FDA Gives Full Approval For Moderna's 'Next Generation' Spikevax Covid mRNA Vaccine For Children 6 Months And Up

This marks the first Covid vaccine formally approved for use in young children, without emergency authorization.

Yesterday, the Food and Drug Administration (FDA) provided full approval for Moderna’s newest Covid mRNA vaccine, Spikevax (mRNA-1273), for young children ages 6-months to 11-years-old. This marks the first Covid vaccine formally approved for use in young children, without emergency authorization.

“The move makes Moderna's vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather than used under emergency authorization, STAT News reported,” Medical Xpress reported.

Interestingly, “The FDA action comes weeks after U.S. Health Secretary Robert F. Kennedy Jr. said the government would no longer recommend the COVID vaccine for healthy children or pregnant people,” Medical Xpress added.

Dr. Fiona Havers, a former U.S. Centers for Disease Control and Prevention (CDC) medical expert, who recently resigned because of RFK Jr.’s new vaccine policies. "Young age by itself is a risk factor for severe COVID," she told STAT News. "We know that more than half of the children who are being hospitalized for COVID are less than age 2, and among those, most of them do not have an underlying medical condition," she added.

Stéphane Bancel, Chief Executive Officer of Moderna, commented on the FDA approval, saying:

"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization. We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."

The updated Spikevax is expected to be rolled out “for eligible populations in the U.S. for the 2025-2026 respiratory virus season,” Moderna adds.

In its listed side effects in the press release, Moderna reports recipients could contract myocarditis and pericarditis.

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving Spikevax, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.

Not long after Kennedy and the FDA’s May announcement that they would no longer recommend the COVID vaccine for healthy children, the FDA soon after approved Moderna’s COVID-19 Vaccine mNEXSPIKE (mRNA-1283), “for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC),” the press release says. That shot should be ready for rollout by the fall and winter months this year.

FDA Approves Moderna's 'Next Generation' Covid mRNA Vaccine That Contains Chimeric Gain-Of-Function Bird Flu Material

The heads of the FDA - Commissioner Dr. Martin Makary, Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, and Vinayak Kashyap Prasad, Director of the Center for Biologics Evaluation and Research (CBER) at the FDA - last month said they are creating a “safe space” for big pharmaceutical companies to pitch their ideas and give their input.

During the FDA’s podcast revealing this, Makary explained within the first minute of the show:

“Yeah, it's amazing when you get the CEOs and leaders of these companies, drug developers, inventors, the scientists in the room, and you say this is a safe space. Tell us your ideas for an FDA that works better for you. It's amazing. They will talk, they will unload, they will share. And so they did.

“[…] But if you want someone to be honest and genuine and sharing their ideas, you have to create a safe space for them. And since we were not answering questions, we were not giving talks. We're not sharing new information from the FDA. We were listening.

“It was amazing how many people told us when they don't have to worry about their shareholders and their employees and investors and everybody else, how they just felt comfortable giving ideas.”

Yesterday, July 10th, Makary celebrated his first 100 days in office, saying he is “proud to celebrate the agency’s accomplishments in the bipartisan effort to Make America Healthy Again.” The Commissioner listed a number of things the FDA is doing to make good on these promises, “Embracing Gold-Standard Science, Transparency and Common Sense,” he calls it; which includes “updated labeling of [Covid-19] mRNA shots to include new safety information about myocarditis and pericarditis.”

Makary also lauds the inclusion of greater use of AI in medical care and guidance in what he describes “Unleashing AI and Big Data.” This includes:

• AI-assisted review – Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork.

• Equipping reviewers with internal AI tools – Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes.

• Building a better adverse event reporting database – Launched a comprehensive effort to consolidate disparate adverse event reporting databases, which will enable far more effective post-market monitoring of drug products.

AI surveillance is a directive discussed in the MAHA Report published earlier this year. Last month, RFK Jr. promoted Americans using wearables and expects to see people use more of them within the next four years. He also redefined MAHA to mean “Make American Biotech Advance” (MABA).

