Latest news with #DrMartyMakary
CNN
30-05-2025
- Business
- CNN
How changes to Covid-19 vaccine policy in the US may affect you
The US Department of Health and Human Services, under Secretary Robert F. Kennedy Jr., has recently made significant changes to how Covid-19 vaccines are approved and the groups they are recommended for. For the past few years, the federal government has broadly approved and recommended an updated Covid-19 shot for everyone ages 6 months and up each fall. But last week, leaders from the US Food and Drug Administration outlined a new framework for the approval process for Covid-19 vaccines that could limit shots to older Americans and people at higher risk of serious Covid-19 infection. On Tuesday, Kennedy announced that the vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention's immunization schedule. These changes, made in unconventional ways, will probably affect access to and availability of Covid-19 vaccine shots for millions. Under the framework outlined by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, updated Covid-19 vaccines will probably be approved for everyone 65 and older and for people 6 months and older who have at least one underlying condition that puts them at 'high risk for severe Covid-19 outcomes.' The CDC lists dozens of conditions that may contribute to higher Covid-19 risk, including asthma, cancer, diabetes, obesity and a history of smoking. These underlying conditions will make between 100 million and 200 million people in the US eligible for a Covid-19 vaccine under the new framework, the FDA leaders estimate. Pregnancy is included on the list of factors that the CDC says have shown 'a conclusive increase in risk' for at least one severe Covid-19 outcome. Kennedy did not offer a specific reason behind the decision to stop recommending the Covid-19 for pregnant people in Tuesday's announcement, but the move appears to directly contradict the new framework outlined a week earlier. For kids and adults younger than 65 who do not have an underlying condition, the FDA says it will require in-depth clinical trials before licensing new vaccines. An independent group of advisers to the CDC – the Advisory Committee on Immunization Practices, or ACIP – is expected meet at the end of June to vote on Covid-19 vaccine recommendations, and they had already been weighing options for more targeted risk-based recommendations than the general guidelines issued in previous years. Experts say next month's meeting could be a pivotal moment in the future of Covid-19 vaccine access, with much uncertainty around what will happen if the advisers recommend a different path forward than officials have outlined. Maybe, but it may be more difficult – and expensive. 'Theoretically, one could find someone who would be willing to provide them the vaccine – and they may have to pay out of pocket to get it – but there's a lot of things that have to align for that to happen,' said Dr. Michelle Fiscus, a pediatrician and chief medical officer of the Association of Immunization Managers. Health care providers, including pediatricians, may be able to provide the Covid-19 vaccine 'off-label' – but they'd need to have the vaccine in stock, which has become increasingly uncommon. The vast majority of Covid-19 vaccinations happen at pharmacies. Pharmacists generally don't have the tools to verify medical history and whether an individual has a condition that makes them high-risk, so many of them could take patients at their word. But the recent announcements from the federal government may have a chilling effect on what providers are willing to do, experts say. It's likely that people who are covered by public insurance such as Medicare and Medicaid and who meet the new FDA eligibility requirements will continue to have Covid-19 vaccines covered, experts say. There's more uncertainty around how private insurance companies will choose to adjust coverage. Some of the conditions that the CDC lists as high-risk for Covid-19 – such as 'physical inactivity' – are loosely defined and may be left up to individual plans to interpret. Under the Affordable Care Act, insurance companies are required to cover vaccines for adults if they've been recommended by ACIP. The committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who would not otherwise be able to afford them. However, there's a gray area around what will happen if ACIP recommendations differ from CDC recommendations, experts say. In a video posted on social media on Tuesday, Kennedy said that changes to the recommendations for children and pregnant people took effect that same day. As of Thursday morning, however, the CDC's