Latest news with #AdvisoryCommitteeonImmunizationPractices
American Military News
29-05-2025
- Health
- American Military News
Video: Covid vaccine no longer recommended by CDC for kids, pregnant women
Secretary of Health and Human Services Robert F. Kennedy Jr. released a video on Tuesday announcing that President Donald Trump's administration was removing healthy children and pregnant women from the list of people recommended by the Centers for Disease Control and Prevention (CDC) to receive the COVID-19 vaccine. In a video shared Tuesday on X, formerly Twitter, Kennedy said, '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 explained that former President Joe Biden's administration encouraged healthy children to 'get yet another COVID shot' last year 'despite the lack of any clinical data to support the repeat booster strategy in children.' 'That ends today,' National Institutes of Health Director Dr. Jay Bhattacharya said. 'It's common sense, and it's good science.' READ MORE: New Chinese Covid strain spreads to US In Tuesday's video, Food and Drug Administration Commissioner Dr. Martin Makary claimed that there was 'no evidence' that healthy children need the COVID-19 booster vaccine. Makary added that most other countries have stopped recommending the vaccine for healthy children. In conclusion to Tuesday's video regarding the CDC's decision to no longer recommend healthy children and healthy pregnant women receive the COVID-19 vaccine, Kennedy said, 'We're now one step closer to realizing President Trump's promise to make America healthy again.' Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from @CDCgov recommended immunization schedule. Bottom line: it's common sense and it's good science. We are now one step closer to realizing @POTUS's promise to Make America Healthy Again. — Secretary Kennedy (@SecKennedy) May 27, 2025 CBS News reported that Kennedy's announcement on Tuesday comes as the Advisory Committee on Immunization Practices is expected to meet in June. The outlet noted that prior to Tuesday's announcement, the Advisory Committee on Immunization Practices had been expected to vote on changes to COVID-19 vaccine recommendations for different groups of Americans. In an email obtained by CBS News, Vianca Rodriguez Feliciano, a Department of Health and Human Services spokesperson, said, 'With the COVID-19 pandemic behind us, it is time to move forward. HHS and the CDC remain committed to gold standard science and to ensuring the health and well-being of all Americans — especially our nation's children — using common sense.'
Yahoo
22-05-2025
- Health
- Yahoo
The far-right learned to weaponize Covid. And it's about to effect all of us.
On Tuesday, the Food and Drug Administration announced plans to significantly curtail people's access to Covid-19 vaccines. Under the new framework, outlined in an article published in the New England Journal of Medicine by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad, routine approval of updated vaccines will be limited to the elderly and vulnerable only. Approval for the rest of the 'healthy' population will require extensive, costly testing. While Makary and Prasad claimed their policy 'balances the need for evidence,' critics noted a number of problems with the plan right away. Some of the research demanded for broad approval of new Covid vaccines was infeasible and even unethical. There were no carve-outs for caregivers upon whom vulnerable people depend. The timing of the release appeared primed to usurp the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, which makes vaccine recommendations. Valid as the criticisms were, the new approach to the Covid vaccines most likely has little to do with practical public health management. Instead, it appears to be an inevitable effort to reinforce narratives favored by the Trump administration and the political right. While it may seem unusual that Donald Trump's FDA would go after vaccines developed through his Operation Warp Speed program in his first term — vaccines he once called the 'gold standard' — America's right wing has been getting solid mileage for years now out of politicizing all things Covid. It began in 2020 with a coordinated push to generate public backlash to lockdowns. The ultimate aim was restoring normalcy, ending a politically and economically inconvenient crisis. Over time, however, the campaign expanded to include more wedges — the virus' origins, school closures, mask mandates and, of course, vaccines. After the emergency declaration ended and the public moved on — with a U.S. Covid death toll standing at well over 1 million — right-wing groups, politicians and media pivoted to rewriting pandemic history. The success of those efforts may have contributed to Trump's return to office after mismanaging the crisis during his first term. The president himself seems to think so. Last month, the White House replaced the informational website with a new page promoting the speculative lab leak theory of the pandemic's origins and featuring sections on the harms of lockdowns and mask mandates. The FDA's new guidance on Covid vaccines can be seen as an extension of this effort, using the imprimatur of the agency to validate misleading and false narratives promoted by the right about the Covid — namely that the vaccines are insufficiently tested with unknown effects and unsuited for young people. Indeed, the authors of the policy were themselves prolific spreaders of those narratives. Makary was already a bestselling author before Covid, and his vocal criticisms of the federal pandemic response and his questioning of the mRNA jabs built up his audience and political influence. The doctor became a favorite of media outlets like Fox News and dark money groups like the anti-vax Brownstone Institute and the Heritage Foundation — which