FDA Chief Downplays COVID Boosters After Suggesting No Updated Shots This Season
The head of the U.S. Food and Drug Administration on Tuesday reportedly raised doubts about the need for COVID booster shots for all Americans and questioned the success of past clinical trials, after earlier suggesting the shots might not be approved for next winter.
'We need some better data,' FDA Commissioner Dr. Marty Makary said at the American Hospital Association's annual meeting in Washington, D.C., according to news outlet HealthDay.
Makary, who last week told CBS News that the shots may not be approved for later this year due to a 'void' of supporting data, said pharmaceutical companies are being urged to use 'gold standard science' to show that the shots have a clinical benefit.
Dr. Marty Makary is seen during his Senate confirmation hearing in Washington in March.
Bill Clark via Getty Images
'We can't just extrapolate from a clinical trial from four or five years ago,' he said Tuesday. 'Americans have a very low uptake and a very low confidence of the COVID boosters right now.'
He also said that the FDA is considering whether to recommend the shots to everyone or primarily to high-risk groups.
'Should we really be putting the full weight of the government to urge vaccination against COVID for a healthy, thin 12-year-old girl with her seventh COVID booster right now today in America?' he said. 'I don't think so.'
Makary, who was confirmed to lead the FDA in March, is a former Johns Hopkins University surgeon and researcher who during the pandemic publicly opposed vaccine mandates and criticized the department that he now leads.
He in particular spoke out against requiring booster shots in young people, with him concluding in a 2022 paper he co-authored that the shots 'are expected to cause a net harm.' That paper was criticized as being unobjective and based on cherry-picked information that excluded opposing data.
The FDA on Wednesday said it will hold a public discussion later this month with independent outside experts to discuss and make recommendations on the selection of the COVID-19 vaccine's 2025-2026 formula.
'The general function of the committee is to provide advice and recommendations to FDA on regulatory issues,' the FDA said in a draft notice of the May 22 meeting that was posted online.
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Scientific American
43 minutes ago
- Scientific American
Inside the Collapse of the America's Overdose Prevention Program
At an addiction conference in Nashville, Tenn., in late April, U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr., spoke about his own experience with drug use. 'Addiction is a source of misery. It's also a symptom of misery,' he said. Kennedy's very personal speech, however, ignored recent federal budget cuts and staffing reductions that could undo national drug programs' recent progress in reversing overdoses and treating substance use. Several experts in the crowd, including Caleb Banta-Green, a research professor at the University of Washington, who studies addiction, furiously spoke up during Kennedy's speech. Banta-Green interrupted, shouting 'Believe science!' before being removed from the venue. (The Department of Health and Human Services did not respond to a request for comment for this article.) 'I had to stand up and say something,' says Banta-Green, who has spent his career working with people who use drugs and was a senior science adviser at the Office of National Drug Control Policy during the Obama administration. 'The general public needs to understand what is being dismantled and the very real impact it's going to have on them and their loved ones.' On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. The Trump administration has defunded public health programs and made plans to consolidate or eliminate the systems that track their outcomes, making it difficult to monitor the deadly consequences of substance use, Banta-Green says. For instance, staff cuts to the Overdose Data to Action program and the Opioid Overdose Prevention and Surveillance program will hamper former tracking efforts at the Centers for Disease Control and Prevention and at local and state health departments' prevention programs. A recently fired policy analyst at the overdose prevention division at the CDC's National Center for Injury Prevention and Control— who wishes to remain anonymous, citing fear of retaliation—tells Scientific American that she used to provide policy support to teams at health departments in 49 states and shared public overdose data and information to Congress. She is a veteran who should have had protected employment status, but she lost her job during federal cuts in February. 'No one else is doing surveillance and data collection and prevention like the CDC was,' she says. 