Health
FDA refuses to review Moderna’s mRNA flu vaccine application
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The U.S. Food and Drug Administration (FDA) refused to consider Moderna’s application for a new flu vaccine using mRNA technology, the company announced Tuesday, a decision that could delay the introduction of a shot designed to offer stronger protection for older adults.
Moderna said it received what’s known as a “refusal-to-file” (RTF) letter from the FDA’s Center for Biologics Evaluation and Research (CBER), citing the lack of an “adequate and well-controlled” study with a comparator arm that “does not reflect the best-available standard of care.”
Stéphane Bancel, chief executive officer of Moderna, said the FDA’s decision did not “identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Bancel said in a statement. “We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations.”
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The FDA refused to review Moderna’s application for a new mRNA-based flu vaccine, citing concerns about the design of its late-stage clinical trial. (iStock)
The rare decision from the FDA comes amid increased scrutiny over vaccine approvals under Health Secretary Robert F. Kennedy Jr., who has criticized mRNA vaccines and rolled back certain COVID-19 shot recommendations over the past year.
Kennedy previously removed members of the federal government’s vaccine advisory panel and appointed new members, and moved to cancel $500 million in mRNA vaccine contracts.
The FDA authorized COVID-19 vaccines for the fall for high-risk groups only. Last May, Kennedy announced the vaccines would be removed from the CDC’s routine immunization schedule for healthy children and pregnant women.
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The FDA’s refusal to review Moderna’s mRNA flu vaccine comes amid broader vaccine policy shifts under Health Secretary Robert F. Kennedy Jr. (Jason Mendez/Getty Images)
According to Moderna, the refusal-to-file decision was based on the company’s choice of comparator in its Phase 3 trial — a licensed standard-dose seasonal flu vaccine — which the FDA said did not reflect the “best-available standard of care.”
Moderna said the decision contradicts prior written communications from the FDA, including 2024 guidance stating a standard-dose comparator would be acceptable, though a higher-dose vaccine was recommended for participants over 65.
Moderna said the FDA “did not raise any objections or clinical hold comments about the adequacy of the Phase 3 trial after the submission of the protocol in April 2024 or at any time before the initiation of the study in September 2024.”
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Moderna said it received a “refusal-to-file” letter from the FDA for its new mRNA flu vaccine, a move that could delay the shot’s rollout. (iStock)
In August 2025, following completion of the Phase 3 efficacy trial, Moderna said it held a pre-submission meeting with CBER, which requested that supportive analyses on the comparator be included in the submission and indicated the data would be a “significant issue during review of your BLA.”
Moderna said it provided the additional analyses requested by CBER in its submission, noting that “at no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.”
The company requested a Type A meeting with CBER to understand the basis for the RTF letter, adding that regulatory reviews are continuing in the European Union, Canada and Australia.
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Fox News has reached out to the Department of Health and Human Services for comment.
Fox News Digital’s Alex Miller and The Associated Press contributed to this report.
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A recent study suggests GLP-1-related weight loss may improve some women’s relationships and employment status.
Rebecca Diamond, professor of economics at Harvard University in Boston, independently published research that found an association between weight-loss medications and a change in women’s social and economic outcomes.
Diamond used the Understanding America Study, a panel survey from the University of Southern California, to compare women who started GLP-1s for weight loss to those who wanted to start but had not yet done so.
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The comparison considered body mass, health, income, employment, partnership status and well-being before treatment.
The study focused on women because they are more likely to use GLP-1s than men. It excluded people taking GLP-1 drugs for diabetes, as their use is driven by a medical condition rather than weight-loss demand.
Women who began GLP-1s for weight loss and were successful in losing weight experienced changes in relationship and employment status, according to the findings. (iStock)
Women who successfully lost weight with GLP-1 medications experienced changes across several life outcomes, including employment, marriage and cohabitation, according to the study.
Marriage and cohabitation rose 29% for single women after about 18 months.
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Among women who were not employed at the start of the study, job prospects increased by 27% after the same amount of time. Those who were already employed did not display any clear upward progress in their careers, however.
Diamond argues that these findings suggest part of the “female obesity penalty” comes from how people are judged when being matched up, either in a new relationship or a new job.
The findings say “more about societal bias than about the medication itself,” a doctor suggested. (iStock)
Dr. Peter Balazs, MD, a hormone and weight-loss specialist from New York and New Jersey, commented on these findings.
“The effects showed up during ‘new match’ situations, such as job interviews or dating, and not within existing jobs or relationships,” Balazs, who was not involved in the study, told Fox News Digital. “This says more about societal bias than it does about the medication itself.”
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Balazs said his patients often report feeling more confident and “visible” after weight loss, which could translate into better interview performance and networking.
