Moderna awarded $590M to help accelerate development of mRNA-based bird flu vaccine: HHS
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(NEW YORK) — Moderna has been awarded approximately $590 million from the federal government to help speed up the development of an mRNA-based bird flu vaccine, alongside other influenza vaccines, health officials announced Friday.
The U.S. Department of Health and Human Services (HHS) said in a press release that the funding will allow the pharmaceutical company to accelerate the development of an H5N1 mRNA influenza vaccine “that is well matched to strains currently circulating in cows and birds and expands the clinical data supporting the use of mRNA vaccines that may be needed if other influenza strains emerge with pandemic potential.”
Moderna said the funding will support the expansion of clinical studies “for up to five additional subtypes of pandemic influenza.”
The U.S. government previously awarded the vaccine manufacturer $176 million in July 2024 to help expedite the development of an mRNA vaccine that could be used for bird flu.
mRNA technology is the same type that was used in the development of some COVID-19 vaccines. While some vaccines use a weakened or inactive virus to stimulate an immune response, mRNA vaccines teach the body how to make proteins that can trigger an immune response and fight off an infection.
Researchers can often design mRNA vaccines more quickly than they can produce the live or weakened pathogens needed for a live-attenuated or inactivated vaccine.
The federal government already has two bird flu vaccine candidates, which use traditional vaccine technology, available in the nation’s stockpile. Officials previously noted they’d have 10 million ready-to-use doses within the beginning of 2025. Vaccines were being stockpiled as a precaution.
“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past. That is why this response has been a top priority for the Biden-Harris Administration and HHS,” HHS Secretary Xavier Becerra said in a statement on Friday. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”
Bird flu cases in humans have been spreading across the country since April 2024 with 67 confirmed cases as of Friday, according to the Centers for Disease Control and Prevention (CDC).
The first death of a human bird flu patient was reported in Louisiana earlier this month. The patient was over the age of 65 and had underlying medical conditions, according to health officials.
Most human cases have occurred after coming into contact with infected cattle, infected poultry farms or other culling operations.
The CDC and other public health officials say there is currently no evidence of human-to-human transmission and the risk to the general public is low.
ABC News’ Mary Kekatos contributed to this report.
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(NEW YORK) — Semaglutide, a medication widely used for diabetes and weight loss, may offer another unexpected benefit — it could help people drink less alcohol.
A study published in JAMA Psychiatry enrolled 48 adults between ages 21 and 65 who had been diagnosed with alcohol use disorder but were not actively seeking treatment.
Half received semaglutide, a type of GLP-1 receptor agonist, while the other half received no treatment. Over the nine-week trial, participants taking semaglutide started at a dose of 0.25 mg per week, which gradually increased to 1.0 mg in the final week — a much lower dose than what’s typically prescribed for weight loss.
”We found the largest effects for outcomes related to drinking quantity or heavy drinking…[semaglutide] appeared to reduce drinking quantity,” said Christian Hendershot, PhD, the study’s lead author and director of clinical research at the USC Institute for Addiction Science, in an interview with ABC News.
In a controlled lab setting, participants taking semaglutide drank less alcohol. However, outside the lab, their overall drinking days and daily alcohol intake did not change significantly. They did, however, report fewer binge-drinking episodes and reduced alcohol cravings.
Hendershot emphasized that the participants were not actively trying to cut back on drinking or become abstinent, making the drug’s impact particularly interesting.
”The reason why semaglutide may have an effect on addictive behaviors and cravings and may play a role in treating alcohol use disorder is still not entirely clear,” said Dr. Stephanie Widmer, an emergency medicine physician and addiction medicine expert. ”More research needs to be done in order to really get a firm grasp on what the pathophysiology is behind this,” she added.
One possible explanation is that GLP-1 receptor agonists increase feelings of fullness, which could make alcohol less appealing, Hendershot said.
Previous animal studies suggest these medications may also affect the brain’s reward system, reducing the desire for substances like alcohol and nicotine. However, it remains unclear if the same effect holds true in humans.
Interestingly, the medication also appeared to reduce cigarette use in a small group of participants who smoked, hinting at broader effects on addictive behaviors.
