RFK Jr. says U.S. will stop funding global vaccine alliance Gavi
The United States will halt its contributions to Gavi, the global alliance that works to expand access to vaccines for children in some of the world's poorest countries, Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday — a move that public health experts said would have deadly consequences.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Los Angeles Times
30 minutes ago
- Los Angeles Times
Contradicting RFK Jr., CDC says the COVID vaccine protects pregnant women, babies, and children
Here's how one of the well-laid plans of Health and Human Services Secretary Robert F. Kennedy Jr. went blooey. Earlier this month, Kennedy dismantled the all-important Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and remade it into the spearhead for his anti-vaccination campaigns. The rejiggered committee met for the first time Wednesday. Unfortunately for Kennedy's goals, the very first presentation it heard from CDC scientists involved the safety of the COVID-19 vaccine, particularly for pregnant women, infants and children. CDC studies found 'no increased risk' that the Moderna and Pfizer mRNA vaccines caused adverse effects during pregnancy, Sarah Meyer, director of the CDC's Immunization Safety Office, said at the meeting, citing data from 28 analyses of 68,000 pregnant women. The data showed no increases in miscarriages, stillbirths, preterm births, major birth defects, neonatal ICU admissions, infant deaths, abnormal uterine bleeding or other pregnancy-related conditions. In fact, the CDC found that 'maternal vaccination is the best protection against COVID-19 for pregnant women and infants less than six months of age,' CDC immunologist Adam MacNeil told the panel. The COVID vaccines aren't approved for infants younger than six months, so maternal immunization is their only protection. That's important because Kennedy, on May 17, removed the vaccines from the recommended list for pregnant women and children. 'It's common sense and it's good science' to remove the recommendation, Kennedy said in a 58-second video posted on X. 'We're now one step closer to realizing President Trump's promise to make America healthy again,' Kennedy crowed, flanked by Marty Makary, the newly appointed commissioner of the Food and Drug Administration, and Jay Bhattacharya, the newly appointed director of the National Institutes of Health. Neither body plays a role in issuing vaccine recommendations for the government. That's the job of the CDC, which has been operating without a director, and which didn't have a representative on the video. Pediatric and obstetric organizations decried the decision, which ran counter to the findings of extensive research. 'Clear benefits of maternal immunization versus COVID in terms of dramatic reductions in maternal mortality and protecting the newborn infant ... has been detailed in the biomedical literature,' vaccinologist Peter Hotez told me by email. I asked Kennedy through his agency's public information team for comment on the CDC presentation, but received no reply. On June 9, Kennedy fired all 17 members of ACIP of the immunization advisory committee and replaced them with eight handpicked members, a cadre that includes 'antivaxxers, the antivax-adjacent, and the unqualified,' as veteran pseudoscience debunker David Gorski noted. The COVID vaccines have been a leading target of anti-vaccine activists, including Kennedy, since they were introduced in 2021. They've been blamed for a host of purported health harms, most of which have been found by researchers to be largely imaginary. The anti-vaccine camp maintains that the vaccines weren't adequately studied before rolling them out to the general public and haven't been sufficiently monitored for adverse effects since then. The CDC officials' presentation debunked almost all these claims. Indeed, Meyer said, the COVID-19 vaccines have been subjected to 'the most extensive safety monitoring program in U.S. history.' The CDC has investigated more than 65 possible adverse effects of the vaccine, Meyer said, including heart attacks, meningitis, spontaneous abortion, seizures and hospitalization. Other than pain at the injection site, fainting and other transitory conditions common to most vaccines, it has found evidence for one condition — myocarditis, a heart inflammation