FDA Approves Moderna ‘Spikevax’ COVID-19 Vaccine for Young Children
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Spikevax Approval for Young Children
The mRNA COVID‑19 vaccine manufacturer Moderna on July 10 announced that the US Food and Drug Administration (FDA) has licensed its “Spikevax” shot for use in children aged six months through eleven years who are considered at increased risk of severe COVID‑19 disease.
Previously, for that age group, Moderna’s mRNA COVID‑19 vaccine was being administered under Emergency Use Authorization (EUA), a regulatory status for FDA unapproved pharmaceutical products that are still considered experimental.
The EUA status was based on the determination of then Secretary of the Health and Human Services (HHS) Alex M. Azar II on March 27, 2020, that the COVID‑19 pandemic posed “a public health emergency” and that “circumstances exist justifying the emergency use” of “an unlicensed biological product”.
The FDA’s approval letter to Moderna, dated July 9 and signed by the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), Dr. Vinay Prasad, states that Spikevax is now licensed for use “in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID‑19”.
Moderna’s press release thanked the FDA for what it called a “diligent scientific review”. The approval letter references three clinical trials underlying the FDA’s supplement approval, one of which is relevant for individuals aged twelve years and older, for whom the shot was already approved.
Of the two relevant for younger children, only one was a randomized, placebo-controlled trial. But like the original trials for adults, long-term safety data won’t be forthcoming because the placebo group was vaccinated away after the FDA granted the shot EUA status for children aged 5 through 7 years.
For efficacy estimates, the primary outcome measured was antibody levels, which is scientifically fraudulent since no correlates of immunity have been established for SARS‑CoV‑2. Just because a person has a certain antibody titer does not mean they are protected against COVID‑19, and a low level of antibodies does not mean that a person is not protected.
A secondary endpoint of the trial was efficacy against infection. No significant efficacy was observed for asymptomatic infection. The results indicated modest efficacy against the outcome of one or more symptoms plus a positive PCR test, but this was based on less than 3 months of follow-up, thus ignoring the known rapid waning and observational studies finding negative vaccine effectiveness after several months.
Like the original trials, it was not designed to measure meaningful outcomes such as efficacy against severe disease, hospitalization, or death. Consequently, the benefits of the shot in young children, who are generally at low risk of severe COVID‑19, have not been shown to outweigh the risks.
The approval of Moderna’s Spikevax runs counter to the intent of health freedom advocates who voted for Donald Trump with the hope of getting Robert F. Kennedy, Jr. into a position to do something to stop people from being harmed by the systematic violation of the right to informed consent that results from public vaccine policies.
We can recall, of course, how the mRNA COVID‑19 vaccines were initially sold to the public based on the lie that two doses would confer durable sterilizing immunity, stopping infection and transmission and thereby creating “herd immunity” that would end the COVID‑19 pandemic.
Many other lies have been told to the public about the safety and effectiveness of these mRNA products, some of which I detailed in my June 3 article “The Deception of the FDA’s New COVID-19 Vaccine Guidance”.
Among the concerns is the finding that vaccine vials are contaminated with plasmid DNA from the manufacturing process, which increases the risk of genomic integration with human DNA and the risk of cancer, but which the FDA has to date completely ignored.
Kennedy launched the “Make America Healthy Again™” or MAHA™ campaign after quitting the presidential race to join forces with Donald Trump, and supporters have been promised that the FDA would now make “evidence-based” decisions. The approval of Spikevax for young children demonstrates the emptiness of that promise and adds to a growing list of deceptive betrayals.
Clinical Trials
Information about the trials referenced in the FDA’s approval letter can be found at ClinicalTrials.gov by looking up the provided IDs (in the “Other terms” search field).
One of the studies cited, trial “NCT04649151”, is titled “A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19 (TeenCove)”. Since it is my aim here to focus on the age group for which the vaccine was previously administered under EUA status, I will not examine this trial. Let’s instead take a closer look at the other two.
Children Aged 6 Months Through 5 Years
Trial “NCT05436834” is titled “A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age”. This study started in June 2022, and the last update was in March 2025. No study results had been published as of that update. The study is ongoing and estimated to be completed in October 2025, with an estimated enrollment of 1,860 children.
It is a non-blind and non-randomized study with no placebo control group.
Instead, subjects are being given different bivalent formulations of Moderna’s vaccine, both containing a component targeting the spike protein of the original Wuhan strain of the virus, long since extinct outside of laboratories. One formulation also contains an Omicron BA.1 component (mRNA-1273.214), and the other contains an Omicron BA.4/BA.5 component (mRNA-1273.815).
The study is designed to evaluate the safety and “immunogenicity” of Moderna’s vaccine when administered as a primary series and as a booster dose.
