Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

Parents should be concerned that the U.S. Food and Drug Administration (FDA) earlier this month granted full approval to Moderna’s “Spikevax” COVID-19 vaccine for children 12 years old and older — because now that the vaccine for school-age kids is no longer an Emergency Use Authorization (EUA) product, states and schools may be more likely to mandate the shots, according to Dr. Meryl Nass.

Nass, an internal medicine physician and member of the Children’s Health Defense (CHD) scientific advisory board, called the FDA’s decision “outrageous and illegitimate.”

“The ACIP [Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices] actually voted to add the COVID vaccines to the childhood schedule in October 2022, Nass said. “So states may begin adding them to their state’s vaccine schedule.”

“That could, in turn, result in public school vaccine mandates for this vaccine,” she added.

The FDA on Sept. 11 fully licensed the Spikevax vaccine for the younger age group. Previously, it was licensed only for ages 18 and up.

The FDA also on Sept. 11 also amended the EUA for Moderna’s COVID-19 vaccine to include its updated monovalent formula, for infants and children ages 6 months through 11 years, that targets the Omicron variant XBB.1.5

Moderna’s updated EUA shot is a monovalent vaccine that targets the Omnicron XBB.1.5 variant.

New shots ‘risk injuring millions of Americans’

Nass and other doctors, including Dr. Peter McCullough and Dr. Pierre Kory, told The Defender the newly licensed “Spikevax” vaccine for kids as young as 12 and the updated shot for infants risk injuring millions of Americans, including children.

“It is reprehensible that the CDC recommends this booster for 12-year-olds when the FDA has no data on how these children might be affected,” Kory said.

“The government’s recommendation on the COVID-19 vaccine goes against everything we are trained to do as physicians and, thus, can only be rationally understood as being crafted in the service of the pharmaceutical industry and its interests rather than in the best health interests of U.S. citizens.”

McCullough said he does not recommend the new boosters, including Moderna’s shots, in his clinical practices.

“The Omicron variant XBB.1.5 that Moderna’s booster is designed for is “long gone,” he said, and the outbreak of the most recent circulating COVID-19 strains, EG.5 and FL.1.5, is “very mild in Americans, most of whom have natural immunity.”

Kory said the dangers of the mRNA shots — for people of all ages — are well-documented. “In my practice alone, we have over 900 patients, most disabled from the mRNA vaccines.”

He added:

“Although not an exhaustive list, the most important physiologic dysfunctions I see in clinical practice are increased autoantibodies to numerous tissues, macrophage activation, immune suppression, antigen tolerance to Covid variants via IgG4 production, micro-clotting leading to sluggish micro-circulatory flow and tissue hypoxia, mast cell activation, decreased nitric oxide synthesis, and impaired energy production from mitochondrial dysfunction.”

Dr. Fred Wagshul, an Ohio pulmonologist and a founder of the FLCCC, said the entire list of catastrophic diseases and conditions aggravated by the mRNA spike protein applies to children as well.

Wagshul said he was alarmed by recent research, presented in testimony to the South Carolina legislature by a molecular biologist and cancer geneticist Phillip Buckhaults, Ph.D., that the Pfizer vaccine contains DNA fragments that would “disrupt the genomic stability” of the human race and wreak havoc on children.

Kory said he has lost faith in U.S. health authorities’ willingness “to consider the scientific evidence objectively, rationally and independently” when it comes to COVID-19 vaccines and therapies.

He said:

“As much as there is no medical justification for the vaccine, there is absolutely no need for any mandates for anything related to COVID-19. The government’s true motivation appears to be to continue pushing a vaccine the public doesn’t want or need in an attempt to not admit that the vaccine campaign has failed in every respect regarding safety and efficacy.”

‘Myocarditis is overwhelmingly found in children’

McCullough, a board-certified internist, cardiologist and epidemiologist with more than 1000 publications and over 685 citations, has written extensively on the risk of myocarditis from COVID-19 vaccination.

He cited recent research showing that six months after being vaccinated, 80% of teens who were diagnosed with vaccine-induced myocarditis still had not recovered.

McCullough said there have been “record rates of injury, disability and death after vaccination with the government-provided COVID-19 genetic products. He said he particularly has concerns about Spikevax:

“The safety profile reported by Moderna on Spikevax, which is known to load the body with the long-lasting, disease-promoting SARS-CoV-2 Spike protein, appears to be the same or worse than the original mRNA vaccines.

“Injection site pain, headache, fatigue, myalgia and chills, are consistent with previous formulations of Spikevax which led to 7.7% of recipients making emergency trips to hospitals as reported in the CDC V-safe data.”

Nass, too, called out the FDA for putting U.S. children and teens at risk of vaccine-induced myocarditis by approving Moderna’s shots. She said:

“The precautionary principle and common sense clearly indicate that no further shots should be given to anyone until the rates of myocarditis, both subclinical, and clinical, and the rates of all other side effects have been established.”

The CDC’s Vaccine Adverse Event Reporting System (VAERS) has historically been shown to report only 1% of actual vaccine adverse events.

According to data retrieved Sept. 27 from VAERS, there have been roughly 473,769 injuries and more than 9,500 deaths reported following vaccination with a Moderna COVID-19 vaccine.

Kory noted, “In 2022, with many fewer vaccines administered compared to 2021, the rate of myocarditis reports to VAERS is averaging 245% higher than last year — [and] the myocarditis is overwhelmingly found in children.”

Kory said the latest research on COVID-19 vaccine-induced myocarditis is “horrifying.”

The authors, including McCullough, analyzed VAERS data which showed that myocarditis reports since 2021 are 223 times higher than the average of all vaccines in the past 30 years, Kory said.

FDA ‘silent’ on data showing increased death following COVID-19 vaccination

Commenting on the FDA’s recent decision, Steve Kirsch, executive director of the Vaccine Safety Research Foundation, said, “No child should be given these newly updated vaccines until there is compelling data on clinical efficacy and all-cause mortality. There is neither.”

Kirsch said, “All world governments are keeping the record-level public health data on these vaccines a secret. If they work so well, why the secrecy?”

He continued:

“From U.S. nursing home data released by the CDC, we now know that the COVID vaccines have increased risk of death from COVID for the very population they were designed to protect.

“The FDA is silent on this data. If the vaccines really saved lives, it would show up in this dataset. It doesn’t.”

Kirsch added that he has publicly challenged any qualified scientist to an open debate on this data. “No takers. That should tell you everything you need to know,” he said.

Nass said that with “approximately 800 million vaccinations in the U.S. over the past three years, there is no excuse to withhold or fail to obtain this information.”

Nass added:

“Federal agencies have not seen fit to provide the public with this information, nor have they done or directed that careful, active surveillance be performed, which involves checking troponin levels, pre-and post-vaccination.

“Until we have this information, no risk-benefit calculation for different age groups and risk groups can be calculated. Without this information normally you cannot roll out any public health program.”