The FDA just approved Moderna's brand-new mRNA vaccine for COVID-19.
This time, it’s not a booster. It’s a completely redesigned shot.
But most don’t know what’s actually in it—or how it works.
Moderna’s new COVID-19 vaccine skips the full spike protein—and something else too: published data.
So what exactly did the FDA approve?
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The Food and Drug Administration has approved Moderna’s next-generation COVID-19 vaccine.
The FDA licensed the vaccine for adults aged 65 and up as well as people aged 12 to 64 who have at least one condition that puts them at higher risk for severe COVID-19, the agency said on May 31.
The vaccine is meant for “active immunization to prevent” COVID-19 for people who have been previously vaccinated with any COVID-19 vaccine.
“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stéphane Bancel, Moderna’s CEO, said in a statement.
People who suffered a severe allergic reaction after receiving any Moderna COVID-19 vaccine, or after receiving any ingredient of mNEXSPIKE, should not get the new vaccine, the FDA said in a package insert.
The vaccine, also known as mRNA-1283, utilizes messenger ribonucleic acid (mRNA), just like Moderna’s already-available COVID-19 vaccine, Spikevax. But it contains just 10 micrograms of mRNA per dose, compared to 50 micrograms in the available vaccine.
Moderna scientists have said that the new vaccine encodes epitopes, or portions of the COVID-19 spike protein, rather than the full-length spike protein.
In a clinical trial of 11,417 people, about half of whom received mNEXSPIKE, the immunogenicity triggered by the new vaccine was the same or better than that prompted by Spikevax, the company told a government advisory panel in April. A lower percentage of mNEXSPIKE recipients contracted COVID-19, and severe COVID-19, the company said.
Other clinical and nonclinical data support the new vaccine, Moderna told a government advisory panel in April.
“What remains consistent throughout all those investigations is this consistent pattern that mRNA 1283 outperforms Spikevax in terms of its ability to induce higher neutralizing antibodies,” Bishoy Rizkalla, a Moderna official, told the committee.
Moderna has not yet published the results in a journal, according to ClinicalTrials.gov, a government database.
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FDA officials announced earlier in May that the regulator would only approve COVID-19 vaccines if companies provided clinical trial data showing the shots provided protection against symptomatic COVID-19 and other clinical endpoints.
The exceptions were for elderly adults and people with underlying risk conditions putting them at higher risk of severe COVID-19 outcomes, as defined by the Centers for Disease Control and Prevention. Those conditions include diabetes and obesity.
For those groups, immunogenicity data would be sufficient, the officials said.
More recently, FDA officials encouraged Moderna, Pfizer, and Novavax to update their COVID-19 vaccines to target LP.8.1, a subvariant of the JN.1 strain.
Moderna on May 23 said it had filed for clearance for an updated version of Spikevax that targets LP.8.1.
On Saturday Moderna said it expects to have mNEXSPIKE available later this year, alongside Spikevax.
Pfizer’s vaccine also uses mRNA technology. Novavax’s vaccine is protein-based.
As part of the approval process, the FDA is requiring Moderna to carry out two post-approval studies, including an observational study of outcomes in women and infants following receipt of the shot in pregnancy, the FDA said in an approval letter.
The CDC, as of this week, no longer recommends pregnant women receive any COVID-19 vaccine.
The Department of Health and Human Services, the FDA’s parent agency, has expressed doubt about the mRNA platform.
In a statement about canceling funding for Moderna’s vaccine candidate against bird flu, a spokesperson told The Epoch Times that “mRNA technology remains under-tested” and has been linked to “legitimate safety concerns,” including heart inflammation.
Doctors long said colonoscopies prevent cancer. Every year, 15 million Americans get screened.
But what this study uncovered might make you think twice before you step into that exam room.
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Although many view a colonoscopy as an uncomfortable or even scary procedure, around 15 million of them are carried out annually in the United States, and 60.6 percent of people aged 50 to 75 without a personal history of colorectal cancer have had one in the past 10 years.
It’s believed that a colonoscopy not only helps find cancer but also prevents cancer from developing from polyps.
Because of its high level of sensitivity and specificity, colonoscopies have been regarded as the gold standard for colon cancer screenings for a long time.
Unexpected Result From a Major Colonoscopy Study
However, a major clinical study, the Nordic-European Initiative on Colorectal Cancer (NordICC) study published in 2022, raised questions about the efficacy of colonoscopies.
Noise isn’t just irritating—it can slowly kill you.
Even the low hum of an office can hijack your stress response, damaging blood vessels and raising the risk of hypertension, stroke, and premature death.
But the antidote is hiding in plain sight: silence. Scientists say it can heal your heart, sharpen your mind, and even rewire your brain.
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In 2006, Dr. Luciano Bernardi, professor of internal medicine at Italy’s University of Pavia and an enthusiastic amateur musician, designed an experiment to study the effects of music on the cardiovascular and respiratory systems of his participants.
Bernardi randomly ordered six types of music and inserted two-minute “pauses” of silence to bring the subjects back to baseline—a control point for experiments.
