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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Health
Cancer-linked herbicide in the spotlight after controversial order: ‘Toxic by design’
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There has been a shake-up in the Make America Healthy Again movement regarding glyphosate, a widely used herbicide that has been the subject of significant controversy.
The debate follows an executive order signed by President Donald Trump that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense.
MAHA supporters have previously pushed a pesticide-free agenda, warning of potential health harms caused by glyphosate.
Dr. Marc Siegel, Fox News senior medical analyst, said he believes there is sufficient evidence linking glyphosate to neurodegenerative diseases, including ALS, Parkinson’s and multiple sclerosis, to warrant limiting exposure.
President Donald Trump signed an executive order that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense. (AP Photo/Charlie Neibergall)
“With Parkinson’s, this association appears to be due to the gut, vagus nerve and brain axis, where the exposure affects the microbiome in the gut, which then ascends slowly up to the brain, causing the neurodegenerative disease years later,” Siegel told Fox News Digital.
“There is also a growing association being found between high-dose glyphosate or occupational exposure and metabolic disorders, liver disease and some cancers, specifically lymphoma.”
He added, “Growing research backs this. I favor limiting it.”
“When we apply them across millions of acres and allow them into our food system, we put Americans at risk.”
Studies have shown that glyphosate, which is used in products such as Roundup, owned by Monsanto, could raise cancer risk.
In one University of Washington study published in the journal Mutation Research, researchers found that exposure to it increased the risk of non-Hodgkin lymphoma by 41%.
The nonprofit Investigate Midwest, which analyzed data from both the U.S. Geological Survey and the National Cancer Institute, also recently found that pesticides may contribute to cancer rates.
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Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to the report.
Investigate Midwest, which is based in Illinois, interviewed more than 100 farmers, environmentalists, lawmakers and scientists as part of a partnership with the Pulitzer Center’s StoryReach U.S. Fellowship.
Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to one study. (iStock)
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate.
Bill Billings, a resident of Red Oak, Iowa, was diagnosed with cancer in 2014.
“The cancer specialist said, very directly, (my) cancer is a result of being exposed to chemicals,” Billings said in the report.
Kelly Ryerson, founder of Glyphosate Facts and owner of the Instagram account @glyphosategirl, told Fox News Digital her journey researching the herbicide began with her own health struggles.
Ryerson, who is based in California, previously struggled with chronic illness and autoimmune issues, which she said improved when she stopped eating gluten.
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate. (iStock)
After attending a medical conference at Columbia University’s Celiac Disease Center, Ryerson began to question modern farming practices rather than the gluten itself.
“A lot of times, farmers are spraying Roundup on our grains right before harvest to facilitate an easier harvest,” she said. “After that easier harvest, because everything’s dry at the same time, those crops go directly to the mill and may end up in our food supply, at alarmingly high levels.”
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In 2015, the International Agency for Research on Cancer (IARC), part of the World Health Organization framework, classified glyphosate as “probably carcinogenic to humans.”
The classification was based on limited evidence of cancer in humans (notably non-Hodgkin lymphoma in some studies) and sufficient evidence in experimental animals.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” a Monsanto spokesperson said. (Wolf von Dewitz/picture alliance via Getty Images)
A spokesperson for Monsanto told Fox News Digital it will comply with Trump’s order to produce glyphosate and elemental phosphorus.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” the spokesperson said.
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HHS Secretary Robert F. Kennedy Jr. has long been a vocal critic of Roundup, working with his legal team in 2018 to award $289 million to a man who alleged the weed killer caused his non-Hodgkin lymphoma, according to reports.
Following backlash to Trump’s executive order, Kennedy said he supports the order but acknowledged that “pesticides and herbicides are toxic by design, engineered to kill living organisms.”
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“When we apply them across millions of acres and allow them into our food system, we put Americans at risk,” he posted on X. “Chemical manufacturers have paid tens of billions of dollars to settle cancer claims linked to their products, and many agricultural communities report elevated cancer rates and chronic disease.”
Fox News Digital reached out to the White House for comment.
Health
Common nighttime noise exposure may trigger heart problems, study suggests
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Living near heavy traffic could negatively impact your heart health.
