CDC launches new national campaign to tackle mental health, substance use among teens

(NEW YORK) — The first oral pill for obstructive sleep apnea (OSA) could be around the corner after pharmaceutical company Apnimed Inc. reported positive results from its stage III clinical trial.

Currently, many people diagnosed with OSA patients require a machine that covers their nose or both the nose and mouth during sleep and delivers air through a mask to help keep their airways open.

Apnimed’s lead candidate AD109 showed “clinically meaningful and statistically significant reductions” in airway obstruction after 26 weeks, the company said in a press release.

AD109, a once-a-day pill, is a neuromuscular modulator that increases upper airway muscle tone, which is how contracted the muscles are in the upper airway.

OSA patients treated with the medication saw a nearly 50% reduction in the severity from baseline at week 26, compared to 6.8% of those in the placebo group.

The reduction was “significant” at the end of the study period, which concluded at 51 weeks. At the end of the trial, nearly 23% of participants saw “complete disease control.”

The results were part of Apnimed’s 12-month study looking at the safety and efficacy of AD109 in adults with mild, moderate and severe OSA.

AD109 was well-tolerated among participants with only mild or moderate adverse events. Which was consistent with prior studies, according to Apnimed. No serious adverse events were reported in the trial.

“With two large Phase 3 studies now demonstrating a consistent and significant efficacy profile for AD109, we are closer to delivering the first oral pharmacotherapy for over 80 million U.S. adults with OSA,” Dr. Larry Miller, CEO of Apnimed, said in a statement. “Given the scale of unmet need in OSA, where the majority of patients remain untreated, we believe AD109, as a simple once-daily oral drug, has the potential to expand and reshape the treatment landscape, which would represent a significant commercial opportunity for Apnimed.”

OSA is a sleep disorder in which the airways become narrowed or blocked while sleeping, causing breathing to pause, according to MedlinePlus.

Soon after falling asleep, people experience loud and heavy snoring. The snoring is often interrupted by a long silent period during which breathing stops and then followed by a loud snort and gasp as the patient attempts to breathe.

This can cause excessive daytime sleepiness and affect quality of life, mental well-being and cardiovascular health.

In addition to a CPAP machine, there are lifestyle changes that people with sleep apnea can make including avoiding alcohol or medications that cause drowsiness and losing excess weight.

Recently, the U.S. Food and Drug Administration (FDA) expanded approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe obstructive sleep apnea for people with obesity.

The clinical trial did examine patients with a wide range of “weight classes” and did not see differences in efficacy based on weight.

Apnimed plans to file a New Drug Application with the FDA in early 2026, according to Miller.

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(WASHINGTON) — The Centers for Disease Control and Prevention’s vaccine advisory committee voted on Thursday to recommend infants receive a newer monoclonal antibody shot for respiratory syncytial virus (RSV).

The Advisory Committee on Immunization Practices (ACIP) voted 5-2 to recommend clesrovimab, made by Merck, for infants 8 months and younger who are not protected by a maternal vaccine.

In a second vote, the committee voted unanimously to update the resolution for the federal Vaccines for Children program to include details about the newly approved antibody shot. About half of all U.S. children are eligible for free or low-cost vaccines.

Usually, the CDC director signs off on the votes for final recommendation but, because there is currently no CDC director, the final decision will go to Health and Human Services Secretary Robert F. Kennedy Jr.

If signed off by Kennedy, clesrovimab will made available along with another RSV shot made by Sanofi/AstraZeneca.

This marks the first vote of the panel since Kennedy dismissed the entire panel and appointed his own hand-selected members.

Currently, RSV vaccines are recommended for pregnant women between 32 and 36 weeks of pregnancy to pass on protection to a fetus, which should last throughout their first RSV season.

For babies 8 months and younger born to mothers who did not receive a maternal RSV vaccine, monoclonal antibody shots are available.

Monoclonal antibodies are proteins manufactured in a lab and mimic the antibodies the body naturally creates when fighting an infection. They do not activate the immune system as would occur with vaccination. The shot is also recommended for a small group of children from 8 months old through 19 months old who are at increased risk for severe RSV.

During the first day of the meeting, on Wednesday, Dr. Georgina Peacock, director of the Immunization Services Division in the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), shared CDC data showing 57% of infants born between April 2024 and March 2025 were protected from RSV by maternal vaccination or receipt of nirsevimab, the shot made by Sanofi/AstraZeneca.

Dr. Cody Meissner, one of the new ACIP members, described the vaccine and antibody data, showing its real-world impacts as a “truly spectacular accomplishment.”

“People should understand this is a truly spectacular accomplishment and will have enormous impact on public health,” he said.

Another ACIP member, Retsef Levi, expressed some skepticism, saying he wanted to see more data on how efficacy for the maternal vaccine changes over time, adding that RSV is a “tricky” virus that “fools interventions in unexpected ways.”

In response, Dr. Adam MacNeil of the NCRID said vaccine efficacy does wane over time, but the maternal RSV vaccine protects newborns and infants when they’re at their most vulnerable, before they develop more robust immune systems.