Yet contrary to his expectations, when the subjects listened to these pauses, they didn’t return to baseline at all—instead, they relaxed.
In fact, they relaxed so much more profoundly during the silent pauses than during even the slowest, most soothing pieces of music that Bernardi had to rethink the whole premise of his experiment.
“The effect was quite remarkable,” Bernardi told The Epoch Times.
He said that the pause (silence) was “much more effective than the music.”
The one that tastes the worst might actually be the best for your health.
The riper it gets, the more sugar it contains—and the less it supports your gut.
But here’s the twist: that brown-spotted banana?
It might be exactly what your body needs when you’re sick.
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Bananas are incredibly popular and are officially the most eaten fruit worldwide. But which banana is better for us—one that is still green, a ripe one, or one that’s beginning to turn brown?
While naturally rich in essential nutrients, their health benefits can vary depending on how ripe they are. Understanding the differences can help you choose the type of banana that is right for you: green, yellow, or yellow with brown spots.
“We all know that bananas ripen over time, but the actual process is fascinating.” Rachel Gargano, chief registered dietitian at Live it Up, told The Epoch Times via email. “Ripening is genetically programmed and includes biochemical and physiological changes, which result in the transformation in taste, texture, and smell that we’re so familiar with.”
Bananas are a fantastic source of vitamins and minerals, essential for maintaining good health.
The vitamins and nutrients in bananas remain relatively consistent throughout the ripening process.
What does change, however, is their antioxidant, starch, and sugar contents, which have different effects on blood sugar and the digestive system.
If you’re not dreaming, your brain is trying to tell you something.
Most people miss this warning.
Dreams are vital for emotional balance, memory, and mental resilience.
When they disappear, it’s often the first sign something deeper is wrong.
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Celeste was an athletic young woman, active and engaged in a busy and, at times, stressful professional life. When the day was done, she slept like a log. However, she rarely dreamed.
While competent at her job, she started to feel increasingly numb when work became more stressful. At times, she might find it tough to relate to others or feel like life was on a conveyor belt—happening around her while she rode along—a somewhat detached observer. I wish I could have told Celeste in the past what I’m about to share with you now.
Your sleep isn’t just about how tired you feel—it’s about how your brain regulates itself overnight. While you may have heard about the importance of “deep sleep,” there’s more to the story.
The tiny locus coeruleus (pronounced “sir-RULE-yes”), a powerhouse of stress regulation, plays a surprising role in deciding when you enter REM sleep.
REM is when dreams happen, but there’s more at play. In fact, your mental health depends on this time for more than wacky, altered realities.
But if your day is filled with stress, your locus coeruleus may stand in the way, disrupting the natural rhythm of your sleep cycles. Let’s dive into the neuroscience behind this hidden sleep regulator.
A common preservative may succeed where billion-dollar Alzheimer’s drugs have failed.
Cheap, safe, and remarkably practical.
With Alzheimer’s now the sixth-leading cause of death, could the solution really be this simple?
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A food preservative used in sodas and thousands of other products may help improve memory and thinking skills in people with Alzheimer’s disease, raising the possibility that an inexpensive household chemical could help combat the nation’s sixth-leading cause of death.
A recent analysis of clinical trial data from 149 people with mild Alzheimer’s disease found that taking sodium benzoate daily for 24 weeks was linked to better thinking skills and lower levels of abnormal proteins in the blood—one of the disease’s hallmarks.
What the Study Found
Current Alzheimer’s treatments are costly and can come with serious side effects, so researchers tested whether sodium benzoate—a pantry preservative—might do more than fight spoilage.
Participants aged 50 to 90 were randomly assigned to receive either a placebo or sodium benzoate at doses of 500, 750, or 1,000 milligrams daily for 24 weeks.
The higher doses produced the most significant results: those taking 750 or 1,000 milligrams daily showed improved cognitive functions—including orientation, word finding, and word recall—along with reduced levels of amyloid beta proteins in their blood. The greatest improvements were seen in participants with higher baseline levels of the more harmful form of amyloid beta.
“You can think of beta amyloid as molecular ‘debris’ that piles up and jams the brain’s wiring system,” Dr. Thomas Holland, a clinician-researcher at the Rush Institute for Healthy Aging, who wasn’t involved in the study, told The Epoch Times. “Over time, this buildup contributes to memory loss and cognitive decline.”
Holland said the findings suggest sodium benzoate may have supported cognition by altering how the body manages amyloid beta—possibly by clearing more of it or producing less.
However, the researchers noted that the exact mechanism remains unknown.
People who took multivitamins had healthier lifestyles—exercised more and smoked less.
Yet despite all that, they died sooner.
These overlooked factors could explain why.
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While nearly one in three Americans takes a daily multivitamin, a large study challenges the belief that these supplements improve health or promote longevity.
Rather than extending lifespan, daily multivitamin use is linked to a 4 percent higher risk of death, according to a large study of healthy U.S. adults conducted by the National Cancer Institute.
The 2024 study challenges the common belief that multivitamins improve health and longevity, even as nearly one in three U.S. adults takes them with those hopes in mind.