Latest news with #MartinA.Makary
Yahoo
21-05-2025
- Health
- Yahoo
FDA announces plans to restrict access for COVID vaccines
The U.S. Food and Drug Administration plans to change its recommendations for getting a COVID-19 vaccination, suggesting the vaccine for those 65 and older and for those older than 6 months of age who have health conditions that make severe COVID-19 symptoms a risk. Those who don't fit one of the categories likely will not have access. 'For all healthy persons — those with no risk factors for severe COVID-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes" before licensing will be granted, according to an article published Tuesday in the New England Journal of Medicine. Manufacturers who make the vaccine for the high-risk group will be encouraged to do the trials for healthy populations as part of their 'postmarketing commitment,' per the New England Journal article, written by Dr. Martin A. Makary, who heads the FDA, and Dr. Vinay Prasad, head of the Center for Biologics Evaluation and Research at the FDA. That organization approves or rejects vaccine licensing applications. 'The views expressed in this article represent the policy position of the Food and Drug Administration,' they wrote. It's likely lots of people won't mind the new policy, given dwindling uptake of annual boosters. The two wrote that in the last two seasons, 'uptake of the annual COVID-19 booster has been poor,' citing Centers for Disease Control and Prevention statistics. Fewer than a quarter of Americans receive boosters, 'ranging from less than 10% for children younger than 12 years of age in the 2024-25 season to 50% of adults over 75 years old.' The report notes that vaccine hesitancy has affected 'even vital immunization programs such as for measles-mumps-rubella (MMR) vaccination, which has been clearly established as safe and highly effective.' The goal, per the FDA officials, is 'evidence-based' COVID-19 booster recommendations. During a media briefing, Prasad said the approach aligns the U.S. with that of other high-income countries and will help improve trust in vaccines. The list of underlying medical conditions that increases risk of severe symptoms should someone catch the novel coronavirus infection is quite long. It includes asthma, cancer, cerebrovascular disease, chronic kidney disease, chronic liver disease, chronic lung disease, cystic fibrosis, diabetes of all types (including gestational), disabilities, heart conditions, HIV, specific mental health conditions (just mood disorders including depression and schizophrenia spectrum disorders), neurological conditions (only dementia and Parkinson's disease), obesity, physical inactivity, pregnancy and recent pregnancy, primary immunodeficiencies, smoking or a history of it, organ or stem-cell transplant, tuberculosis and use of immunosuppressant medications or corticosteroids. The report notes the need to balance competing evidence while providing access to as many as 100 to 200 million Americans. 'We simply don't know whether a healthy 52-year-old woman with a normal (body mass index) who has had COVID-19 three times and has received six previous doses of COVID-19 vaccine will benefit from a seventh dose,' the two FDA officials said, noting the change would 'compel much-needed evidence generation.' 'I find it refreshing to see the clarity in these guidelines,' Rick Bright, a former federal vaccine official, told NPR. 'The FDA is signaling a major departure from the one-size-fits-all approach that's largely defined the U.S. vaccination policy until now. Not everyone is at equal risk and public policy should reflect that reality.' NPR noted worry by some that 'the regulatory move sends the misleading message that the vaccines have not been adequately evaluated and that it would limit the availability of the vaccines because insurers would no longer pay for the shots for everyone.' Critics also said it's an unneeded move for vaccines that are 'safe and effective.' And some worry about long COVID, which impacts younger people as well as older people. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told NPR the move violates U.S. Health and Human Services Secretary Robert F. Kennedy's promise not to take vaccines away from anyone. If insurers won't pay, Osterholm said, then many won't be able to afford them. CNN reported that it's not clear if manufacturers will commit to the trials being sought, as they cost a lot and take time. The New York Times reported that an FDA spokesman said the clinical trials 'would be required, not just recommended or anticipated.' CNN noted the change is already becoming apparent. 'Just days before the FDA's announcement, it approved the Novavax COVID-19 vaccine, which was six weeks past its planned approval deadline. The FDA restricted the use of the vaccine to people 65 and older and those 12 and up with underlying health conditions.' Per the Associated Press, 'Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. The virus was the underlying cause for two-thirds of those and it was a contributing factor for the rest. Among them were 231 children whose deaths were deemed COVID-related, 134 of them where the virus was the direct cause — numbers similar to yearly pediatric deaths from the flu. Per the Times, 'Deaths from COVID have fallen each year since the start of the pandemic, but there were still roughly 1,000 deaths per week last winter, most of them in adults 75 and older. In the year ending in August, the CDC reported 150 pediatric deaths, a number comparable to deaths among children in a typical flu season.'
