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 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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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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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.

A common medication for diabetes may slow down age-related vision loss, according to new research.

People with diabetes who were over the age of 55 and taking metformin — a prescription drug most commonly used to treat type 2 diabetes — were 37% less likely to develop intermediate age-related macular degeneration (AMD) over five years compared to those not taking it.

Researchers at the University of Liverpool used eye pictures from 2,000 people who received routine diabetic eye disease screenings over the course of five years.

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Next, they assessed whether AMD was present in the photos and how severe each case was, before comparing the differences between people taking metformin and those who did not take it, according to a press release.

They also adjusted for factors that could potentially skew the results, such as age, sex and how long they’d had diabetes.

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“Most people who suffer from AMD have no treatment, so this is a great breakthrough in our search for new treatments,” said Nick Bear, an ophthalmologist at the University of Liverpool in the U.K., who led the research.

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“What we need to do now is test metformin as a treatment for AMD in a clinical trial. Metformin has the potential to save many people’s sight,” he added.

While the results are promising, researchers noted that the study was observational, meaning it shows a link between the drug and eye health, but does not prove metformin was the direct cause of the improvement.

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The study also focused only on people with diabetes. It is unclear whether the drug would have the same effect on people without the condition.

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Additionally, the researchers did not have data on the specific doses of metformin patients took or how strictly they followed their prescriptions.

Metformin is an off-patent, low-cost drug already widely used to manage blood sugar, according to Mayo Clinic.

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Scientists believe its anti-inflammatory and anti-aging properties may help protect the retina.

Mayo Clinic says metformin is generally safe, but can cause digestive side effects and vitamin B12 deficiency in some patients.

Drinking two to three cups of coffee daily could reduce the risk of dementia, according to new observational research published in The Journal of the American Medical Association.

American researchers analyzed four decades of data from more than 130,000 doctors and nurses, finding that moderately caffeinated coffee and tea intake can lower the risk of cognitive decline, according to SWNS.

The analysis revealed that not only did participants with the highest intake of caffeinated coffee have a lower risk of dementia, but there also appeared to be a “sweet spot” where it was most effective.

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Previous findings on the relationship between coffee and dementia have been inconsistent due to limited follow-up data. To address this, researchers used information from the Nurses’ Health Study and the Health Professionals Follow-Up Study, tracking healthcare professionals from midlife through older age.

Over a follow-up period of up to 43 years, the team analyzed self-reported dietary patterns collected through questionnaires administered every four years.

This long-term approach allowed scientists to account for changes in coffee and tea consumption over time, while monitoring for both clinical dementia diagnoses and subtle shifts in cognitive function.

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By adjusting for variables such as smoking, physical activity and underlying health conditions, the researchers were able to isolate the specific relationship between caffeine intake and long-term brain health, SWNS noted.

Of the 131,821 participants involved in the long-term analysis, 11,033 developed dementia.

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The analysis revealed that participants with the highest intake of caffeinated coffee had an 18% lower risk of dementia compared with those who reported little or no consumption.

These participants also performed better on tests of overall cognitive function, the report noted. While higher tea intake yielded similar results, decaffeinated coffee did not, suggesting that caffeine is likely the driving neuroprotective factor.

The cognitive benefits were most pronounced in those who consumed two to three cups of caffeinated coffee or one to two cups of tea daily.

Dementia affects more than six million Americans and 55 million people worldwide, with the National Institutes of Health reporting more than 100,000 U.S. deaths annually. 

Experts emphasize that early prevention is crucial, as current treatments offer only modest benefits once symptoms appear. This has led scientists to investigate the role that specific lifestyle factors play in cognitive decline.

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“When searching for possible dementia prevention tools, we thought something as prevalent as coffee may be a promising dietary intervention,” senior study author Daniel Wang, an assistant professor at Harvard Medical School, noted in a press release from SWNS.

Both coffee and tea contain bioactive ingredients such as polyphenols and caffeine, which may reduce inflammation and cellular damage while defending against cognitive decline. Researchers referred to these properties as “neuroprotective.”

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Contrary to some previous studies, higher caffeine intake did not produce negative effects; instead, it provided consistent neuroprotective benefits even for those with a high genetic predisposition to the disease, per SWNS.

Despite the encouraging findings, Wang cautioned that the effect size is small and should be viewed as just one of many ways to protect cognitive health during aging.