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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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New blood test detects 90% of aggressive prostate cancer cases, beating current screenings

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New blood test detects 90% of aggressive prostate cancer cases, beating current screenings

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A new test could make it easier to detect high-risk prostate cancer cases earlier.

The blood test, called Stockholm3, is showing promise in clinical trials, beating out the traditional, standard prostate-specific antigen (PSA) test.

In a new study published in the Annals of Internal Medicine, researchers from the Karolinska Institutet in Sweden studied the test’s efficacy in more than 12,000 men — mostly Swedish or European — aged 50 to 74.

NEW PROSTATE CANCER TEST PINPOINTS DISEASE BETTER THAN PSA OPTION, STUDY FINDS

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All participants were tested with PSA and Stockholm3 and were followed for two years. During the follow-up period, 443 men were diagnosed with aggressive prostate cancer.

Stockholm3 detected 90% of aggressive prostate cancer cases compared to 74% for PSA tests.

Stockholm3 detected 90% of aggressive prostate cancer cases compared to 74% for PSA tests. (iStock)

Stockholm3 missed “significantly fewer” serious cancer cases than PSA. The number of men incorrectly classified as high-risk was similar across both tests, according to a press release.

Thorgerdur Palsdottir, a researcher at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, wrote in a statement that one of the major challenges in prostate cancer is being able to identify the cases that are “truly dangerous.”

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“Our results show that Stockholm3 identifies significantly more aggressive cancer cases than PSA without increasing the number of unnecessary follow-ups,” she said.

“These results point toward a potential change in how prostate cancer screening can be conducted,” the researcher added. “A more precise blood test could enable earlier detection of aggressive disease while reducing the number of unnecessary follow-up examinations and procedures.”

“A more precise blood test could enable earlier detection of aggressive disease while reducing the number of unnecessary follow-up examinations and procedures,” a researcher commented. (iStock)

Study co-author Hari Vigneswaran, chief medical officer of Stockholm3-maker A3P Biomedical, commented on these “promising” findings in an interview with Fox News Digital.

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He confirmed that the PSA has been the standard for prostate cancer screening since the 1990s despite its “well-documented limitations.”

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“It leads to invasive and costly follow-up testing, contributes to over-diagnosis of non-aggressive cancers and, most importantly, it misses a substantial share of aggressive disease,” Vigneswaran said.

When aggressive prostate cancer is found while still confined in the prostate, the five-year survival is close to 100%. (iStock)

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When aggressive prostate cancer is found while still confined in the prostate, the five-year survival rate is close to 100%, which highlights the importance of early detection, according to the doctor.

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Data from the National Cancer Institute’s SEER database show that metastatic prostate cancer has risen over the past decade, suggesting that “we have not improved early detection of the aggressive, curable disease that screening is meant to catch,” Vigneswaran said.

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“The goal of screening is to find the cancers that need treatment while they are still curable, without raising the number of men who screen positive but don’t have aggressive disease,” he said.

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Stockholm3 could reduce the need for unnecessary MRIs and biopsies, according to the researcher. (Getty Images)

Stockholm3 could reduce the need for unnecessary MRIs and biopsies, according to the researcher.

The findings did have some limitations. Stockholm3 is an investigational device and is not available for sale in the U.S., Vigneswaran noted.

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The test estimates a man’s risk of aggressive prostate cancer, but a biopsy remains the gold standard for confirming the disease.

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The company plans to seek FDA approval to use the test for routine screening and will “generate the evidence needed to support that pathway, including U.S. data,” Vigneswaran said.

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This Protein Smoothie Trick Helps Women Over 40 Lose Twice as Much Fat

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This Protein Smoothie Trick Helps Women Over 40 Lose Twice as Much Fat


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This Protein Smoothie Trick Helps Women Lose Twice as Much Fat




















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These leafy greens could help protect your lungs, study suggests

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These leafy greens could help protect your lungs, study suggests

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Scientists have linked eating leafy green vegetables such as spinach, kale and broccoli to better lung health.

There are two primary forms of vitamin K found in foods. The primary kind is vitamin K1, found mainly in vegetables, which plays a major role in the body’s blood-clotting process.

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Vitamin K2 is found in fermented foods, certain dairy products, eggs and meats and helps regulate calcium in the body and supports bone health.

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Researchers at Australia’s Edith Cowan University examined whether dietary intake of vitamins K1 and K2 was associated with chronic obstructive pulmonary disease (COPD), asthma and lung function.

Leafy green vegetables are high in vitamin K1, a nutrient that researchers have observed conributes to improved lung health. (iStock)

“Chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma, are among the most prevalent noncommunicable diseases worldwide and were the third leading cause of death in 2019, accounting for 4 million deaths and affecting 454.6 million individuals globally,” the scientists reported in the introduction to their study, published in The American Journal of Clinical Nutrition.

“Although asthma and COPD can be managed with available treatments, neither condition is curable, underscoring the need for effective prevention strategies,” they added.

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The leading cause of COPD is smoking, the Mayo Clinic reported. Exposure to other irritants, such as dust, chemicals and pollution, can also cause it.

The researchers analyzed data from 179,062 participants over a 10-and-a-half-year period and concluded that, “Higher dietary vitamin K1 intake was associated with better lung function and a lower rate of COPD.”

Researchers found that people who increased their vitamin K1 intake were less likely to develop COPD. (iStock)

Participants who consumed the most vitamin K1 had a 16% lower likelihood of COPD, the researchers observed. The effects were more pronounced in smokers and participants with high-risk occupations.

Consumption of vitamin K2 did not result in lower COPD rates.

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“No association was observed for vitamin K1 or vitamin K2 intakes and asthma,” the researchers also wrote.  

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Associate Professor Marc Sim, who was involved in the study, said that it’s likely Vitamin K activates a protein that may help keep lung tissue flexible and prevent damage.

Because the study was observational, it cannot prove that vitamin K1 directly reduces COPD risk, only that higher intake was associated with better lung health.

Researchers have associated higher consumption of leafy green vegetables with better lung function. (iStock)

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Just one extra serving of leafy greens “is an achievable way to boost your vitamin K1 intake,” said Chengfeng Li, one of the study’s researchers.

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Other foods rich in vitamin K1 include collard greens, Swiss chard, Brussels sprouts and turnip greens.

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