A European study, published in the journal Environmental Research, found that exposure to nighttime road traffic noise is linked to changes in the blood, leading to worsened cholesterol and cardiovascular risks.
The researchers considered data from the U.K. Biobank, Rotterdam Study, and Northern Finland Birth Cohort 1966, including more than 272,000 adults over the age of 30, according to a press release.
Nighttime road noise exposure was estimated at all participants’ homes based on national noise maps. Researchers also took blood samples to measure the participants’ metabolic biomarkers for disease, then mapped the link between nightly noise levels and existence of biomarkers.
Exposure to loud noise was associated with increased concentrations of cholesterol-related biomarkers. (iStock)
The study found that people exposed to louder noise at night — especially sounds above 55 decibels — showed changes in 48 different substances in their blood. Twenty of these associations “remained robust” throughout all cohorts.
Exposure to loud noise was associated with increased concentrations of cholesterol-related biomarkers, especially LDL “bad” cholesterol, IDL (intermediate-density lipoprotein) and unsaturated fatty acids.
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As noise levels increased, starting at around 50 decibels, cholesterol markers rose steadily, the release stated.
The authors concluded that this study “provides evidence that nighttime road traffic noise exposure from 50 dB upward is associated with alterations in blood cholesterol and lipid profiles in adults.”
Researchers noted a link between traffic noise and cardiometabolic disease. (iStock)
Study co-author Yiyan He, doctoral researcher at the University of Oulu in Finland, noted that in this type of research, small effect sizes are expected, and environmental exposures such as traffic noise are “typically modest.”
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“Despite this, we observed statistically robust and consistent associations across many biomarkers, especially those related to LDL and IDL lipoproteins,” she told Fox News Digital.
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“We also identified a clear exposure-response pattern starting at around 50 dB, suggesting that metabolic changes become more evident as noise levels increase.”
This aligns with public health guidance, as the World Health Organization recommends lower nighttime noise limits at around 40 to 45 dB, Yiyan He added.
“This finding may clarify the association between traffic noise and cardiometabolic diseases,” the researchers wrote. (iStock)
“The 55 dB level is often used as an interim benchmark associated with substantial noise annoyance and sleep disturbance,” she said. “In our study, we observed associations not only at 55 dB, but also indications of effects emerging at around 50 dB.”
The strength and consistency of the cholesterol-related associations were surprising, as these changes are usually “subtle.”
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“Instead, we found consistent associations across multiple large European cohorts, which strengthens confidence that the findings may reflect real biological patterns,” Yiyan He went on. “We were also interested to see that effects were minimal below ~50 dB, suggesting a possible threshold-like pattern.”
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The researcher noted that these findings were consistent across genders, education levels and obesity status.
The study was restricted to White Europeans, which posed a limitation. There was also a lack of information on the fasting status in the UK Biobank.
Changes in cholesterol levels were more severe than researchers expected. (iStock)
“Fasting can influence levels of certain metabolites, particularly fatty acids,” Yiyan He said. “However, based on UK Biobank documentation, fewer than 10% of participants were fasting for at least eight hours, and our main findings focused on cholesterol-related biomarkers, which are generally less sensitive to short-term fasting.”
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The researchers also lacked information on bedroom location, indoor noise exposure and time spent at home.
“These factors may introduce non-differential exposure misclassification,” Yiyan He said. “Additionally, noise exposure estimates were based on participants’ temporary residential addresses at the time of blood sampling, without considering the duration of residence.”
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“Many of these limitations would tend to bias results toward the null, so the consistent associations we observed remain noteworthy.”
Experts recommend taking measures to limit traffic noise at night. (iStock)
Based on this latest research, Yiyan He noted that nighttime noise is a “health-relevant exposure,” not just “an annoyance.”
“Our findings suggest that nighttime traffic noise may subtly but consistently affect metabolic health,” she said. “While the changes in cholesterol and lipid levels for any one individual are small, traffic noise affects a very large number of people, which means the potential public health impact could be substantial.”
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The researcher recommends taking measures like improving sound insulation, using noise-reducing strategies and placing bedrooms on the quieter side of the home when possible.
“Because sleep is a key pathway linking noise to health, protecting the nighttime sleep environment is especially important,” she added.
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