Is FDA Approval of Spikevax for Young Children a GOOD Thing?

Yesterday, I published an analysis of the FDA’s approval of Moderna’s “Spikevax” mRNA COVID‑19 vaccine for young children, characterizing it as a setback for the health freedom movement and an indication that instead of the “evidence-based” policymaking that HHS Secretary Kennedy promised, it is just business as usual.

Dr. Meryl Nass, whom I greatly respect, has a different take. She argues that it’s not that bad and actually has one positive result.

I’m open to the possibility that I’ve been looking at this the wrong way and should change my mind. So, I’ll take this opportunity to challenge my own point of view. Let’s examine this together, and if you think I’m erring on any point of fact or drawing any illogical conclusions, please let me know in the comments.

The first point Dr. Nass makes is that, as I also explained in my article, the approval was only for individuals aged six months and up who have an underlying medical condition that the CDC considers a risk factor for severe COVID‑19 (or for anyone aged 65 and older).

She interprets this as meaning that healthy individuals under age 65 can no longer get the shot.

Nass quotes Dr. Jeremy Faust at MedPage Today making that same argument, albeit from the very different mainstream perspective that this “ban for most children” is a bad thing because the shots are so wonderful.

Never mind the matter of DNA contamination that the FDA continues to ignore . . .

Never mind the problem of “original antigenic sin” and findings of negative vaccine effectiveness after several months of rapidly waning immunity . . .

Never mind how superior natural immunity is an opportunity cost of vaccination . . .

Never mind how the original trials were “badly designed” and basically useless, according to Dr. Jay Bhattacharya, who is now NIH Director, and Dr. Martin Kulldorff, who was appointed last month to sit on the CDC’s Advisory Committee on Immunization Practices (ACIP) . . .

Never mind how the FDA’s updated approval of Spikevax was based on a trial that modeled that exact same useless design (as detailed in my analysis) . . .

Never mind the reanalysis of trial data published in the journal Vaccine finding that getting an mRNA COVID‑19 vaccine was more likely to result in hospitalization for a serious adverse event of special interest than to prevent hospitalization for COVID‑19 . . .

The lead author of that study, Joseph Fraiman, has joined other scientists and healthcare professions in signing “The Hope Accord”, which calls for “the immediate suspension of the COVID‑19 mRNA vaccine products” on the grounds that “A growing body of evidence suggests that the widespread rollout of the novel Covid-19 mRNA vaccine products is contributing to an alarming rise in disability and excess deaths.”

But never mind all that! The shots are wonderful, in the mainstream view represented by Dr. Faust. Of course, none of the valid concerns about the shots ever manage to enter the mainstream discourse. (And if you appreciate my independent journalism, please consider supporting me.)

Returning to Dr. Nass’s article, she also argues (emphasis added),

If a doctor gives someone under 65 who is healthy a booster shot and the person has a serious side effect, they can now sue the doctor and Moderna for the side effect, which was not possible for kids under 12 before, as an EUA.

EUA is the “emergency use authorization” under which the shots have been administered to children as young as six months. This regulatory status is for FDA unapproved products still considered experimental.

If it were true that the FDA’s updated approval for Spikevax removes legal immunity, I would have to take that positive outcome into account and reassess my view.

However, I don’t believe this is correct.

As I noted in my analysis, 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.

And neither doctors nor manufacturers can be sued in that circumstance due to legal immunity under the PREP Act.

Former HHS Secretary Xavier Becerra on December 11, 2024, extended the “emergency” declaration under which this legal immunity is conferred until December 31, 2029.

That leaves us with the question of whether a licensed COVID‑19 vaccine—which is to say one that is FDA approved and not distributed under EUA status—is no longer covered under the legal immunity provided under the PREP Act.

For the manufacturers to be liable for vaccine injuries, this would have to be true.

However, the “Covered Countermeasures” for which legal immunity is conferred under the PREP Act are not limited to COVID‑19 vaccines with EUA status; shots that are “licensed by FDA” and “FDA approved” are also covered and “eligible for coverage under the Countermeasures Injury Compensation Program [CICP]”, as stated in an amendment to the emergency declaration in the Federal Register in May 2023.

A manufacturer would have to be found guilty of “willful misconduct” to be held liable for vaccine injury—regardless of whether the vaccine is administered under EUA or approved status.

Hence, Moderna still has legal immunity against Spikevax injury lawsuits.

The other route to legal immunity for the manufacturer would be if HHS added COVID‑19 vaccines to the list of covered vaccines under the Vaccine Injury Compensation Program (VICP), which was established under the 1986 National Vaccine Childhood Injury Act to effectively shift the financial burden for vaccine injuries away from the pharmaceutical industry and onto the taxpaying consumers.

To be covered under the VICP, a vaccine must be recommended by the CDC for use in children or pregnant women, and it must be subject to the excise tax that funds the program, which is $0.75 per dose (so the tax on an MMR vaccine, for example, is $2.25, since it’s three vaccine doses combined).

There is a seemingly popular belief that “the shots have been removed from the routine childhood schedule” (to quote from the Brownstone Institute), which is misinformation ironically propagated by Dr. Robert Malone, who now sites on the CDC’s Advisory Committee on Immunization Practices (ACIP), which is responsible for making vaccine recommendations.