recommended immunization schedule posted online had not changed. Last week's editorial from Makary and Prasad said that the new framework for vaccine approval would be adopted 'moving forward.' The FDA officials say the new policy balances the need to swiftly approve vaccines – to have them ready by the fall respiratory virus season for the most vulnerable adults and children – against the need for more evidence before offering them to others. Under this newly proposed framework, the FDA says, it will require additional evidence from vaccine manufacturers before approving updated Covid-19 shots for healthy kids and adults. The officials said those studies should last a minimum of six months, which would preclude any findings from influencing approvals in time for this fall. The CDC's independent vaccine advisers meet at the end of June and are expected to vote on this fall's Covid-19 vaccine recommendations. Their decisions have guided vaccine policy in the US for decades, but it's unclear how much influence it will have over the newly announced changes. HHS still hasn't signed off on two of the three recommendations that were made at the group's last meeting, in April. The Covid-19 vaccines that are currently available in the US have been approved by the FDA after rigorous analysis and are considered safe. In their editorial outlining the new framework for Covid-19 vaccine approval, the FDA's Makary and Prasad said that 'the benefit of repeat dosing … is uncertain,' but they did not present evidence that Covid-19 vaccines themselves are unsafe. The agency says it will approve vaccines for healthy kids and adults only after studies that prove that the shots can prevent symptomatic Covid-19 better than a placebo. However, the new plan doesn't take into account other effects of Covid-19 infections, such as long Covid. These changes to Covid-19 vaccine policy limit opportunities to protect people who are at high risk, including young children and pregnant people, experts say 'We have vaccines that we know were critical in saving lives during the pandemic and we continue to see the morbidity and mortality from Covid-19,' Fiscus said. 'It's very concerning that people who would choose to protect themselves or their children with a vaccine may have that choice taken away.' CNN's Brenda Goodman contributed to this report.
CNN
29-05-2025
- Business
- CNN
How changes to Covid-19 vaccine policy in the US may affect you
The US Department of Health and Human Services, under Secretary Robert F. Kennedy Jr., has recently made significant changes to how Covid-19 vaccines are approved and the groups they are recommended for. For the past few years, the federal government has broadly approved and recommended an updated Covid-19 shot for everyone ages 6 months and up each fall. But last week, leaders from the US Food and Drug Administration outlined a new framework for the approval process for Covid-19 vaccines that could limit shots to older Americans and people at higher risk of serious Covid-19 infection. On Tuesday, Kennedy announced that the vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention's immunization schedule. These changes, made in unconventional ways, will probably affect access to and availability of Covid-19 vaccine shots for millions. Under the framework outlined by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, updated Covid-19 vaccines will probably be approved for everyone 65 and older and for people 6 months and older who have at least one underlying condition that puts them at 'high risk for severe Covid-19 outcomes.' The CDC lists dozens of conditions that may contribute to higher Covid-19 risk, including asthma, cancer, diabetes, obesity and a history of smoking. These underlying conditions will make between 100 million and 200 million people in the US eligible for a Covid-19 vaccine under the new framework, the FDA leaders estimate. Pregnancy is included on the list of factors that the CDC says have shown 'a conclusive increase in risk' for at least one severe Covid-19 outcome. Kennedy did not offer a specific reason behind the decision to stop recommending the Covid-19 for pregnant people in Tuesday's announcement, but the move appears to directly contradict the new framework outlined a week earlier. For kids and adults younger than 65 who do not have an underlying condition, the FDA says it will require in-depth clinical trials before licensing new vaccines. An independent group of advisers to the CDC – the Advisory Committee on Immunization Practices, or ACIP – is expected meet at the end of June to vote on Covid-19 vaccine recommendations, and they had already been weighing options for more targeted risk-based recommendations than the general guidelines issued in previous years. Experts say next month's meeting could be a pivotal moment in the future of Covid-19 vaccine access, with much uncertainty around what will happen if the advisers recommend a different path forward than officials have outlined. Maybe, but it may be more difficult – and expensive. 