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AUTHOR COMMENTARY

Job 13:4 But ye are forgers of lies, ye are all physicians of no value.

Just when you thought MAHA couldn’t get any more pathetic - now we understand why Kennedy and the FDA celebrated no longer approving the Covid mRNA shots for children: they were about ready to approve the “improved” version to deployed and injected into the arms of little children later this winter.

But even when Bobby claimed on X that the Covid shots were removed from the CDC’s children’s vaccine schedule, they were still there; and even now the Covid shots are STILL listed on the CDC’s vaccination schedule for children 6-months and up. Absolutely nothing has changed.

Hence, this is why this meme exists:

The list of nonsense keeps getting longer and longer:

• Bill Gates Had ‘Quite Intriguing’ Dinner With Trump Discussing Vaccines, As Pfizer CEO Cozies Up To Trump And Has Built ‘Good Relation’ With RFK Jr.

• Trump USDA Quietly Approves Bird Flu Vaccine To Tackle Outbreak, Ramps Up Security, Imports Eggs, Provides Additional Funding For New Vaccines Delivered Through Drinking Water

• Trump To Usher In The "Golden Age Of Vaccines" With Project Stargate, With The Aid Of Larry Ellison's Oracle To Track Recipients With 'Precision Accuracy'

• Trump FDA To Fast-Track Self-Amplifying mRNA Bird Flu Vaccine, RFK Jr. Promises To Produce Effective Shots

• Reversal: RFK Jr.'s HHS Terminates Multi-Million-Dollar Contracts With Moderna To Produce mRNA Bird Flu Vaccines. Is This A Distraction?

• US And Argentina Announce Partnership To Create Alternative To World Health Organization

• White House Publishes 'MAHA Report' That Is Full Of Errors And Fake Studies, Pushes For "Safer" Vaccines And 'AI Surveillance'

• FDA Approves Moderna's 'Next Generation' Covid mRNA Vaccine That Contains Chimeric Gain-Of-Function Bird Flu Material

• HHS And NIH Launches Next-Generation Universal Vaccine Platform 'Generation Gold Standard' To Treat Bird Flu, Covid And Other Viruses

• USDA Reveals Plan To Vaccinate Poultry Farms For Bird Flu In July, As NIH And USDA Develop mRNA H5N1 Shot For Cattle

• RFK Jr. Rebrands MAHA As "Make American Biotech Accelerate" (MABA), As FDA Says They Are Creating A 'Safe Space' For Pharmaceutical Companies

• RFK Jr.'s Faces Blowback From His Own Supporters After Promoting Wearables And "Make American Biotech Advance" As MAHA Movement Sputters

• Moderna Announces 'Positive' Phase-3 Results For Universal mRNA Flu Vaccine, Paving The Way For FDA Approval

• RFK Jr. Says He Wants 'To Restore Public Trust In Vaccines.' Appoints Dr. Robert Malone To New CDC Advisory Committee

• RFK Jr. Says He Will No Longer Ban Pharmaceutical Ads On TV But Wants To Make Them 'More Honest,' Breaks Major Campaign Promise

• Make America Healthy Again Is DEAD And A Complete Failure! Big-Pharma And Big-Ag Will Continue To Flourish Under Trump 2.0

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[7] Who goeth a warfare any time at his own charges? who planteth a vineyard, and eateth not of the fruit thereof? or who feedeth a flock, and eateth not of the milk of the flock? [8] Say I these things as a man? or saith not the law the same also? [9] For it is written in the law of Moses, Thou shalt not muzzle the mouth of the ox that treadeth out the corn. Doth God take care for oxen? [10] Or saith he it altogether for our sakes? For our sakes, no doubt, this is written: that he that ploweth should plow in hope; and that he that thresheth in hope should be partaker of his hope. (1 Corinthians 9:7-10).

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