The study is not designed to determine vaccine effectiveness in preventing SARS‑CoV‑2 infection or COVID‑19 disease. Instead, effectiveness is to be presumed based on measurements of antibodies—a practice called “immunobridging”.
Children with a SARS‑CoV‑2 infection within 90 days of a scheduled dosing are excluded instead of being monitored to determine whether a recent infection places children at higher risk of vaccine-related adverse events.
Children who may have had natural immunity from an infection more than 90 days prior may be included, but there is no indication that investigators have tested for anti-nucleocapsid antibodies to distinguish between immunologically naïve and children with pre-existing natural immunity.
By including naturally immune children, who are more likely to have a robust antibody response to a vaccine dose, and by instead treating them as immunologically naïve, the study is biased in favor of greater immunogenicity of the mRNA injections.
Moreover, this study design assumes immunity is dependent on a certain level of antibodies in the blood, which has not been scientifically demonstrated.
With SARS‑CoV‑2, cellular immune responses are arguably more important. As La Jolla Institute for Immunology reported in September 2020, “the bulk of evidence” points toward “a much bigger role for T cells than antibodies”.
While playing a role in preventing SARS-CoV-2 from infecting cells, “antibodies don’t seem to play an important role in controlling acute COVID-19. Instead, T cells and helper T cells in particular are associated with protective immune responses.”
The FDA has nevertheless allowed the vaccine manufacturers to rely on antibody titers as a surrogate measure of immunity—even though no “protective” titer has been scientifically demonstrated.
Dr. Prasad and FDA Commissioner Marty Makary both know this. In fact, before joining the government, they both signed a citizens petition to the FDA criticizing this practice as scientifically invalid.
But now that they have joined the criminal organization in Washington, they are rubber-stamping the continuance of this scientific fraud as though it were now magically an “evidence-based” practice.
This goes to show how being corrupt or corruptible is practically a job requirement for government officials.
Children Aged 6 Months Through 11 Years
Trial “NCT04796896” is titled “A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age”. It started in March 2021 and shows as completed in March 2024. The trial information was last updated on June 13, 2025.
Children enrolled in the study were either healthy or had chronic conditions considered “stable”. Also known as the “Kid Cove Study”, it received taxpayer funding from the Biomedical Advanced Research and Development Authority (BARDA) and National Institute of Allergy and Infectious Diseases (NIAID), both subagencies of HHS.
The government also directly partnered with Moderna in the development of its mRNA COVID‑19 vaccine and has a financial stake in the vaccine’s success.
Findings from this clinical trial have been previously reported in January 2022 by Lynch et al. in the Journal of Neurosurgical Anesthesiology, in May 2022 by Creech et al. in the New England Journal of Medicine (NEJM), in November 2022 by Anderson et al. in the NEJM.
This was a randomized, saline placebo-controlled trial in which solicited adverse events (AEs) post-vaccination were monitored for 7 days and unsolicited AEs for up to 28 days. Additionally, up to 2 years of follow up occurred for serious adverse events (SAEs), adverse events of special interest (AESIs), medically attended adverse events (MAAEs), and AEs leading to discontinuation from the study.
However, long-term safety follow up was hampered by the fact that the trial was unblinded and placebo recipients offered the vaccine after the FDA granted it EUA status for children aged 5 through 11 years on October 29, 2021.
In this trial, the primary endpoint measured for efficacy was again the immunobridging fraud, in which antibody titers were compared between the enrolled children and those observed in adults aged 18 to 25 years from a different trial.
Secondary endpoints were incidence of SARS‑CoV‑2 infection and COVID‑19 disease.
For efficacy estimates, the median duration of observation for the 2-to-5-year-olds was 71 days after the second dose, and for 6-to-23-month-olds, it was just 68 days. This ignores the known rapid waning of vaccine effectiveness and observational studies finding negative effectiveness in children after several months post-vaccination.
Additionally, children were not considered fully vaccinated until 14 or more days post-vaccination, which biases efficacy estimates upward, as statistically demonstrated by Norman Fenton and Martin Neil. This is known as the “case-counting window bias”.
As reported by Anderson et al., in the cohort of children aged 6 to 23 months, there were 1,762 participants in the vaccinated group and 593 in the placebo group; and among those aged 2 to 5 years, there were 3,040 in the vaccinated group and 1,008 in the placebo group.
Among those aged 2 to 5 years, incidence of serious AEs was considered “low overall” and similar between groups, whereas in the infant age group, “eight serious adverse events occurred” in the vaccinated group “and none occurred in the placebo group.” This evidently caused no concern among trial investigators or the FDA.