produced the Trump 2.0 blueprint, 'Project 2025.' Makary got to testify before the GOP-led House Select Subcommittee on the Coronavirus Pandemic at its first hearing in February 2023 and participate in the wellness roundtable Sen. Ron Johnson, R-Wis., convened in September. During his testimony before Congress, Makary called the decision to offer booster doses to children a 'tragic mistake.' He also falsely indicated that no healthy children had died from Covid in the United States to argue the jabs presented a greater risk than the virus to that young population. The FDA commissioner role was the big prize, however. Serving under his ally, Health and Human Services Secretary Robert Kennedy Jr. — a longtime anti-vaccine activist who called the Covid jab 'the deadliest ever made' — Makary was bound to take a stab at the vaccines. All of the signs were there. One of his first acts was to bring on another vaccine skeptic, Dr. Tracy Beth Høeg, a physical medicine doctor and epidemiologist who had worked in Florida Gov. Ron DeSantis' Health Department, as his special assistant. The pair had collaborated on a Brownstone project called the Norfolk Group, which crafted an outline for a congressional inquiry into the federal Covid response ahead of the subcommittee hearing. With Høeg on the team, Makary's FDA held up the scheduled approval of the Novavax booster, eventually scaling it back and limiting it to the elderly and the vulnerable in a precursor to Tuesday's policy announcement. Earlier this month, Makary also brought Prasad into the agency as its top vaccine regulator. Prasad, like Makary, has a link to Brownstone and spent years criticizing the FDA over Covid jabs, hyping up safety concerns about rare side effects like myocarditis, questioning their efficacy and suggesting that the risk-benefit ratio disfavored approval. Prasad has become known for his aggressive posture, extreme statements and demands for randomized-controlled trials for all Covid mitigations, including new boosters. Although in his academic research, he has praised the vaccines — a paper he co-authored in June called them 'a miraculous, life-saving advance offering staggering efficacy in adults' — his demeanor online betrays his position. Prasad has argued that mRNA research ought to be deprioritized by the National Institutes of Health, and in March, he posted on X mocking the drop in Moderna's stock price over the previous year, writing, 'MRNA technology is so promising and everyone wants it!! 🥳.' His advocacy brought him a massive online following and also paid off politically. In 2022, the pair were two of the loudest voices lambasting the FDA for allegedly approving the bivalent omicron-specific boosters without adequate testing behind them. In a post on Twitter — now X — that October, Makary lamented, 'It appears the FDA no longer requires clinical trial data Pfizer & Moderna's new Omicron vax (tested in 8 mice) was authorized today for children, who are at the highest risk of vaccine-induced myocarditis.' 'FDA bypassed their expert advisers…The most political FDA & CDC in U.S. history,' he wrote. As The Wall Street Journal noted the previous month in an infographic, the bivalent doses did not need to undergo human testing for safety since the original omicron strain vaccines did. 'The changes simply update proven shots,' the graphic explained. 'The process is similar to the development of the annual flu shots, which are given without testing them in people.' Days after the Journal piece, Prasad — who at the time claimed to be a political 'liberal' in the vein of Elizabeth Warren and Bernie Sanders — argued in a YouTube video, as he wrote in the tweet sharing it, 'a bivalent covid booster is NOT LIKE the annual flu shot and…human studies (not 8-10 mice) are needed.' Prasad's post was later boosted by Dr. Jay Bhattacharya, today the director of the National Institutes of Health. Another of his tweets was shared by Makary. Billions of doses have been given over the years. There has been extensive safety monitoring of the vaccines, which have saved millions of lives in the United States and prevented even more hospitalizations. The data shows they reduce Covid transmission and the odds of getting long Covid and offer robust protection against severe illness and death. With the current leadership at FDA and HHS, the incentives are simply stacked against humane vaccine policy. The only question is how far the agency will go. Is this new guidance the start of a complete phase-out of the vaccines, and might other immunizations follow? Time will tell. This article was originally published on
Yahoo
22-05-2025
- Health
- Yahoo
FDA Will Approve COVID-19 Vaccine Only for Older Adults and High-Risk Groups
On May 20, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes. However, healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups. FDA Commissioner Martin Makary and the agency's head of vaccines, Vinay Prasad, described the new framework in an article published in the New England Journal of Medicine and in a public webcast. The Conversation U.S. asked Libby Richards, a nursing professor involved in public health promotion, to explain why the changes were made and what they mean for the general public. Libby Richards: Until the May 20 announcement, getting a yearly COVID-19 vaccine was recommended for everyone ages 6 months and older, regardless of their health risk. According to Makary and Prasad, the Food and Drug Administration is moving away from these universal recommendations and instead taking a risk-based approach based on its interpretation of public health trends – specifically, the declining COVID-19 booster uptake, a lack of strong evidence that repeated boosters improve health outcomes for healthy people and the fact that natural immunity from past COVID-19 infections is