'There's so much that's been cut.' (When approached for an interview by Scientific American, a CDC spokesperson said, 'Honestly, the new administration has changed how things normally work' and did not make anyone available for questions.) What Gets Measured Gets Managed Provisional data suggest that deaths from drug use declined by almost 25 percent in 2024, though overdoses remain the leading cause of death for Americans aged 18 to 44. Cuts to the National Survey on Drug Use and Health will make it difficult to measure similar statistics in the future. Because substance use is highly stigmatized, Banta-Green says it's important to have diverse, localized and timely data from multiple agencies to accurately capture the need for services—and the ways they're actually used. 'You can't design public health or policy responses if you don't know the scale of the need,' he says. Overdose trends vary by region—for example, usage of the synthetic opioid fentanyl appeared earlier on the East Coast than the West—so national averages can obscure critical local patterns. These regional differences can offer important insights into which interventions might be working, Banta-Green says. For instance, important medications such as naloxone rapidly reverse opioid overdoses in emergency situations. But getting people onto long-term medications, including methadone and buprenorphine, which reduce cravings and withdrawal symptoms, can more effectively prevent mortality in both the short and long term. Declining deaths may also mask tragic underlying dynamics. Successful interventions may not be the only cause of a drop in overdoses; it could also be that the people who are most vulnerable to overdose have recently perished and that there are simply fewer remaining at risk. 'It's like a forest fire burning itself out,' Banta-Green says. This underscores the need for the large-scale data collection threatened by the proposed budget and staff cuts at the CDC and National Institutes of Health, says Regina LaBelle, an addiction policy expert at Georgetown University. 'What [the administration is] doing is shortsighted' and doesn't appear to be based 'on the effectiveness or the outcomes of the programs that [it's] cutting,' she says. For example, despite promising to expand naloxone access, the Trump administration's latest budget proposal cuts funding for a critical program that distributes the lifesaving medication to first aid responders. 'A Chance at Redemption' When LaBelle was acting director of the White House Office of National Drug Control Policy during the Biden administration, she led efforts to expand evidence-based programs that provided clean syringes and tested users' drugs for harmful substances. These strategies are often referred to as 'harm reduction,' which LaBelle describes as 'a way you can meet people where they are and give them the services they need to keep them from dying.' José Martínez, a substance use counselor based in Buffalo, N.Y., says harm-reduction practices helped save his life. When Martínez got his first job as a peer advocate for people using drugs, he was still in a chaotic part of his own addiction and had been sleeping on the street and the subway—and regularly getting into fights—for a decade. The day after he was hired to help provide counseling on hepatitis C, he got into a New York City shelter. As his bruises healed, he learned life skills he was never taught at home. 'For a lot of people, drug use is a coping tool,' he says. 'The drug is rarely the problem. Drug use is really a symptom.' Working with others who understood that many people need help minimizing risks gave Martínez a chance to make progress toward recovery in a way that he says abstinence-only treatment programs couldn't. 'I don't agree that somebody should be sober in order for them to do things different,' he says. Over the past six years working for the National Harm Reduction Coalition, Martínez started a national support network for other peer program workers and community members—people who share their experiences and are a trusted source of education and support for others using drugs. 'There's never no time limit,' he says. 'Everybody works on their own pace.' Though Martínez's program doesn't take federal funding, the Trump administration is cutting similar kinds of peer programs. Martínez says doing this peer work gives many users a sense of purpose and stability—and helps them avoid previous behaviors. The proposed 2026 federal budget will slash the CDC's opioid surveillance programs by $30 million. It also creates a new subdivision called the Administration for a Healthy America that will consolidate the agency's prevention work, along with existing programs at the Substance Abuse and Mental Health Services Agency (SAMHSA), which often coordinates grants for treatment programs. The programs formerly conducted through SAMHSA are also facing cuts of more than $1 billion. Advocates fear this will include a shift toward funding abstinence-only priorities, which, Martínez says, 'will definitely mean that we're going to have more overdoses.' (Some research suggests abstinence-based treatment actually puts people at a higher risk of fatal overdose than those who receive no treatment at all.) 