'Theoretically, one could find someone who would be willing to provide them the vaccine – and they may have to pay out of pocket to get it – but there's a lot of things that have to align for that to happen,' said Dr. Michelle Fiscus, a pediatrician and chief medical officer of the Association of Immunization Managers. Health care providers, including pediatricians, may be able to provide the Covid-19 vaccine 'off-label' – but they'd need to have the vaccine in stock, which has become increasingly uncommon. The vast majority of Covid-19 vaccinations happen at pharmacies. Pharmacists generally don't have the tools to verify medical history and whether an individual has a condition that makes them high-risk, so many of them could take patients at their word. But the recent announcements from the federal government may have a chilling effect on what providers are willing to do, experts say. It's likely that people who are covered by public insurance such as Medicare and Medicaid and who meet the new FDA eligibility requirements will continue to have Covid-19 vaccines covered, experts say. There's more uncertainty around how private insurance companies will choose to adjust coverage. Some of the conditions that the CDC lists as high-risk for Covid-19 – such as 'physical inactivity' – are loosely defined and may be left up to individual plans to interpret. Under the Affordable Care Act, insurance companies are required to cover vaccines for adults if they've been recommended by ACIP. The committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who would not otherwise be able to afford them. However, there's a gray area around what will happen if ACIP recommendations differ from CDC recommendations, experts say. In a video posted on social media on Tuesday, Kennedy said that changes to the recommendations for children and pregnant people took effect that same day. As of Thursday morning, however, the CDC's recommended immunization schedule posted online had not changed. Last week's editorial from Makary and Prasad said that the new framework for vaccine approval would be adopted 'moving forward.' The FDA officials say the new policy balances the need to swiftly approve vaccines – to have them ready by the fall respiratory virus season for the most vulnerable adults and children – against the need for more evidence before offering them to others. Under this newly proposed framework, the FDA says, it will require additional evidence from vaccine manufacturers before approving updated Covid-19 shots for healthy kids and adults. The officials said those studies should last a minimum of six months, which would preclude any findings from influencing approvals in time for this fall. The CDC's independent vaccine advisers meet at the end of June and are expected to vote on this fall's Covid-19 vaccine recommendations. Their decisions have guided vaccine policy in the US for decades, but it's unclear how much influence it will have over the newly announced changes. HHS still hasn't signed off on two of the three recommendations that were made at the group's last meeting, in April. The Covid-19 vaccines that are currently available in the US have been approved by the FDA after rigorous analysis and are considered safe. In their editorial outlining the new framework for Covid-19 vaccine approval, the FDA's Makary and Prasad said that 'the benefit of repeat dosing … is uncertain,' but they did not present evidence that Covid-19 vaccines themselves are unsafe. The agency says it will approve vaccines for healthy kids and adults only after studies that prove that the shots can prevent symptomatic Covid-19 better than a placebo. However, the new plan doesn't take into account other effects of Covid-19 infections, such as long Covid. These changes to Covid-19 vaccine policy limit opportunities to protect people who are at high risk, including young children and pregnant people, experts say 'We have vaccines that we know were critical in saving lives during the pandemic and we continue to see the morbidity and mortality from Covid-19,' Fiscus said. 'It's very concerning that people who would choose to protect themselves or their children with a vaccine may have that choice taken away.' CNN's Brenda Goodman contributed to this report.