”Preclinical studies indicate that GLP-1 receptor agonists reduce not just alcohol intake, but also nicotine self-administration and nicotine-related reward,” Hendershot noted. However, no FDA-approved medications currently exist to treat both alcohol and nicotine dependence.
Another unexpected benefit was that those treated with semaglutide lost 5% of their body weight over the course of the study. While this result is consistent with previous research, Hendershot noted the need to evaluate potential side effects, particularly in individuals with lower BMIs.
The study did have several important limitations. It was small, lasted only nine weeks, and was conducted in a controlled setting that may not fully reflect real-world drinking behaviors.
Additionally, because participants were not actively trying to reduce their alcohol consumption, their motivation—or lack of it—could have influenced the results, Henderson implied.
Still, the findings suggest semaglutide could play a role in reshaping addiction treatment. According to the National Institutes of Health, only three medications are currently FDA-approved to treat alcohol dependence, and many individuals with the condition never receive any treatment.
In 2023, more than 2 million people had alcohol use disorder, yet only about 8% received treatment.
”If semaglutide proves to be a better option than the three FDA-approved drugs that are currently in use, this would be a huge breakthrough for many,” Widmer said.
Dr. Christopher Wachuku is an internal medicine preliminary intern at Lankenau Medical Center and a member of the ABC News Medical Unit.
(NEW YORK) — Transgender adults who received gender-affirming hormone therapy had a significantly lower risk of moderate-to-severe depression over four years compared to those who did not receive such care, according to a new study published in the journal JAMA Network Open.
The study tracked 3,592 transgender, nonbinary, and gender-diverse adults and found that those prescribed hormones like estrogen or testosterone had a 15% lower risk of depression symptoms, reinforcing the mental health benefits of this treatment.
The findings “support the mental health-promoting role of hormones” and their status as “a medically necessary treatment,” said Sari Reisner, an associate professor of epidemiology at University of Michigan School of Public Health and one of the study’s authors. “Hormones play a vital role in the mental health of trans people who need them.”
The study acknowledges that other factors, such as mental health treatment, social support and other influences on mood, could have affected the findings. It also did not track the duration patients received gender-affirming hormone therapy or whether they underwent other forms of gender-affirming care, such as surgery.
Transgender people in the U.S. are two to three times more likely to have a history of depression, according to the Centers for Disease Control and Prevention. The study warns that mental health disparities continue to worsen in transgender and gender diverse communities, as access to gender-affirming care becomes more difficult.
Dr. Alexes Hazen, a New York City plastic surgeon specializing in gender-affirming procedures, says she has seen a rise in depression among her patients in recent months. Many have expressed concerns over the wave of state laws restricting or banning gender-affirming care, which has made finding treatment more difficult and left many feeling hopeless.
“Unfortunately, some states are not as friendly to patients and care providers,” Hazen said. “Some states have publicly stated their allegiance to trans and nonbinary folks, and those places will become safe havens for care.”
As barriers to gender-affirming care grow, the new study underscores its importance for mental health in transgender patients. These services “address the pervasive mental health inequities that trans people experience,” Reisner said, emphasizing that access to this care is both medically necessary and essential for reducing depression risk.
“Our findings underscore the importance of protecting and upholding the right to accessible healthcare for trans people,” Reisner said,
Hazen recommended community-based health centers that cater to LGBTQ+ patients as a key resource for gender-affirming care. The study also reinforced the importance of these clinics, arguing that the gender-affirming treatment they provide improves access and supports mental health, particularly for those in underserved communities.
Alice Gao, MD, MPH, is a family medicine resident at Temple Northwest Community Family Medicine and a member of the ABC News Medical Unit.
(WASHINGTON) — During his confirmation hearings two weeks ago to lead the Department of Health & Human Services (HHS), Robert F. Kennedy Jr. repeated several unfounded claims about autism.
Kennedy, an environmental lawyer who has made money through books, speeches and lawsuits while sharing vaccine skepticism, refused to say that vaccines don’t cause autism despite many high-quality studies finding no such link.
He stated during the hearing that autism rates have “have gone from 1 in 10,000 … and today in our children, it’s one in 34.” His claims have been repeated by President Donald Trump on Truth Social.