'The general public needs to understand what is being dismantled and the very real impact it's going to have on them and their loved ones.' —Caleb Banta-Green, addiction research professor These cuts could disproportionately affect communities already facing higher overdose rates: Martínez, who is Puerto Rican, notes that U.S. Black, Latino and Indigenous communities have experienced drug overdose death increases in recent years. In many states, overdose deaths in Black and brown communities remain high while white overdose death rates are declining. Looming cuts to Medicaid programs, LaBelle warns, are likely to worsen inequalities in health care access, which tends to make communities of color more vulnerable. In Kentucky, where Governor Andy Beshear recently celebrated a 30 percent decline in overdose deaths, Shreeta Waldon, executive director of the Kentucky Harm Reduction Coalition, says the reality is more nuanced. While national overdose deaths declined in white populations from 2021 to 2023, for example, they continued to rise among people of color. Black and Latino communities often face barriers when accessing health services, many of which have been shaped by predominantly white institutions. Waldon says it's essential for people from diverse backgrounds to participate in policy decisions and necessary to ensure that opioid abatement funds —legal funds used toward treatment and prevention—are distributed fairly. Without adequate federal funding, Waldon predicts treatment programs in Kentucky will become backlogged—potentially pushing more people into crisis situations that lead to emergency services or incarceration rather than to recovery. These financial and political pressures are not only making it harder to find support for people in crisis; they also reduce opportunities to discuss community needs. Waldon says she knows some social workers who now avoid terms such as 'Black woman' or 'marginalized' in grants and public talks out of fear of losing funding. But people currently needing treatment for substance-use disorder are not necessarily aware of the federal funding news—or 'what's about to hit them when they try to go get treatment and they're hit with barriers,' Waldon says. 'That's way more important to me than trying to tailor the way I talk.' Funding and staffing cuts don't just limit resources for the people most in need. They limit the ability to understand where someone is coming from, which undermines efforts to provide meaningful care, Martínez says. Harm reduction is more than the services and physical tools given to community members, he says. It's about the approach. 'When you look at a whole person, you plant the seed of health and dignity,' he says. 'If everybody deserves a chance at redemption, then we've got to rethink how we're approaching things.'
Medscape
an hour ago
- Medscape
AI Device Enhances Skin Cancer Diagnosis in Primary Care
An artificial intelligence (AI)–enabled handheld elastic scattering spectroscopy (ESS) device improved the sensitivity for skin cancer diagnosis and management by primary care physicians (PCPs), with better overall diagnostic accuracy. METHODOLOGY: ESS is a sampling technique that distinguishes between benign and malignant tissue without surgical biopsy and the ESS device is cleared by the US Food and Drug Administration for use by nondermatologist expert physicians. An AI-enabled handheld ESS device was developed to aid PCPs in the management of suspicious skin lesions. This companion study of the DERM-SUCCESS study conducted across 22 primary care sites in the United States evaluated the impact of the device on PCPs' diagnostic performance in the detection and management of skin cancer. The study involved 108 PCPs (65.7% men) who assessed 50 skin lesion cases (25 benign and 25 malignant) from 50 patients (median age, 59 years; 100% White individuals) in two phases: First, with visual assessment without using the handheld device, followed by an assessment using the device, separated by a 2-hour break. For each lesion, they provided a diagnosis, management decision, and level of confidence in their assessment. The validated device emitted light pulses over specific areas of a lesion to analyze lesion structure and classified lesions as 'Investigate Further' or 'Monitor,' with a 1-10 score reflecting the degree of similarity to malignant lesions. The coprimary endpoints were (1) the referral sensitivity of physicians, a measurement of the ability to appropriately refer malignant cases for further evaluation (management sensitivity) and (2) the referral sensitivity and specificity