widespread. The FDA states it wants to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups. The FDA's decision to adopt a risk-based framework for the COVID-19 vaccine aligns with the expected recommendations from the Advisory Committee on Immunization Practices, an advisory group of vaccine experts offering expert guidance to the Centers for Disease Control and Prevention on vaccine policy, which is scheduled to meet in June 2025. But while this advisory committee was also expected to recommend allowing low-risk people to get annual COVID-19 vaccines if they want to, the FDA's policy will likely make that difficult. Although the FDA states that its new policy aims to promote greater transparency and evidenced-based decision-making, the change is controversial – in part because it circumvents the usual process for evaluating vaccine recommendations. The FDA is enacting this policy change by limiting its approval of the vaccine to high-risk groups, and it is doing so without any new data supporting its decision. Usually, however, the FDA broadly approves a vaccine based on whether it is safe and effective, and decisions on who should be eligible to receive it are left to the CDC, which receives research-based guidance from the Advisory Committee on Immunization Practices. Additionally, FDA officials point to Canada, Australia and some European countries that limit vaccine recommendations to older adults and other high-risk people as a model for its revised framework. But vaccine strategies vary widely, and this more conservative approach has not necessarily proven superior. Also, those countries have universal health care systems and have a track record of more equitable access to COVID-19 care and better COVID-19 outcomes. Another question is how health officials' positions on COVID-19 vaccines affect public perception. Makary and Prasad noted that COVID-19 vaccination campaigns may have actually eroded public trust in vaccination. But some vaccine experts have expressed concerns that limiting COVID-19 vaccine access might further fuel vaccine hesitancy because any barrier to vaccine access can reduce uptake and hinder efforts to achieve widespread immunity. The New England Journal of Medicine article includes a lengthy list of conditions that increase the risk of severe COVID-19 and notes that about 100 million to 200 million people will fall into this category and will thus be eligible to get the vaccine. Pregnancy is included. Some items on the list, however, are unclear. For example, the list includes asthma, but the data that asthma is a risk factor for severe COVID-19 is scant. Also on the list is physical inactivity, which likely applies to a vast swath of Americans and is difficult to define. Studies have found links between regular physical activity and reduced risk of severe COVID-19 infection, but it's unclear how health care providers will define and measure physical inactivity when assessing a patient's eligibility for COVID-19 vaccines. Most importantly, the list leaves out an important group – caregivers and household members of people at high risk of severe illness from COVID-19 infection. This omission leaves high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with. Multiple countries the new framework refers to do include this group. According to the FDA, the benefits of multiple doses of COVID-19 vaccines for healthy adults are currently unproven. It's true that studies beyond the fourth vaccine dose are scarce. However, multiple studies have demonstrated that the vaccine is effective at preventing the risk of severe COVID-19 infection, hospitalization and death in low-risk adults and children. Receiving multiple doses of COVID-19 vaccines has also been shown to reduce the risk of long COVID. The FDA is requiring vaccine manufactures to conduct additional large randomized clinical trials to further evaluate the safety and effectiveness of COVID-19 boosters for healthy adults and children. These trials will primarily test whether the vaccines prevent symptomatic infections, and secondarily whether they prevent hospitalization and death. Such trials are more complex, costly and time-consuming than the more common approach of testing for immunological response. This requirement will likely delay both the timeliness and the availability of COVID-19 vaccine boosters and slow public health decision-making. Not automatically. Under the new FDA framework, healthy adults who wish to receive the fall COVID-19 vaccine will face obstacles. Health care providers can administer vaccines 'off-label', but insurance coverage is widely based on FDA recommendations. The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. The FDA's focus on individual risks and benefits may overlook broader public health benefits. Communities with higher vaccination rates have fewer opportunities to spread the virus. High-risk children age 6 months and older who have conditions that increase the risk of severe COVID-19 are still eligible for the vaccine under the new framework. As of now, healthy children age 6 months and older without underlying medical conditions will not have routine access to COVID-19 vaccines until further clinical trial data is available. Existing vaccines already on the market will remain available, but it is unclear how long they will stay authorized and how the change will affect childhood vaccination overall. Libby Richards is a professor at Purdue University's School of Nursing. Her research efforts focus on understanding and intervening on the individual and interpersonal influences on physical activity behavior, including examination of dyadic relationships in physical activity promotion and community-based interventions. The post FDA Will Approve COVID-19 Vaccine Only for Older Adults and High-Risk Groups appeared first on Katie Couric Media.