In fact, though, the COVID‑19 vaccine remains on the CDC’s childhood schedule, as I explained in each of these articles:

• The Deception of the FDA’s New COVID-19 Vaccine Guidance
• Why RFK Jr’s Wearables Push Is Raising Alarm Among Health Freedom and Privacy Advocates
• The AAP’s Lawsuit Against RFK, Jr: Much Ado about Nothing
• FDA Approves Moderna ‘Spikevax’ COVID-19 Vaccine for Young Children

Under federal law, if the CDC “recommends a vaccine to the Secretary for routine administration to children, the Secretary shall, within 2 years of such recommendation,” amend the table of covered injuries to include the newly recommended vaccine.

That is to say, it’s not his choice: the HHS Secretary is legally obligated to add CDC-recommended routine vaccinations to the VICP injury table.

However, being added to the Vaccine Injury Table alone is not sufficient for a manufacturer to be protected by the legal immunity conferred under the VICP. The vaccine must also be subject to the excise tax under federal law—a determination of Congress, not the executive HHS agency.

The definition of a “taxable vaccine” under federal law would have to be updated by an act of Congress before a new vaccine could confer legal immunity to the manufacturer under the VICP.

Short of that happening, COVID‑19 vaccines remain “covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program.”

In August 2023, a bill was introduced into Congress that would have amended federal law to automatically include any vaccine “which is included on the Vaccine Injury Table” as a “taxable vaccine”. Fortunately, it died.

To summarize, manufacturers still have legal immunity under the CICP for both EUA-administered and licensed COVID‑19 vaccines.

The CDC added the COVID‑19 vaccine to its childhood schedule in February 2023 upon the recommendation of ACIP.

The two-year deadline for the HHS Secretary to add the shot to the VICP injury table has passed. The Secretary at the time this legal obligation became due was Xavier Becerra, who headed HHS under the Biden administration.

That legal obligation now falls on Secretary Kennedy, but he could argue that it no longer applies to the COVID‑19 vaccine since the CDC updated its schedule to classify the shot as a “shared clinical decision making” recommendation.

This changed its status from a vaccine recommended for all children routinely to one that CDC recommends parents talk to their child’s pediatrician about—with the American Academy of Pediatrics (AAP) maintaining routine COVID‑19 vaccination as “standard of care” in pediatric practices throughout the US.

The CDC seems to indicate a distinction between its updated recommendation and a “routine” vaccination, stating:

Unlike routine, catch-up, and risk-based recommendations, shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian.

By issuing the Secretarial Directive that led to the schedule update, even though the CDC didn’t remove its recommendation for “healthy” children to receive the shot, as Kennedy claimed had been done on May 27, the HHS Secretary may have blocked COVID‑19 vaccines from being added to the injury table and hence stopped manufacturers from receiving legal immunity under the VICP.

On the other hand, the CDC’s webpage for its Vaccine Information Statements (VISs), last updated on May 29, when the schedule change occurred, still categorizes COVID‑19 vaccines as a “Routine” shot—as opposed to “Non-Routine” shots like anthrax, rabies, and ebola vaccines.

So, depending on how one defines “routine” for the purpose of CDC recommendations, the HHS Secretary may or may not be legally obligated to add the COVID‑19 vaccine to the VICP injury table—the first step toward manufacturers being granted legal immunity under the 1986 law.

And in any event, COVID‑19 vaccine manufacturers still have legal immunity under the CICP, which will continue to apply through 2029, barring another extension of the “emergency” declaration by the HHS Secretary.

This leaves Secretary Kennedy with the option of using his legal authority to terminate the “emergency” declaration—since nobody in their right mind would argue that COVID‑19 poses an “emergency” threat to children warranting their subjection to a mass uncontrolled experiment without properly informed consent. (Not that there aren’t plenty of insane people in government and the media.)

Terminating the “emergency” would trigger the process for revocation of EUA status for COVID‑19 vaccines, which would truly result in Dr. Faust’s nightmare scenario of healthy children no longer being eligible for the vaccine—unless administered “off label” by doctors, similar to how flu shots are administered to pregnant women despite the package inserts explicitly stating that safety and effectiveness “have not been established in pregnant women or nursing mothers.”

(Sure, flu shots are approved for all persons aged six months and up, which technically includes pregnant women, but according to the FDA itself, an “on label” use necessarily means that the use of the product “is supported by strong scientific data” as being “safe and effective for its intended uses.”)

COVID‑19 vaccines are likewise administered to pregnant women despite the package inserts explicitly warning that the available data “are insufficient to inform vaccine-associated risks in pregnancy.”

Anyhow, while Kennedy has legal authority to terminate the “emergency” declaration, to get through the Senate confirmation process, he made the compromise of promising Congress to “do nothing as HHS Secretary that makes it difficult or discourages people from taking vaccines”—so terminating the emergency declaration would undoubtedly prompt calls for his removal.

In sum, I stand by my own analysis that the FDA’s approval of Spikevax is a negative outcome and a betrayal. The “MAHA” leadership promised “evidence-based” policymaking within FDA, and instead we’ve seen sleight-of-hand moves whereby HHS and its subagencies have doubled down on the mRNA shots, ensuring they not only remain on the market but will continue to be injected into children and pregnant women.

I encourage my readers to check my linked sources and verify my analysis for themselves, and feel free to share your own comments or corrections below.

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