Health

FDA refuses to review Moderna’s mRNA flu vaccine application

Published

3 weeks ago

February 11, 2026

FDA refuses to review Moderna’s mRNA flu vaccine application

NEWYou can now listen to Fox News articles!

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.”

RFK JR. DEFENDS FIRING SPREE AT CDC, VOWS ‘NEW BLOOD’ AT AGENCY

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.

SEN BERNIE SANDERS CALLS ON RFK JR TO RESIGN FOLLOWING DEPARTURE OF CDC OFFICIALS

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.”

RFK JR LAUNCHES INVESTIGATION INTO SCHOOL FOR ALLEGED VACCINATION OF CHILD WITHOUT PARENTAL CONSENT

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.

CLICK HERE TO DOWNLOAD THE FOX NEWS APP

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.

Related Topics:cold and flu Featured regulation Robert F. Kennedy Jr.vaccines

Click to comment

Health

What’s healthier to drink: cold or hot water? Here’s what an expert says

Published

1 hour ago

March 7, 2026

Press Room

What’s healthier to drink: cold or hot water? Here’s what an expert says

NEWYou can now listen to Fox News articles!

A viral wellness trend asks a simple question — is warm or cold water healthier? — but the science behind it is more nuanced.

Previous research shows that food and beverage temperature has a measurable effect on things like anxiety and gut discomfort.

One of the most long-standing health claims is that ice-cold water boosts calorie burn by forcing the body to heat it up. While this is grounded in science, the actual impact may be minimal.

Ultimately, experts say, the health impact of water temperature depends on the goal — weight loss, athletic performance, digestion or comfort.

Does cold water boost weight loss?

“As per research, in the 90 minutes after consuming cold or room temperature water, energy expenditure increases minimally by 2.9% (cold water) and 2.3% (room temperature),” Tanya Freirich, a registered dietitian and diabetes expert in North Carolina, told Fox News Digital.

Extra water may suppress the appetite or may play a part in energy production and expenditure, experts say. (iStock)

While the body does expend energy to warm up cold water, Freirich noted that it’s “not significant enough to make it worthwhile” for weight loss. Hot water doesn’t exactly melt fat, however, she added.

For those looking to lose or manage weight, Freirich suggests focusing on “how much” rather than “how cold.” She pointed to research involving overweight women who added an extra 1.5 liters of water to their daily intake. Over eight weeks, the participants saw measurable weight loss.

YOUR BEDROOM TEMPERATURE COULD BE PUTTING YOUR HEART IN SERIOUS DANGER, STUDY WARNS

“The extra water may suppress the appetite or may play a part in energy production and expenditure,” Freirich said. The temperature of drinking water should not affect how well the body utilizes nutrients, she added, noting that more research is needed.

For those exercising in heat and humidity, the goal should be to rehydrate without excessive fluid loss through sweat. Research on thermoregulation suggests there is an ideal water temperature for athletes.

The temperature of drinking water should not affect how well the body utilizes nutrients, according to an expert. (iStock)

While drinking water can trigger sweating as the body regulates its temperature, 60.8 degrees Fahrenheit was associated with the least amount of perspiration.

CLICK HERE FOR MORE HEALTH STORIES

“Cool, but not cold,” Freirich emphasized. Drinking water in this specific range helps the body rehydrate efficiently without causing gastrointestinal distress.

Warm water and digestion

There are several reasons someone might opt for warm water, including its effect on relaxation and digestion. Studies have found that warmer liquids can accelerate gastric emptying, effectively waking up the gut.

TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ

The benefits may be mental as well. Freirich points to research showing that hot black tea leads to lower levels of cortisol — the body’s primary stress hormone — and greater subjective relaxation after stressful tasks.

The preference for warm water often stems from its effect on the rest and digestion. Studies have found that warmer liquids can accelerate gastric emptying, effectively waking up the gut. (iStock)

Medical triggers

Freirich warns that very cold water can cause difficulty for those with swallowing disorders, or can trigger migraines and “brain freeze” in people with sensitive nerves.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

Furthermore, those with irritable bowel syndrome (IBS) may find that ice-cold drinks trigger digestive discomfort.

Ultimately, the best temperature is the one that encourages people to drink, the dietitian said. The general recommendation for adults is to consume seven to eight glasses of water per day.

CLICK HERE TO DOWNLOAD THE FOX NEWS APP

“Most importantly, it is important for everyone to stay adequately hydrated,” Freirich said.

Khloe Quill is a lifestyle production assistant with Fox News Digital. She and the lifestyle team cover a range of story topics including food and drink, travel, and health.

Health

Alarming report reveals what’s driving deadly cancer surge in young adults

Published

13 hours ago

March 6, 2026

Press Room

Alarming report reveals what’s driving deadly cancer surge in young adults

NEWYou can now listen to Fox News articles!

On the lookout

→ Brain aging may accelerate after cancer treatment

→ Ozempic-style drugs could slash complication risks after heart attacks

→ Aging process could accelerate due to ‘forever chemicals’ exposure

Weight-loss drugs may prevent deadly heart complications by opening blocked blood vessels after heart attacks, groundbreaking new research reveals. (iStock)

Conversation starters

→ Do collagen supplements really improve skin? Major review reveals the truth

→ ChatGPT could miss your serious medical emergency, study suggests

→ Diabetes surge could be driven by ‘healthy’ breakfasts, doctor warns

Medical advances

→ Diabetes breakthrough approach could protect cells and prevent disease

→ Decades-old seizure drug could have potential for Alzheimer’s prevention

Stat of the week

More than 59% of women are predicted to have high blood pressure by 2050.

CLICK HERE FOR MORE HEALTH STORIES

This article was written by Fox News staff.

Health

176 Lbs—Gone! Why One Woman’s Gentle Weight-Loss Tips Really Work

Published

1 day ago

March 6, 2026

Press Room

176 Lbs—Gone! Why One Woman’s Gentle Weight-Loss Tips Really Work

Cheri’s Gentle Weight-Loss Approach Helped Her Lose Big | Woman’s World

Use left and right arrow keys to navigate between menu items.

Use escape to exit the menu.

Create a free account to access exclusive content, play games, solve puzzles, test your pop-culture knowledge and receive special offers.
Already have an account? Login