Yahoo
21-05-2025
- Health
- Yahoo
FDA limits access to COVID-19 vaccine to older adults and other high-risk groups – a public health expert explains the new rules
On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes. However, healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups. FDA Commissioner Martin Makary and the agency's head of vaccines, Vinay Prasad, described the new framework in an article published in the New England Journal of Medicine and in a public webcast. The Conversation U.S. asked Libby Richards, a nursing professor involved in public health promotion, to explain why the changes were made and what they mean for the general public. Until the May 20 announcement, getting a yearly COVID-19 vaccine was recommended for everyone ages 6 months and older, regardless of their health risk. According to Makary and Prasad, the Food and Drug Administration is moving away from these universal recommendations and instead taking a risk-based approach based on its interpretation of public health trends – specifically, the declining COVID-19 booster uptake, a lack of strong evidence that repeated boosters improve health outcomes for healthy people and the fact that natural immunity from past COVID-19 infections is widespread. The FDA states it wants to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups. The FDA's decision to adopt a risk-based framework for the COVID-19 vaccine aligns with the expected recommendations from the Advisory Committee on Immunization Practices, an advisory group of vaccine experts offering expert guidance to the Centers for Disease Control and Prevention on vaccine policy, which is scheduled to meet in June 2025. But while this advisory committee was also expected to recommend allowing low-risk people to get annual COVID-19 vaccines if they want to, the FDA's policy will likely make that difficult. Although the FDA states that its new policy aims to promote greater transparency and evidenced-based decision-making, the change is controversial – in part because it circumvents the usual process for evaluating vaccine recommendations. The FDA is enacting this policy change by limiting its approval of the vaccine to high-risk groups, and it is doing so without any new data supporting its decision. Usually, however, the FDA broadly approves a vaccine based on whether it is safe and effective, and decisions on who should be eligible to receive it are left to the CDC, which receives research-based guidance from the Advisory Committee on Immunization Practices. Additionally, FDA officials point to Canada, Australia and some European countries that limit vaccine recommendations to older adults and other high-risk people as a model for its revised framework. But vaccine strategies vary widely, and this more conservative approach has not necessarily proven superior. Also, those countries have universal health care systems and have a track record of more equitable access to COVID-19 care and better COVID-19 outcomes. Another question is how health officials' positions on COVID-19 vaccines affect public perception. Makary and Prasad noted that COVID-19 vaccination campaigns may have actually eroded public trust in vaccination. But some vaccine experts have expressed concerns that limiting COVID-19 vaccine access might further fuel vaccine hesitancy because any barrier to vaccine access can reduce uptake and hinder efforts to achieve widespread immunity. The New England Journal of Medicine article includes a lengthy list of conditions that increase the risk of severe COVID-19 and notes that about 100 million to 200 million people will fall into this category and will thus be eligible to get the vaccine. Pregnancy is included. Some items on the list, however, are unclear. For example, the list includes asthma, but the data that asthma is a risk factor for severe COVID-19 is scant. Also on the list is physical inactivity, which likely applies to a vast swath of Americans and is difficult to define. Studies have found links between regular physical activity and reduced risk of severe COVID-19 infection, but it's unclear how health care providers will define and measure physical inactivity when assessing a patient's eligibility for COVID-19 vaccines. Most importantly, the list leaves out an important group – caregivers and household members of people at high risk of severe illness from COVID-19 infection. This omission leaves high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with. Multiple countries the new framework refers to do include this group. According to the FDA, the benefits of multiple doses of COVID-19 vaccines for healthy adults are currently unproven. It's true that studies beyond the fourth vaccine dose are scarce. However, multiple studies have demonstrated that the vaccine is effective at preventing the risk of severe COVID-19 infection, hospitalization and death in low-risk adults and children. Receiving multiple doses of COVID-19 vaccines has also been shown to reduce the risk of long COVID. The FDA is requiring vaccine manufactures to conduct additional large randomized clinical trials to further evaluate the safety and effectiveness of COVID-19 boosters for healthy adults and children. These trials will primarily test whether the vaccines prevent symptomatic infections, and secondarily whether they prevent hospitalization and death. Such trials are more complex, costly and time-consuming than the more common approach of testing for immunological response. This requirement will likely delay both the timeliness and the availability of COVID-19 vaccine boosters and slow public health decision-making. Not automatically. Under the new FDA framework, healthy adults who wish to receive the fall COVID-19 vaccine will face obstacles. Health care providers can administer vaccines 'off-label', but insurance coverage is widely based on FDA