the American people' about the need for additional COVID measures such as booster shots. 'The greatest perpetrator of misinformation during the pandemic has been the United States government,' Makary said at a 2023 roundtable organized by Republicans. Last week, Bhattacharya said at a disastrous town hall with his NIH staff that it's 'possible that the NIH partly sponsored' research that he claims might have caused the COVID pandemic, prompting a walkout in protest by dozens of staffers.