The votes comes after the group announced on Wednesday it would review the current childhood immunization schedule.

Martin Kulldorff, the ACIP’s new chair, said two new work groups would be established, one focusing on the cumulative effects of children and adolescents receiving all recommended vaccines on the schedule and another reviewing vaccines that haven’t been examined for more than seven years.

The latter group may discuss whether the hepatitis B vaccine is necessary at birth before a baby leaves the hospital, according to Kulldorff.

“The number of vaccines that our children and adolescents receive today exceeds what children in most other developed nations receive and what most of us in this room received when we were children,” Kulldorff said.

The American Academy of Pediatrics put out a video on Wednesday, saying immunization policy through ACIP is “no longer a credible process” and that it will continue to publish its own vaccine recommendations for children.

In the morning, CDC staff presented data on COVID-19 vaccines, showing safety and efficacy as well as a reduction in hospitalizations and deaths.

For the 2024-25 updated COVID vaccine against emergency department and urgent care encounters, the CDC found 79% effectiveness for children between nine months and 4 years old, 57% effectiveness among children between five and 17 years old and 34% effectiveness for those aged 18 and older.

Kulldorff asked where the data shows COVID-19 vaccine effectiveness from placebo-controlled trials. Dr. Adam MacNeil, from the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said the CDC’s evaluation of effectiveness came from real-world data.

“Randomized clinical control trials are not necessarily comparable to what we’re currently seeing with the vaccine,” MacNeil said. “Where we’re trying to now monitor is the real-world impacts of these vaccines as opposed to clinical trial data, which was certainly extensively documented.”

The ACIP members also discussed questions about potential safety signals surrounding the COVID vaccine, with the CDC determining that myocarditis and pericarditis — inflammation of the heart muscle and the sac around the heart, respectively — are still risks, but no other risks have been found.

ABC News’ Sony Salzman contributed to this report.

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(NEW YORK) — Two U.S. hospitals are the latest to announce they will be ending some, or all, of their pediatric gender-affirming care services at the end of the month.

Kaiser Permanente, a health care company that manages 40 hospitals across several states — including California, Oregon and Virginia — said it is pausing gender-related surgeries for patients under age 18 on Aug. 29. It noted that other gender-related care will continue.

Children’s National Hospital in Washington, D.C. said it will also stop prescribing gender-affirming medications on Aug. 30. It follows a move the hospital made in late January to pause all puberty-blockers and hormone prescriptions for minors.

Since President Donald Trump’s second term began in January, at least 17 major hospital systems in at least nine states and the District of Columbia have paused, discontinued, canceled or ended pediatric gender services, according to an ABC News tally, amid mounting legal and regulatory concerns.

In January, Trump signed an executive order stating the U.S. would not “fund, sponsor, promote, assist, or support” gender transition of those under age 19 and would “rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”

Transgender adults and youth may experience extreme psychological distress due to a mismatch in their gender presentation and identity. They experience significantly higher rates of suicide than the general population, but some studies suggest gender-affirming care eases those feelings of distress.

While some individuals and groups have called for a slower approach to gender-affirming care for minors, other pediatric gender care experts and advocates have said ending such care can have a harmful effect on patients’ mental health and well-being.

They say the government is interfering in conversations meant to be held only between patients, their families and doctors, and that doctors are not being allowed to follow the established medical guidelines that medical associations like the American Academy of Pediatrics, the Endocrine Society and the World Professional Association for Transgender Health have endorsed.

“This is health care provided by licensed clinicians according to standards of care that have been around for many years,” Kellan Baker, a senior adviser for health policy with the Movement Advancement Project, a nonprofit think tank that focuses on LGBTQ+ issues, told ABC News.

“To have the government interfering … overreaching into the private conversations between patients and families and their doctors and telling doctors that they cannot provide the care that they know that their patients need — that is a very serious government overreach,” he added.

Evidence for gender-affirming care
Gender-affirming care may include medical, surgical, mental health and non-medical services. It can range from allowing a child to pick their pronouns to more invasive treatments typically prescribed for older teens.

Early gender affirming care can be “crucial” to overall health and well-being, allowing a child to focus on social transitions and can help build up confidence while dealing with the health care system, the federal Office of the Assistant Secretary for Health wrote during the Biden administration.

Gender-affirming care is supported by multiple major medical organizations. Studies have shown many of the treatment options are generally safe and that care can have a positive impact on mental health, which psychotherapy alone cannot provide, some experts said.

Some experts have questioned the significance of the interventions on long-term mental health as well as the possibility of regret and point out potential risks on future fertility.

“It’s deeply disappointing that hospital systems have relented to the political pressure, not scientific pressure, to end these sorts of programs,” Dr. Marci Bowers, a gynecologic and reconstructive surgeon at Mills-Peninsula Medical Cener in Burlingame, California, told ABC News. “We have decades of evidence-based information that suggests that gender-related health care is beneficial to patients and their families with very, very, very scant incidences of regret or disappointment in that care.”

A spokesperson for Children’s National Hospital told ABC News it was discontinuing the prescription of gender-affirming medications in light of “escalating legal and regulatory risks” to the hospital, its providers and families.