Daily Mail
22-05-2025
- Health
- Daily Mail
RFK Jr lays bare shocking state of America's young... with most now too sick or weak to serve in armed forces
Robert F Kennedy Jr has unveiled his flagship Make America Healthy Again (MAHA) report which lays bare the epidemic of chronic disease in young people. It astonishingly suggests three in four young Americans are too sick to fight for their country due to surging rates of obesity, diabetes and neurological disorders. Experts told the startling figure represents an 'issue of national security' leaving the US unable to defend itself from foreign adversaries. The 60-page document echoes many of Kennedy's proposed culprits behind the country's health issues, including ultraprocessed foods, environmental toxins like pesticides and a lack of physical activity. It also criticizes the 'overmedicalization' of children, with its most anticipated controversial viewpoint involving cutting down on childhood vaccines. The report suggests the current childhood vaccines have not been properly tested for safety and efficacy - a stance most experts disagree with. Spearheaded by Kennedy and health agency leaders like Dr Marty Makary of the FDA and Dr Jay Bhattacharya of the National Institutes of Health (NIH), the Making Our Children Healthy Again assessment does not offer specific policies or proposed initiatives. Those will instead come in a strategy document to be released in August. Dr Aseem Malhotra, chief medical advisor to the MAHA Commission, told 'This comprehensive report lays bare the crisis of chronic disease in America and alludes to root causes.' The surge of chronic diseases 'The health of American children is in crisis,' the report states. Over 40 percent of the nation's 73 million children have at least one chronic health condition, according to the CDC. These include asthma, allergies, obesity, autoimmune diseases and behavioral disorders like ADHD. In particular, over 40 percent of Americans are obese, meaning they have a body mass index (BMI) over 30. And one in five children over six are obese, a 270 percent increase compared to the 1970s. 'Although estimates vary depending on the conditions included all studies show an alarming increase over time,' the authors wrote. Additionally, 350,000 children have been diagnosed with diabetes, most of whom with type 2. This represents a 600 percent surge since the 1980s by 2060 if current trends continue. Echoing Kennedy, the report also cites an increase in autism, which now affects one in 31 American children. In the early 2000s, that number was closer to one in 150. Childhood cancer has also increased 40 percent since 1975, and rates of mental health conditions like depression have doubled in the last decade. All of these factors have left 75 percent of Americans ages 17 to 24 ineligible for military service, 'posing a threat to our nation's health economy and military readiness.' The cause of the epidemic The MAHA commission believes America's reliance on ultraprocessed foods can largely be blamed for a surge in chronic diseases. For example, 70 percent of the food in the country's food supply is considered ultraprocessed, meaning it is filled with added sugars, fats and artificial additives. Ultraprocessed foods also make up 50 percent of the diets of pregnant and newly postpartum mothers, causing ill effects to carry over to their children. 'The excessive consumption of UPFs has led to depletion of essential micronutrients and dietary fiber while increasing the consumption of sugars and carbohydrates which negatively affects overall health,' the authors state. They cite a recent report in Nature Medicine that estimates sugar-sweetened beverages alone may be responsible for 1.2 million new cases of heart disease and 340,000 deaths worldwide in 2020 alone. Artificial additives like Red 40 have also been tied to hyperactivity in children and increased diagnoses of conditions like ADHD. MAHA's health officials also slammed children's exposure to environmental toxins, including pollution, pesticides, microplastics and 'forever chemicals.' Microplastics in particular have been shown to be endocrine-disrupting, meaning they alter levels of sex-based hormones like estrogen and testosterone. The authors wrote: 'Children are particularly vulnerable to chemicals during critical stages of development in utero infancy early childhood and puberty. 'Even minor exposures during critical periods—in utero infancy early childhood and adolescence—can result in developmental delays or permanent harm.' The overmedicalization of children MAHA also warns that today's children are being 'overmedicated,' putting them at risk of lasting side effects. They cite one in five US children are estimated to be taking at least one prescription medication in the past 30 days. Rates are highest in teens, 27 percent of whom take one or more drugs daily. Prescriptions for stimulants, which are used to treat ADHD, have doubled in boys from 2006 to 2022, with one in four boys taking one by age 17. Additionally, prescriptions for antidepresants increased 1400 percent from 1987 to 2014, and the use of antipsychotics rose 800 percent from 1995 to 2009. The experts warn that while much of this increase is due to general medical advancement, overmedicalization can lead to lasting effects. Psychiatric drugs have been shown to cause seizures and manic episodes, while antidepressants carry the risk of dependence and an increased risk of suicidal thoughts. In one of its more controversial viewpoints, the MAHA commission also criticized the US childhood vaccine schedule. Since 1986, the number of recommended vaccines for a child by the time they reach age one has increased from three to 29, including those administered to pregnant mothers. The authors note that while the amount of vaccines in the recommended schedule is higher than peer nations, there is limited data on the safety of the US schedule compared to other countries. They also noted the Vaccine Adverse Event Reporting System (VAERS) may not been reliable because it relies on patients and doctors to report effects. 'Many health care professionals do not report to VAERS because they are not mandated to do so or they may not connect the adverse event to vaccination,' the authors said. The viewpoints echo those of RFK Jr, who has long been critical of vaccines, despite stating during his confirmation hearings that he would not strip away vaccinations. However, health agencies have already reported initiatives to investigate vaccines, such as CDC research into the long disproven theory that vaccines cause autism. The authors wrote: 'Vaccines benefit children by protecting them from infectious diseases. But as with any medicine vaccines can have side effects that must be balanced against their benefits.