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“Weight loss (commonly) improves confidence, which opens new business and relationship opportunities,” he went on. “Weight loss has hormonal impacts as well, so the normalization of hormones and the profound metabolic and psychological relief that comes with it can be a factor, too.”
“Weight loss (commonly) improves confidence, which opens new business and relationship opportunities,” an expert said. (iStock)
Dr. Krishna Vyas, a plastic surgeon at Blechman Plastic Surgery in New York, told Fox News Digital in a separate interview that many patients seek breast lifts or body contouring after significant GLP-1 weight loss, after which they find themselves “re-engaging with life.”
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“That confidence effect is real in the exam room,” said the surgeon, who also was not involved in the research. “This study, however, showed no clear improvement in depression, loneliness or life satisfaction, even as marriage and employment rates climbed dramatically.”
“The opportunities opened, yet the women didn’t report feeling better, which suggests it was largely the gatekeepers who changed, not the women.”
Potential limitations
Because this was an observational study rather than a randomized clinical trial, it could only show an association — not cause and effect. The findings are also considered preliminary because the paper has not yet been peer-reviewed, the author acknowledged.
“Additionally, since the study only looked at women, that introduces another layer of potential bias,” Balazs noted. “I’d be interested to see whether the findings would be the same if the study included men or compared them directly.”
“Weight loss has hormonal impacts as well, so the normalization of hormones and the profound metabolic and psychological relief that comes with it can be a factor, too,” an expert said. (iStock)
Another limitation is that the information from the individuals studied was self-reported, the expert noted.
The researchers were also unable to determine whether people who found new jobs were earning more money.
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“Additionally, even though GLP-1 users appeared to have better outcomes on paper, they did not report greater overall life satisfaction,” Balazs added. “That raises important questions about whether these external changes translate into meaningful improvements in well-being.”
Fox News Digital reached out to the study researcher and multiple human resources organizations requesting comment.
New York City health officials warn of Legionnaires’ disease outbreak
Health officials in New York City have issued a warning about a Legionnaires’ disease outbreak, with 23 confirmed cases and 17 hospitalizations. Dr. Stephanie Widmer, an emergency medicine attending physician, details how the bacterial pneumonia is contracted, emphasizing it’s from warm water in large cooling towers, not drinking water. She also discusses symptoms and curability with antibiotics.
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New York City health officials announced Friday that the first person has died in connection with a growing Legionnaires’ disease outbreak on Manhattan’s Upper East Side as the number of confirmed infections continued to rise.
“I am saddened to report that one person has died in connection with the Legionnaires’ disease community cluster on the Upper East Side,” New York City Health Commissioner Dr. Alister F. Martin said in a statement.
“My deepest condolences are with their loved ones, and out of respect to their personal privacy, we will not be releasing any additional information on the individual.”
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A 3D illustration of Legionella pneumophila, the bacteria that causes Legionnaires’ disease, a severe form of pneumonia. (iStock)
The death comes as the outbreak has sickened 67 people as of Thursday night, up from 63 cases reported a day earlier. Twelve people remain hospitalized, according to city health officials.
Investigators are tracing the outbreak to Legionella pneumophila bacteria found in 76 cooling towers across the Upper East Side and one on the Upper West Side. Buildings that tested positive, including the Solomon R. Guggenheim Museum, have been ordered to clean and disinfect their cooling towers.
Legionnaires’ disease is a severe form of pneumonia caused by Legionella bacteria, which naturally occurs in water but can multiply in building water systems such as cooling towers. The illness can be treated with antibiotics if diagnosed early.
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A blood sample tests positive for Legionella bacteria, which causes Legionnaires’ disease. (iStock)
Cooling towers, commonly found on rooftops, help regulate large building cooling systems and can release mist containing the bacteria. Health officials have emphasized that the outbreak is not linked to New York City’s drinking water or indoor air conditioning.
Health officials urged anyone who lives, works or has visited the affected area since late June and develops flu-like symptoms to contact a health care provider immediately.
Symptoms typically appear two to 14 days after exposure and include fever, cough, shortness of breath, muscle aches and headaches. The disease spreads through contaminated water droplets and is not spread from person to person.
New York City health officials are urging anyone who has visited Manhattan’s Upper East Side since late June to watch for symptoms of Legionnaires’ disease. (iStock)
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Older adults, smokers and people with chronic lung disease or weakened immune systems face the highest risk of severe illness. According to the Centers for Disease Control and Prevention, about 1 in 10 people diagnosed with Legionnaires’ disease die from complications.
City health officials said early diagnosis and prompt treatment with antibiotics can significantly improve outcomes for patients who become infected.
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