“We know this change will have a significant impact on affected patients, families and staff, and our care teams are working directly with families of current patients to support them,” the statement read, in part. “Mental health and other support services for patients remain available. LGBT patients are always welcome at Children’s National for other medical needs and treatment.”

Similarly, a spokesperson for Kaiser Permanente pointed ABC News to actions from the administration, including the Department of Justice issuing subpoenas to doctors and clinics providing gender-affirming care to transgender youth.

“As the legal and regulatory environment for gender-affirming care continues to evolve, we must carefully consider the significant risks being created for health systems, clinicians, and patients under the age of 19 seeking this care,” the statement read, in part. “After significant deliberation and consultation with internal and external experts, including our physicians, we’ve made the difficult decision to pause surgical treatment for patients under the age of 19 in our hospitals and surgical centers.”

The hospital said it would work to identify clinicians performing surgery if a patient’s planned operation was canceled and, if a clinician is available, the hospital said it will work with patients and their families to coordinate care and provide coverage for surgical treatment.

Bowers — the Mills-Peninsula gynecologic and reconstructive surgeon — said if somebody is in treatment and that treatment is suddenly withdrawn, it can be extremely difficult, and patients can experience psychosocial and personal setbacks. She said treatment gave patients a psychological boost.

‘When you look and you talk to these individuals, they are happier about themselves,” she said. “They’re happier about their bodies. They’re happier about their choice of friends, how they see themselves in the world. They’re more optimistic. So those are softer measures, but they’re important, and those things matter.”

She also said withdrawing medical care can be a major disruption to patients’ lives because families may have to move to receive care that is now no longer being provided locally.

Baker — the Movement Advancement Project’s health policy adviser — said he sees the actions from the administration as a “campaign of terror” against health care institutions, doctors and families, and that decisions about continuing or discontinuing gender-affirming care should remain between patients and their health care providers.

“This is about health care providers working together with patients and parents to get kids what they need,” Baker said. “It’s nothing more. It’s nothing less. All that trans people are trying to do is live their lives, and all the parents of trans kids are trying to do is love their kids.”

Concern after HHS report
Not all experts are opposed to the closures. Dr. Kristopher Kaliebe, a child and adolescent psychiatrist and professor at the University of South Florida Morsani College of Medicine, believes the retrenchment reflects long-standing scientific concerns.

“Clinicians have quietly recognized for years that the evidence base for these interventions in minors is weak,” he told ABC News. “There’s no strong proof that they improve mental health, and we simply don’t know the long-term outcomes.”

In May, the Department of Health and Human Services (HHS) released what it called a “comprehensive review” of transgender care for children and teens, calling for broader use of psychotherapy for young people with gender dysphoria rather than gender-affirming care.

The authors of the review were not named, so their credentials have not been reviewed and the paper has not yet been peer-reviewed by independent scientists yet — a step this is typically necessary before changing any guidelines that health care providers follow.

The more than 400-page document details possible harm from medical interventions for youth, including the use of puberty blockers and potentially associated risks, such as infertility.

It follows systematic reviews from Sweden, Finland and the U.K. that have resulted in the three countries restricting gender-affirming care. England’s National Health Service ended prescribing puberty blockers for minors experiencing gender dysphoria outside of clinical trials. Sweden and Finland have followed psychotherapy-first models.

Kaliebe called the HHS review a needed step, saying, “For the first time, the federal government acknowledged openly that these interventions are experimental and that we need high-quality data, especially long-term tracking of outcomes.”

However, Bowers dismissed the HHS review as derivative, saying the team that put the report together didn’t appear to conduct its own review and rather “pirated” reviews conducted overseas.

“There were a lot of other mischaracterizations throughout that report,” Bowers said. “Most experts, frankly, scoff at what they saw. … It’s disappointing. It sounds more like politics than it does practical and factual matter.”

Baker concurred, referring to the report as a “really shocking government document,” suggesting it was commissioned right after Trump’s January executive order with a pre-determined outcome.

“I’m a health services researcher by training … and I’m very familiar with evidence-based medicine and systematic reviews, and one of the ways that you need to make sure that you’re approaching work like that is to not have your thumb on the scale,” he said. “You don’t go in with a research question that has already been decided, where the outcome has already been decided. That’s not good science. It’s not science at all.”

He said producing the report so quickly after the executive order was issued — a little over three months — was too short of a timeline for a thorough review and he criticized not having the names of the authors on the report to ensure there were no conflicts of interest and that the authors were experts in their field.

Experts have said they are in favor of more research being conducted — Kaliebe emphasized the need for rigorous tracking of harms and a clearer study of psychotherapeutic approaches.

Bowers argued that while stronger research is welcome, cutting off services altogether harms real people.

“We know from decades of clinical experience that when care is affirming, young people are happier and healthier,” she said. “That’s what parents see, even if politics obscures it.”

If you or someone you know is struggling with thoughts of suicide, free, confidential help is available 24 hours a day, seven days a week. Call or text the national lifeline at 988.

 

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