Among 2-to-5-year-olds, vaccine efficacy against the CDC’s definition of clinical COVID‑19 disease, which is one or more symptoms plus a positive PCR test, was estimated at only 36.8%. Among 6-to-23-month-olds, efficacy was estimated at 50.6%, thus barely reaching the threshold of 50% originally required by the FDA for its original emergency use authorizations of mRNA COVID‑19 vaccines in December 2020.
No statistically significant efficacy against asymptomatic infection was observed in either cohort. In other words, there is no good scientific evidence that vaccinated children will be less likely to become infected and spread the virus to others.
According to the updated Spikevax package insert, available from the FDA’s website, an efficacy analysis was done on 3,578 participants aged 6 years through 11 years of age randomized to either vaccine or placebo (2,694 versus 884 children).
The estimated efficacy was 82.8%, but this was based on COVID‑19 cases that occurred between September 1, 2021, and the unblinding that evidently occurred the following month. The estimate thus again ignores the known rapid waning of immunity. It was also done “during the period when Delta was the predominant strain in circulation”—rendering it practically irrelevant today.
In another analysis for infants aged 6 months through 23 months, outcomes were compared between 1,686 vaccinated participants and 854 placebo recipients, resulting in an estimated 43.2% efficacy based on the CDC’s definition of clinical disease. For the more meaningful trial definition of two symptoms, or at least one more severe symptom, the efficacy estimate was not statistically significant.
Another ‘Badly Designed’ Trial
To reiterate a key point, the “Kid Cove” trial upon which the FDA based its decision to license Moderna’s Spikevax for children under age twelve, including infants as young as six months, was not designed to measure meaningful outcomes: no vaccine efficacy was demonstrated against serious disease, hospitalization, or death from COVID‑19.
This was a problem with the original trials, as previously observed by Dr. Jay Bhattacharya, the current director of the National Institutes of Health (NIH), and Dr. Martin Kulldorff, who was appointed last month to sit on the CDC’s Advisory Committee on Immunization Practices (ACIP).
In a paper published this past January in the Journal of the Academy of Public Health, Bhattacharya and Kulldorff described the original trials as “badly designed”, with “fundamental design flaws”, including the failure to measure the most important clinical endpoints, which made the trials “not useful.”
The trials used by the FDA to approve Moderna’s COVID‑19 vaccine for use in young children employed the same useless design.
The difference this time is that this scientific fraud was rubber-stamped by HHS Secretary Kennedy under the guise of the “MAHA” movement with the misguided aim of “restoring trust” in the so-called “public health” establishment.
If the lockdown madness and its coerced mass vaccination endgame taught us anything, it’s that the government health agencies are completely unworthy of our trust, and they can’t be fixed because they aren’t broken; they are working exactly according to design.
HHS Disinformation
Some additional background context is important to understand how we arrived at Spikevax getting FDA approved for young children despite the absence of evidence for a benefit that would outweigh the risk of long-term harm.
On May 20, CBER Director Dr. Vinay Prasad and FDA Commissioner Dr. Marty Makary published an article in the NEJM titled “An Evidence-Based Approach to Covid-19 Vaccination”.
Among the fervent “MAHA” loyalists, the regulatory approach proposed by Prasad and Makary was accepted at face value. The new guidelines were hailed as an imperfect yet nevertheless dramatic step in the right direction.
Others, however, saw it not as a victory for health freedom but just a public relations ploy from the administration of President Donald Trump, the proud executor of “Operation Warp Speed”, the government’s partnership with the pharmaceutical industry that resulted in the rapid production and distribution of the mRNA COVID‑19 vaccines.
In my analysis titled “The Deception of the FDA’s New COVID-19 Vaccine Guidance”, I detailed how the aim of the NEJM article was to deceptively appease members of the health freedom movement by creating an illusion that the FDA was moving toward evidence-based policymaking while HHS was in fact digging in its heels on the continued use of the mRNA vaccines despite wholly inadequate trials and reliance on outright scientific fraud.
Another example of this effective psy-op occurred when Secretary Kennedy publicly announced that the CDC had removed the COVID‑19 vaccine from its recommended schedules for healthy children and pregnant women, even though this policy change never occurred.
Instead, as I explained in my analysis of the Prasad and Makary article, the CDC updated its recommendations in ways that ensure that children and pregnant women will continue to be injected with these mRNA products.
I reiterated that analysis in my July 10 article “The AAP’s Lawsuit Against RFK, Jr: Much Ado about Nothing”, in which I explained how the American Academy of Pediatrics (AAP) and other trade organizations are suing Secretary Kennedy and other defendants in HHS for changes to the CDC’s COVID‑19 vaccine recommendations that never occurred.
Dr. Robert Malone, another newly appointed member of ACIP, has since confirmed my analysis that the lawsuit is “completely frivolous” because “pregnant women remain eligible to receive the COVID‑19 vaccine”, and “HHS policy is to recommend that they consult with a doctor before doing so.”