of physicians who knew the device results. Biopsy results served as the reference standard for both. TAKEAWAY: Management sensitivity was higher for physicians after using the AI-enabled device compared with when they did not have the device results (91.4% vs 82%; P = .0027). PCPs' diagnostic sensitivity also increased from 71.1% without the use of the AI device to 81.7% with the use of the AI device ( P = .0085). = .0027). PCPs' diagnostic sensitivity also increased from 71.1% without the use of the AI device to 81.7% with the use of the AI device ( = .0085). Device-aided management and diagnostic specificity decreased, though not significantly. The use of the device led to 11.8% more benign lesions being incorrectly referred but also led to 9.4% more malignant lesions being correctly referred. In physician management decisions, the proportion of high-confidence assessments increased from 36.8% without the use of the device to 53.4% after the use of the device, and the observed area under the curve performance improved from 0.708 to 0.762. PCPs using the device were better at detecting malignant lesions than by chance (odds ratio, 6.8; P < .0001). Most PCPs reported benefits from the device, including improved confidence in clinical assessments and management decisions. IN PRACTICE: 'The findings demonstrate that utilization of the ESS device output may improve physician performance in the management of suspicious lesions and referral of skin cancer to ensure timely diagnosis,' the authors of the study wrote. SOURCE: This study was led by Laura K. Ferris, of the Department of Dermatology at The University of North Carolina at Chapel Hill. It was published online on May 30, 2025, in Journal of Primary Care & Community Health . LIMITATIONS: The device could not directly affect how PCPs managed lesions owing to the study design because the device was experimental. Clinical information was provided, but the PCPs could not perform hands-on evaluations, which did not reflect real clinical practice but aligned with telemedicine. The study included only White patients, which limited the results for the assessment of different skin types. DISCLOSURES: This study was funded by DermaSensor, Inc. The authors declared no relevant conflicts of interest.
Yahoo
an hour ago
- Yahoo
Inherited Genetic Trait Predicts Resistance to Immunotherapy for Deadly Skin Cancer
NEW YORK, June 5, 2025 /PRNewswire/ -- Tests in 1,225 patients with the most deadly form of skin cancer reveal for the first time a genetic trait among most of those who did not respond to the latest cancer treatments, known as immune checkpoint inhibitors. Metastatic melanoma, as the disease is formally named, kills nearly 10,000 Americans annually. While the drugs have proven highly successful in treating metastatic melanoma and several other cancers, the therapies are known to not work for almost half of those who are prescribed them, usually after initial chemotherapy or surgery have failed to stem the growth of new cancer cells. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the new study involved a genetic analysis of blood samples from the ongoing landmark CheckMate-067 Phase 3 trial being conducted in over 100 medical centers in 19 countries. Study results showed that patients with a specific type of genetic mutation, called MT haplogroup T (HG-T), were 3.46 times less likely to respond to checkpoint therapy than those without HG-T. Mutations are changes encoded in the DNA of abnormal or different cells. Researchers found the HG-T changes in immunotherapy-resistant patients' cell powerhouse structures, or mitochondria. Mitochondrial DNA is unique in that it is passed down only from a mother to her offspring, with no genetic contribution or copy from the father, as is traditionally found in a cell's control center, or nuclear DNA. Over time, mitochondrial DNA has evolved worldwide into subgroups labeled from A to Z based on their common mutations. Publishing in the journal Nature Medicine online June 5, the researchers say they decided to focus on mitochondrial DNA not just because of its unique lineage but also due to previous research showing it played a role in immune cell development. In the CheckMate trial, immunotherapy drugs, such as nivolumab, were used alone or in combination with another checkpoint inhibitor, ipilimumab, in preventing postsurgical recurrence of melanoma. The drugs work by blocking molecules (the checkpoints) that sit on the surface of immune T cells to keep them from attacking cancer cells like they would invading viruses or bacteria. The body normally uses checkpoints to recognize healthy cells, but in cancer, tumor cells have hijacked and turned off the checkpoints to evade immune system detection. Immunotherapies block checkpoints, making cancer cells more "visible" and vulnerable again to immune cells. To validate their CheckMate