seen especially in men aged 12 to 29. That appears to be a short-term condition, with 83% of patients recovering within 90 days of onset, and more than 90% fully recovered within a year. No deaths or heart transplants are known to have occurred, the CDC data show. No confirmed cases were seen in children younger than 5. The myocarditis rate among vaccine recipients aged between 6 months and 64 years appeared to spike in 2020-22, when it seemed to be related to the original vaccine and the original booster. After the booster was reformulated, the rate among those aged 12 to 39 fell to about one case per million doses in 2024-25 — half the rate found in the general population. Despite the relative rarity of myocarditis, the condition has underpinned a campaign by anti-vaccine activists to take the vaccines off the market. Among them is Joseph Ladapo, the Florida surgeon general, who in 2022 advised males aged 18-39 not to get the COVID vaccine. His advisory earned him a crisp upbraiding from the then-heads of the FDA and CDC, who informed him by letter that 'the known and potential benefits of these vaccines clearly outweigh their known and potential risks.... Not only is there no evidence of increased risk of death following mRNA vaccines, but available data have shown quite the opposite: that being up to date on vaccinations saves lives compared to individuals who did not get vaccinated.' And on Wednesday, just as the CDC team was telling ACIP that the myocarditis effect had ebbed to insignificance, the FDA announced that it was expanding the warning label on the mRNA vaccines to increase the caution about myocarditis — a change with the potential to undermine acceptance of the vaccines. Overall, the rate of death seven days after mRNA vaccinations has been lower than the background rates among the general population for the most common causes of death — such as heart disease, cancer and stroke. I've written before that Kennedy's anti-science campaign against vaccination — or more properly, his science-free campaign — has set the stage for a public health crisis in the U.S. Videos posted on X citing nonexistent evidence is no substitute for medical judgments based on science. They won't make America healthy, but will make Americans much sicker. Kennedy's actions are potentially deadly, and the CDC has the data to prove it.
Medscape
34 minutes ago
- Medscape
Semaglutide Benefits Adults With Type 1 Diabetes + Obesity
CHICAGO — Once-weekly semaglutide improved glycemia and reduced weight without increasing hypoglycemia in adults with type 1 diabetes (T1D) and obesity, new research presented at the American Diabetes Association (ADA) 85th Scientific Sessions found. The study results were simultaneously published in NEJM Evidence . 'Semaglutide was effective in lowering or improving time in range, without increasing time below range; it produced weight loss of at least 5%; and it was very safe,' said lead investigator Viral N. Shah, MD, professor of medicine and director of diabetes clinical research at the Center for Diabetes and Metabolic Diseases, Indiana University, Indianapolis. 'We didn't find any difference in severe hypoglycemia between semaglutide and a placebo, and we did not find any [diabetic ketoacidosis] in the entire study,' Shah told Medscape Medical News . 'I think the results are very encouraging, and I hope that industry will take it on and do a regulatory approval trial for semaglutide in type 1,' he added. Over a Third Met Composite Endpoint The 26-week ADJUST-T1D randomized clinical trial investigated semaglutide vs placebo in 72 adults with T1D and obesity (BMI ≥ 30) who were using automated insulin delivery (AID) systems. The trial was investigator-initiated and funded by Breakthrough T1D, not Ozempic manufacturer Novo Nordisk, although the company did provide the drug. A total of 72 patients were randomized 1:1 to receive once-weekly semaglutide, up to 1 mg, or placebo for 26 weeks. Participants had a mean age of 40 years, a mean diabetes duration of 23 years, a mean baseline A1c of 7.8, BMI 35, and body weight 102 kg. Two thirds were using the Tandem Control IQ AID system. The primary endpoint was a composite of continuous glucose monitoring (CGM)-based time in range 70-180 mg/dL of > 70%; time below 70 mg/dL of < 4%; and ≥ 5% weight reduction. A total of 13 of the 36 (36.1%) in