This is similar to how the COVID‑19 vaccine remains on the CDC’s childhood schedule as a “shared clinical decision making” recommendation. Basically, the CDC continues to recommend that children and pregnant women get the shot after consulting with a doctor.
Of course, every vaccine requires an individualized risk-benefit analysis, and the fact that the CDC doesn’t provide this caveat with all of its recommendations just illustrates the extraordinary perversity and unscientific nature of its policymaking.
In the concluding paragraph of my analysis of the AAP’s lawsuit, I warned:
It seems that the powers that be want us to be intently focused on the left hand tossing bones to members of the health freedom movement who helped Trump win the election while the right hand pulls the strings necessary for the continued injection of mRNA COVID‑19 vaccines into children and pregnant women despite the absence of data from randomized, placebo-controlled trials demonstrating the long-term safety and effectiveness of this practice.
No sooner had I published that warning than Moderna announced the FDA’s approval of its Spikevax shot for young children despite the absence of evidence from randomized, placebo-controlled trials that the long-term benefits of the vaccine outweigh the long-term harms.
The government officials responsible for continuing this policy of rubber-stamping these shots know perfectly well how inadequate the data are as a basis for FDA licensure. The fact that they are pursuing policies they had criticized before joining the government sufficiently illustrates the fundamental problem of a total lack of scientific integrity within the “public health” establishment.
Other examples of how MAHA™ has served to hijack and misdirect the health freedom movement include the HHS Secretary’s support for the biotech industry, including a push for gene therapy, and his push to use taxpayers’ dollars with the goal of getting “every American” to use wearable biometric data tracking devices.
We can anticipate that Trump-voting defenders of HHS policies under Secretary Kennedy will argue that the licensure of Spikevax for young children is really a strategic victory because it excludes “healthy” children from getting the FDA-approved shot.
However, that assessment effectively treats unhealthy children as sacrificial lambs, and my own view is that we must not compromise when it comes to the health of our children.
Moreover, the FDA-approved Spikevax and the EUA-authorized Moderna COVID‑19 Vaccine “have the same formulation and can be used interchangeably”, according to the FDA.
Consequently, the mRNA shots can continue to be injected into healthy infants and toddlers, as well as healthy adults under age 65, under EUA status.
In my analysis of the AAP’s lawsuit against HHS, I wrote:
As HHS Secretary, Kennedy has authority under 42 U.S. Code § 247d to terminate the “emergency” declaration under which the shots were granted EUA status. Were he to do that, it would trigger the process of revoking the EUA status for COVID‑19 vaccines. This would at least protect this vulnerable population from continued mass experimentation with no logical possibility for properly informed consent.
So why hasn’t he?
The HHS Secretary has missed his opportunity to protect all children aged 6 months through 11 years, choosing instead to rubber-stamp the continued use of these mRNA products in that age group under full FDA licensure.
He could still choose to at least protect “healthy” children by revoking the absurd premise that COVID‑19 poses and “emergency” threat to children.
In my analysis of the FDA’s new guidance for the industry, I warned about the sleight-of-hand of purporting to base any new authorizations or approvals of COVID‑19 vaccines on “evidence-based” policymaking when the true aim was to cement in place corrupt policymaking and the continued use and development of vaccinations based on the mRNA platform.
As another example of the sleight-of-hand, MAHA enthusiasts celebrated HHS’s termination of a contract with Moderna to develop an mRNA-based vaccine against the H5N1 “bird flu” even while the FDA approved its mNEXSPIKE COVID‑19 booster shot for use in the elderly and anyone aged 12 and older with a condition that the CDC considers a risk factor for severe disease—which includes pregnant women.
Other mRNA products Moderna has in the pipeline include vaccines against seasonal influenza, a COVID‑19 and influenza combination shot, respiratory syncytial virus (RSV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus (HSV), varicella-zoster virus (VZV), human immunodeficiency virus (HIV), Zika virus, Nipah virus (NiV), Lyme bacteria, and norovirus.
Of course, the mRNA vaccines were developed from decades of research into the use of mRNA for gene therapy, so Moderna is naturally also pursuing gene therapy applications for its platform.
The evidence increasingly indicates that MAHA™ has hijacked and is now misdirecting the health freedom movement with the aim of “restoring trust in vaccines”, which anyone who has been involved in the grassroots health freedom movement for any length of time must recognize as the wrong mission.
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About Jeremy R. Hammond
I am an independent journalist dedicated to exposing state propaganda designed to manufacture consent for criminal government policies. I provide deeply researched analyses on critical issues including US foreign policy, the economy, and health freedom.
I am a Research Fellow at The Libertarian Institute and author. My books include Obstacle to Peace: The US Role in the Israeli-Palestinian Conflict and The War on Informed Consent.
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