Yahoo
20-05-2025
- Health
- Yahoo
FDA Approves First-Ever Blood Test for Alzheimer's—Here's What We Know
As of 2023, an estimated 6.7 million Americans aged 65 and older were living with Alzheimer's disease, according to the Alzheimer's Association. With that number projected to more than double to 13.8 million by 2060, the FDA has just approved the first blood test designed to help diagnose the disease—marking a major step forward in early detection and treatment. Manufactured by Fujirebio Diagnostics, the test will be used on individuals 55 and older who are currently exhibiting signs and symptoms of the disease. Alzheimer's disease is a type of dementia that affects memory and thinking capabilities. It may start with mild memory lapses like forgetting where your keys are, and eventually can turn into severe memory issues like forgetting loved ones. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' FDA Commissioner Martin A. Makary, M.D., M.P.H., said in a press release. 'Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' While there are several methods for diagnosing Alzheimer's, one of the most common is through the detection of amyloid plaques—or abnormal protein deposits that form between nerve cells in the brain. Traditionally, plaques are identified using amyloid PET scans, which are both expensive and time-consuming. Another option is a cerebrospinal fluid (CSF) test, which involves collecting CSF via an invasive lumbar puncture, or spinal new blood test takes the need for PET scans or spinal taps out of the equation by measuring the ratio of two proteins—pTau217 and β-amyloid 1-42. The ratio can help clinicians determine whether amyloid plaques are present in the brain. In a clinical study, 91.7% of people who received a positive blood test result also had amyloid plaques confirmed by a PET scan or CSF test. 97.3% of people who got a negative blood test result also had no amyloid plaques according to the PET or CSF test. The results indicate that the test is a reliable way to detect and rule out amyloid plaques without the need for invasive strategies like brain scans or spinal taps. 'Nearly 7 million Americans are living with Alzheimer's disease, and this number is projected to rise to nearly 13 million,' said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. 'Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients who are earlier in the disease.' According to the FDA, the main concern with the blood test is the possibility of a false positive, which "could lead to an inappropriate diagnosis of, and unnecessary treatment for Alzheimer's disease." It's also important to note that this new blood test is not intended to be used as a stand-alone diagnostic test and should be utilized in conjunction with other clinical evaluations or additional testing.
Yahoo
20-05-2025
- Health
- Yahoo
FDA approves blood test to detect Alzheimer's disease
Without expensive or invasive tests, diagnosing Alzheimer's disease has been largely a look at symptoms and the assessment of an expert or use of expensive and invasive tests. But that's likely to change with news that the U.S. Food and Drug Administration has approved a blood test that helps with the diagnosis. The test has a complicated name: The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. But the goal of the test, created by Fujirebio Diagnostics, is simple: Early detection of beta-amyloid plaques linked to the neurocognitive disease in adults 55 and older who are exhibiting signs and symptoms of the disorder. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' FDA Commissioner Dr. Martin A. Makary said in a news release. 'Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' The test measures two proteins from human plasma — forms of tau and amyloid — which have been linked to the disease, calculating a ratio that 'is correlated to the presence or absence of amyloid plaques in the patient's brain, reducing the need' for an expensive positron emission tomography (PET) brain scan, which not only costs a lot, but exposes one to radiation. The other option, a lumbar puncture, or spinal tap, is sometimes used to look at cerebrospinal fluid to detect the presence of beta-amyloid. The new test relies on a simple blood draw. As Deseret News has reported, blood tests can speed recruiting for research, reduce wait times and make access to treatments easier. The data used to win FDA approval included a comparison of findings from 499 individual plasma samples taken from adults who were cognitively impaired against findings from an amyloid PET scan and the spinal tap samples. Nearly 92% of those who showed amyloid on the other tests also were positive signs of amyloid on the new blood test. Just over 97% of those with negative blood test results were also negative on the PET scan and spinal fluid test. The test was indeterminate in fewer than 20% of the samples. 'These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer's disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information,' according to the FDA. The release noted the main risks are the possibility of a false positive or a false negative. The former could cause distress, unneeded treatment for Alzheimer's and delay in correct diagnosis. The latter could delay treatment for Alzheimer's at a time when early treatment yields the best results for certain medications, including Leqembi, which slows progression of the disease. 'Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options,' per the FDA. There is no cure at this time, but recent treatments have slowed progress, making early detection vital. The new test was granted 'breakthrough device' designation, meaning that it aids 'more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.' It was granted approval through the pathway that says a new submission is 'substantially equivalent' to an already authorized device — in this case, the test that uses a spinal tap and cerebrospinal fluid samples.