It’s unclear where Kennedy got his 1 in 10,000 statistic. In 2000, approximately 1 in 150 children in the U.S. born in 1992 were diagnosed with autism compared with 2020, during which one in 36 children born in 2012 were diagnosed, according to data from the Centers for Disease Control and Prevention.
Some psychiatrists and autism experts told ABC News it’s important to highlight the rising rates of autism, and that at least Kennedy is putting a spotlight on it.
“On the bright side, I think it is really important to place an emphasis on these very high rates, it’s kind of great putting a spotlight on autism, these increased rates,” Dr. Karen Pierce, a professor in the department of neurosciences at the University of California, San Diego and co-director of the UCSD Autism Center of Excellence, told ABC News. “We need more funding. We need more infrastructure to support everybody who is now recognized as on the spectrum. So, I think that that’s actually a really good thing.”
However, the experts said Kennedy and others are missing important context about why autism rates are increasing. They say reasons may include a combination of widening of the definition of the spectrum and of types of symptoms associated with autism spectrum disorder (ASD) as well as people having children at older ages, better awareness and access to diagnostic testing.
“With the rates increasing, there certainly are valid reasons for that,” Pierce said. “There’s better awareness, and doctors can find autism a lot easier than they could before in the past…. and I think a very big reason is just better record keeping nowadays and easier access to reviewing records.”
What is autism?
ASD is a developmental disability caused by differences in the brain, according to the CDC.
People with ASD often communicate, interact, behave and learn differently, the CDC says. ASD symptoms typically begin before age 3 and can last a lifetime, although symptoms may change over time.
“There can be differences in how one is reading social cues and interpreting them, and then there’s also certain behaviors that we see,” Dr. Anna Krasno, clinical director of the Koegel Autism Center at the University of California, Santa Barbara, told ABC News.
“So those include a preference for sameness, a difficulty with transitioning, some cognitive and behavioral rigidity,” she continued. “We also see intense interests, so topics that people are super, super into and want to research, repetitive speech and motor movements. And then we also see really significant sensory differences as well.”
ASD is a spectrum, which means symptoms vary by person — some need little support in their daily lives and some may need a great deal of support in performing day-to-day activities. Some may have advanced conversation skills and others may be nonverbal.
Wider recognition, better understanding
Experts told ABC News there is a wider recognition and a better understanding of what is now understood as autism/ASD.
Traits of what is now known as ASD are built on early observations in the 1940s from Austrian-American psychiatrist Dr. Leo Kanner and Austrian physician Dr. Hans Asperger.
A 1943 paper from Kanner described 11 children who presented with “inborn autistic disturbances of affective contact” while Asperger’s 1944 report focused on boys who had marked social difficulties; unusual, circumscribed interests; and good verbal skills.
It was not until 1978 that autism was recognized as a developmental disorder distinct from schizophrenia by the World Health Organization. It was also in the 1970s that psychologists and psychiatrists first came to describe autism as a spectrum.
“When autism was first described, it was new to people understanding that there was a condition that included social communication difficulties and restricted and repetitive behavior, and people primarily only recognized it when it was at its most extreme,” Dr. Jeremy Veenstra-VanderWeele, division director in child and adolescent psychiatry at Columbia University, told ABC News.
“And so, if you go back and read the initial descriptions today, those are kids who we would recognize in the waiting room, recognize in the grocery store, in whom autism would be very obvious and would not require much assessment in order to diagnose,” he continued.
Better diagnostic tools
Experts say another reason for the increase in rates is having better diagnostic tools than what was available decades ago.
There is no single tool used as the basis of an ASD diagnosis. Typically, tools rely on descriptions from parents or caregivers of a child’s development and a professional’s observation of a child’s behavior, according to the CDC.
Currently, the Autism Society encourages all children to be screened for signs of autism by their family pediatrician three times by the age of three — at nine, 18, and 24 or 30 months. If a child shows symptoms of ASD, more rigorous diagnostic testing can be carried out by a specialist including a full neuropsychological exam.
Additionally, the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) provides standard criteria for helping diagnose autism.
Under DSM-5, a child meets the criteria if they have deficits in three areas of social communication and interaction and at least two of four types of restricted, repetitive behaviors.
