‘Concerning and Bewildering’: FDA Grants Full Approval of Moderna COVID Vaccine for ‘At-Risk’ Infants and Children
Critics questioned the decision, citing a lack of safety data, a long list of serious adverse events and the low risk COVID-19 poses to children.
The U.S. Food and Drug Administration (FDA) today granted full approval of Moderna’s Spikevax COVID-19 vaccine for infants and children ages 6 months to 11 years who are at “increased risk” from the virus.
The vaccine was previously available to children ages 6 months through 11 years under emergency use authorization. It is now fully approved for all adults age 65 and older, and children and adults between 6 months and 64 years who are at higher risk of COVID-19.
Writing on Substack, epidemiologist Nicolas Hulscher called the FDA’s decision “gravely worrisome.”
“It shows, once again, that our regulatory agencies remain fully captured by the Bio-Pharmaceutical Complex,” he wrote.
Dr. Larry Palevsky, a pediatrician, said the approval raises several questions:
“I haven’t seen any data related to the use of this injection in the pediatric population. Has anyone? On what legitimate basis did the FDA approve this injection?
“What clinical criteria qualify children to be ‘at risk?’ Who decides these criteria, or are they up to the random opinion of the physician administering and selling this injection?”
According to Moderna, the Spikevax vaccine will be available in the U.S. for the 2025-2026 cold and flu season.
Moderna CEO Stéphane Bancel said in a news release:
“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.”
No announcement about the expanded approval was available on the FDA’s website as of press time. The FDA and the U.S. Department of Health and Human Services did not immediately respond to a request for comment.
Vaccine approved despite ‘mountain of evidence’ of health risks for kids
According to Hulscher, “This approval comes despite a mountain of evidence linking the shots to catastrophic harms, some of which include heart damage, brain damage, cancer, and mass death.”
The package insert for Spikevax lists several adverse events, including trouble breathing, swelling of the face and throat, a rapid heartbeat, dizziness and weakness, myocarditis, fainting, febrile seizures, fatigue, headache, nausea, vomiting, irritability, sleepiness, and others.
These risks “are greater and more severe than the actual symptoms of COVID, especially as they pertain to the pediatric population,” Palevsky said.
According to the U.S. government-run Vaccine Adverse Event Reporting System (VAERS), 73,075 cases of adverse events related to COVID-19 vaccines in people ages 17 and younger were reported as of June 27. Of these, 6,138 cases were classified as serious.
The reports included 15,053 adverse event cases filed following Moderna’s COVID-19 vaccine. Of those, 710 were serious.
These figures may underestimate the true incidence of adverse events, as a 2011 Harvard report found that less than 1% of all adverse events are reported to VAERS.
“In the last four years, more children have suffered from severe health outcomes related to the injection of previous COVID shots than they have experienced severe symptoms from COVID itself,” Palevsky said.
Biologist Christina Parks, Ph.D., said there are “several elements” of the FDA’s approval that are “concerning and bewildering.” She cited several “core safety concerns” regarding mRNA vaccines that “have yet to be addressed.”
Parks said:
“Given the known toxicity of the full-length spike protein, why do current vaccines still code for the production of the spike protein in persons receiving the vaccine?
“Immunological susceptibility to hyperinflammation is at the core of vulnerability to both severe COVID as well as COVID vaccine-induced adverse reactions. Where is the CDC [Centers for Disease Control and Prevention] guidance on which immunological markers should be evaluated to determine whether the benefit of receiving a Moderna vaccine in the ‘at-risk’ children will outweigh the risk of chronic inflammation or an adverse event?”
Studies link mRNA vaccines to myocarditis, other serious side effects
Multiple studies have linked COVID-19 vaccines to health risks in children. Here are just a few:
According to a study published in the journal Pediatric Rheumatology in May, children and adolescents who received at least one COVID-19 vaccine had a 23% higher risk of developing autoimmune disease compared to unvaccinated children.
An FDA-funded study published in the journal eClinicalMedicine in September 2024 showed that 60% of young people who were hospitalized with myocarditis after receiving an mRNA COVID-19 vaccine still showed signs of myocardial injury roughly six months after getting the shot.
A preprint study published in May 2024 of 1.7 million children in England found cases of myocarditis or pericarditis only in those children who received the COVID-19 shots. No cases were identified in children who didn’t receive the vaccine.
A 2023 study published in the journal Circulation found that young males who had myocarditis lacked neutralizing antibodies to the spike protein.
In 2023, the CDC identified myocarditis and pericarditis as adverse events related to the mRNA COVID-19 vaccines produced by Pfizer and Moderna, based on evidence of “a causal association between mRNA COVID-19 vaccines” and these conditions.
A study published in the journal Molecular Systems Biology in March linked mRNA COVID-19 vaccines to long-term changes in genetic structures that can provoke an inflammatory response, and lead to the onset of cancer and autoimmune disorders.
A study published last year in The Pediatric Infectious Disease Journal found that children who received mRNA COVID-19 vaccines showed signs of an altered immune system response one year after vaccination.
“The CDC and Moderna both know that the full-length spike protein is toxic and likely the cause of myocarditis in young males, yet they are recommending the Moderna vaccine for 11-year-old males without making any changes to the vaccine or its administration that might mitigate this potential risk,” Parks said.
Last month, the FDA approved updated versions of package inserts for the Pfizer and Moderna COVID-19 vaccines to include stronger warnings about the risks of myocarditis and pericarditis.
CDC recommends ‘shared clinical decision-making’ before kids get COVID shot
In May, Health Secretary Robert F. Kennedy Jr. announced that the COVID-19 vaccine for healthy children and pregnant women would be removed from the CDC immunization schedule. At that time, the CDC recommended the vaccine for all children ages 6 months and older and all pregnant women.
The recommendation included three doses of the vaccine for babies by the age of 9 months.
Kennedy said the data did not show that healthy children and pregnant women benefited from the vaccine.
However, his announcement sparked confusion, as the changes weren’t yet visible on the CDC website. Days later, the agency updated the COVID-19 vaccine schedule for children, recommending “shared clinical decision-making” between parents and providers for children ages 6 months to 17 years who are not moderately immunocompromised.
Pfizer’s COVID-19 vaccine for infants and children ages 6 months to 12 years is still administered under emergency use authorization. Novavax’s Nuvaxovid vaccine is fully approved only for people 65 and older and those between 12 and 64 who are at increased risk of COVID-19 infection.
On Tuesday, Moderna’s shares rose 8.83% after six medical organizations sued Kennedy over changes to COVID-19 vaccine recommendations for pregnant women and healthy children.
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Breaking: CDC Removes COVID Vaccine Recommendation for Healthy Kids, Healthy Pregnant Women
Kids, Teens Who Got COVID Vaccine Had 23% Higher Risk of Autoimmune Disease
60% of Young People With COVID Vaccine-induced Myocarditis Showed Heart Damage 6 Months Later
Kids Who Received mRNA COVID Vaccines Had Altered Immune Systems a Year Later
We used to NOT give "vaccines" to the immunocompromised, sick or "at risk"...to protect them from having a bad reaction. Now, they are the first on the list.
Absolutely despicable