Latest news with #RobertF.KennedyJr.
New York Post
3 hours ago
- Health
- New York Post
FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
The US Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. Advertisement 4 The FDA has approved Moderna's next-generation COVID-19 vaccine for people older than 65. REUTERS 'The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,' CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. Advertisement The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. Advertisement 4 The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval. REUTERS FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. Advertisement 4 Department of Health and Human Services secretary Robert F. Kennedy Jr. is tightening regulatory scrutiny on vaccines. Getty Images The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. 4 Moderna's COVID-19 shots are mRNA-based. dpa/picture alliance via Getty Images The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. Advertisement While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
Express Tribune
4 hours ago
- Health
- Express Tribune
CDC updates COVID vaccine guidance, open option for healthy children
Moderna logo is seen displayed in this illustration taken, May 3, 2022. Photo: REUTERS Listen to article The US Centers for Disease Control and Prevention said COVID-19 vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Health Secretary Robert F. Kennedy Jr.'s announcement that the agency would remove the shots from its immunisation schedule. 🇺🇲 #BREAKING: The CDC kept Covid shots on an updated vaccination schedule for children, days after Health Secretary Robert F. Kennedy Jr. said they would be taken off. Source: the New York Times — Ali (@iamsakibali1) May 30, 2025 In a schedule published late on Thursday, the CDC said any COVID vaccination in healthy children aged 6 months to 17 years should follow "shared clinical decision-making" between a child's parents and their healthcare provider. Kennedy, a long-time vaccine skeptic who oversees the CDC, the Food and Drug Administration and the National Institutes of Health, had said on Tuesday the recommendations would be dropped. "As of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunisation schedule," Kennedy said in a video posted on the X platform. A spokesperson for the Department of Health and Human Services said there was no contradiction between Kennedy's statement and the CDC schedule, which no longer provides a broad recommendation for healthy children. Kennedy's announcement prompted criticism from medical experts who said the health secretary circumvented the government's decision-making process on vaccines and could prevent health insurance coverage for COVID shots to vulnerable Americans. The Infectious Diseases Society of America said on Tuesday that removing the recommendation "does the opposite of what Americans have been asking for when it comes to their health — it takes away choices and will negatively impact them." It added infants and children may "develop severe disease and may suffer from prolonged symptoms due to long COVID, which can negatively impact their development." Nearly 1,900 children up to 18 years of age died of COVID in the US, according to CDCupdated in 2023. The makers of COVID vaccines available in the US — Pfizer,Moderna and Novavax — did not immediately respond to requests for comment. Traditionally, the CDC's Advisory Committee for Immunisation Practices would meet and vote on changes to the immunization schedule or recommendations on who should get vaccines before the agency's director made a final call. The committee had not voted on the changes announced by Kennedy. Last week, the FDA said it plans to require new clinical trials for approval of annual COVID boosters for healthy Americans under 65, effectively timing them to older adults and those at risk of developing severe illness. Reporting by Susan Heavey in Washington, Puyaan Singh in Bengaluru and Michele Gershberg in New York; Editing by Alan Barona, Shounak Dasgupta and William Mallard
The Sun
4 hours ago
- Health
- The Sun
US FDA approves Moderna's next-gen Covid vaccine for adults 65 or older
THE U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors, Moderna said in a statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is increasing regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine, branded mNEXSPIKE, can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule.
The Sun
4 hours ago
- Health
- The Sun
FDA approves Moderna's new Covid shot for seniors, at-risk
THE U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors, Moderna said in a statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is increasing regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine, branded mNEXSPIKE, can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule.
Yahoo
8 hours ago
- Business
- Yahoo
HHS budget proposal details significant cuts to National Institutes of Health, other agencies
A budget proposal for the US Department of Health and Human Services details extensive cuts to funding for the National Institutes of Health, part of an effort to consolidate the work of its 27 institutes into just eight while reducing the agency's budget nearly 40%. The proposed cuts to federal health agencies were first revealed in a preliminary memo from White House budget officials in April. A newly released Budget in Brief document for fiscal year 2026 lays out HHS Secretary Robert F. Kennedy Jr.'s plan to prioritize his Make America Healthy Again initiative with a $94.7 billion discretionary budget. The budget for the US Centers for Disease Control and Prevention would be slashed from more than $9 billion to just over $4 billion and funding for the US Food and Drug Administration cut from about $7 billion to just over $6.5 billion. However, some of the biggest changes will be felt at the NIH, where the budget document lists 2026 funding at $27.5 billion, down from nearly $48.5 billion in 2025. In the reorganized HHS, only three areas of the NIH – the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the National Institute on Aging – are set to be preserved. Institutes researching childhood illnesses, mental health, chronic disease, disabilities and substance abuse would be shuffled into five new entities: the National Institute on Body Systems, National Institute on Neuroscience and Brain Research, National Institute of General Medical Sciences, the National Institute of Disability Related Research and National Institute of Behavioral Health. But even the surviving institutes won't be spared cuts: The National Institute of Allergy and Infectious Diseases had a budget of more than $6.5 billion in 2025 but will receive just over $4 billion in 2026. The National Cancer Institute, which received more than $7 billion for 2025, will get about $4.5 billion next year. And the National Institute on Aging will see its budget cut from $4.4 billion to less than $2.7 billion in 2026. The proposed NIH budget assumes a 15% cap on indirect costs that research institutions can charge the government, itself a highly controversial change that has been blocked in the courts. The new document also details plans for the Administration for Healthy America, a new agency created under Kennedy that will consolidate divisions such as the Substance Abuse and Mental Health Services Administration, the Health Resources and Services Administration and several parts of the CDC. The new AHA is set to receive $14 billion in the 2026 budget. The 2026 HHS budget 'reflects the President's vision of making Americans the healthiest in the world while achieving his goal of transforming the bureaucracy,' the document says. At the NIH, restructuring 'will create efficiencies … that will allow the agency to focus on true science, and coordinate research to make the best use of federal funds.' But expert groups were more critical of the proposal. The NIH cuts 'would have far-reaching and irreversible consequences not only to the entire biomedical research enterprise, but also to the millions of Americans who rely on advances in biomedical research to safeguard and improve their health and their very lives,' Dr. Stephen Jameson, president of the American Association of Immunologists, said in a statement Friday. The agency supported hundreds of thousands of jobs in 2024 and contributed nearly $100 billion in economic activity across the US, Jameson said. 'Undermining NIH support threatens both local economies and our national competitiveness on the global scale.' Research!America, a nonprofit that advocates for science and innovation, said it was 'alarmed' by the budget proposal. 'If the proposal is enacted, Americans today and tomorrow will be sicker, poorer, and die younger,' President and CEO Mary Woolley said in a statement. 'American research has a proven track record of increasing survival, reducing the burden of illness, and creating jobs. Cutting research funding helps no one; instead, it hurts everyone.'