Daily Mail
20-05-2025
- Health
- Daily Mail
Trump's FDA announces radical change to Covid vaccine schedule that will affect millions
The FDA has revealed a radical shift in its Covid vaccination policy. The agency says it is now set to only recommend Covid vaccines to older adults over 65 and people who are immunocompromised. It marks a major shift from the current policy, recommending a dose of the updated Covid vaccine to everyone aged six months and over. And it could leave millions unable to get the vaccine through their health insurance. But the FDA head Dr Marty Makary says the change is needed, adding that there is no clear benefit from vaccinating millions of healthy people against Covid every year. He says it has fostered public distrust and led many to forgo vital vaccinations, such as that against measles — with the US recording its biggest outbreak in two decades this year. The new policy was revealed in an editorial published Tuesday in the New England Journal of Medicine, authored by Dr Makary and the FDA's head on vaccines Dr Vinay Prasad. It is set to be unveiled at a press conference later today, and will likely affect people seeking an updated Covid shot in fall 2025. They wrote: 'Over the past two seasons, uptake of the annual Covid booster has been poor. Less than 25 percent of Americans received boosters each year. 'There may even be a ripple effect: Public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles-mumps-rubella vaccination.' The change will more closely align the US with other nations, like the UK, Canada and Australia — which all only recommend updated Covid shots to older adults. Uptake of the updated Covid vaccinations has been in free-fall, with latest CDC data showing barely 20 percent of adults received the shot this respiratory virus season. The pair added: 'While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid... '... the US adopted a one-size-fits-all regulatory framework and has granted broad marketing authoritzation to all Americans over the age of six months.' 'The US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. 'We reject this view.' The pair said Covid vaccines for young adults would be approved, but only after pharmaceutical companies could demonstrate that they create protective antibody concentrations in the group. Dr Noel Brewer, a public health expert at the University of North Carolina, Chapel Hill, and who sits on the CDC's vaccine recommendation committee, told CNN that he supported the change. 'The proposed policy moves the US into line with other countries. This global view of public health is a welcome development,' he said. Dr Paul Offit, a pediatrician at the Children's Hospital of Philadelphia and a member of the FDA's vaccines advisory group, disagreed, however. He said: 'We have been using an evidence-based approach to Covid vaccination, but they kind of swoop in and believe that for the first time, we're going to get, as they say, "gold standard" data, robust data, for the first time, because, according to them, we don't have that, but we do have that. 'That's why we've made good decisions about the vaccines. That's why that vaccine is remarkably safe. I mean, the mRNA vaccines are remarkably safe.' The FDA is set to announce the policy in a press conference at 1pm today.
Wall Street Journal
20-05-2025
- Health
- Wall Street Journal
Trump Administration Toughens Requirements for Covid Vaccine Approval
The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency's new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too. The original Covid-19 shots were tested in large, randomized controlled trials against placebos. Subsequent versions, updated to match new strains, were tested to ensure they triggered immune systems to fight the virus. Such testing looks for antibodies in people who have received the shots and is easier to conduct than trials looking at whether the shots prevent hospitalization or other outcomes.