the semaglutide group vs zero in the placebo group met the composite endpoint. The between-group difference was 36 percentage points ( P < .001). Semaglutide treatment was associated with a nearly eightfold better chance of achieving the primary outcome (odds ratio, 7.77). Among the secondary outcomes, A1c reductions from baseline to week 26 were 0.7 with semaglutide vs 0.4 with placebo; increased percent time in range was 11.1% vs 2.3%; reductions in CGM mean glucose were 15.7 mg/dL vs 3.6 mg/dL; and reductions in percentage time above 180 mg/dL were 11.1% vs 2.7%. All of those differences were significant, Shah reported. The percentage of time spent below 70 mg/dL from baseline was low and the change from baseline didn't differ significantly between the two groups, 0.1% vs 0.4%. Body weight change at 26 weeks were reductions of 9.2 kg vs 0.4 kg, and BMI drops were 3.3 vs 0.2. Those differences were also significant, Shah said. Daily insulin requirements from baseline to week 26 were reduced significantly by 22.3 units per day with the semaglutide group compared to the placebo group. A total of 57 gastrointestinal events were reported by 19 patients in the semaglutide group vs 13 gastrointestinal events were reported by 9 patients in the placebo group. Two from each group experienced severe hypoglycemia. There were no diabetic ketoacidosis events in either group. The number of people who discontinued the trial early due to persistent gastrointestinal adverse events was three in the placebo group vs two in the semaglutide group. 'Prohibitively Expensive for Those With T1D' Asked to comment, Nicholas B. Argento, MD, senior clinical endocrinologist and diabetes technology director at the Maryland Endocrine and Diabetes Center, Columbia, Maryland, said that the trial 'was small but showed the benefit of using adjunctive therapy in T1D.' There is an 'unmet need' in patients with T1D with a high BMI and suboptimal glycemic control, he told Medscape Medical News Despite proven cardiorenal benefits of both GLP-1 agonists and SGLT2 inhibitors in type 2 diabetes, 'none are approved for use in T1D, which means that they are generally not covered by insurance.' These medications 'end up being prohibitively expensive for those withT1D to access,' Argento noted. But there is no reason to believe we would not see similar benefits in those with T1D, who have a very high cardiorenal risk, he said. 'ADJUST-T1D shows that T2D agents like semaglutide can definitely benefit T1Ds with no safety concerns.' For the time being, Shah pointed to this section of the ADA Standards of Care that was just added in the 2025 edition: A diagnosis of type 1 diabetes does not preclude also having features classically associated with type 2 diabetes (eg, insulin resistance, obesity, and other metabolic abnormalities), and until more precise subsets are used in clinical practice, it may be appropriate to categorize such an individual as having features of both type 1 and type 2 diabetes to facilitate access to appropriate treatment (eg, glucagon-like peptide 1 receptor agonist [GLP-1 RA] or sodium–glucose cotransporter 2 [SGLT2] inhibitor therapies for potential weight and other cardiometabolic benefits) and monitoring systems. 'We use that language from the Standards of Care in prior authorization,' Shah told Medscape Medical News . Independent Industry Consultant Charles Alexander, MD, told Medscape Medical News , 'This small study is very encouraging but unlikely to lead to [US Food and Drug Administration] approval for semaglutide in T1D. In contrast, two much larger currently recruiting global studies of tirzepatide in T1D NCT06914895 and NCT06962280 are more likely to lead, if successful, to FDA approval.' Shah received research support from, does consulting, speaking, and/or serves on advisory boards for Alexion, Novo Nordisk, Dexcom, Enable Bioscience, Zucara Therapeutics, Lilly, Breakthrough T1D, NIH, Insulet, Tandem Diabetes Care, Medtronic, Ascensia Diabetes Care, Embecta, Sanofi, Sequel Med Tech, Biomea Fusion, Lumosfit, and Genomelink. Argento has consulted or been on advisory boards for Eli Lilly Diabetes, Dexcom, DiabeLoop, ConvaTec, and Senseonics and served on the speakers' bureaus for Boehringer-Ingelheim, Dexcom, Eli Lilly Diabetes, MannKind, Novo Nordisk, Xeris, and Zealand Pharmaceuticals. Alexander had no disclosures.
