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FDA refuses to review Moderna’s mRNA flu vaccine application

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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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Heart disease threat projected to climb sharply for key demographic

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Heart disease threat projected to climb sharply for key demographic

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A new report by the American Heart Association (AHA) included some troubling predictions for the future of women’s health.

The forecast, published in the journal Circulation on Wednesday, projected increases in various comorbidities in American females by 2050.

More than 59% of women were predicted to have high blood pressure, up from less than 49% currently.

The review also projected that more than 25% of women will have diabetes, compared to about 15% today, and more than 61% will have obesity, compared to 44% currently.

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As a result of these risk factors, the prevalence of cardiovascular disease and stroke is expected to rise to 14.4% from 10.7%.

The prevalence of cardiovascular disease and stroke in women is expected to rise to 14.4% from 10.7% by 2050. (iStock)

Not all trends were negative, as unhealthy cholesterol prevalence is expected to drop to about 22% from more than 42% today, the report stated.

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Dr. Elizabeth Klodas, a cardiologist and founder of Step One Foods in Minnesota, commented on these “jarring findings.”

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“The fact that on our current trajectory, cardiometabolic disease is projected to explode in women within one generation should be a huge wake-up call,” she told Fox News Digital.

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“Hypertension, diabetes, obesity — these are all major risk factors for heart disease, and we are already seeing what those risks are driving. Heart disease is the No. 1 killer of women, eclipsing all other causes of death, including breast cancer.”

Cardiovascular disease is the leading cause of death for women in the U.S. and around the world. (iStock)

Klodas warned that heart disease starts early, progresses “stealthily,” and can present “out of the blue in devastating ways.”

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The AHA published another study on Thursday revealing one million hospitalizations, showing that heart attack deaths are climbing among adults below the age of 55.

The more alarming finding, according to Klodas, is that young women were found more likely to die after their first heart attack than men of the same age.

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“This is all especially tragic since heart disease is almost entirely preventable,” she said. “The earlier you start, the better.”

Children can show early evidence of plaque deposition in their arteries, which can be reversed through lifestyle changes if “undertaken early enough and aggressively enough,” according to the expert.

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Moving more is one part of protecting a healthy heart, according to experts. (iStock)

Klodas suggested that rising heart conditions are associated with traditional risk factors, like smoking, high blood pressure, high cholesterol, diabetes, obesity and a sedentary lifestyle.

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Doctors are also seeing higher rates of preeclampsia, or high blood pressure during pregnancy, as well as gestational diabetes. Klodas noted that these are sex-specific risk factors that don’t typically contribute to complications until after menopause.

The best way to protect a healthy heart is to “do the basics,” Klodas recommended, including the following lifestyle habits.

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Klodas especially emphasized making improvements to diet, as the food people eat affects “every single risk factor that the AHA’s report highlights.”

“High blood pressure, high blood sugar, high cholesterol, excess weight – these are all conditions that are driven in part or in whole by food,” she said. “We eat multiple times every single day, which means what we eat has profound cumulative effects over time.”

“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health,” a doctor said. (iStock)

“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health.”

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The doctor also recommends changing out a few snacks per day for healthier choices, which has been proven to “yield medication-level cholesterol reductions” in a month.

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“Keep up that small change and, over the course of a year, you could also lose 20 pounds and reduce your sodium intake enough to avoid blood pressure-lowering medications,” Klodas added.

“Women should not view the AHA report as inevitable. We have power over our health destinies. We just need to use it.”

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Vanessa Williams, 62, Opens up About Weight Loss and HRT After Menopause

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Vanessa Williams, 62, Opens up About Weight Loss and HRT After Menopause


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Common vision issue linked to type of lighting used in Americans’ homes

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Common vision issue linked to type of lighting used in Americans’ homes

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Nearsightedness (myopia) is skyrocketing globally, with nearly half of the world’s population expected to be myopic by 2050, according to the World Health Organization.

Heavy use of smartphones and other devices is associated with an 80% higher risk of myopia when combined with excessive computer use, but a new study suggests that dim indoor lighting could also be a factor.

For years, scientists have been puzzled by the different ways myopia is triggered. In lab settings, it can be induced by blurring vision or using different lenses. Conversely, it can be slowed by something as simple as spending time outdoors, research suggests.

Nearsightedness occurs when the eyeball grows too long from front to back, according to the American Optometric Association (AOA). This physical elongation causes light to focus in front of the retina rather than directly on it, making distant objects appear blurry.

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The study suggests that myopia isn’t caused by the digital devices themselves, but by the low-light environments where they are typically used. (iStock)

Researchers at the State University of New York (SUNY) College of Optometry identified a potential specific trigger for this growth. When someone looks at a phone or a book up close, the pupil naturally constricts.

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“In bright outdoor light, the pupil constricts to protect the eye while still allowing ample light to reach the retina,” Urusha Maharjan, a SUNY Optometry doctoral student who conducted the study, said in a press release.

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“When people focus on close objects indoors, such as phones, tablets or books, the pupil can also constrict — not because of brightness, but to sharpen the image,” she went on. “In dim lighting, this combination may significantly reduce retinal illumination.”

High-intensity natural light prevents myopia because it provides enough retinal stimulation to override the “stop growing” signal, even when pupils are constricted. (iStock)

The hypothesis suggests that when the retina is deprived of light during extended close-up work, it sends a signal for the eye to grow.

In a dim environment, the narrowed pupil allows so little light through that the retinal activity isn’t strong enough to signal the eye to stop growing, the researchers found.

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In contrast, being outdoors provides light levels much brighter than indoors. This ensures that even when the pupil narrows to focus on a nearby object, the retina still receives a strong signal, maintaining healthy eye development.

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The team noted some limitations of the study, including the small subject group and the inability to directly measure internal lens changes, as the bright backgrounds used to mimic the outdoors made pupils too small for standard equipment.

Researchers believe that increasing indoor brightness during close-up work could be a simple, testable way to slow the global nearsightedness epidemic. (iStock)

“This is not a final answer,” Jose-Manuel Alonso, MD, PhD, SUNY distinguished professor and senior author of the study, said in the release.

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“But the study offers a testable hypothesis that reframes how visual habits, lighting and eye focusing interact.”

The study was published in the journal Cell Reports.

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