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.
Cholesterol-Lowering Drugs: What You’re Not Being Told
You’ve heard it for years: lower your cholesterol, protect your heart.
But what if that advice left out something important?
A massive 10-year study tracking over 12 million people found that when cholesterol drops below a certain point the risk of death actually goes up.
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Can lowering cholesterol levels reduce the risk of heart disease?
Is it worth taking statins to lower cholesterol?
Cai Kaizhou, president of Taiwan Natural Orthopedics Institute and attending physician of the Department of Orthopedics at National Taiwan University Hospital, recently spoke about the cholesterol myth in NTDTV’s Health 1+1 program and revealed the real key to cardiovascular health.
Cholesterol is a key substance for body repair, but it’s been demonized in the past 50 years, according to Cai. People’s fear of cholesterol mainly stems from concerns about heart disease but cholesterol is not the only or main cause of it. While the intention of lowering cholesterol is to prevent heart disease, that alone does not mean its incidence will decrease proportionally.
A 2019 study published in Scientific Reports tracked 12.8 million Koreans for 10 years. The results showed that below a certain level (< 200 mg/dL), the lower the total cholesterol level, the higher the all-cause mortality rate. The all-cause mortality and total cholesterol levels were exhibited in a U-shaped curve, with the negative correlation at the lower end being more evident than the positive correlation at the upper end, and the correlation is exactly the same for all age groups.
Cai said that the results are contrary to the common belief that lowering cholesterol can reduce mortality, and as everyone’s cholesterol level is different, we should not blindly pursue lowering cholesterol but instead focus on other factors that cause heart disease, such as vascular inflammation.
Bananas could lower your blood pressure faster than meds.
A new study found that eating three green bananas a day for just two weeks slashed blood pressure in hypertensive patient
No side effects. No prescriptions. Just a fruit that worked like natural medicine.
So how does it work—and why do green bananas unlock this effect?
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Bananas have long been celebrated for their digestive benefits—a status that endures today.
For centuries, Ayurveda has considered bananas as cooling and moisturizing, helping to ease inflammation and dryness in the digestive tract. Traditional Chinese medicine (TCM) uses unripe bananas for diarrhea and colitis, while ripe ones help treat ulcers and constipation.
In conventional medicine, bananas are also suggested as an aid in digestion. They’re a key part of the BRAT (bananas, rice, applesauce, toast) diet, which is often recommended for soothing digestive issues such as nausea, vomiting, and diarrhea, especially during recovery from stomach flu or food poisoning.
Beyond their digestive benefits, bananas help lower blood pressure and enhance mood.
A little about us: We’re a team of journalists and researchers on a mission to give you REAL and honest information about your health.
Side effects of reading our posts may include: critical thinking.
Follow us for more daily threads—backed by hard data.
Common Sweetener May Be Silently Harming Your Brain and Heart
Erythritol is sold as a safe, healthy sugar alternative.
It’s found in protein bars, baked goods, and “sugar-free” snacks.
But new research suggests it could raise your risk of heart attack and stroke.
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Recent research finds that a popular low-calorie sugar substitute, generally considered a healthy alternative, may potentially increase the risk of heart attack and stroke.
Findings in cell studies, presented at the 2025 American Physiology Summit but not yet peer-reviewed or published, suggest that erythritol—often used in candies and baked goods—might affect the function of blood vessels.
Researchers warned the sweetener could inhibit the brain’s ability to produce a crucial compound that helps maintain healthy blood flow, but cautioned that more comprehensive studies are needed before drawing definitive conclusions about its safety.
Increase in Oxidative Stress
For this study, researchers found that when human brain cells were exposed to erythritol, these cells exhibited increased oxidative stress—an imbalance in the body between free radicals and antioxidants that can lead to a range of detrimental health effects, including chronic conditions such as cardiovascular disease, neurodegenerative disorders, cancer, and inflammatory diseases.
Additionally, these cells also produced less nitric oxide after being exposed to erythritol. Nitric oxide, a vital compound that allows blood vessels to widen, was reduced.
This reduction in nitric oxide may increase heart attack and stroke risk, according to the authors.
“X-Men” actor Adan Canto died from a rare appendix tumor—and now researchers are sounding the alarm.
Appendix cancer is rising fastest in younger adults, especially older millennials, who now face 4X the risk their grandparents did.
There’s no screening test. Colonoscopies don’t catch it.
And by the time most people are diagnosed, it’s already too late.
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When “X-Men” actor Adan Canto died at just 42 from a tumor in his appendix, it cast a spotlight on a cancer so rare that many physicians have never encountered it.
His death in January 2024 drew attention to a troubling trend that researchers are only beginning to understand: Rates of appendiceal cancer are rising sharply among Gen X and millennials.
A new study published in the Annals of Internal Medicine shows that the rate of appendiceal cancer has quadrupled among people born in the mid-1980s compared to those born in the 1940s.
Millions struggle with kidney stones every year. Diet, dehydration, and genetics usually take the blame.
But scientists just found something hiding in your body that plays an even bigger role.
It’s not what you think. And it could change how we prevent kidney stones forever.
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The urinary tract microbiome, also known as the urobiome, is home to various microorganisms. Researchers from Mahidol University in Thailand found that certain bacteria within the urobiome play crucial roles in promoting or preventing kidney stone formation.
The discovery sheds new light on this painful condition that affects approximately 10 percent of the U.S. population.
The study, published in the journal Microbiome, showed that Lactobacillus acidophilus (L. acidophilus) helped prevent the formation of calcium crystals that cause kidney stones. In contrast, Escherichia coli (E. coli) promoted kidney stone formation.
“The urinary tract of healthy individuals is known to harbor several bacterial genera,” the authors wrote, citing Lactobacillus. “Alterations in such bacterial community or urinary microbiome have been reported in many kidney diseases, including KSD [kidney stone disease].”
Contrasting Actions of 2 Key Bacteria
Researchers investigated how L. acidophilus, commonly found in the urine of healthy individuals, might prevent kidney stone formation. They compared its effects with E. coli, known to promote stone development.
The study examined their interactions with calcium oxalate crystals—a common component of kidney stones.
Oxalate, which is obtained through the diet, typically binds with calcium from food and exits through the bowels. In other words, if oxalate binds with calcium in the gut, it’s not a problem. But excess oxalate in the diet, without calcium, can be absorbed into the bloodstream, where it binds with calcium in the urine, forming calcium oxalate kidney stones that can’t exit the body easily.
A Forgotten Antibiotic Just Shook Up the Lyme Disease Debate
In a pair of new studies, one overlooked drug eliminated Lyme bacteria at doses 100x lower than standard antibiotics—without wrecking the gut microbiome.
Even more surprising? It might prevent infection entirely.
And it's already FDA-approved.
Now the question is… why hasn’t this been used all along?
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Scientists may be closing in on two major advances in the fight against Lyme disease: an overlooked antibiotic that eliminates the infection at exceptionally low doses and new insights into why symptoms often persist long after treatment.
In a pair of studies published recently in Science Translational Medicine, scientists showed that piperacillin—a Food and Drug Administration-approved antibiotic—cleared Lyme infections in mice at doses up to 100 times lower than those of doxycycline, the current first-line treatment.
Unlike doxycycline, piperacillin targets the Lyme disease bacteria specifically, sparing the gut microbiome from the disruption that typically accompanies doxycycline use.