While the first edition of DSM came out in 1952, it was not until the third edition, DSM-3, in which autism was listed under an entirely new “class” of conditions — the Pervasive Developmental Disorders.
Veenstra-VanderWeele said the change in the criteria is another reason why the number of those diagnosed with autism rose. He likened it to changing the definition of what it means to be tall.
“To just use a crude example, if you would define somebody as tall if they were over six-foot-six, and then 30 years later, say that somebody is tall if they’re over five-foot-10, you’d get very, very different numbers, and that’s part of what’s happened here,” he said.
Pierce added that because of limited knowledge and awareness in the past, there may have been many children who were underdiagnosed and misdiagnosed.
“It’s understandable that people wouldn’t even necessarily think that somebody has autism, because nobody knew what really autism was,” she said. “So, you know, large numbers of people were just put in the books as just having special education needs, maybe as a language delay or of having a cognitive impairment.”
Older reproductive age
Some studies have suggested that people who become pregnant at an older age have an increased risk of giving birth to a child with autism.
A 2012 review and meta-analysis of 16 papers from researchers in New York, London, Israel and Sweden found an association between advanced maternal age and the risk of autism.
Advanced paternal age may also be a risk factor. A 2006 study conducted jointly by researchers in New York, London and Israel found that men who were above age 40 were 5.75 times more likely to have a child with ASD compared to men younger than age 30 after controlling for other factors.
However, questions still swirl about whether or not there is a risk from the age of parents, and not all researchers are convinced.
“I know that there is some research looking at maternal and paternal age with regard to autism, and there’s research around environmental causes,” Krasno said. “I think where I always firmly land is that it is inherited, and it is genetic. So, I don’t know the exact correlation between age and diagnostic rate, but we do know that genetics are highly associated with diagnosis.”
Environmental risk factors
Researchers are also divided over whether or not environmental risk factors play a role in causing autism.
The National Institute of Environmental Health Sciences says the “clearest evidence” involves events before and during birth, including prenatal exposure to air pollution or pesticides; maternal obesity or diabetes; extreme prematurity; and periods of oxygen deprivation to the brain during birth.
“But these factors alone are unlikely to cause autism. Rather, they appear to increase a child’s likelihood for developing autism when combined with genetic factors,” NIEHS states on its website.
Pierce said from the studies she’s read, evidence suggests autism is a genetic condition. She added the environmental factors may play a role but “to a small degree.”
Myth that vaccines cause autism
The myth that vaccines cause autism was born out of a fraudulent 1998 study, hypothesizing that the measles, mumps, rubella vaccine caused intestinal inflammation, which, in turn, led to the development of autism.
The paper has since been discredited by health experts, retracted from the journal in which it was published, and its primary author, Andrew Wakefield, lost his medical license after an investigation found he had acted “dishonestly and irresponsibly” in conducting his research.
More than a dozen high-quality studies have since found no evidence of a link between childhood vaccines and autism.
However, Kennedy has held fast to this claim, saying during a 2023 interview on Fox News that he believes autism comes from vaccines.
During the HHS confirmation hearings, Kennedy said he was not “anti-vaccine” but “pro-safety.” At the same time, Kennedy repeatedly refused throughout the hearings to say that vaccines were not linked to autism, while still insisting he supports vaccination in general.
Experts told ABC News there is no evidence to suggest a link between vaccines and autism, and perpetuating the myth can be dangerous.
“Once there’s a lie and it’s spread, it doesn’t matter that it’s a lie. Once people hear it, then they believe that it’s true despite all of the Herculean efforts to disprove it and debunk it,” Pierce said. “There’s no evidence for it whatsoever, and there’s actually extremely, as far as scientific evidence is concerned, there’s extremely strong evidence to suggest absolutely not.”
Christopher Banks, president and CEO of the Autism Society of America, said the false claim that vaccines cause autism can divert financial resources from much-needed research.
“Instead of advancing support and therapies, time and funding are wasted disproving a debunked theory,” he said. “This misinformation also fuels stigma, implying that autism is something to be feared rather than understood and supported, leading to discrimination against autistic individuals.”
ABC News’ Dr. Jade Cobern, Cheyenne Haslett and Will McDuffie contributed to this report.