Newsweek
17-05-2025
- Health
- Newsweek
New Alzheimer's Test Approved by FDA—What to Know
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration (FDA) has cleared marketing for a new blood test to diagnose Alzheimer's disease in people who are already exhibiting symptoms. This new test is the first blood test ever approved for diagnostics of the disease, according to a press release issued Friday by the FDA. People suffering from the Alzheimer's suffer from memory loss that eventually erases their ability to complete everyday tasks. "Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients," FDA Commissioner Martin A. Makary said in the press release. Newsweek reached out to Makary for further comment via email Saturday during non-working hours. Why It Matters Alzheimer's affects an estimated 7.2 million people in the U.S. age 65 and over, with 74 percent of those patients aged 75 or older, according to the Alzheimer's Association 2025 Disease Facts and Figures report. The new test is set to create more accessible diagnostic results and decrease the reliance on more invasive testing such as Positron Emission Tomography (PET) scans. Early detection can lead to better, more effective treatment that delays more intense symptoms of the disease. This illustration made available by the National Institute on Aging/National Institutes of Health depicts cells in an Alzheimer's affected brain, with abnormal levels of the beta-amyloid protein clumping together to form plaques. This illustration made available by the National Institute on Aging/National Institutes of Health depicts cells in an Alzheimer's affected brain, with abnormal levels of the beta-amyloid protein clumping together to form plaques. National Institute on Aging, NIH via AP What To Know While the disease has a higher percentage in older age groups, researchers believe about 110 people out of 100,000, aged 30 to 64 years, could be suffering from the disease. An estimated 1 in 9 people over the age of 65 are believed to suffer from Alzheimer's dementia. The new test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, detects amyloid plaques through blood testing, a type of protein indicative of Alzheimer's, the Alzheimer's Association explained in a Friday press release. These plaques can be seen in patients through a PET scan, according to the FDA. The Mayo Clinic discovered a way to prevent the accumulation of such proteins nearly a decade ago, meaning they can be identified and treated more quickly with the latest device. This device is not the first to be used in clinical trials, but it is the first to receive FDA clearance for marketing. While the test is not supposed to be all inclusive, it should help medical professionals in part of their wider diagnostic practices for treating Alzheimer's, the FDA's press release said. What People Are Saying Director Michelle Tarver of the Center for Devices and Radiological Health said in the FDA press release: "Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million. Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease." FDA Commissioner Martin A. Makary said in the FDA press release: "Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined. Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients." Maria C. Carrillo, Alzheimer's Association chief science officer, said in a press release: "Today marks another important step in Alzheimer's disease diagnosis. For too long Americans have struggled to get a simple and accurate diagnosis; with today's action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier." She added: "This interest in early diagnosis and treatment highlights how important it is that we keep advancing toward diagnostic testing that is simple to administer and widely available." What Happens Next? Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio still has a few hurdles before it is widely approved and available for diagnostic use. While clearance for this device is currently only for marketing, it was given a breakthrough device designation, meaning the development of the product is expedited because of its ability to help diagnosis damaging health conditions.
Economic Times
17-05-2025
- Health
- Economic Times
US FDA approves world's first blood test for Alzheimer's, and what it means
TIL Creatives A nurse prepares the world's first FDA-approved blood test for Alzheimer's, offering families hope, answers, and a path forward When her mother began forgetting names and losing her way home, Maria Torres feared the worst, but had no easy path to answers. Now, a simple blood test could finally offer families like hers the clarity they've long needed. The US Food and Drug Administration (FDA), in a landmark diagnosis for dementia, has approved the world's first blood test designed to detect dementia disease in its early stages. The Lumipulse Plasma Ratio test, developed by Fujirebio Diagnostics, offers a less invasive and more accessible alternative to traditional diagnostic methods. Alzheimer's disease, a progressive neurological disorder, affects over 6 million people in the United States, with numbers expected to rise significantly in the coming decades. Early and accurate diagnosis is crucial for managing the disease and exploring treatment options. Also Read: Microplastics in the brain worsen the situation of dementia in the US The Lumipulse test works by measuring specific proteins in the blood that are associated with the presence of amyloid plaques in the brain, a hallmark of Alzheimer's disease. Previously, detecting these plaques required costly and invasive procedures like PET scans or spinal taps. With this new blood test, a simple blood draw can provide valuable diagnostic studies have demonstrated the test's efficacy, with results showing high accuracy in identifying amyloid plaques. In a study involving 499 cognitively impaired individuals, the blood test's findings closely matched those obtained from PET scans and spinal fluid tests. The FDA emphasized that the test should be used in conjunction with other clinical evaluations to determine the appropriate course of Commissioner Martin A. Makary said,"Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined. Knowing that 10 percent of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double."The approval of the Lumipulse test also has implications for treatment accessibility. Two FDA-approved drugs, Leqembi and Kisunla, have shown promise in slowing the progression of Alzheimer's by targeting amyloid plaques. However, their use requires confirmation of plaque presence, which the new blood test can facilitate more Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, remarked, "Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease."While the test represents a significant advancement, experts caution that it is not intended for individuals without symptoms and should be administered under medical supervision.