findings, researchers then checked their initial results against samples from 397 metastatic melanoma patients of similar age and gender, whose immunotherapy treatment records were stored at NYU Langone as part of the International Germline Immuno-Oncology Melanoma Consortium (IO-GEM). Results again revealed the same link of immunotherapy resistance to HG-T. "Checkpoint immunotherapy has become the mainstay in cancer care in the past decade, especially for those with metastatic melanoma, but until now it has never been clearly explained why nearly half will not respond to treatment," said study co-lead investigator and epidemiologist Kelsey Monson, PhD. "Our study results offer the first scientific evidence of a genetic biomarker, or presence of a mitochondrial mutation known as MT haplogroup T, to help explain why and identify those metastatic melanoma patients who are most likely to not respond to immunotherapy for the disease," said study co-lead investigator and molecular biologist Robert Ferguson, PhD. "Our findings make possible future testing for the presence of MT haplogroup T to determine which metastatic melanoma patients are most likely to not respond to checkpoint therapy, so other treatment options can be considered, which in turn could improve overall outcomes," said senior study investigator Tomas Kirchhoff, PhD. "These study results also raise the possibility that other mitochondrial haploid variants could influence which patients respond to other immune therapies," said Kirchhoff, an associate professor in the Department of Population Health at NYU Grossman School of Medicine and a member of the Perlmutter Cancer Center. Among the study's other key findings was that treatment-resistant HG-T patients had more underdeveloped T cells than nonresistant patients without HG-T. Researchers traced this poor differentiation to increased resilience to reactive oxygen species (ROS), chemicals commonly linked to inflammation, suggesting that HG-T conferred some form of ROS protection that stunted T cell attack. Kirchhoff says that further experiments are needed to determine the precise role played by mitochondrial genetics, ROS metabolism, and antitumor T cell immunity in cancer therapy. The more immediate next step is a prospective clinical trial to assess whether non-HG-T patients fare better on immunotherapy than patients with HG-T, and whether this applies to other mitochondrial haplogroups and cancers. Funding for the study was provided by National Institutes of Health grants R01CA227505, F99CA274650, P50CA225450, and P30CA008748, with additional support from Melanoma Research Alliance grant MRA-686192. Further funding support was provided by Italian Ministry of Health Ricerca Corrente grants M2/2 and L1-2. Both drugs used in the CheckMate trial are manufactured by the pharmaceutical company Bristol Myers Squibb, which sponsored the trial and provided the patient specimens and data used in the analysis. Besides Monson, Ferguson, and Kirchhoff, NYU Langone researchers involved in this study are co-investigators Joanna Handzlik, Leah Morales, Jiahan Xiong, Vylyny Chat, Sasha Dagayev, Alireza Khodadadi-Jamayran, Danny Simpson, Esther Kazlow, Anabelle Bunis, Chaitra Sreenivasaiah, Malid Ibrahim, Iryna Voloshyneya, Yuting Lu, Yongzhao Shao, Michelle Krogsgaard, Janice Mehnart, and Iman Osman. Other study co-investigators are Wouter Ouwerkerk and Rosalie Luiten, at Amsterdam University Medical Center in the Netherlands; Mariaelena Capone, Gabriele Madonna, and Paolo Ascierto, at the National Tumor Institute Fondazione G. Pascale in Naples, Italy; Anna Pavlick and Hao Tang, at Weill Cornell Medicine in New York; John Haanen, at the Netherlands Cancer Institute in Amsterdam; Sonia Dolfi and Daniel Tenney at Bristol Myers Squibb in Princeton, New Jersey; Thomas Gajewski, at the University of Chicago; Stephen Hodi and Osama Rahma, at Dana-Farber Cancer Institute in Boston; Keith Flaherty and Ryan Sullivan, at Massachusetts General Hospital and Harvard University in Boston; Kasey Couts and William Robinson, at the University of Colorado in Aurora; Igor Puzanov, at Roswell Park Comprehensive Cancer Center in Buffalo, New York; Marc Ernstoff, at the National Cancer Institute in Bethesda, Maryland; Michael Postow, at Memorial Sloan Kettering Cancer Center in New York; and Jason Luke, at the University of Pittsburgh in Pennsylvania. About NYU Langone Health NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient Inc. has ranked NYU Langone No. 1 out of 115 comprehensive academic medical centers across the nation for three years in a row, and U.S. News & World Report recently placed nine of its clinical specialties among the top five in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise. Media ContactDavid STUDY DOI:10.1038/s41591-025-03699-3 STUDY LINK: View original content to download multimedia: SOURCE NYU Langone Health System