recommendations. The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. The FDA's focus on individual risks and benefits may overlook broader public health benefits. Communities with higher vaccination rates have fewer opportunities to spread the virus. High-risk children age 6 months and older who have conditions that increase the risk of severe COVID-19 are still eligible for the vaccine under the new framework. As of now, healthy children age 6 months and older without underlying medical conditions will not have routine access to COVID-19 vaccines until further clinical trial data is available. Existing vaccines already on the market will remain available, but it is unclear how long they will stay authorized and how the change will affect childhood vaccination overall. This article is republished from The Conversation, a nonprofit, independent news organization bringing you facts and trustworthy analysis to help you make sense of our complex world. It was written by: Libby Richards, Purdue University Read more: Low vaccine booster rates are now a key factor in COVID-19 deaths – and racial disparities in booster rates persist COVID-19 vaccines: CDC says people ages 65 and up should get a shot this spring – a geriatrician explains why it's vitally important Nurses' attitudes toward COVID-19 vaccination for their children are highly influenced by partisanship, a new study finds Libby Richards has received funding from the National Institutes of Health, the American Nurses Foundation, and the Indiana Clinical and Translational Sciences Institute
Time of India
20-05-2025
- Health
- Time of India
New FDA rules: Easier Covid vaccine access for vulnerable, tougher for healthy
Healthy Americans may soon find it harder to get in future as the FDA now demands stronger clinical proof of effectiveness before approving shots for those without risk factors. The US Food and Drug Administration (FDA) is overhauling how it approves Covid-19 vaccines and is introducing stricter requirements for healthy people while easing access for those at higher risk of serious illness, Dr. Tired of too many ads? go ad free now Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary, said in an editorial published Tuesday in the New England Journal of move could significantly limit vaccine availability for millions of Americans who were previously eligible. Under the updated guidelines, future Covid-19 booster shots will likely be available in the fall to adults aged 65 and older, as well as to people as young as 6 months who have medical conditions that increase their risk of severe illness. For these groups, vaccine makers will only need to demonstrate that a shot generates strong antibody responses, a type of study known as . What is immunobridging They are usually done in a smaller number of people, and quite quickly so that in case an expects wave of disease hits, the vaccine manufacturing can increase the production in time to have large numbers of shots ready. This method is similar to how seasonal flu vaccines are approved each year and continues a practice the FDA has already been following with Covid-19 shots in recent years. 'No clear evidence of healthy individuals getting benefitted from Covid shots' According to the study, there's no enough evidence that healthy kids and adults get clinically meaningful benefit from regular Covid-19 shots. They want to see placebo-controlled trials, particularly in adults ages 50 to 64, before recommending the shots for other groups. Dr. Noel Brewer, a professor of public health and health behavior at the University of North Carolina at Chapel Hill and a member of the CDC's Advisory Committee on Immunization Practices, supports the FDA's revised approach. 'The proposed policy moves the US in line with other countries. Tired of too many ads? go ad free now This global view of public health is a welcome development,' Brewer, who sits on the CDC's Advisory Committee on Immunization Practices, and was part of the working group mulling the change to Covid vaccine recommendations, was quoted as saying by CNN. How the move will affect vaccine eligibility for Americans In the new framework, the bar will be higher for healthy individuals aged 6 months to 64 years with no risk factors. For them, the FDA will require randomized, placebo-controlled trials that show the vaccine not only boosts antibodies but also prevents symptomatic Covid-19. The agency will also consider secondary outcomes such as reductions in severe illness, hospitalization, and death. The change would mean that millions of healthy adults and children may no longer qualify for updated Covid-19 shots, barring stronger evidence from manufacturers. The authors of the study argue that current data does not support regular Covid-19 vaccination for healthy individuals in terms of meaningful clinical benefits. Long Covid not factored into the new study FDA's updated criteria doesn't mention long Covid, a lingering set of symptoms that can affect people for months after infection. Research has shown that vaccination can reduce the risk of long Covid by 25% to 60%, but this factor will not influence approval decisions under the new framework. Prasad and Makary say their approach is to protect the most vulnerable while restoring public confidence in the vaccine approval process. They noted that nearly three-quarters of Americans aged 6 months and older have an underlying condition that qualifies them as high-risk under CDC definitions. The authors say millions of Americans under 65 will still qualify to get a Covid-19 vaccine if they want one if they have any of a broad range of health conditions identified by the CDC as putting a person at high risk of severe disease from Covid-19. 'Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,' the FDA officials wrote. FDA expands access to plasma treatment for COVID-19
