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.
Pfizer’s data didn’t just go missing—it was edited.
In an exchange with @RWMaloneMD, Pfizer admitted its biodistribution studies were done “in close consultation” with the FDA.
Images were cropped and dimmed to make the COVID vaccine look confined to the arm, when unedited images revealed mRNA spreading to organs like the kidneys and adrenal glands.
If the FDA helped shape that illusion, what else in the “safe and effective” story was rewritten to hide the truth?
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Data on how parts of a Pfizer-BioNTech COVID-19 vaccine spread in the bodies of mice were withheld from regulatory submissions to the U.S. FDA, according to a new comparison of those submissions and similar documents sent to Japanese regulators.
Byram Bridle, who has a PhD in immunology and is an associate professor of immunology and virology at the University of Guelph in Canada, authored the comparison. It was dated Aug. 13 and released on Oct. 4 by Dr. Robert Malone, a vaccine adviser to the U.S. government.
“The findings of this report raise serious questions about the integrity of the health regulatory process during the declared COVID-19 pandemic,” Bridle said in his conclusions.
Pfizer, BioNTech, and the FDA did not respond to requests for comment.
This everyday fruit can rewire your brain in just 7 days.
A 2024 double-blind trial showed mango extract boosted memory, focus, and mental speed—without side effects.
Participants even felt calmer, with fewer mood swings and better stress control.
But that’s only the beginning—its hidden benefits for your gut, heart, and skin are just as extraordinary.
This one will surprise you...
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Once considered exotic and only eaten in tropical climates, mangoes have become one of the world’s most popular fruits.
Often carrying the moniker of “king of fruits,” the mangoes’ abundant fiber and moisturizing properties have made it a trusted remedy for soothing digestion and promoting regularity for centuries.
Today, scientists are catching up to this ancient wisdom and discovering mango’s digestive benefits. Even more health-promoting effects, such as its brain-enhancing abilities, are being uncovered.
Key Nutrients
A 2025 study published in the International Journal of Current Microbiology and Applied Sciences highlights mango’s growing reputation as a functional food. “Mango is increasingly recognized for its role in health promotion and disease prevention, with its nutritional profile and medicinal properties supporting its place in preventive healthcare,” the authors wrote.
Mangoes are rich in:
• Fiber: One mango has 5.38 grams of fiber. A medium-sized mango can offer about 15 to 20 percent of the recommended daily fiber intake for adults.
• Vitamin C: One mango contains 122 milligrams of vitamin C, which is considerably more than an orange, which has just 82.7 milligrams.
• Folate (vitamin B9): One mango has 144 micrograms of folate.
• Mangiferin: A polyphenol that is abundant in mangoes.
Health Benefits
In a study published in Nutrients in 2017, researchers said that mango is “a fruit that should be included in everyone’s diet for its multifaceted biochemical actions and health-enhancing properties.”
Most liver cancer is preventable—yet few people realize it.
Everyday habits are quietly driving up countless cases of this deadly cancer.
And one ingredient found in thousands of everyday products may be even more toxic to your liver than alcohol.
Once you understand what your liver can and can’t handle, prevention is simple.
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Liver cancer rates are climbing fast.
As fast food chains, supersized sodas, sedentary lifestyles, and chronic infections have become more prevalent over the past 50 years, liver cancer is increasingly linked to everyday choices.
The bright side is that up to 60 percent of cases could be prevented by addressing key risks.
The Everyday Foods That Bring Back Your Skin’s Natural Glow
Sugar and processed foods don’t just harm your health—they quietly make your skin age faster than time itself.
Inside your body, a hidden sugar reaction stiffens collagen and elastin, slowly stealing your skin’s smoothness and natural light.
But here’s the surprising part: certain everyday foods can block this process and help restore your skin’s youthful radiance—naturally.
Curious which ones work best?
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“Diet profoundly and undoubtedly influences how our skin ages,” Dr. Trisha Khanna, a dermatologist and Medical Advisory Board member at Codex Labs, told The Epoch Times.
More people are turning to food to care for their skin, and for good reason. While we cannot stop the natural aging process, diet can influence how skin looks and feels over time.
However, skin aging is a complex process shaped by both genetics and environmental factors. Because nutrients must be digested, absorbed, and delivered to the skin, improvements take time. Much like aging, healing is gradual.
What Speeds Up Skin Aging
One major culprit in skin aging is glycation, a process in which sugars bind to proteins like collagen and elastin.
This reaction changes the structure and function of these proteins, making skin stiffer and more prone to wrinkles and sagging.
Normally, the body has ways to break down and clear glycation through natural defense systems.
Elevated Vitamin B12 Levels May Signal Hidden Disease
New research shows people with unusually high B12 face up to a 20-fold higher risk of developing a deadly type of cancer.
Doctors warn these spikes can appear years before a tumor is detected—long before symptoms begin.
Could your latest blood test be the first sign something’s wrong?
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Vitamin B12 is a vital nutrient that keeps the body running.
Without enough of it, people can develop anemia, fatigue, brain and nerve problems, and even cognitive decline.
Most people get enough vitamin B12 from their diet or supplements.
However, what happens when B12 levels are unusually high?
“Abnormally high blood B12 levels are often not caused by taking too much. Instead, they may reflect underlying diseases or metabolic problems,” Dr. Wenjie Bi, a medical practitioner at the University of Tokyo, told The Epoch Times.
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.