Medscape
35 minutes ago
- Medscape
Mifepristone Improves A1C in T2D With Hypercortisolism
CHICAGO — Mifepristone treatment improved glycemic control and led to weight loss and a reduction of waist circumference in patients with poorly controlled type 2 diabetes (T2D) and hypercortisolism, according to new data from the CATALYST trial. Results from the prevalence phase of the study, presented last year, indicated that 24% (253) of the 1055 patients enrolled had hypercortisolism, as determined by dexamethasone suppression test. The figure was surprising, as the expected prevalence was 8%. The current data were presented at the American Diabetes Association (ADA) 85th Scientific Sessions and simultaneously published in Diabetes Care . 'These findings demonstrate a potentially promising treatment solution' for these patients, who are often frustrated with their diabetes care, said study author John Buse, MD, PhD, Verne S. Caviness Distinguished Professor of Medicine at the University of North Carolina School of Medicine, Chapel Hill, North Carolina, in a press release. The CATALYST Trial: Latest Results In the second phase of CATALYST, individuals who had abnormal cortisol suppression were offered the opportunity to take part in a randomized trial of mifepristone, a medication that reduces the effects of cortisol. It is currently FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or T2D. The trial took place at 36 sites in the US. A total of 136 patients with T2D (A1c of 7.5%-11.5%, who were on multiple medications) and hypercortisolism were randomized 2:1 to mifepristone (300-900 mg once daily; 91 patients) or placebo (45 patients) for 24 weeks, with stratification by presence/absence of an adrenal imaging abnormality. Almost 40% of the patients were women, and the mean age was 63 years. The mean A1c was 8.55%, and mean BMI was 33.3. Twenty-eight percent of participants had adrenal imaging abnormalities. The medication reduced A1c by 1.5% (95% CI, -1.79 to -1.14). For those taking placebo, A1c declined 0.2% from 8.41% to 8.36% (95% CI, -0.56 to 0.27). Within the first 12 weeks, 30% of those taking mifepristone reduced or discontinued fast-acting insulin compared to 11% of those taking placebo. And half reduced or discontinued long-acting insulin compared to 13% of those taking placebo. 'As their A1c came down, they didn't need the insulin,' Buse told reporters at a press conference at the meeting. Patients taking mifepristone also lost 4.4 kg of body weight and had a 5.2 cm (2.05 in) reduction in waist circumference from baseline. However, almost 50% of those taking mifepristone discontinued due to adverse events compared to just 18% of those taking placebo. A total of 62% of patients on mifepristone reported having treatment-related adverse events, said Buse, adding that people on mifepristone primarily experience glucocorticoid withdrawal syndrome or hypokalemia. Mifepristone 'is a challenging drug to use,' he said, and 'it's important to set expectations appropriately with patients about steroid withdrawal symptoms and how to manage them.' CATALYST already demonstrated that hypercortisolism was likely a culprit in almost a quarter of patients with poorly controlled diabetes, and screening with a dexamethasone suppression test is relatively easy, said Buse. The treatment phase of CATALYST showed 'that identifying and addressing hypercortisolism is a novel path to improving diabetes care in millions of people worldwide,' he added. The CATALYST investigators 'believe that there's sufficient evidence now to suggest guideline changes at the American Diabetes Association and other international health organizations.' This study was funded by Corcept Therapeutics. Buse disclosed serving on an advisory panel/as a consultant for Altimmune, Antag Therapeutics, Amgen, APstem Therapeutics, Aqua Medical, AstraZeneca, Boehringer Ingelheim, CeQur, Corcept Therapeutics, Dexcom, Eli Lilly, embecta, GentiBio, Glyscend, Insulet, Medtronic MiniMed, Mellitus Health, Metsera, Novo Nordisk, Pendulum Therapeutics, Praetego, Stability Health, Tandem Diabetes Care, Terns Pharmaceuticals, Vertex Pharmaceuticals, and Zealand Pharma; and having stocks/shares in Glyscend, Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, and Stability Health.
